Lilly lung cancer drug raises patient survival in trial

Eli Lilly and Co.’s experimental lung cancer medicine increased survival among patients compared with those on chemotherapy alone.

Shares in the Indianapolis-based drugmaker rose as much as 5.5 percent Tuesday morning after the announcement.

The drug, called necitumumab, met the primary endpoint of increasing overall survival in a trial involving 1,093 patients with non-small cell lung cancer whose disease had spread, the company said in a statement. Necitumumab was tested in patients with a type of tumor known as squamous cell carcinoma.

If approved, the drug would be a potent boost to Lilly’s product portfolio. It would also mean a critical new therapy for a cancer that’s proven difficult to treat with drugs such as Avastin that directly target tumors, as opposed to more broadly active chemotherapy drugs.

“This is a clear upside surprise,” Mark Schoenebaum, an analyst with ISI Group LLC, said in a note to clients.

Next year, Lilly plans to release full results from the study at a scientific meeting and anticipates submitting it to regulatory authorities. Non-small cell lung cancer accounts for about 85 percent of lung cancer, and patients with squamous cell carcinoma make up about 30 percent of those patients. Lung cancer is the leading cause of cancer death in the U.S.

“If apprved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer,” Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology, said in a prepared statement.

Lilly shares were up 4.4 percent, to $55.93 each at 10:46 a.m. The shares have gained 26 percent in the last 12 months as of Monday’s close.

Analysts had “basically zero” expectations for necitumumab, Schoenebaum said in his note. The drug failed in a prior non-squamous lung cancer trial, he said.

“We really need to see the full data to understand risk/benefit,” Schoenebaum said.

The most common adverse events seen in the study included rash. Less frequent, yet serious, side effects included blood clotting, Lilly said.

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Tomosynthesis reduces breast cancer screening recall rate

Main Category: Medical Devices / Diagnostics
Also Included In: Breast Cancer
Article Date: 01 Aug 2013 - 1:00 PDT Current ratings for:
Tomosynthesis reduces breast cancer screening recall rate

Digital tomosynthesis is an effective tool for reducing the recall rate in breast cancer screening, according to a new study published online in the journal Radiology.

Digital mammography is the gold standard for breast cancer screening, but may yield suspicious findings that turn out not to be cancer. These false-positive findings are associated with a higher recall rate, or the rate at which women are called back for additional imaging or biopsy.

Digital breast tomosynthesis has shown promise at reducing recall rates, particularly in younger women and in those with dense breast tissue. Tomosynthesis is similar to mammography in that it relies on ionizing radiation to generate images of the breast. However, unlike conventional mammography, tomosynthesis allows for three-dimensional (3-D) reconstruction of the breast tissue, which can then be viewed as sequential slices through the breast.

"Tomosynthesis increases the conspicuity of cancers by removing superimposed and overlapping tissue from the view," said Brian M. Haas, M.D., from Yale University School of Medicine in New Haven, Conn.

In the study, Dr. Haas worked with Liane E. Philpotts, M.D., also of Yale University, and other colleagues to compare screening recall rates and cancer detection rates in two groups of women: those who received conventional digital mammography alone and those who had tomosynthesis in addition to mammography.

Of the 13,158 patients who underwent screening mammography, 6,100 received tomosynthesis. The cancer detection rate was 5.7 per 1,000 in patients receiving tomosynthesis, compared with 5.2 per 1,000 in patients receiving mammography alone. The addition of tomosynthesis resulted in a 30 percent reduction in the overall recall rate, from 12.0 percent for mammography alone to 8.4 percent in the tomosynthesis group.

"All age groups and breast densities had reduced risk for recall in the tomosynthesis group," Dr. Haas said. "Women with dense breasts and those younger than age 50 particularly benefited from tomosynthesis."

Lower recall rates help reduce patient anxiety and also reduce costs from additional diagnostic examinations, Dr. Haas said.

Tomosynthesis has one significant drawback: a radiation dose approximately double that of digital mammography alone. However, Dr. Haas noted that new technology approved by the U.S. Food and Drug Administration could reduce the dose.

"The technology involves taking the tomosynthesis data and collapsing it into planar imaging that resembles 2-D mammography," he said. "It has the potential to eliminate the need for acquisition of the conventional 2-D images in addition to the tomosynthesis images."

The research group is currently in the process of comparing the cancers found on tomosynthesis with those found on mammography. They are also tracking the study group for interval cancers - those that develop in the interval between screenings - to make sure that the reduced recall rate associated with tomosynthesis is not resulting in missed cancers.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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"Comparison of Tomosynthesis Plus Digital Mammography and Digital Mammography Alone for Breast Cancer Screening." Collaborating with Drs. Haas and Philpotts were Vivek Kalra, M.D., Jaime Geisel, M.D., Madhavi Raghu, M.D., and Melissa Durand, M.D.

Radiology is edited by Herbert Y. Kressel, M.D., Harvard Medical School, Boston, Mass., and owned and published by the Radiological Society of North America, Inc.

RSNA is an association of more than 51,000 radiologists, radiation oncologists, medical physicists and related scientists promoting excellence in patient care and health care delivery through education, research and technologic innovation. The Society is based in Oak Brook, Ill. (RSNA.org)

For patient-friendly information on breast imaging, visit http://radiologyinfo.org.

Radiological Society of North America

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New drug targets discovered for aggressive breast cancer

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Research publication: The research findings described in the press release was published in the July 2nd, 2013 issue of PNAS (Proceedings of the National Academy of Sciences, USA) under the title “Protein tyrosine phosphatase UBASH3B is overexpressed in triple-negative breast cancer and promotes invasion and metastasis”.

Authors: Shuet Theng Leea,1, Min Fenga,1, Yong Weib,1, Zhimei Lia, Yuanyuan Qiaoa, Peiyong Guanc, Xia Jianga, Chew Hooi Wonga, Kelly Huynhd, Jinhua Wangd, Juntao Lic, K. Murthy Karuturic, Ern Yu Tane, Dave S. B. Hoond, Yibin Kangb, and Qiang Yua,f,g*

a. Cancer Biology and Pharmacology, Genome Institute of Singapore, Agency for Science, Technology and Research, Singapore 138672;

b. Department of Molecular Biology, Princeton University, Princeton, NJ 08544;

c. Information and Mathematical Science, Genome Institute of Singapore, Agency for Science, Technology and Research, Singapore 138672;

d. Department Molecular Oncology, John Wayne Cancer Institute, Santa Monica, CA 90404;

e. Department of General Surgery, Tan Tock Seng Hospital, Singapore 308433;

f. Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; and

g. Cancer and Stem Cell Biology, Duke-National University of Singapore Graduate Medical School, Singapore

1. These authors contributed equally to this study.

* Correspondance: Qiang Yu, yuq@gis.a-star.edu.sg. Tel: (65)6808-8127

[1] Protein tyrosine phosphatases, are a group of enzymes that remove phosphate groups from phosphorylated tyrosine residues on proteins. These enzymes are key regulatory components in signal transduction pathways and cell cycle control, and are important in the control of cell growth, proliferation, differentiation and transformation. (https://en.wikipedia.org/wiki/Protein_tyrosine_phosphatase)

Agency for Science, Technology and Research (A*STAR), Singapore

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Singapore scientists discover new drug targets for aggressive breast cancer

Main Category: Breast Cancer
Also Included In: Genetics
Article Date: 30 Jul 2013 - 2:00 PDT
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Singapore scientists discover new drug targets for aggressive breast cancer

Scientists at A*STAR's Genome Institute of Singapore (GIS) led in a study that has identified genes that are potential targets for therapeutic drugs against aggressive breast cancer. These findings were reported in the July 2013 issue of PNAS.

