Anti-herpes virus drug treatment may benefit some chronic fatigue syndrome patients

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 30 Jul 2013 - 0:00 PDT Current ratings for:
Anti-herpes virus drug treatment may benefit some chronic fatigue syndrome patients

Many experts believe that chronic fatigue syndrome (CFS) has several root causes including some viruses. Now, lead scientists Shara Pantry, Maria Medveczky and Peter Medveczky of the University of South Florida's Morsani College of Medicine, along with the help of several collaborating scientists and clinicians, have published an article in the Journal of Medical Virology suggesting that a common virus, Human Herpesvirus 6 (HHV-6), is the possible cause of some CFS cases.

Over 95 percent of the population is infected with HHV-6 by age 3, but in those with normal immune systems the virus remains inactive. HHV-6 causes fever and rash (or roseola) in infants during early childhood, and is spread by saliva. In immunocompromised patients, it can reactivate to cause neurological dysfunction, encephalitis, pneumonia and organ failure.

"The good news reported in our study is that antiviral drugs improve the severe neurological symptoms, including chronic pain and long-term fatigue, suffered by a certain group of patients with CFS," said Medveczky, who is a professor of molecular medicine at USF Health and the study's principal investigator. "An estimated 15,000 to 20,000 patients with this CFS-like disease in the United States alone may ultimately benefit from the application of this research including antiviral drug therapy."

The link between HHV-6 infection and CFS is quite complex. After the first encounter, or "primary infection," all nine known human herpesviruses become silent, or "latent," but may reactivate and cause diseases upon immunosuppression or during aging. A previous study from the Medveczky laboratory showed that HHV-6 is unique among human herpesviruses; during latency, its DNA integrates into the structures at the end of chromosomes known as telomeres.

Furthermore, this integrated HHV-6 genome can be inherited from parent to child, a condition commonly referred to as "chromosomally integrated HHV-6," or CIHHV-6. By contrast, the "latent" genome of all other human herpesviruses converts to a circular form in the nucleus of the cell, not integrated into the chromosomes, and not inheritable by future generations.

Most studies suggest that around 0.8 percent of the U.S. and U.K. population is CIHHV6 positive, thus carrying a copy of HHV-6 in each cell. While most CIHHV-6 individuals appear healthy, they may be less able to defend themselves against other strains of HHV-6 that they might encounter. Medveczky reports that some of these individuals suffer from a CFS-like illness. In a cohort of CFS patients with serious neurological symptoms, the researchers found that the prevalence of CIHHV-6 was over 2 percent, or more than twice the level found in the general public. In light of this finding, the authors of the study suggest naming this sub-category of CFS "Inherited Human Herpesvirus 6 Syndrome," or IHS.

Medveczky's team discovered that untreated CIHHV-6 patients with CFS showed signs that the HHV-6 virus was actively replicating: determined by the presence of HHV-6 messenger RNA (mRNA), a substance produced only when the virus is active. The team followed these patients during treatment, and discovered that the HHV-6 mRNA disappeared by the sixth week of antiviral therapy with valganciclovir, a drug used to treat closely related cytomegalovirus (HHV-5). Of note, the group also found that short-term treatment regimens, even up to three weeks, had little or no impact on the HHV-6 mRNA level.

The investigators assumed that the integrated virus had become reactivated in these patients; however, to their surprise, they found that these IHS patients were infected by a second unrelated strain of HHV-6.

Further studies are needed to confirm that immune dysregulation, along with subsequent chronic persistence of the HHV-6 virus, is the root cause of the IHS patients' clinical symptoms, the researchers report.

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

The USF-led study was supported by the HHV-6 Foundation and the National Institutes of Health.

Article citation: “Persistent human herpesvirus-6 infection in patients with an inherited form of the virus; ” Shara N. Pantry, Maria M. Medveczky, Jesse H. Arbuckle, Janos Luka,Jose G. Montoya, Jianhong Hu, Rolf Renne, Daniel Peterson, Joshua C. Pritchett, Dharam V. Ablashi, andPeter G. Medveczky; Journal of Medical Virology; published online July 25, 2013; DOI: 10.1002/jmv.23685

University of South Florida (USF Health)

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Obese kidney failure patients receive survival benefit from transplantation

Main Category: Transplants / Organ Donations
Also Included In: Urology / Nephrology;  Obesity / Weight Loss / Fitness
Article Date: 25 Jul 2013 - 0:00 PDT Current ratings for:
Obese kidney failure patients receive survival benefit from transplantation

Most obese individuals with kidney failure can prolong their lives by receiving a kidney transplant, although this survival benefit is lower in severely obese individuals. That's the conclusion of a new study published in the American Journal of Transplantation. The findings will hopefully decrease differences in access to transplantation for obese patients.

