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Healing With 'Vigilance'

Healing With 'Vigilance'Commenting on a recent study of the effect of chemotherapy on younger breast cancer patients, two Tufts researchers warn against drawing hasty conclusions from clinical trials.

Boston [10.16.06] In an editorial published recently in the Journal of the National Cancer Institute, Tufts School of Medicine Associate Professor John Erban and Professor Joseph Lau commented on a study showing that younger breast cancer patients undergoing chemotherapy treatment suffer from more serious side effects than once thought. Erban and Lau warn that clinical trials designed to test a drug's effectiveness may be inadequate in pinpointing certain toxicities in the long term.

"Clinical trials in cancer are usually powered to assess endpoints such as disease-free and overall survival, rather than the toxicities of interventions," Erban—director of Tufts-New England Medical Center’s breast cancer program—and Lau—director of its Evidence-based Practice Center (an initiative of the federal Agency for Healthcare Research and Quality)—wrote in the editorial entitled "On the Toxicity of Chemotherapy for Breast Cancer—the Need for Vigilance."

The study in the Journal, authored by Dr. Michael J. Hassett of Boston's Dana-Farber Cancer Institute and colleagues, found that breast cancer patients under the age of 64 experienced side effects from chemotherapy at rates three to four times higher than previously indicated. The study acknowledges a difficulty in the medical community in predicting which women will suffer ill effects from chemotherapy and which will not.

The Tufts authors supported the continued development of patient-focused treatments, but warned against complacency in tracking the side effects associated with such therapies.

"As we enter the new era of targeted therapies, we must be especially vigilant for the potential of late adverse effects," they wrote. "As new drugs of increasing efficacy and few acute toxicities emerge, the tendency will be to push them to market, and there will be few incentives for longer term toxicity studies."

According to Erban and Lau, younger breast cancer survivors need to be particularly mindful of their cardiovascular and bone health, since they are key indices of long-term toxicity from chemotherapy drugs.

"Because the survival benefit of a few percentage points estimated by these studies may be offset by acute, chronic and late-onset toxicities, it is important to be aware that events such as heart attacks and hip fractures may not emerge for years or even decades after treatment," they wrote.

A long-term perspective is needed in clinical trials in order to comprehensively evaluate toxicity risks, the researchers wrote.

"Without careful long-term tracking of late adverse effects, there is a risk that very important toxicity events will occur unnoticed," Erban and Lau wrote in the editorial. "Moreover, current trial design is incapable of assessing the toxicities that may occur from rapid sequential use of novel agents."

They cited the need for improvement in the reporting of data from clinical trials.

"The poor reporting of harms data in clinical trials is a widespread problem in many areas, including oncology," the Tufts researchers wrote. "Effort should be directed at establishing standards of reporting and collection of this information from future breast cancer clinical trials."

The faultiness of certain clinical studies in determining potentially fatal side-effects from chemotherapy, they contend, show the limitations of such studies.

"Clinical trials data are only an estimate of the worth of a drug," they said. "Healthy skepticism and diligent reporting of potential toxicities should continue even after an agent enters general use."

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