Out of the 1.5 million women diagnosed with breast cancer in the world annually, nearly one in seven of these is classified as triple negative. Patients with triple- negative breast cancer (TNBC) have tumours that are missing three important proteins that are found in other types of breast cancer. The absence of these three proteins make TNBC patients succumb to a higher rate of relapse following treatment and have lower overall survival rates. There is currently no effective therapy for TNBC. Using integrated genomic approaches, GIS scientists led by Dr. Qiang Yu, in collaboration with local and international institutions, set out to search for targets that can be affected by drugs. The scientists discovered that a protein tyrosine phosphatase[1], called UBASH3B, is overexpressed in one third of TNBC patients.

UBASH3B controls the activity of an important breast cancer gene. The researchers found that deleting this gene expression markedly inhibits TNBC cell invasive growth and lung metastasis in a mouse model. They also showed that patients with TNBC tumours that have high levels of UBASH3B tend to be more likely to have early recurrence and metastasis.

Lead author Dr Qiang Yu said, "The identification of target genes is always the most crucial first step towards treating a disease. It is heartening to know that UBASH3B is an important element of the pro-invasive gene network and targeting UBASH3B not only inhibits TNBC invasive growth, but also significantly reduces metastasis."

Tan Tock Seng Hospital consultant surgeon Dr Tan Ern Yu, a collaborator and co- author of the study said, "Some TNBC patients relapse soon after standard treatment while others remain free of disease for a long time. Being able to predict which patients are more likely to relapse is important since these patients may benefit from more aggressive treatments. But currently, doctors are unable to reliably do so. Further validation will show whether UBASH3B can be developed into a means of identifying these high-risk patients as well as a new form of treatment." Dr Dave Hoon, Director, Department Molecular Oncology at the John Wayne Cancer Institute, USA, and co-author said, "Recent large-scale genomic analysis of breast cancer show that triple negative breast cancer are highly heterogeneous and patients tumors can have different molecular profiles. Unlike more common breast cancers that often express oestrogen, progesterone or HER2 can be targeted by specific agents such as hormone therapy or Herceptin. TNBC is the most difficult breast cancer to treat. The finding can help us develop new approaches for targeted therapy for this highly aggressive breast cancer."

UBASH3B is expressed in high levels not only in American TNBC patients, but also in local Asian patients. This important information shows that the clinical significance of this finding is not limited to one specific ethnic group.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject.

[1] Protein tyrosine phosphatases, are a group of enzymes that remove phosphate groups from phosphorylated tyrosine residues on proteins. These enzymes are key regulatory components in signal transduction pathways and cell cycle control, and are important in the control of cell growth, proliferation, differentiation and transformation. (https://en.wikipedia.org/wiki/Protein_tyrosine_phosphatase)

The research findings described in the press release was published in the July 2nd, 2013 issue of PNAS (Proceedings of the National Academy of Sciences, USA) under the title “Protein tyrosine phosphatase UBASH3B is overexpressed in triple-negative breast cancer and promotes invasion and metastasis”.

Authors: Shuet Theng Lee, Min Feng, Yong Wei, Zhimei Li, Yuanyuan Qiao, Peiyong Guan, Xia Jiang, Chew Hooi Wong, Kelly Huynh, Jinhua Wang, Juntao Li, K. Murthy Karuturi, Ern Yu Tan, Dave S. B. Hoon, Yibin Kang, and Qiang Yu

A*STAR’s Genome Institute of Singapore

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Treatments for tuberculosis, cancer will likely improve following breakthrough in detecting DNA mutations

Main Category: Tuberculosis
Also Included In: Cancer / Oncology;  Genetics
Article Date: 30 Jul 2013 - 0:00 PDT Current ratings for:
Treatments for tuberculosis, cancer will likely improve following breakthrough in detecting DNA mutations

The slightest variation in a sequence of DNA can have profound effects. Modern genomics has shown that just one mutation can be the difference between successfully treating a disease and having it spread rampantly throughout the body.

Now, researchers have developed a new method that can look at a specific segment of DNA and pinpoint a single mutation, which could help diagnose and treat diseases such as cancer and tuberculosis. These small changes can be the root of a disease or the reason some infectious diseases resist certain antibiotics. The findings were published online in the journal Nature Chemistry.

"We've really improved on previous approaches because our solution doesn't require any complicated reactions or added enzymes, it just uses DNA," said lead author Georg Seelig, a University of Washington assistant professor of electrical engineering and of computer science and engineering. "This means that the method is robust to changes in temperature and other environmental variables, making it well-suited for diagnostic applications in low-resource settings."

DNA is a type of nucleic acid, the biological molecule that gives all living things their unique genetic signatures. In a double strand of DNA, known as a double helix, a series of base pairs bond and encode our genetic information. As genomics research has progressed, it's clear that a change of just one base pair - a sequence mutation, an insertion or a deletion - is enough to trigger major biological consequences. This could explain the onset of disease, or the reason some diseases don't respond to usual antibiotic treatment.

Take, for example, tuberculosis ?" a disease that's known to have drug-resistant strains. Its resistance to antibiotics often is due to a small number of mutations in a specific gene. If a person with tuberculosis isn't responding to treatment, it's likely because there is a mutation, Seelig said.

Now, researchers have the ability to check for that mutation preventatively.

Seelig, along with David Zhang of Rice University and Sherry Chen, a UW doctoral student in electrical engineering, designed probes that can pick out mutations in a single base pair in a target stretch of DNA. The probes allow researchers to look in much more detail for variations in long sequences - up to 200 base pairs ?" while current methods can detect mutations in stretches of up to only 20.

"In terms of specificity, our research suggests that we can do quadratically better, meaning that whatever the best level of specificity, our best will be that number squared," said Zhang, an assistant professor of bioengineering at Rice University.

The testing probes are designed to bind with a sequence of DNA that is suspected of having a mutation. The researchers do this by creating a complimentary sequence of DNA to the double-helix strand in question. Then, they allow molecules containing both sequences to mix in a test tube in salt water, where they naturally will match up to one another if the base pairs are intact. Unlike previous technologies, the probe molecule checks both strands of the target double helix for mutations rather than just one, which explains the increased specificity.

The probe is engineered to emit a fluorescent glow if there's a perfect match between it and the target. If it doesn't illuminate, that means the strands didn't match and there was in fact a mutation in the target strand of DNA.

The researchers have filed a patent on the technology and are working with the UW Center for Commercialization. They hope to integrate it into a paper-based diagnostic test for diseases that could be used in parts of the world with few medical resources.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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The research was funded by the National Institutes of Health, the National Science Foundation and the Department of Defense's Advanced Research Projects Agency.

University of Washington

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Discovery of new target for breast cancer drugs

Main Category: Breast Cancer
Article Date: 24 Jul 2013 - 0:00 PDT
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Discovery of new target for breast cancer drugs

Scientists have identified higher levels of a receptor protein found on the surface of human breast tumour cells that may serve as a new drug target for the treatment of breast cancer. The results, which are published in EMBO Molecular Medicine, show that elevated levels of the protein Ret, which is short for "Rearranged during transfection", are associated with a lower likelihood of survival for breast cancer patients in the years following surgery to remove tumours and cancerous tissue.