Obesity is increasing in patients with kidney failure. In some studies, obese kidney failure patients who are on dialysis have a lower risk of dying prematurely than non-obese patients. In contrast, obese kidney transplant recipients have a higher risk of dying prematurely than non-obese recipients. Therefore determining the survival benefit of transplantation in obese transplant recipients is an important issue.

Using data from the United States between 1995 and 2007, John Gill, MD, MS, of the University of British Columbia, in Vancouver, and his colleagues determined the risk of premature death in transplant recipients grouped by body mass index (BMI) compared with transplant candidates with the same BMI who were on the transplant waiting list. The analysis included 208,498 patients, and obesity was defined as a BMI of 30 kg/m2 or higher.

Among the major findings:

Obese patients with a BMI of 30 to 39 kg/m2 derived a similar survival advantage from transplantation as non-obese patients, which equated to more than a 66 percent reduced risk of dying within one year of transplantation.Obese patients with a BMI of 40 or higher derived a lower survival advantage from transplantation (a 48 percent reduced risk of dying within one year), and a survival advantage was uncertain in Black patients with a BMI of 40 or higher.Differences in obese compared with non-obese patients were not as profound with transplantations using kidneys from live donors.

The risk of dying early after transplantation was greater in obese compared with non-obese patients.

"Our study shows that obese patients derive a survival advantage from transplantation, and obesity should not exclude patients from consideration of transplantation," said Dr. Gill. "Also, improved early post-transplant care may help reduce the early risk of death in obese patients, and living donor transplantation may be a useful strategy to mitigate the risks of transplantation in obese transplant candidates."

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

Gill et al. The Survival Benefit of Kidney Transplantation in Obese Patients, American Journal of Transplantation; Published Online: July 25, 2013 (DOI: 10.1111/ajt.12331).

Wiley

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Modern dentistry may benefit from discovery of an evolutionary compromise for long tooth preservation

Main Category: Dentistry
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Modern dentistry may benefit from discovery of an evolutionary compromise for long tooth preservation

Researchers at the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and the Senckenberg Research Institute in Frankfurt am Main, Germany, have conducted stress analyses on gorilla teeth of differing wear stages. Their findings show that different features of the occlusal surface antagonize tensile stresses in the tooth to tooth contact during the chewing process. They further show that tooth wear with its loss of dental tissue and the reduction of the occlusal relief decreases tensile stresses in the tooth. The result, however, is that food processing becomes less effective. Thus, when the condition of the occlusal surface changes during an individual's lifetime due to tooth wear, the biomechanical requirements on the existing dental material change as well - an evolutionary compromise for longer tooth preservation.

First, the researchers created 3D digital models of three gorilla lower second molars differing in wear stages. In a second step they applied a Software tool (Occlusal Fingerprint Analyser) developed in the Senckenberg Research Institute to precisely determine tooth to tooth contacts. They then used an engineering approach, finite element analysis (FEA), to evaluate whether some dental traits usually found in hominin and extant great ape molars have important biomechanical implications.

The results show that in unworn and slightly worn molars (with a well-formed occlusal relief that is most effective for processing food) tensile stresses concentrate in the grooves of the occlusal surface. In such a condition, the different crests of a molar carry out important biomechanical functions, for example, by reinforcing the crown against stresses that occur during the chewing process. Due to a loss of tooth tissue and a reduction of the occlusal relief the functionality of these crests diminishes during an individual's lifetime. However, this reduced functionality of the crests in worn teeth is counterbalanced by an increase in contact areas during tooth to tooth contacts, which ultimately contributes to a dispersion of the forces that affect the occlusal surface.

This suggests that the wear process might have a crucial influence in the evolution and structural adaptation of molars enabling to endure bite forces and to reduce tooth failure throughout the lifetime of an individual. "It seems that we observe an evolutionary compromise for long tooth preservation. Even though worn teeth are not as efficient they still fulfill their task. This would not be the case if they were lost prematurely", says Stefano Benazzi of the Max Planck Institute for Evolutionary Anthropology. He adds: "Tooth evolution and dental biomechanics can only be understood, if we further investigate tooth function in respect to the dynamic changes of tooth structures during the lifespan of individuals".

