Clinical Trials
for Older Patients

June 7, 1998 One of the stereotypes prostate cancer survivors have to fight is the idea of this as an "old man's disease." In fact, as a recent Veteran Affairs study found, prostate cancer typically begins well before old age, in a man's fifties. And a significant number of men are diagnosed with aggressive disease in their early forties.
     At the same time, today elderly cancer patients are at last getting more attention. Prostate cancer patients may want to watch this trend. Many men are indeed diagnosed around retirement age. Some older men with prostate cancer may want to enter clinical trials. Others may want to be assured that the drugs they rely on have been tested on men of their own age.
     

Medicare Coverage for Clinical Trials

Trials Designed for Older Patients

Elderly Stay Away from Clinical Trials

Why is limelight falling on the elderly patient? Several things are happening at once. Firstly, the population is aging. Secondly, researchers have woken up to relative neglect of older cancer patients. Efforts are under way to attract these patients into clinical trials.
     "Cancer researchers are realizing that we must improve our understanding of the treatment needs of elderly cancer patients," says Dr. Frank Haluska, MD, Ph.D. of Massachusetts General Hospital. At the ASCO meeting in Los Angeles this May, Dr. Haluska said the elderly are under-represented in major clinical trials.
     The biotech industry is racing to create better cancer drugs. More people are needed as subjects for testing these drugs. Industry and medical researchers are hoping older cancer patients will enter trials. Why has this not happened up till now? The official view is, seniors have had a hard time participating in trials because of uncertainty over whether Medicare will pay for all the required tests.

Medicare Coverage for Clinical Trials
Patient organizations and oncologists are calling for swift passage of the Medicare Cancer Clinical Trials Coverage Act (S.381). The bipartisan bill has been introduced in the House by Representatives Nancy Johnson (R-CT) and Benjamin Cardin (D-MD); it is also backed by Senator Jay Rockefeller (D-WV) and Senator Connie Mack (R-FL).
     The bill would establish a five-year demonstration project to guarantee Medicare recipients coverage of routine costs in high quality, peer-reviewed cancer clinical trials. Typically, the costs in question are for tests (CAT scans, bone scans, etc.) needed to record the patients' status at the beginning of the trial and to prove the drug's effects as the trial proceeds.
     Even though federal regulations state that Medicare will cover usual patient care costs provided in research settings, some Medicare carriers deem such care part of an "experimental" procedure, and deny coverage. This may discourage some patients from participating in trials or force them to make special efforts to ensure coverage.
     Senators Rockefeller and Mack are asking the cancer community to work to secure more Senate cosponsors for the Medicare Cancer Clinical Trials Coverage Act. The bill has already secured 21 cosponsors.

Trials Designed for Older Patients
New evidence that older cancer patients need drugs specially designed for their age group — and of how this affects trials — comes from women with breast cancer. A study presented at the ASCO meeting finds that "elderly patients whose breast cancer has spread to the lymph nodes do not appear to be able to tolerate standard chemotherapy using the more toxic drug Methotrexate as well as younger patients."
     This study of more than a thousand women found that "elderly patients experienced increased toxicity with full dose of standard chemotherapy CMF (Cyclophosphamide, Methotrexate, 5-Fluorouracil)." Patients over 65 years of age experienced more toxicity than younger patients. Patients over the age of 70 had more side effects than any other group.
     The researchers say: "This finding will help physicians tailor oncology care to this patient population, providing as much active treatment as can be tolerated, and selecting the most appropriate active drugs available." So far, no special trials have been designed to examine effects of drugs on older prostate cancer patients.

Elderly Stay Away from Clinical Trials
According to one of the largest clinical trial groups in the USA, less than half the expected number of patients over 65 enroll in clinical trials. This estimate is based on information stored in the National Cancer Institute (NCI) nationwide cancer registry, known as SEER (Surveillance, Epidemiology and End Results).
     In the USA, information about everyone who is treated for cancer is entered in SEER. So the researchers were able to check the makeup of clinical trials against the national "population" of all US cancer patients. Southwest Oncology Group (SWOG) checked SEER and found that the elderly represented only 25% of participants in their trials, compared to 63% in the registry.
     This was not true for enrollment by gender and race. Women make up 41% of patients in SWOG clinical trials and 43% of those registered as having cancer. African Americans make up 10% in each category.

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