"Our findings suggest that Ret kinase might be an attractive and novel alternative therapeutic target in selected groups of breast cancer patients," remarked Nancy Hynes, Professor at the Friedrich Miescher Institute for Biomedical Re-search and the University of Basel, Switzerland. "Initial experiments in mice that serve as model organisms for the study of breast cancer have revealed that specific inhibitors significantly block the spread of cancer and decrease the number of metastatic tumours found in the lungs."

The scientists examined tumour tissue microarrays of more than 100 breast cancer patients who had undergone surgery to remove their tumours. Antibodies were used to detect the levels of Ret in the samples. In other experiments, four different cancer cell lines were used and injected into mice to study the effects of Ret inhibitors on the progress and spread of the cancer.

"Our findings demonstrate that blocking Ret kinase not only decreases the growth of tumours but also impacts the potential of the cancer to spread throughout the body," Hynes said.

Targeting receptor tyrosine kinase enzymes with antibodies or small molecular inhibitors is a clinically validated approach for cancer therapy. However, only a subset of patients are eligible for these types of treatments which makes it essential to discover additional inhibitors that could be useful in breast cancer therapy.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Dr. Albana Gattelli was supported by grant KG101234 from Susan G. Komen for the Cure®

"Ret inhibition decreases growth and metastatic potential of estrogen receptor positive breast cancer cells", Albana Gattelli, Ivan Nalvarte, Anne Boulay, Tim C. Roloff, Martin Schreiber, Neil Carragher, Kenneth K. Macleod, Michaela Schlederer, Susanne Lienhard, Lukas Kenner, Maria I. Torres-Arzayus and Nancy E. Hynes, doi: 10.1002/emmm.201302625

European Molecular Biology Organization

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Female cancer patients unhappy with insufficient fertility support

Main Category: Fertility
Also Included In: Women's Health / Gynecology;  Cancer / Oncology;  Pediatrics / Children's Health
Article Date: 24 Jul 2013 - 1:00 PDT Current ratings for:
Female cancer patients unhappy with insufficient fertility support

Young female cancer patients are unhappy about the way fertility preservation options are discussed with them by doctors before starting cancer treatment, according to a new study by researchers from the University of Sheffield and The Children's Hospital, Sheffield.

The pioneering study discovered that only 40 per cent of young female cancer patients were happy with the way their doctors discussed the options they had to preserve fertility, before undergoing chemotherapy or radiotherapy which can have a harmful effect on a patient's fertility.

Researchers conducted the ground breaking study by asking 290 young cancer patients attending support group conferences organised by the Teenager Cancer Trust in 2004 and 2011.

Their views were collected anonymously using 'Who wants to be a millionaire?' style handsets to answer questions projected onto a big screen. All questions were answered by both male and female cancer patients aged between 13 and 22 years old who had been treated for a variety of cancers in UK hospitals.

Steph Hayter, 23, from Hampshire was diagnosed with Acute Lymphoblastic Leukemia age 19. She said: "Having a family has always been important to me so when the doctors told me the treatment would damage my fertility I was devastated.

"I knew I needed to start treatment quickly but it would have been nice to be given some choice in the matter or at least the chance to talk to a fertility expert.

"Neither was offered and I felt like I had lost all control. It was as if health professionals didn't think that it was a big deal because I was just a teenager; that made me feel silly for being so upset".

The findings, published in Pediatric Blood and Cancer, revealed that in 2004 just 38 per cent of young female patients recalled their doctor talking to them about fertility preservation opinions, such as egg freezing, before starting treatment.

In 2011 this number grew significantly to 69 per cent; however a staggering 50 per cent of patients were unhappy about the discussion - effectively the same as in 2004.

Dr Allan Pacey, a fertility expert from the University of Sheffield's Department of Human Metabolism, said: "Fertility issues are important for cancer patients because some chemotherapy and radiotherapy treatments can lead to infertility.

"Whilst we have been banking sperm for cancer patients for over 30 years, we are only just able to start offering fertility preservation for females by banking eggs. However, unfortunately this is more complex to perform and is not a realistic option if cancer treatment cannot be delayed."

Researchers also discovered that the majority of young male cancer patients (64 per cent) were broadly happy with what was discussed with them with roughly the same percentage recalling their doctors talking through fertility issues with them before their cancer treatment started.

Dr Dan Yeomanson, Consultant Pediatric Oncologist for Sheffield Children's NHS Foundation Trust, said: "This study highlights the need to discuss fertility issues with young patients, especially females, before treatment begins even if there are no options available for fertility preservation.

"Given the wealth of information that needs to be given before treatment begins, it is easy to see why fertility issues are sometimes not handled as well as they could be. While all oncologists aim to provide the best possible care to teenagers and young adults, this study has highlighted some important gaps which are clearly of key significance to patients."

The researchers suggest that collecting data in this way serves a bellwether providing an overview of practice across the UK and calls for a rethink of how fertility issues are discussed with young people diagnosed with cancer, both in terms of timing of discussions and their content.

The authors intend to conduct the survey again in 2018 with the same age group to see if the situation has improved.

Simon Davies, Chief Executive of Teenage Cancer Trust said: "Young people have a fundamental right to be made aware of the fertility problems cancer treatments can cause.

"Fertility is something many young people won't even have considered yet and it is incredibly important that these issues are discussed and that all options are understood. Health professionals have a duty to give clear information about all the long term effects of treatments and hopefully this work will help keep this front of mind for those working with young people with cancer."

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Teenage Cancer Trust: Around seven young people aged between 13 and 24 are diagnosed with cancer every day in the UK. They need expert treatment and support from the moment they hear the word ‘cancer.’ Teenage Cancer Trust are the only charity dedicated to making this happen.

University of Sheffield

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Family cancer risk may be wider than relative's specific type

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Academic Journal
Main Category: Cancer / Oncology
Also Included In: Genetics
Article Date: 25 Jul 2013 - 0:00 PDT Current ratings for:
Family cancer risk may be wider than relative's specific type

People with a family history of cancer have an increased risk of developing not only the same cancer, but also a different form of the disease, according to a study published in the journal Annals of Oncology.

Researchers from Italy, Switzerland and France analyzed 12,000 cases of cancer occurring in 13 different sites of the body between 1991 and 2009. These were compared with 11,000 people without cancer.

Information on any cancer in the family, particularly in first-degree relatives (directly related), was collected in both groups. Other details collected included:

Age of diagnosisBody shapeLifestyle habits, including smoking and alcohol intakeSociodemographic characteristicsDietPersonal medical historyUse of oral contraceptives and hormone replacement therapy

The researchers say that the results of the study confirmed links already known, like the increased risk of developing the same cancer as a close relative.

But the researchers also say that the most interesting results of the study revealed that family members who had relatives with a specific form of cancer were also at higher risk of developing a different form of the disease.

The results revealed:

Family members who had a first-degree relative with cancer of the larynx were 3.3 times more likely to develop oral and pharyngeal cancerFamily members who had first-degree relative with with oral or pharyngeal cancer were 4 times more likely to develop oesophageal cancer Female family members who had a first-degree relative who suffered from breast cancer were 2.3 times more likely to develop ovarian cancerFamily members who had a first-degree relative who had bladder cancer were 3.4 times more likely to develop prostate cancer.