"The results have strong implications for understanding the functional biomechanics of dental traits, for deciphering the evolutionary trend of our masticatory apparatus and might have important implications in modern dentistry for improving dental treatments", says Jean-Jacques Hublin, director of the Department of Human Evolution at the Max Planck Institute for Evolutionary Anthropology.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

In the commenting procedure on early benefit assessment pursuant to the German Act on the Reform of the Market for Medicinal Products (AMNOG), under certain circumstances drug manufacturers may submit to the Federal Joint Committee (G-BA) additional documents for dossiers. The Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed such additional information for two studies comparing the antibiotic fidaxomicin, which is used for diarrhoea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults with diarrhoea caused by Clostridium difficile. IQWiG already presented an assessment pursuant to AMNOG in April 2013.

On the basis of the dossier submitted by the manufacturer, an advantage of fidaxomicin for the outcome "global cure" could be inferred for severe cases and recurrences. However, the magnitude of this advantage could not be inferred from the data presented. In addition, it could not be excluded that more severe side effects occurred precisely in these cases, thus outweighing advantages with regard to global cure. An overall conclusion on added benefit was therefore not possible.

Greater harm not proven in patients with severe disease

In the commenting procedure the manufacturer subsequently provided study results in a form that allows the weighing of positive and negative effects. Whereas no statistically significant difference between fidaxomicin and vancomycin was shown for all-cause mortality, the data provide proof of an added benefit for the outcome "global cure" in patients with severe or recurrent disease. In addition, in these subpopulations there is no suggestion of greater harm from fidaxomicin than from vancomycin.

An overall conclusion is thus possible: an added benefit of fidaxomicin versus the appropriate comparator therapy (vancomycin) is now proven for the treatment of patients with severe or recurrent Clostridium difficile infections. IQWiG classifies the extent of added benefit as minor.

An added benefit in patients with mild disease was not claimed by the manufacturer.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the G-BA conducted a commenting procedure in which the manufacturer submitted additional information. The G-BA subsequently commissioned IQWiG on 28 May 2013 to undertake a new assessment including the additional data.

If, in the course of the discussions on a commission of the G-BA, a need for further revision arises, IQWiG presents its report in the form of an addendum. The Institute sent this addendum to the contracting agency (the G-BA) on 12 June 2013. The G-BA then decides on the extent of the added benefit in each case, thus completing the early benefit assessment.

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

The website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin (English-language information [addendum and health information] will also be available in the near future; if you would like to be informed when this is published, please send an email to info@iqwig.de).

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.

Addendum

Benefit assessment (dossier assessment)

Institute for Quality and Efficiency in Health Care

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27 Jul. 2013. APA
Institute for Quality and Efficiency in Health Car. (2013, July 27). "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263932.php.

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'Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections'

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Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

In the commenting procedure on early benefit assessment pursuant to the German Act on the Reform of the Market for Medicinal Products (AMNOG), under certain circumstances drug manufacturers may submit to the Federal Joint Committee (G-BA) additional documents for dossiers. The Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed such additional information for two studies comparing the antibiotic fidaxomicin, which is used for diarrhoea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults with diarrhoea caused by Clostridium difficile. IQWiG already presented an assessment pursuant to AMNOG in April 2013.

On the basis of the dossier submitted by the manufacturer, an advantage of fidaxomicin for the outcome "global cure" could be inferred for severe cases and recurrences. However, the magnitude of this advantage could not be inferred from the data presented. In addition, it could not be excluded that more severe side effects occurred precisely in these cases, thus outweighing advantages with regard to global cure. An overall conclusion on added benefit was therefore not possible.

Greater harm not proven in patients with severe disease

In the commenting procedure the manufacturer subsequently provided study results in a form that allows the weighing of positive and negative effects. Whereas no statistically significant difference between fidaxomicin and vancomycin was shown for all-cause mortality, the data provide proof of an added benefit for the outcome "global cure" in patients with severe or recurrent disease. In addition, in these subpopulations there is no suggestion of greater harm from fidaxomicin than from vancomycin.

An overall conclusion is thus possible: an added benefit of fidaxomicin versus the appropriate comparator therapy (vancomycin) is now proven for the treatment of patients with severe or recurrent Clostridium difficile infections. IQWiG classifies the extent of added benefit as minor.

An added benefit in patients with mild disease was not claimed by the manufacturer.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the G-BA conducted a commenting procedure in which the manufacturer submitted additional information. The G-BA subsequently commissioned IQWiG on 28 May 2013 to undertake a new assessment including the additional data.

