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Chemotalk NewsletterChemotalk Newsletter, Vol. 8: January 1, 2009
Hello, 2009! We got through another one, and for some of us that really is a milestone. I'm fairly new to this process of gathering health news, but it looks to me like important announcements about developments in research don't get released at the end of the year. It would make sense, since people are focusing on the holidays and wrapping things up for the past year. I'm trying to keep this newsletter from becoming cancer-dominated, but it ain't easy. Cancer still inspires so much fear and includes so many sub-categories, that there's an almost endless supply of news related to research and treatment. Not so much, with the other diseases or conditions for which chemo is given. But once in awhile, some non-cancer-related good news does show up. A NEW SYSTEM IMPROVES DISTRIBUTION OF DONATED LIVERS Thanks to a new liver transplant allocation system that gives preference to patients with the greatest need, rather than time spent on a waiting list, racial disparities among those waiting for new livers are narrowing. Blacks are no longer much more likely to die or become too sick for a transplant while on the waiting list, although there are still noticeable gender gaps, according to the study published in the Nov. 26 issue of the Journal of the American Medical Association. The new MELD (Model for End-Stage Liver Disease) scoring system was introduced in 2002. "Post-MELD, the disparity between blacks and whites went away," said Dr. Cynthia A. Moylan, lead author of the study and a transplant hepatology fellow at Duke University Medical Center in Durham, N.C. "The sickest patients get" the organs, she said. The study is the first comprehensive look at the success of the new system. Currently, there are more than 16,000 people in the United States waiting for a new liver, according to the United Network for Organ Sharing (UNOS). And according to an accompanying editorial in the journal, overall survival rates for liver transplantations normally exceed 90% one year after the surgery. A liver transplant is the only hope for long-term survival for people with end-stage liver disease. Prior to 2002, allocation of livers from deceased donors was based on time spent on the waiting list, as well as subjective measures by a physician, Moylan said. "The system had multiple problems, and one was racial disparity," she said. 'They [blacks] were underrepresented on the waiting list and less likely to receive a transplant. People who were able to wait for long periods of time were less likely to need a transplant. Also, the old system could be manipulated. For instance, patients in intensive care were given preferential status, so doctors sometimes put patients in the ICU to bump them up on the list. "Doctors were trying to do the best thing for their patient, but it was disadvantaging those who really did need a transplant," said Dr. Richard Freeman, of Tufts University. The MELD score, which predicts the risk of dying within three months, is based on a formula incorporating three laboratory tests. "MELD is based on pure blood tests, and it's hard to manipulate patients' blood tests," Freeman said. "The waiting time is taken out. It's based on who's sicker." The authors of the new study looked at patients, black and white, on the Organ Procurement and Transplantation Network waiting list for liver transplantation between Jan. 1, 1996, and Dec. 31, 2000 (pre-MELD), and between Feb. 28, 2002, and March 31, 2006 (post-MELD). Before MELD, 27% of black patients died or became too sick for a transplant within three years of registering for a liver, compared with 21.7% of whites. After MELD, that gap narrowed considerably with 26% of blacks dying or becoming too sick for a transplant, compared with 22% of whites. While blacks were less likely than whites to receive a new liver within three years of registering on the pre-MELD list, in the post-MELD era this is no longer the case. Gender, however, is another story. Women are more likely to die or become too sick for a liver transplant under the post-MELD system. And they are -- and were -- less likely to receive a new liver within three years, regardless of the era. This likely is the result of several factors, including women's smaller size (meaning they need a smaller liver), higher likelihood of having an autoimmune disease, and the fact that women have less muscle mass, likely affecting some of the MELD calculations. More evidence is emerging that adding a serum sodium test to the MELD calculation might right the gender imbalance. * * * HIGHER CHEMO DOSE PROLONGS LIVES OF LEUEMIA PATIENTS Preliminary results of a study sponsored by the U.S. National Cancer Institute show that a high dose of the chemotherapy drug daunorubicin prolonged survival for patients with previously untreated acute myeloid leukemia (AML), a cancer of the blood and bone marrow. This study included 633 patients, aged 16 to 60, who were randomly assigned to receive either high-dose or standard-dose daunorubicin. Both doses were given in combination with another chemotherapy drug called ara-C (cytarabine). The patients in the high-dose group received double the dose of daunorubicin per square meter of body surface area, on each of the first three days of treatment. The standard dose is 45 mg/m2. Patients in the high-dose group had a median overall survival of 23.7 months, compared to 15.1 months for those in the standard-dose group. Both groups had similar frequencies of serious treatment-related toxicity, according to the study, conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). "The findings of this large clinical trial are important, because they will likely change practice and improve the outcome for many patients with AML," Dr. Martin Tallman, chairman of the ECOG leukemia committee and a professor of medicine at Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center in Chicago, said in an NCI news release. More than 13,000 people in the United States will be diagnosed with AML in 2008. Most cases occur in adults, and about half occur in those younger than 60. Only about one-third of AML patients survive the disease, and the odds of survival decrease with age. * * * PHASE 111 RESULTS FOR MS DRUG SHOWS EXCELLENT PROMISE Initial results from the one-year Phase III TRANSFORMS study show the investigational oral compound FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with RELAPSING-REMITTING MULTIPLE SCLEROSIS. Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex®*)[1]. The annualized relapse rate at one year for patients given FTY720 0.5 mg was 0.16, representing a 52% reduction compared to a relapse rate of 0.33 for interferon beta-1a (p<0.001). The FTY720 1.25 mg dose also showed a significant reduction in relapses with a rate of 0.20 representing a 38% reduction against interferon beta-1a (p<0.001). No statistically significant difference was seen between the two FTY720 doses[1]. Comprehensive analyses of the TRANSFORMS study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. "We are encouraged by the early results from TRANSFORMS, which represent a major step towards delivering an effective oral treatment for people with relapsing-remitting MS," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "These positive results reinforce the potential for FTY720 to provide a significant advance in the future treatment of this devastating disease." TRANSFORMS (TRial Assessing injectable interferoN vS FTY720 Oral in RrMS) is the first of three studies to report results in one of the largest Phase III clinical programs ever conducted in MS, involving more than 3,400 patients around the world. As a head-to-head trial against interferon beta-1a, TRANSFORMS was designed to assess the efficacy of FTY720 compared to an established disease-modifying therapy in reducing relapse rates in patients with relapsing-remitting MS, the most common form of the disease. Two other studies - FREEDOMS and FREEDOMS II - are two-year placebo-controlled Phase III studies to assess the impact of FTY720 in reducing the frequency of relapses and slowing the progression of disability, and to further characterize the benefit-risk profile. Data from these studies to support regulatory submissions are expected in 2009. TRANSFORMS was a one-year worldwide double-blind, double-dummy study that enrolled 1,292 patients. The study had three arms: oral FTY720 0.5 mg and 1.25 mg once-daily, and the active comparator interferon beta-1a given once-weekly by intra-muscular injection. The patient population in TRANSFORMS was consistent with the demographics and disease state seen in Phase III clinical trials for other disease-modifying treatments for relapsing-remitting MS. The safety profile of FTY720 seen in TRANSFORMS was in line with previous clinical experience. The compound was generally well-tolerated with 87% of FTY720-treated patients completing the study on treatment. The proportion of patients discontinuing therapy was 10% in the FTY720 0.5 mg group, 15% in the FTY720 1.25 mg group, and 12% in the interferon beta-1a group. The most commonly reported adverse events, seen in more than 10% of patients in all three study arms, were headache, nasopharyngitis and fatigue. Influenza-like symptoms were reported in 37% of patients treated with interferon beta-1a and in 4% of patients treated with FTY720. Adverse effects seen in FTY720-treated patients included transient reductions in heart rate at the start of treatment, minor increases in blood pressure, and elevations in liver enzymes (also seen with interferon beta-1a). In general, the safety profile of the FTY720 0.5 mg dose appeared to be better than that of the 1.25 mg dose, including lower rates of infections and bradycardia. Further analyses of the TRANSFORMS data and results from the ongoing Phase III studies will help to provide a more comprehensive assessment of FTY720's benefit-risk profile. * * * ANTIOXIDENTS DURING CANCER TREATMENT GET MIXED REVIEWS Conflicting news headlines have many cancer patients confused about antioxidant use during treatment. Although some reports claim that supplements like vitamins E and C, beta-carotene and selenium increase the success of radiation and chemotherapy, additional research says otherwise. American Institute for Cancer Research - infoZine - In fact, two new studies report that antioxidant supplements can DECREASE effectiveness of these cancer treatments. Amid this overload of information, patients and family members are unsure what to believe. Antioxidants, compounds found in plant foods, can take the shape of vitamins, minerals or phytochemicals. One of the many reasons that health experts recommend a mostly plant-based diet is its rich supply of antioxidant compounds, that alleviate and prevent damage to our cells caused by “free radicals,” natural byproducts of many cell processes. By guarding cells against DNA damage, antioxidants play an important role in the cancer process. However, while free radicals can pose a health risk, they are also part of the normal protocol our body uses to get rid of damaged cells. In fact, radiation and chemotherapy treatments utilize free radicals to damage the DNA of cancer cells and stimulate cell destruction. This fact has many experts worried that antioxidant supplements could interfere with treatment itself by wiping out the needed free radicals. Others argue that antioxidants taken during treatment offer added protection to healthy cells and reduce side effects. For now, the evidence supports both views.