Dr. Eva Negri, head of the Laboratory of Epidemiologic Methods at the Mario Negri Institute for Pharmacological Research, Milan, Italy, says of the results:

"Besides confirming and quantifying the well-known excess risks of people developing the same cancer as their first-degree relative, we have identified increased risks for developing a number of different cancers."

"We have also found that if a patient was diagnosed with certain cancers when they were younger than 60, the risks of a discordant cancer developing in family members were greater."

Dr. Negri adds that because this study analyzed a large number of people, this revealed links in some rare forms of cancer.

She adds:

"For some rare cancers, a weak association with a different, common cancer can, on a population level, reveal a higher attributable risk than a strong association with the risk of developing the same cancer. For example, for ovarian cancer we found that a family history of breast cancer had a stronger attributable risk of ovarian cancer than the far rarer, albeit stronger, association with family history of ovarian cancer."

The researchers say that some of the results of this study could be due to shared habits among family members, such as smoking or drinking. But she adds that the results show there are many cancer syndromes appearing among close relatives that show how the presence of genetic factors could influence the development of cancer in multiple sites of the body.

Dr Negri says:

"These findings may help researchers and clinicians to focus on the identification of additional genetic causes of selected cancers and on optimizing screening and diagnosis, particularly in people with a family history of cancer at a young age."

Written by Honor Whiteman

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Family history of cancer and the risk of cancer: a network of case–control studies, published in the journal Annals of Oncology, July 25, 2013

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Hope for women with hormone resistant breast cancer

Main Category: Breast Cancer
Article Date: 24 Jul 2013 - 1:00 PDT
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Hope for women with hormone resistant breast cancer

A new finding provides fresh hope for the millions worldwide with oestrogen receptor positive breast cancer. Australian scientists have shown that a specific change, which occurs when tumours become resistant to anti-oestrogen therapy, might make the cancers susceptible to treatment with chemotherapy drugs.

Seventy percent of breast cancer patients have oestrogen receptor positive cancer, and most patients respond well to anti-oestrogen therapies, for a few years at least. Within 15 years, however, 50% will relapse and eventually die from the disease.

Dr Andrew Stone, Professor Susan Clark and Professor Liz Musgrove, from Sydney's Garvan Institute of Medical Research, in collaboration with scientists from Cardiff University, have demonstrated that the BCL-2 gene becomes epigenetically 'silenced' in resistant tumours. This process is potentially detectable in the blood, providing a diagnostic marker. Their findings are now online in the international journal Molecular Cancer Therapetics.

Epigenetics involves biochemical changes in our cells that directly impact our DNA, making some genes active, while silencing others. Epigenetic events include DNA methylation, when a methyl group - one carbon atom and three hydrogen atoms - attaches to a gene, determining the extent to which it is 'switched on' or 'switched off'.

Dr Stone and colleagues have shown in human disease, as well as in several different cell models, that BCL-2 is silenced in oestrogen-resistant tumours by DNA methylation.

"The main purpose of the BCL-2 gene is to keep cells alive, so when the gene is silenced, cells become more vulnerable to chemotherapy," said Dr Stone.

"The next step will be to test our findings in clinical studies. We propose that if the BCL-2 gene is silenced, patients with oestrogen receptor positive breast cancer would benefit from combination therapy. In other words, tamoxifen could be used in combination with a chemotherapy drug, to kill off vulnerable tumour cells."

"Excitingly, this is something that could be implemented into clinical practice very quickly, since the technology now exists to profile methylation of BCL-2 in all patients - both oestrogen responsive and oestrogen resistant patients. In addition, the proposed chemotherapy drugs are already in use."

"If such a test were to be implemented, we believe it could help patients much earlier - hopefully shutting down tumours at an early stage."

Further information

Oestrogen is a hormone that drives reproduction, menstruation and menopause in women. Oestrogens are also present in men, but to a lesser degree.

Many breast cells have oestrogen receptors on their surface. When one of those cells becomes malignant and starts to multiply, an oestrogen receptor positive tumour develops. Typically these tumours are fed by high concentrations of oestrogen in the bloodstream, triggered by circumstances such as late first pregnancy, not breastfeeding, or too much body fat.

At present, there are three different therapeutic strategies for oestrogen receptor positive breast cancer: blocking the body's production of oestrogen with aromatase inhibitors; preventing oestrogen from 'binding' to the oestrogen receptor by 'binding' the drug tamoxifen instead; and destroying the oestrogen receptor completely.

Tamoxifen, now the gold standard treatment, became available in the 1970s.

Endocrine therapies, including tamoxifen, are inexpensive and well-tolerated, and are usually given for 5 years. Over time, however, many tumours become resistant to therapy. When one form of treatment starts to fail, a second is put in place, and then a third. Response times shrink, and tumours start to spread to other parts of the body, usually the brain, lungs, liver and bone.

At this late stage, there is little that can be done to help someone, as the brain, lungs, liver and bone are parts of the body that cannot be biopsied or operated upon.

While breast cancer predominantly targets women, with 1 in 9 women being affected, it also affects 1 in 100,000 men, some of whom have oestrogen responsive cancers.

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More people beating skin cancer - UK report

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Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology
Article Date: 25 Jul 2013 - 3:00 PDT Current ratings for:
More people beating skin cancer - UK report

Cancer Research UK says more and more people are surviving malignant melanoma, the most dangerous form of skin cancer. Their latest statistics, published online this week, reveal that more than 8 in 10 people diagnosed with malignant melanoma will now survive the disease. Forty years ago, the survival rate was only around 5 in 10.

The charity says the improvement is most likely due to better treatments and earlier diagnosis, and also because people are more aware of the symptoms.

The report shows that 80% of men and 90% of women live more than ten years after being diagnosed with malignant melanoma compared with only 38% of men and 58% of women in the early 70s.

In the UK every day, around 35 people discover they have malignant melanoma, totalling nearly 13,000 new cases a year.

Professor Richard Marais, director of the Cancer Research UK Paterson Institute for Cancer Research at the University of Manchester, says in a statement that much of the huge progress in the fight against skin cancer is down to the generosity of supporters who have funded research that increases understanding of the disease and finds new ways to beat it. He says:

"More and more people are beating skin cancer but we can't stop there and we need to develop better treatments for the 2 out of 10 where things don't look so good."

There are now some very effective new drugs, such as vemurafenib, which was developed with the help of research funded by the charity.

"Although these drugs do not cure skin cancers, they can give patients with advanced melanoma valuable extra months and show the progress we are making," Marais adds.

Skin cancer is one of the fastest rising cancers in the UK, which the charity says is likely due to more Britons sunbathing than before, and the rise of cheap package holidays in earlier decades.

Treatment for skin cancer is more likely to succeed the earlier the disease is detected.

The key to early diagnosis, says Dr. Harpal Kumar, Cancer Research UK's chief executive, is to get to know your skin, notice anything unusual, such as a change to a mole or a blemish that hasn't healed after a few weeks, and see your doctor.

One area that has seen enormous progress in research on melanoma is genetics.

Melanoma is really an umbrella term for the most virulent types of skin cancer. It is a highly complex disease from a genetic point of view: melanoma tumors have more mutations per cell than any other type of cancer.

An example of how scientists are investigating the genetics of melanoma is following up on the knowledge that ultraviolet light from the sun damages DNA, which increases the chance of normal skin cells becoming cancerous.

Scientists can use the information gained from studying how UV light damages DNA to develop new treatments.

One study by Cancer Research UK, which is looking at genetic changes that cause skin cancer, is collecting samples of tissue and blood from people diagnosed with melanoma and non-melanoma skin cancer of the head and neck.