If, in the course of the discussions on a commission of the G-BA, a need for further revision arises, IQWiG presents its report in the form of an addendum. The Institute sent this addendum to the contracting agency (the G-BA) on 12 June 2013. The G-BA then decides on the extent of the added benefit in each case, thus completing the early benefit assessment.

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

The website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin (English-language information [addendum and health information] will also be available in the near future; if you would like to be informed when this is published, please send an email to info@iqwig.de).

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.

Addendum

Benefit assessment (dossier assessment)

Institute for Quality and Efficiency in Health Care

Please use one of the following formats to cite this article in your essay, paper or report:

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Institute for Quality and Efficiency in Health Car. "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. MediLexicon, Intl., 27 Jul. 2013. Web.
27 Jul. 2013. APA
Institute for Quality and Efficiency in Health Car. (2013, July 27). "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263932.php.

Please note: If no author information is provided, the source is cited instead.

'Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections'

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Premature Newborns Benefit From "Kangaroo Care"

Main Category: Pediatrics / Children's Health
Article Date: 14 Jul 2013 - 0:00 PDT Current ratings for:
Premature Newborns Benefit From "Kangaroo Care"

New research in the Journal of Newborns & Infant Nursing Reviews concludes that so-called "kangaroo care" (KC), the skin-to-skin and chest-to-chest touching between baby and mother, offers developmentally appropriate therapy for hospitalized preterm infants.

In the article, "Kangaroo Care as a Neonatal Therapy," Susan Ludington-Hoe, RN, CNM, PhD, FAAN, from Case Western Reserve University's Frances Payne Bolton School of Nursing, describes how KC delivers benefits beyond bonding and breastfeeding for a hospital's tiniest newborns.

"KC is now considered an essential therapy to promote growth and development of premature infants and their brain development," Ludington-Hoe reports.

But while KC's benefits are known, its use is not widely promoted by hospitals, she says.

Ludington-Hoe encourages hospitals to incorporate KC-type features by modifying neonatal intensive care units to make them calming places, positioning babies to promote physical and motor development, decreasing how much babies are handled to reduce their stress, improving wake-sleep cycles and promoting a newborn's ability to stabilize important functions, like its heartbeat and to synchronize physiologic functions with his mother's for optimal development.

Kangaroo Care for preemies involves the mother nestling the baby on her chest for at least one hour at a time and ideally for 22 hours a day for the first six weeks, and about eight hours a day for the next year.

Throughout Scandinavia and the Netherlands, KC is widely practiced, said the researcher. They practice 24/7 Kangaroo Care because mothers are told that they have to be their baby's place of care, and they make arrangements so that someone else watches children at home so that the infant is always in maternal or paternal KC while hospitalized. It continues at home where mothers wear wraps that securely contain the infant on her chest to prevent falling.

Ludington-Hoe reports that this approach is standard care in Scandinavia and Germany, where many preemies leave the hospital about three weeks earlier than in the United States. Also, KC is used in those countries after normal births and continues for three full months.

In previous research, benefits of KC have extended from childbirth to age 16, showing improved cognitive and motor development in newborns that received KC during hospitalization.

Neonatal intensive care units may adjust from open, brightly lighted nurseries to quieter single rooms, but such changes can't offer Kangaroo Care's scope of developmental benefits if the mothers aren't also there to snuggle their babies, Ludington-Hoe concludes.

Among the researcher's findings: babies respond more positively to their mothers than nurses, and experience less pain and stress when receiving some medical procedures while in their mothers' arms, and infant's brains mature faster and have better connectivity if they have received KC versus not having received KC. Mothers make the difference in how quickly preemies grow and develop.

Preemies held by their mothers in a prone position for an extended time tend to sleep better, which aids brain development. Infants adjust their heartbeats and body temperatures to their mother's and absorb immune benefits from their mother's skin, the researcher found.

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

Ludington-Hoe wrote Kangaroo Care: The Best You Can Do To Help Your Preterm Infant, a go-to guide since its publication in 1993. She also co-authored How to Have a Smarter Baby: The Infant Stimulation Program For Enhancing Your Baby's Natural Development with Susan K. Golant (1987).

Case Western Reserve University

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Patients With Aggressive Form Of Acute Lymphocytic Leukemia May Benefit From Advanced Genetics Technologies

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Genetics
Article Date: 11 Jul 2013 - 1:00 PDT Current ratings for:
Patients With Aggressive Form Of Acute Lymphocytic Leukemia May Benefit From Advanced Genetics Technologies

New evidence suggests that using advanced genetics technologies to monitor for remaining cancer cells after treatment may soon become an effective tool to inform treatment decisions and ultimately predict patient outcomes for patients with a particularly aggressive form of acute lymphocytic leukemia (ALL). Study results were published online in Blood, the Journal of the American Society of Hematology (ASH).

