It is well known that chemotherapy has adverse, often toxic, effects, but the decision to undergo such difficult treatment rarely takes into account the critical issue of quality of life. Aggressive treatment may prolong survival, but how much of the extended time is compromised by chemotherapy-related illnesses?

This question is the basis of a new and highly unusual analysis of nine clinical trials involving nearly 4,000 women treated for breast cancer. All study participants were age 50 years or older and had node-positive, or stage II, breast cancer (evidence of cancer in the lymph nodes).

The new analysis was conducted by an international team headed by Dr. Richard D. Gelber of the Harvard Medical School (The Lancet, 20 April 1996). It devised a statistical method for measuring the quality-of-life differences between the women given the relatively nontoxic endocrine drug, tamoxifen, and those given chemotherapy and tamoxifen. Also included in the mix is another important question: How important to a woman is a reduced rate of cancer recurrence, even if it has little effect on her survival? Most chemotherapy trials show that the drugs delay cancer recurrence but do not extend life.

The statistical method used to weigh these crucial elements was based on a meta-analysis of quality-adjusted survival. The findings favored the women taking tamoxifen alone.

At the seven year follow-up, women given chemotherapy plus tamoxifen had a 26% lower rate of recurrence, but there was no significant difference in survival between the two groups. There is no standard chemo regimen for stage II breast cancer; the participants were taking any one of several three- to five-drug regimens for 2-24 months, thus reflecting the same variations in treatment given outside clinical trials.

The value of chemotherapy to older women was in doubt until a decade ago, when studies showed a reduced rate of recurrence. (Women over age 50 are the overwhelming majority of those diagnosed with breast cancer.) Now virtually all women with breast cancer are given chemotherapy with or without tamoxifen.

Often physicians don't explain to their patients that a multiple drug regimen following initial treatment with surgery or radiation does not always translate into prolonged survival. (See Questioning Chemotherapy by Ralph Moss, Ph.D., Book Review, HealthFacts, July 1995).

But cancer recurrence is very upsetting, and many women with breast cancer would accept drug treatment even if delaying the return of cancer were its only benefit. And most would accept the adverse effects of chemotherapy for the possibility of prolonged survival, according to a survey cited by Dr. Gelber and colleagues in which 104 women who had received three-drug chemotherapy were presented with different hypothetical scenarios: "Suppose that without treatment you would live five years. Based on your experience of chemotherapy, what period of survival would make six months of initial treatment worthwhile?" Responses showed that 77% of the women would accept the chemotherapy for as little as 12 additional months of survival time, and 89% would accept it for an additional 24 months of survival.

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