It’s important that researchers are addressing this crucial question. But larger, better-designed studies are needed to offers answers we can trust. For now, we don’t know who, if anyone, might benefit from extra antioxidants beyond what we get from a healthy plant-based diet. The optimal timing of antioxidant supplementation is also unclear. Healthcare providers are often taught, “First, do no harm.” For now, that probably means hold off on antioxidant supplements during treatment until we know more. * * * NEW DRUG LOOKS PROMISING FOR HARD-TO-TREAT CANCER According to Associated Press, the drug in question, a compound called QB1-139, created by Quintessence Biosciences Inc., had received federal approval to begin clinical trials. The trial will start in January on 20 patients at the University of Wisconsin Cancer Center. What makes this particular drug of such potential importance is that it has shown to "significantly inhibit growth of human pancreatic, non-small-cell lung, prostate and ovarian solid tumors in animal testing." The potential of any drug that shows promise against some of the most pernicious of cancers, is good news, indeed. * * * HEALTH TIP: WARNING SIGNS FOR OVARIAN CANCER The early signs of ovarian cancer are often so subtle that they're missed, tragically until the disease has spread and become difficult to treat successfully. Having just lost a dear friend to the disease, I think repeating the warning signs from the U.S. National Cancer Institute is a really good idea: • Frequent or constant fatigue. • Constipation, nausea, diarrhea, indigestion, and/or gas. • A feeling of pressure or pain in the abdomen, pelvis, back, or legs. • A swollen or bloated abdomen. These symptoms can mimic symptoms of other conditions, so it's best to have them evaluated by a doctor. * * * POSITIVE MEMORY RESULTS FOR PHASE 11 TRIAL OF C105 IN MS Another drug in the pipeline for people with MS: A 6-week, placebo-controlled Phase 11 study of the drug C105, known commercially as Laquinimod, has shown positive results in MULTIPLE SCLEROSIS patients with documented cognitive dysfunction. The active group obtained significantly higher scores on secondary outcome measures of memory and learning. While the results did not reach statistical significance for either of the two primary outcome measures focusing on processing speed and executive function (the Symbol Digit Modalities Test and the Subject's Global Assessment), the significant memory findings coupled with an encouraging safety profile (a limited side-efect profile) clearly define the drug's effects and differentiate it from d-amphetamine in clinically meaningful ways, Cognition Pharmaceuticals said. Continued analyses of study data in several domains is in process. The company said that C105 demonstrated efficacy in improving memory function in patients with cognitive impairment secondary to MS. At the 30mg peak dose, the active group exhibited statistically significant improvement in performance on measures of both verbal and nonverbal delayed recall as well as improved memory retention. "We are extremely encouraged by very strong findings in the areas of verbal and visual memory and learning from our trial. These memory results are consistent with and fit well with our understanding of the mechanism of action of C105 as documented in a range of preclinical and clinical studies," according to Cognition Pharmaceuticals President and Chief Scientific Officer David Erlanger, Ph.D. MS affects 2.5 million people worldwide. Of these, approximately 45 percent have significant memory problems. ABOUT THE STUDY Most of us, non-professionals in the healthcare field, have at best a cursory knowledge of how a clinical trial actually works. This piece gave as comprehensive, yet understandable a version as I've seen, and I thought it was worthwhile to pass it along. The more we know about this stuff, the better equipped we are to make sensible decisions: "The Phase 2 trial was conducted by Cognition Pharmaceuticals, which described it as a randomized, double-blind, placebo-controlled, dose-titration study. A total of 151 subjects from 33 sites in the United States were randomized into the six-week trial at a ratio of 2:1, active to placebo. The population was composed of patients with a clinically definitive diagnosis of Multiple Sclerosis with evidence of cognitive impairment at intake. Inclusion criteria mandated that all enrolled patients demonstrate a pattern of impairment on the Symbol Digit Modalities test (a measure of processing speed), the California Verbal Learning Test (a measure of verbal learning and memory) and the Paced Auditory Serial Addition Test (a measure of working memory). "Patients were screened for depression at intake, and those with evidence of an untreated Major Depressive Disorder were excluded. Dose was titrated over 14 days, and patients remained on a therapeutic dose for another 14 days. "Patients were administered a standardized cognitive assessment battery (MACFIMS; Minimal Assessment of Cognitive Function in Multiple Sclerosis) at screening and stable peak dose, and a subset of this battery was administered on intervening study days and at a follow up visit." * * * Finally, here are some excellent tips to consider before you begin Chemotherapy. The American Cancer Society suggests that before you start chemo, ask your doctor these questions: • How will I know if the chemotherapy is working, and how will it help my prognosis? • How long will my treatments last? • What side effects can I expect, and how can I manage them? • Will any side effects subside after the chemotherapy has ended, or are they permanent? • Can I still live a normal life while on chemo? Can I go to work (or school)? • How can I physically and mentally prepare for chemotherapy? If my own experience is any indication, you may be surprised at how well you handle the experience! Okay, folks... We start a new year. In spite of whatever goes on in the economic world, it's still within our power, each one of us, to have affect our health profile. Nobody reading this is doing everything he or she could do, to stay healthy. We all fail at it, some more than others. But we can do better. We owe it to our families, but mostly we owe it to ourselves. Happy New Year! And if you have any thoughts of how this newsletter could be improved, please email me directly, at jesmer_e@pacbell.net Elaine Jesmer
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