Chemotalk Newsletter

Chemotalk Newsletter, Vol. 6:  November 1, 2008

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Happy Thanksgiving, in advance ...

EVER HEAR OF THE 510(k) REVIEW? WELL, LISTEN UP ...

No, this has nothing to do with your money. Not directly, anyway. It's the system by which the F.D.A. regulates some medical devices used in treatment for diseases under discussion here. Following are portions of a story that ran October 27, 2008, in The New York Times...

"The nation's system for regulating medical devices was set up more than three decades ago, when devices played a much smaller role in medicine. A growing chorus of doctor, consumer advocates and health insurance executives say it is overdue for an overhaul."

The reason for these professionals' concerns is the belief that some devices are released to the public too soon, without sufficient evidence that they offer more help than harm.

"The process has become 'a barrier to evidence development', said Dr. Winifred S. Hayes, whose firm, Hayes Inc., evaluates new health care technologies.

"...Medical devices did not come under the government's purvue until 1976, after Congress responded to deaths linked to the Dalkon Shield, an intrauterine contraceptive device.

"Because the new law would not apply to devices on the market before 1976, Congress did not want makers of newer products to be at a competitive disadvantage. So lawmakers provided the quick review process for any new product deemed 'SUBSTANTIALLY EQUIVALENT' to something already on the market. That expedited process became known as a 510(k) review under the relevant section of the law."

Critics claim that more control over these devices is necessary. Of the 41 medical devices that went through a full review (not the one that happens under the 510{k} review) and in which the F.D.A. reached a decision, 27 received approval. But during that same time period, the F.D.A. reviewed 3,052 devices under the more cursory process and cleared 2,640 of them.

To make an even longer story short, if a doctor offers a therapy that includes a non-traditional device (like a MammoSite, instead of traditional radiation for breast cancer patients), it would behoove us make sure the doctor gives us full disclosure about its F.D.A. status. That's not to say such devices don't work out. In some cases, a specific tool may be the only choice. But it's good to be reminded that in many cases, more EVIDENCE that it's "substantially equivalent" to traditional treatment would be a good thing to have, when you make your decision.

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KEEPING IT MOVING

From CURE MAGAZINE, an excellent piece addressing a problem that can pose an added challenge to anyone going through chemo: constipation.

Chemo and opioids used to treat cancer-related pain can affect the nerve supply to the bowel and slow down the natural movement and rhythm of the intestines. Fortunately, many advances have been made to alleviate constipation without interfering with cancer treatment or pain relief.

In addition to the over-the-counter remedies, including stimulant laxatives that increase contractions in the bowel, stool softeners which help retain water in the bowel to soften the stool, and osmotic laxatives which use osmosis to pull water into the intestines, in April, 2008 the FDA approved Relistor, to treat opioid-induced constipation in patients with late-stage, advanced illnesses, including CANCER, AIDS and lung disease.

Relistor is given by injection and blocks the opioid receptor in the gastrointestinal tract. But because it can't cross the blood-brain barrier, it doesn't interfere with the opioids' pain-relieving properties in the brain. It's the first such drug approved for opioid-induced constipation, and studies are under way for others.

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NEW TREATMENT FOR UTERINE (ENDOMETRIAL) CANCER

Rhode Island Hospital, in Providence, R.I., has announced it is the first hospital in the world to administer the Axxent Electronic Brachytherapy System, recently approved by the FDA for treatment of UTERINE CANCER. The system works by targeting radiation treatment via a mini X-ray device that is inserted into the tumor through a catheter. The Axxent system cuts down on the number of radiation treatments required, eliminates radioactive isotopes and enables doctors and nurses to treat patients while in the same room as the radiation process. Uterine cancer, also referred to as endometrial cancer, affects 40,000 women annually, and hospital officials report that the electronic brachytherapy system may be able to treat up to two-thirds of these cases. They also report positive results for the system when used in treating breast cancer patients since last year.