Approximately 25 to 30 percent of all adults with ALL, the second most common type of acute leukemia, have what is known as Philadelphia chromosome-positive (Ph+) ALL, a rapidly progressing form of the disease caused by a genetic abnormality that is associated with a poor prognosis. Following their first complete remission, one of the most common preventive treatments Ph+ ALL patients undergo is an allogeneic stem cell transplant, in which a patient receives stem cells from a sibling or unrelated matched donor; however, this procedure can be associated with harsh side effects and may not be universally available. Some research conducted since the introduction and subsequent success of a new class of cancer drugs called tyrosine kinase inhibitors (TKIs), which target the abnormal, leukemia-causing protein BCR-ABL and have greatly improved survival rates, suggests that stem cell transplantation may not be necessary for some Ph+ ALL patients. However, clinicians lack a reliable method for predicting disease progression and determining whether a patient's disease is aggressive enough to warrant a stem cell transplant or if TKI therapy plus chemotherapy will likely eradicate the disease.

Despite the advent of these powerful, targeted cancer therapies, some cancer cells may linger in a patient's body following the primary course of treatment. However, data from several recent studies have suggested that monitoring the amount of this remaining cancer cell population, known as minimal residual disease (MRD), may be an effective indicator of a patient's risk of relapse. Consequently, clinicians have increasingly employed several highly sensitive monitoring tools to detect MRD, such as multi-parameter flow cytometry (MFC) and real-time quantitative polymerase chain reaction (RQ-PCR), that search for genetic aberrations in a patient's blood and bone marrow that indicate the presence of cancerous cells. Although this method has proved effective for several other types of leukemia, the reliability of these tools specific to Ph+ ALL is not yet fully understood.

"The arrival of tyrosine kinase inhibitors has marked the beginning of an exciting era in which we can begin considering alternative preventive cancer treatments and look to spare patients from the risk of toxicities that often accompany stem cell transplants," said lead study author Farhad Ravandi, MD, of The University of Texas MD Anderson Cancer Center in Houston. "Now that we know that these drugs are effective, we can take the next step and focus on studying lingering disease in Ph+ ALL patients to guide more effective treatments and ultimately predict and manage possible relapse."

To better understand how technology that tracks indicators of MRD could potentially predict Ph+ ALL patients' survival and inform treatment decisions, Dr. Ravandi and a team of MD Anderson researchers conducted a decade-long study to monitor whether a negative MRD reading was associated with prolonged survival. Between 2001 and 2011, Dr. Ravandi's team monitored 76 adult patients (average of 54 years old) with Ph+ ALL who had achieved complete remission after a treatment regimen including at least one course of induction chemotherapy plus a TKI followed by treatment with a TKI (either dasatinib or imatinib) and chemotherapy, and two years of TKI maintence therapy. All study participants began with fewer than 5 percent cancer cells in their body and none had undergone stem cell transplant, nor were they at an otherwise hightened risk of relapse. Utilizing MFC and RQ-PCR technologies, investigators monitored patients for MRD after first remission and every three months thereafter.

Results from the investigation suggested that when used together, MFC and RQ-PCR monitoring technologies were effective in predicting the majority of disease progression and patient outcomes in this population. Among 44 patients who showed evidence of MRD in the first year of follow-up (either by MFC or RQ-PCR results), 13 relapsed, including 9 of 22 of the highest risk patients who showed positive MFC at three months and beyond. Thirteen of 54 patients who maintained negative MRD from three months and beyond had relapsed.

While the MRD readings observed by Dr. Ravandi and his team did not accurately predict all patient outcomes in the study population, researchers note that these results indicate that the combination of MFC and RQ-PCR technologies represents a valuable prognostic tool to measure the likelihood of a patient relapse. However, researchers caution that it is too early to integrate the use of these technologies into treatment guidelines regarding the neccessity of stem cell transplant for Ph+ ALL patients.

"While our results aligned with our observed outcome in this study and the MFC and RQ-PCR technologies are very sensitive, these tools do not yet provide absolute results. We advise that each treatment decision be made on a patient-to-patient basis to take into account each patient's different genetics," said Dr. Ravandi. "The next step is to refine and standardize our approach to better define which patients are truly disease-free and who should be recommended for more aggressive treatment."

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