The researchers are examining the samples to find genetic changes that may be responsible for the cancer and to discover how the immune system reacts to the cancer.

In another piece of research, scientists have discovered that people who have inherited a faulty gene called p16 or CDKN2A have a higher risk for developing melanoma than people who do not have the faulty gene.

They are now running a long-term study to find out how genes and environment affect risk of developing melanoma.

Fortunately thanks to new tools like DNA sequencing, scientists are able to sort through huge volumes of data to decode each melanoma tumor's genetic "fingerprint."

For example, Prof. Marais was the lead author on another Cancer Research UK study that recently revealed how DNA sequencing helped the team find possible new treatment targets for a rare form of cancer known as mucosal melanoma.

The list of known gene flaws that cause melanoma is growing. This opens doors to new drugs that can target the effect of these faulty genes by blocking the signalling pathways that cause cells to malfunction and make tumors grow and spread.

There are currently about 100 new drugs being developed to treat melanoma, and new combinations of drugs show promise as treatments that block these tumor-causing signalling pathways.

In a recent journal report, Brian Nickoloff, director of a dermatology and cutaneous sciences division at Michigan State University's College of Human Medicine in the US, and colleagues outline recent advances that have put melanoma at the forefront of cancer research.

Nickoloff says he has been working in this field for 30 years, and "now is by any measure the most exciting time for melanoma research."

"In the past melanoma outsmarted us, but now we're starting to outsmart melanoma," he adds.

For more information on the latest melanoma research see the Cancer Research UK web page.

Written by Catharine Paddock PhD
Copyright: Medical News Today
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New approach for studying deadly brain cancer

Main Category: Cancer / Oncology
Also Included In: Neurology / Neuroscience
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
New approach for studying deadly brain cancer

Human glioblastoma multiforme, one of the most common, aggressive and deadly forms of brain cancer, is notoriously difficult to study. Scientists have traditionally studied cancer cells in petri dishes, which have none of the properties of the brain tissues in which these cancers grow, or in expensive animal models.

Now a team of engineers has developed a three-dimensional hydrogel that more closely mimics conditions in the brain. In a paper in the journal Biomaterials, the researchers describe the new material and their approach, which allows them to selectively tune up or down the malignancy of the cancer cells they study.

The new hydrogel is more versatile than other 3-D gels used for growing glioma (brain cancer) cells in part because it allows researchers to change individual parameters - the gel's stiffness, for example, or the presence of molecular signals that can influence cancer growth - while minimally altering its other characteristics, such as porosity.

Being able to adjust these traits individually will help researchers tease out important features associated with the initial growth of a tumor as well as its response to clinical therapies, said University of Illinois chemical and biomolecular engineering professor Brendan Harley, who led the study with postdoctoral researcher Sara Pedron and undergraduate student Eftalda Becka. Harley is an affiliate of the Institute for Genomic Biology at Illinois.

The researchers found that they could increase or decrease the malignancy of glioma cells in their hydrogel simply by adding hyaluronic acid, a naturally occurring carbohydrate found in many tissues, especially the brain.

Hyaluronic acid (HA) is a key component of the extracellular matrix that provides structural and chemical support to cells throughout the body. HA contributes to cell proliferation and cell migration, and local changes in HA levels have been implicated in tumor growth.

"Hyaluronic acid is one of the major building blocks in the brain," Harley said. "The structure of a newly forming brain tumor has some of this HA within it, but there's also a lot of the HA in the brain surrounding the tumor."

Previous studies have used hydrogels made out of nothing but hyaluronic acid to study gliomas, Harley said. "The problem there is that HA is structurally not very strong." It also is difficult to adjust the amount of HA that the glioma cells are exposed to if their environment is 100 percent HA, he said.

In the new study, Pedron observed how glioma cells behaved in two different hydrogels - one based on methacrylated gelatin (GelMA) and the other using a more conventional polyethylene glycol (PEG) biomaterial. These two materials vary in one important trait: GelMA is a naturally derived material that contains adhesive sites that allow cells to latch onto it; synthetic PEG does not.

"The purpose of having these two systems was to isolate the effect of HA on glioma cells," Pedron said. If changing HA levels produced different effects in different gels, that would indicate that the gels were contributing to those effects, she said.

Instead, Harley and Pedron found that additions of HA to glioma cells had "very similar" effects in both materials. Adding too little or too much HA led to reduced malignancy, while incorporating just enough HA led to significantly enhanced malignancy. This held true for multiple types of glioblastoma multiforme cells. This suggests that "it's the HA itself that is likely the cause for this malignant change," Harley said.

"If you have a material that allows you to selectively tune up or down malignancy, that will allow you to ask lots of questions about treatment methods for more malignant or less malignant forms of glioma. It also will allow scientists to try to get a response that's closer to what you see in the body," he said.

"If you talk to pathologists, they'll say a biomaterial will never allow you to grow a full brain tumor, which is probably true," Harley said. "But it's realistic to think that a well-designed biomaterial will allow you to study aspects of glioma growth and treatment in a way that's much richer than simply looking in a petri dish and much more accessible than trying to study tumor development within the brain itself."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject.

The U. of I. department of chemical and biomolecular engineering, the Institute for Genomic Biology and the Campus Research Board supported this research.

University of Illinois at Urbana-Champaign

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Physician bonuses help drive increases in laparoscopic colon cancer surgery with minimal benefits for patients, says McMaster study

Main Category: Colorectal Cancer
Article Date: 24 Jul 2013 - 2:00 PDT Current ratings for:
Physician bonuses help drive increases in laparoscopic colon cancer surgery with minimal benefits for patients, says McMaster study

Financial incentives for Ontario surgeons are likely a key factor driving greater use of laparoscopic colon cancer surgery, says a study led by a McMaster University surgeon.

The research, published online by the Annals of Surgical Oncology, found that between 2002 and 2009 there was an increase in laparoscopic versus traditional open techniques for colon and rectal cancer surgery. These increases were associated with only minimal decreases in how long patients stayed in hospital after surgery and no changes in the survival of patients.

The authors point out that in October 2005, the Ontario physician billing schedule was altered, providing surgeons with a 25% premium if laparoscopic rather than open techniques were used for colon cancer. Most of the incentives went to surgeons already enthusiastic about laparoscopic approaches.

"Our paper highlights two important issues," said principal investigator Dr. Marko Simunovic, an associate professor of surgery of McMaster's Michael G. DeGroote School of Medicine.

"First, in our publicly funded health care system we need to critically review the advantages and disadvantages of new expensive technologies or treatments before they're widely introduced into the province. Second, Ontario physicians provide high quality care to the best of their abilities - one should question the logic of financial incentives."

Simunovic added: "A 25% bonus for laparoscopic surgery sends a strong signal to surgeons that they should provide this service, even though the available evidence to date does not demonstrate superiority for laparoscopic versus open techniques."

The more expensive laparoscopic surgery usually results in a smaller visible scar and a slightly shorter hospital length of stay.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our colorectal cancer section for the latest news on this subject.

The research was funded by Canadian Institutes for Health Research.

Annals of Surgical Oncology

DOI: 10.1245/s10434-013-3123-2

McMaster University

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Targeting HER1 receptor for peptide cancer vaccine, therapeutic agents

Main Category: Breast Cancer
Also Included In: Lung Cancer;  Colorectal Cancer;  Immune System / Vaccines
Article Date: 26 Jul 2013 - 1:00 PDT
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Targeting HER1 receptor for peptide cancer vaccine, therapeutic agents

Small proteins called peptides that consist of 10 to 50 amino acids are being studied as cancer vaccines and as possibly safer, more effective and less costly alternatives to the monoclonal-antibody-based drugs and small-molecule inhibitors now used to treat many malignancies.

Researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James) have identified two regions on the HER1/EGFR receptor, a protein important for cancer-cell growth and metastasis, and for poor patient survival, as targets for peptide agents.

The receptor molecules extend bristle-like from the surface of cancer cells in abnormally high numbers. It is activated by growth factors in the blood and released by other cells in the tumor, stimulating tumor growth.

"Our findings could lead to novel peptide vaccines and mimetic inhibitors that target HER1 in tumors of the breast, lung, colon and head and neck, and that overcome many of the significant shortcomings of antibody-based drugs such as cetuximab," says principal investigator Pravin Kaumaya, PhD, director of the division of vaccine development at the OSUCCC - James.

"Such peptide agents might enable the development of combination immunotherapies using either HER2 vaccines or VEGF therapy that avoid the mechanisms of resistance or secondary treatment failures sometimes experienced with antibody treatment," says Kaumaya, who is also professor of obstetrics and gynecology, of molecular and cellular biochemistry, and of microbiology at Ohio State.

The study is published in the Journal of Immunology.

HER1 is a member of the epithelial growth factor (EGF) family of cell-surface receptors, which includes the HER2 receptor. These receptors play a central role in the development of a variety of human cancers, including certain breast cancers, lung cancer, colorectal and head and neck cancers.

Kaumaya and his colleagues evaluated three sequences of peptides to determine which were the most specific and immunogenic (i.e., raised the strongest immune response in test animals), and therefore were best suited for use as vaccines or therapeutics. The three sequences, or epitopes, were based on the site of contact between HER1 and the growth factor that normally binds with it, epithelial growth factor (EGF).

Key technical findings included:

Two of the sequences (382-410 and 418-435) were identified as best for use as cancer therapy or a cancer vaccine; The 382-410 epitope overlaps the binding site of cetuximab, an antibody agent that inhibits HER1 binding; however, the 418-435 epitope significantly inhibited tumor growth in transplantable breast and lung cancer models; The vaccine constructs were highly immunogenic and established immunological memory in a rabbit model.

"Overall," Kaumaya says, "our results show that the 418-435 epitope has great potential for use as a vaccine or treatment option for HER1-expressing cancers."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject.

Funding from the NIH/National Cancer Institute (grant CA084356) supported this research.

Other Ohio State researchers involved in this study were Kevin Chu Foy, Ruthie M. Wygle, Megan J. Miller, Jay P. Overholser and Tanios Bekaii-Saab. Ohio State University Medical Center Please use one of the following formats to cite this article in your essay, paper or report:

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Factors that link HPV and oesophageal cancer

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Ear, Nose and Throat;  Cancer / Oncology
Article Date: 26 Jul 2013 - 1:00 PDT Current ratings for:
Factors that link HPV and oesophageal cancer

The human papillomavirus (HPV) triples the risk of people developing yet another cancer, oesophageal squamous cell carcinoma (OSCC), according to research led by University of New South Wales (UNSW) academics.

In addition to causing cervical, anal and genital cancers, HPV has more recently been found to cause some head and neck cancers.

"One of the main issues is this form of oesophageal cancer is usually diagnosed quite late and so has a very high mortality," says the first author of the paper, Dr Surabhi Liyanage, a PhD candidate with the School of Public Health and Community Medicine, UNSW Medicine.

OSCC is the most common of two types of oesophageal cancer. While it is rare in Australia, it is the sixth highest cause of cancer-related deaths world-wide. It is particularly prevalent in China, South Africa and Iran among men in their mid-70s to 80s. It is unknown why the prevalence is so high in those countries, but it is thought to be linked to dietary, lifestyle and environmental factors.

"HPV is another factor which we can add to a long list of causes of OSCC," says Dr Liyanage. "Smoking and alcohol are the main causes, as well as the consumption of extremely hot liquids, lots of red meat and possibly environmental toxins in the diet."

The findings, published today in PLOS ONE, could have implications for vaccination programs around the world.

"This is an important new finding which resolves a previous uncertainty," says senior author, UNSW Professor Raina MacIntyre.

"Given that the most common two cervical cancer-causing HPVs are now preventable by early vaccination, this may be significant in countries where OSCC is frequently found," says Professor MacIntyre, head of the School of Public Health and Community Medicine.

"In China, it is one of the leading causes of cancer death, so Chinese health authorities could consider this in any deliberations they are having about potential benefits of HPV vaccination in their population," she says.

Currently, HPV vaccinations are used most commonly in young people in developed countries to prevent cervical cancer.

"Time will tell whether our universal HPV vaccination program has any additional benefit in prevention of cancers other than cervical cancer," says Professor MacIntyre.

"The findings from this meta-analysis should rekindle the debate about looking at the potential causative role for oncogenic HPVs in oesophageal cancer," says another of the authors and a leader in HPV vaccination, Dr Suzanne Garland, from the Royal Women's Hospital in Melbourne.

"These findings will assist the expert group, International Agency for Research on Cancer (IARC), which examines evidence for potential oncogenic roles in various cancers," says Dr Garland. "We look forward to a potential review by IARC of the meta-analysis and other studies in establishing a role or not for HPV."

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Children with cancer receiving home care at greater risk for central line infections

Main Category: Cancer / Oncology
Also Included In: Pediatrics / Children's Health;  Infectious Diseases / Bacteria / Viruses;  Caregivers / Homecare
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Children with cancer receiving home care at greater risk for central line infections

Pediatric cancer patients whose central lines are used to treat them at home develop three times as many dangerous bloodstream infections from their devices than their hospitalized counterparts, according to the results of a new Johns Hopkins Children's Center study.

Findings of the research, reported online in the journal Pediatric Blood & Cancer, provide valuable insight into the safety of central line uses outside the hospital and underscore the need to carefully evaluate the benefits and risk of sending a child home with one, the investigators say.

Furthermore, the results highlight the importance of better understanding the risks of at-home central line care and designing infection-prevention strategies.

"The health care system as a whole has spent a lot of time and energy studying hospital acquired bloodstream infections and has made serious progress in reducing their burden as a result. It is now time that we did the same for central line infections acquired outside the hospital," says lead investigator Michael Rinke, M.D., Ph.D., a pediatrician and safety expert at Johns Hopkins Children's Center.

"Some children with central lines do well at home and will have no complications, but based on our findings, we feel clinicians should remain vigilant when sending home certain special categories of pediatric cancer patients who face higher infection risk by virtue of their condition, device type or a combination of the two," Rinke adds.

A central line, or a central venous catheter, is a tube placed into a major blood vessel in the neck, chest or groin to serve as a temporary portal for injected medications and fluids. Inserted incorrectly, mishandled or simply handled too frequently, the central line can become a gateway for bacteria into the bloodstream, which can lead to serious complications, including organ damage and even death. Beyond the human toll, each infection can cost up to $45,000 in additional treatment, research has shown.

The study followed 319 children with cancer treated at Johns Hopkins who had central lines and received treatment between 2009 and 2010. Nearly all children were treated in the hospital at some point and sent home thereafter. In hospitalized children, there were 19 bloodstream infections over 8,682 days spent with a central line, compared with 55 such episodes over 84,705 days in the at-home group - or nearly three times the number of infections seen in hospitalized children.