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TWO NEW TESTS IMPROVE DIAGNOSIS OF RHEUMATOID ARTHRITIS

The Cypress Bioscience company is launching its first two novel personalized medicine services at the American College of Rheumatology Annual Scientific Meeting in San Francisco on October 24-29, 2008. The initial personalized medicine services facilitate improved diagnostic, prognostic and therapeutic decision making for rheumatologists treating patients with RHEUMATOID ARTHRITIS.

Avise PG(SM) is a test that supports dose optimization and therapeutic decision making for patients taking methotrexate (MTX), a widely used first-line therapy for RA. Avise MCV(SM) is a test that aids in the diagnosis and prognosis of RA. Both tests are available exclusively from Cypress Bioscience and are performed using standard blood samples sent to the company's CLIA-certified laboratory in San Diego.

Avise PG offers rheumatologists insight into a patient's metabolism of MTX by measuring levels of MTX polyglutamates, the active metabolites of MTX. Historically, physicians have depended solely on a patient's response, as gauged by clinical signs and symptoms, to determine whether MTX therapy has been optimized. As patients' metabolism of MTX varies markedly, Avise PG can help physicians determine whether patients may benefit from continued dose escalation or additional time on MTX therapy, or whether patients need a change in their treatment.

Avise MCV is a sensitive and specific test that improves on traditional biomarkers used to help diagnose RA. Early diagnosis and appropriate treatment of RA are critically important in the prevention of erosive joint destruction and disability. Avise MCV measures antibodies to mutated citrullinated vimentin, a protein found in patients with RA, which is believed to be involved in the pathogenesis of the disease. Avise MCV is used for first-line diagnostic testing of patients who present with symptoms of RA, and offers prognostic insight with respect to disease progression while improving diagnostic accuracy.

"To date, rheumatology has not benefited from advances in personalized medicine to the same extent as fields such as oncology. Cypress Bioscience is committed to developing personalized medicine tools to help rheumatologists individualize patient care with the goal of improving both the diagnosis and treatment of rheumatologic diseases," said R. Michael Gendreau, MD, PhD, Chief Medical Officer at Cypress Bioscience.

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RESEARCHERS CLAIM CHEMO JAB 'CAN CURE EARLY TESTICULAR CANCER'

Studies conducted in Canada have shown that Carboplatin, which is often used to treat OVARIAN and LUNG CANCER, can replace radiotherapy to cure early-stage seminoma, a form of TESTICULAR CANCER. The drug is being hailed as a "safer cure" for the cancer by experts, with fewer long-term risks.

About 40 to 45% of testicular cancers are early-stage seminoma and between 780 and 880 men are diagnosed with this stage of the disease each year in the UK.

In the early stages, the cancer is either confined to the testicle or causes slight enlargement of the lymph nodes in the pelvis or abdomen. It is nearly always curable and more than 95% of men diagnosed with early-stage seminoma live for more than five years after diagnosis. In the largest ever trial of the disease, a single carboplatin injection was used to treat 573 patients with early-stage seminoma. The results were compared with 904 men given two or three weeks of daily radiotherapy, the current standard treatment.

Those patients given carboplatin experienced fewer side effects and were able to get back to their normal lives quicker than the men on radiotherapy, the research found.

Of 573 patients given carboplatin, a total of 5% relapsed within three years. But none of the men died from their cancer following further treatment.

Men with seminomas usually have the testicle removed where the cancer occurred. In one in 20 cases, the other testicle also develops cancer. Those patients treated with carboplatin were far less likely to develop cancer in the other testicle.

Dr Ben Mead, honorary senior lecturer in medical oncology at the University of Southampton's School of Medicine, who presented the study, said: "We were pleased by the results of this huge trial. Giving patients a carboplatin injection rather than radiotherapy is less unpleasant with fewer long-term risks."

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NEW DRUG FOR CUTANEOUS T-CELL LYMPHOMA

This is the kind of news that people with rare cancers look for, because so little research is actually focused on any disease that has very few occurrances in any given year. Curaneous T-cell lymphoma (CTCL) is one of those diseases--about 3,000 new cases a year--and denileukin diftitox (Ontak) has just been approved to treat it.

The drug targets cells that contain a certain receptor known as IL2. A receptor is a molecule found on the surface of cells. Ontak works by killing cancer cells that have the IL2 receptor by targeting a component of the receptor called CD25, the company said in a news release. T-cells are used by the body to fight infections. In CTCL, these cells become cancerous, causing skin lesions. About 2,900 people in the United States are diagnosed with the disease each year, Eisai said. A clinical trial involving 144 patients with CTCL cells that bore the CD25 receptor showed the drug offered a significant benefit over a non-medicinal placebo, the company said. Common side effects included fatigue, mild nausea and elevated liver function. People who take the drug also are at higher risk of capillary leak syndrome, which is characterized by at least two of the following symptoms: edema, low blood pressure, and low levels of albumen.

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BONE MARROW MAY REPAIR DAMAGE CAUSED BY MULTIPLE SCLEROSIS

Scientists at Yale University think cells from bone marrow might hold promise for repairing nerve cells damaged by multiple sclerosis. While the research is in its early stages, the first safety testing in humans could begin within a year. "The beauty of the potential use of bone marrow is you don't have to go into the brain to remove nerve (stem) cells," said Dr. Jeffery Kocsis, associate director of the Neuroscience and Regeneration Research Center of Yale University. Kocsis and his colleagues have already transplanted specialised stem cells from adult bone marrow into rats and produced substantial regrowth of important nerve cells. In MS, stem cells from bone marrow would be used to regenerate the growth of myelin, the fatty coating that insulates nerve cells in the central nervous system and enables messages to be sent. In Canada, the Multiple Sclerosis Scientific Research Foundation is funding a project to find out whether transplanting bone marrow stem cells in MS can stop the disease. So far, the first four participants treated have come through the procedure safely. The study, at the University of Ottawa, involves 32 people with rapidly-progressing MS who are likely to become severely disabled. 24 will receive bone marrow transplantation. The other 8, who do not want the procedure, will be the control group. The study is led by neurologist Dr Mark Freedman and bone marrow transplant physician Dr Harold Atkins. Recruitment began in October 2000.

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STUDY SHOWS TAMOXIFEN CUTS FRACTURE RISK

Tamoxifen--taken orally as a tablet for more than 30 years to treat BREAST CANCER by interfering with the activity of the female hormone estrogen, which can promote cancer-- also reduces the risk of osteoporosis-related fractures, according to a new study. "The effects are almost instantaneous," said study author Dr. Andrew Cooke, head of radiation oncology at CancerCare Manitoba in Winnipeg, Manitoba, Canada. However, he added, "The risk goes right back up once you stop it. The good news is, it reduces fracture risk when you are on it. Once you stop, you are not protected." The findings are published in the Nov. 10 issue of the Journal of Clinical Oncology. Previous studies have found that women on tamoxifen have increased bone mineral density. And patients taking tamoxifen, compared to another class of breast cancer drugs, aromatase inhibitors, have a reduced risk of fracture. For the new study, Cooke and his colleagues compared more than 11,000 women aged 50 and older who had osteoporotic fractures of the spine, wrist or hip with more than 33,000 control patients who did not have fractures. All the women were matched for age, ethnicity and other health problems. The researchers also noted whether the women were currently taking tamoxifen, had done so in the past, or had never used the drug. Current use of tamoxifen reduced osetoporosis-related fracture risk overall by 32 percent and reduced hip fractures by 53 percent. "It obviously helps," said Cooke. But, he added, the study did not find that women who had taken tamoxifen in the recent past were protected against fractures. Breast cancer patients are known to be at increased risk for osteoporosis and all types of fractures because of the effects of chemotherapy and other drugs used to treat the disease. Tamoxifen is often used to treat patients with early stage breast cancer and those whose cancer has spread.