"We have a wealth of data on the safety of central lines among hospitalized children and have designed solid protocols to reduce the risk of invasive bloodstream infections among such children, but we don't really have a good understanding of central line safety once the child leaves the hospital," says senior investigator Marlene Miller, M.D., M.Sc., director of Pediatric Quality and Safety at Johns Hopkins Children's Center. "Our study sheds some light on that issue."

Rinke and colleagues say several potent risk factors for infection emerged among children treated at home. Patients with recently placed central lines, those with recent bone marrow transplants and those with past infections were at highest risk, the study found. In addition, children with a type of central line tunneled under the skin that remains open, rather than implanted, in the chest, were found to be at greatest risk for infection. But because this type of central line is handled more frequently, it remains unclear whether the increased risk stems from the frequency of access or from the anatomic positioning of the device itself, the researchers say.

The investigators emphasize that central line care, even in the hospital, requires experienced clinicians and trained family members familiar with infection-prevention protocols - a level of care that is not always taught to families before the patient is discharged home.

"Teaching family members the 101 of central line cleaning and care can go a long way toward reducing infection risk and is something that should become part of the formal discharge routine in each and every hospital," Rinke says.

Such instructions, he adds, have been part of the Johns Hopkins Children's Center discharge protocol since 2010.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject.

The research was funded by the National Institutes of Health under grant number 5KL2RR025006 and by the Agency for Healthcare Research and Quality under grant number K08HS021282, with additional funding from the Children's Hospital Association.

Other Hopkins investigators on the study included Aaron Milstone, M.D., M.H.S.; Allen Chen, M.D., Ph.D., M.H.S.; Kara Mirski, B.A.; Elizabeth Colantuoni, Ph.D.; Miriana Pehar, R.N.; and Cynthia Herpst, R.N.

Johns Hopkins Medicine

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Potential for new, less invasive ways to detect and treat bladder cancer

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject.

Fisher and Dasgupta collaborated on this study with Devanand Sarkar, M.B.B.S., Ph.D., Harrison Research Scholar and member of the Cancer Molecular Genetics program at VCU Massey, associate professor in the Department of Human and Molecular Genetics at VCU School of Medicine and associate scientific director of cancer therapeutics at VIMM; Shilpa Bhatia, Ph.D., postdoctoral research scientist in the VCU Department of Human and Molecular Genetics; Swadesh K. Das, Ph.D., instructor in the VCU Department of Human and Molecular Genetics and VIMM member; Luni Emdad, M.B.B.S., Ph.D., member of the Cancer Molecular Genetics program at VCU Massey, assistant professor in the VCU Department of Human and Molecular Genetics and VIMM member; Aleksandar Janjic, research technician in the VCU Department of Human and Molecular Genetics; Mitchell E. Menezes, Ph.D., postdoctoral research scientist in the VCU Department of Human and Molecular Genetics; Nitai D. Mukhopadhyay, Ph.D., assistant professor in the Department of Biostatistics at VCU School of Medicine; and Chunbo Shao, M.D., Ph.D., postdoctoral research scientist in the Department of Otolaryngology at Johns Hopkins University in Baltimore, MD.

This study was supported by National Institutes of Health grant CA097318, the National Foundation for Cancer Research, the Elisa U Pardee Foundation and, in part, by VCU Massey Cancer Center's NIH-NCI Cancer Center Support Grant P30 CA016059.

"Novel Role of MDA-9/Syntenin in Regulating Urothelial Cell Proliferation by Modulating EGFR Signaling" Santanu Dasgupta, Michelle Menezes, Swadesh K Das3, Luni Emdad, Aleksandar Janjic, Shilpa Bhatia, Nitai Mukhopadhyay, Chunbo Shao, Devanand Sarkar, and Paul B. Fisher, Published OnlineFirst July 19, 2013; doi: 10.1158/1078-0432.CCR-13-0585

Virginia Commonwealth University

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Inovio Pharmaceuticals' potent hTERT DNA cancer vaccine shows potential to reduce tumors and prevent tumor recurrence

Main Category: Cancer / Oncology
Also Included In: Immune System / Vaccines
Article Date: 24 Jul 2013 - 4:00 PDT Current ratings for:
Inovio Pharmaceuticals' potent hTERT DNA cancer vaccine shows potential to reduce tumors and prevent tumor recurrence

Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that in a preclinical study with two animal models, Inovio's hTERT (human telomerase reverse transcriptase) DNA cancer vaccine administered with Inovio's CELLECTRA® adaptive electroporation delivery technology generated robust and broad immune responses, broke the immune system's tolerance to its self-antigens, induced T-cells with a tumor-killing function, and increased the rate of survival. Because high levels of hTERT expression are found in 85% of human cancers, regardless of type, Inovio's cancer candidate holds the potential to perform as a "universal" cancer therapeutic based on these early but unprecedented results. Following this strong preclinical data, Inovio plans to advance its synthetic hTERT cancer vaccine, INO-1400, into clinical trials in 2014.

These results appear in the American Association for Cancer Research journal, Cancer Immunology Research, in a paper entitled: "Highly optimized DNA vaccine targeting human telomerase reverse transcriptase stimulates potent antitumor immunity," authored by Inovio researchers and collaborators.

Dr. J. Joseph Kim, Inovio's president and CEO, said: "Inovio has demonstrated in multiple published human studies that our synthetically optimized DNA vaccines delivered with our CELLECTRA delivery system generate best-in-class T-cell immune responses. Here we show that in monkeys our hTERT DNA cancer vaccine generated T-cell immune responses more than 18-fold higher than the previous best results of a peer's hTERT therapeutic vaccine, which was also a DNA vaccine delivered with electroporation. We are particularly enthusiastic about our vaccine's potential use as a "universal" cancer therapeutic, given that hTERT is present in the vast majority of cancer types yet rare in normal cells. We plan to develop INO-1400 to treat breast and lung cancers and then expand to other cancer types. This hTERT therapy adds to a growing Inovio oncology franchise spearheaded by our phase II candidate, VGX-3100 for treating HPV-related pre-cancers and cancers, as well as our near clinical INO-5150 to treat prostate cancer."

Data from both murine and human systems over the past 10 years have demonstrated that TERT-specific cytotoxic T-lymphocytes (CTLs) can recognize and kill TERT-expressing tumor cells in multiple types of cancers. In fact, previous research has shown that breast cancer patients who mounted an hTERT-specific CTL response exhibited significantly longer rates of survival. However, the immune system's tolerance of cancer cells and their associated antigens produced in the body, which exists to prevent autoimmune diseases, often restricts the immune system's antitumor response. A major challenge for cancer vaccine development has been to develop approaches to break this tolerance in tumor-bearing hosts. Recent advances in our understanding of antigen presentation and tolerance have led Inovio to create this synthetic DNA vaccine targeting the hTERT antigen.

Inovio constructed a highly optimized synthetic DNA vaccine with multiple proprietary features. Using its novel consensus design approach, two differentiating mutations were incorporated in the vaccine sequence to assist T-cells to more readily recognize self-made hTERT antigens and kill the cancer cells to which these antigens are attached (i.e. break tolerance). In addition, Inovio's use of a full length antigen DNA sequence encompasses multiple epitopes (parts of an antigen that are recognized by the immune system), potentially helping the immune system by providing multiple opportunities to overcome a tumor's ability to evade recognition by T-cells.

In the study, Inovio researchers confirmed that vaccination with Inovio's DNA vaccine delivered by adaptive electroporation induced hTERT-specific cellular immune responses with significantly greater T-cell magnitude compared to prior non-Inovio studies. Over four vaccinations there was a significant dose response, showing the value of multiple vaccinations to increase the immune response and highlighting the limitation of alternative technologies that are not amenable to multiple vaccinations such as viral vectors. Vaccination elicited multiple epitopes not only in mice, but also in monkeys, indicating a broad vaccine-induced immune response.

Study results showed that mice vaccinated with Inovio's DNA cancer vaccine and then challenged with a cancerous tumor experienced delayed tumor growth and longer overall survival compared with non-vaccinated mice. Mice first challenged with a tumor and then treated with the hTERT DNA vaccine displayed killing activity of the targeted cancer cells expressing the hTERT antigen, with no killing of normal cells that did not express the hTERT antigen. The treated mice experienced significantly smaller tumors and also longer overall survival. Vaccinated animal results were compared to a control group of animals that did not receive Inovio's DNA cancer vaccine.

In monkeys, whose TERT is 96% similar to human TERT and therefore a highly relevant model for immunotherapeutic vaccine development, the hTERT DNA vaccine elicited strong and broad TERT-specific immune responses and demonstrated the potential to eliminate tumor cells.

Overall, in these studies researchers observed that administration of a synthetic highly optimized hTERT DNA vaccine delivered with electroporation was capable of breaking immune tolerance, and eliciting robust and diverse antigen-specific CTLs, which are responsible for clearing cancerous cells, as well as a potent antitumor response. A favorable safety profile emerged from this study, showing that the vaccine-induced CTLs appeared not to be associated with any major toxicities or organ damage.

The expression of hTERT is thought to correlate with tumor survival and hTERT is associated with 85% of human tumors. Furthermore, there is growing recognition that it may be necessary to target stem cells that produce cancerous cells and recent studies have suggested that cancer stem or stem-like cells also express hTERT. These factors highlight the importance of an effective hTERT-targeting vaccine/immunotherapy and point to the potential benefit of Inovio's novel cancer vaccine.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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'Inovio Pharmaceuticals' potent hTERT DNA cancer vaccine shows potential to reduce tumors and prevent tumor recurrence'

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Innovative technique seeks to prevent lymphedema in breast cancer patients

Main Category: Breast Cancer
Also Included In: Clinical Trials / Drug Trials;  Lymphology/Lymphedema
Article Date: 24 Jul 2013 - 2:00 PDT
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Innovative technique seeks to prevent lymphedema in breast cancer patients

A team of surgeons and members of the breast cancer program of the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital/Columbia University Medical Center is conducting a two-year pilot study of an innovative microsurgery technique coupled with imaging technology to not only prevent lymphedema but also potentially detect and treat it early.

Lymphedema, the accumulation of lymph fluid in the arm and painful swelling due to blocked lymph drainage, occurs in up to 13 percent of breast cancer patients after sentinel node biopsy and external-beam radiation, increasing to 40 percent following complete axillary lymph node dissection (ALND) and radiation.

Lymphedema can also affect other cancer patients. Surgery and radiation after lymph node removal can cause scarring that blocks the lymph ducts, not only in the underarm but also in the legs, groin, pelvis, or neck after treatment for uterine, prostate, ovarian, or prostate cancer, as well as lymphoma and melanoma.

It can be difficult to treat lymphedema, which often requires lifelong therapy with compression garments to prevent lymphangitis (inflammation) and cellulitis in the affected limb. The condition can greatly affect quality of life for breast cancer patients and, some studies suggest, is associated with a two-to-three-fold increase in mortality in the six years following a cancer diagnosis.

The current study of the lymphatic microsurgical preventive healing approach (LYMPHA) is the first to be conducted outside of the University of Genoa in Italy, where it was developed. Dr. Sheldon M. Feldman, the principal investigator, was invited by the developers, Drs. Francesco Boccardo and Corradino Campisi, to observe their team in 2012.

The LYMPHA technique creates a bypass to restore lymphatic flow by connecting lymph vessels to a branch of the axillary vein, a pathway normally severed by node removal or blocked by tissue fibrosis resulting from radiation, says Dr. Feldman, chief of the Division of Breast Surgery and the Vivian L. Milstein Associate Professor of Clinical Surgery at NewYork-Presbyterian/Columbia University Medical Center.

Previous techniques for preserving lymphatic flow were lengthy and complex, and surgeons could not predict which patients would develop lymphedema or benefit from intervention. The LYMPHA bypass adds only 20-30 minutes to breast cancer surgery and ALND. "In addition to removing all potentially cancerous lymph nodes, we can now restore lymphatic flow and reduce the patient's risk of developing lymphedema," says Dr. Feldman.

Prior to ALND, a blue dye normally used to identify sentinel nodes is injected into the upper arm to map the lymphatic circulation from the arm. During the node dissection, the surgeon preserves a branch of the axillary vein and keeps a suitable length for reaching the lymphatic vessels.

The vein connection, or anastomosis, is then performed by a microvascular surgeon, using a sleeve technique in which the lymphatic vessels are inserted into the cut end of the vein to restore normal lymph flow. A mastectomy is performed at the same time as the node removal and LYMPHA procedure.

Before their surgery, study patients undergo an imaging technique known as lymphoscintigraphy, using a radiotracer such as technetium, and bioimpedance spectroscopy with a device called the L-Dex, to establish baseline lymphatic volume in the arms.

In addition to the regular follow-up visits normally scheduled after an ALND, postoperative monitoring includes physical exams for lymphedema, lymphoscintigraphy, and L-Dex bioimpedance spectroscopy to confirm that the LYMPHA bypass is open and functioning.

"We actually use the L-Dex routinely before breast cancer surgery. Then if patients need lymph node dissection, we carefully monitor them with the L-Dex. If they begin to develop increasing lymph volume in their arm, even if there's been no external change, we know they are on their way to developing lymphedema," says Dr. Feldman. "By using a support sleeve and seeing a physical therapist (for range-of-motion exercises), they may never experience lymphedema."

This study is part of a comprehensive lymphedema management in the breast cancer program at NewYork-Presbyterian/Columbia encompassing education, lymphedema prevention, and, in the future, potential treatment of patients with lymphedema who have not responded to decongestive therapy, which involves wrapping of the limb and specialized massage for drainage.

The LYMPHA pilot study seeks to enroll 10 patients with confirmed nodal metastases whose veins are suitable for the bypass.

The next step would be a multicenter trial throughout the U.S. to confirm the efficacy of the LYMPHA procedure. Eventually it could become the standard of care for cancer patients needing ALND. The lymphatic-venous bypass could also potentially be used to treat patients with lymphedema that is not well controlled with decongestive therapy. The earlier treatment begins, the more likely the condition is to be reversible.

Says Dr. Feldman, "We can now help patients maintain a normal quality of life by most effectively preventing and treating lymphedema without compromising their cancer treatment. We never want to let quality of life trump the cancer treatment. We want both - we don't want people to experience lymphedema."

To be considered for the study, breast cancer patients needing lymph node dissection should contact Amiya Vaz at 212-305-1317 or by email at: av2454@columbia.edu.

Article adapted by Medical News Today from original press release. Source: NewYork-Presbyterian Hospital
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'Innovative technique seeks to prevent lymphedema in breast cancer patients'

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