Aromatase inhibitors are also used in breast cancer treatment. They work by lowering the amount of estrogen in the body but have been associated with DECREASED BONE DENSITY, UPPING FRACTURE RISK.

The new study adds to information about tamoxifen's effects, said Dr. Christy Russell, associate professor of medicine at the University of Southern California Keck School of Medicine, and chair of the American Cancer Society's Breast Cancer Advisory Group. "We have known from large breast cancer trials comparing tamoxifen to aromatase inhibitors that the fracture rates were higher in [those who got] aromatase inhibitors than tamoxifen," she said. "But we had not known whether the fracture rate on tamoxifen was lower than in women not being given tamoxifen and given nothing. This study gives that information." Russell said the study results may cause some doctors to rethink when they prescribe tamoxifen and aromatase inhibitors. Currently, some doctors use aromatase inhibitors alone for postmenopausal breast cancer patients, while others use tamoxifen then aromatase inhibitors. The new findings may lend weight to the value of giving tamoxifen first, she said. Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer, said the take-home message from the new study was this: "If you switch from tamoxifen to aromatase inhibitors, or if you stop tamoxifen, you must be aware your osteoporosis risk may increase." Women should then ask their doctor how best to protect their bone health, he said.

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NEW DRUG FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS PATIENTS

A drug which was developed in Cambridge and initially designed to treat a form of leukemia has also proven effective against combating MULTIPLE SCLEROSIS.

The study, led by researchers from the University of Cambridge, has found that alemtuzumab not only stops MS from advancing in patients with early stage active relapsing-remitting multiple sclerosis (RRMS) but may also restore lost function caused by the disease. The findings were recently published in the New England Journal of Medicine.

The new study, found that alemtuzumab reduces the number of attacks experienced by people with relapsing-remitting multiple sclerosis by 74% over and above that achieved with interferon beta-1a, one of the most effective licensed therapies for similar cases of MS. More importantly, alemtuzumab also reduced the risk of sustained accumulation of disability by 71% compared to interferon beta-1a.

The investigators showed that many individuals in the trial who received alemtuzumab recovered some of their lost functions and so were less disabled after three years than at the beginning of the study, in contrast to worsening disability in the interferon beta-1a treated patients. These findings suggest that alemtuzumab may allow damaged brain tissue to repair, enabling the recovery of neurologic functions lost following poor recovery from previous MS attacks.

The new research shows that alemtuzumab is a much more effective treatment for early-stage RRMS than the currently approved drug interferon beta-1a. However, as the study was a Phase 2 clinical trial, additional research will need to be conducted before the drug is considered for approval in the treatment of MS.

"Alemtuzumab is the most promising experimental drug for the treatment of multiple sclerosis, and we are hopeful that the Phase 3 trials will confirm that it can both stabilize and allow some recovery of what had previously been assumed to be irreversible disabilities," according to the principal investigator Alastair Compston, Professor of Neurology and the Head of the Department of Clinical Neurosciences at the University of Cambridge. Alemtuzumab works by destroying one population of white blood cell (lymphocytes) and, by shutting down the immune system, inhibits the damage to brain tissue that occurs in MS.

The main side effect of treatment is, paradoxically, that people can develop other autoimmune diseases as the immune system gradually recovers following exposure to alemtuzumab. During the trial, 20% of people treated with alemtuzumab developed an over- or under-active thyroid gland. Rarely (3%) people developed a low platelet count and were vulnerable to bleeding. Although potentially very serious, this complication can be easily treated if recognised early.

The Phase 2 clinical study involved 334 patients who had been diagnosed with early-stage RRMS but had not previously been treated. The patients were followed for three years to determine the efficacy of the treatments as well as the effect on the patients' disabilities.

Until next month, eat well.

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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