News Release

Adverse effects of chemotherapy may be under-reported

Peer-Reviewed Publication

Journal of the National Cancer Institute

Young breast cancer patients who receive chemotherapy may have a higher number of serious side effects than reported in clinical trials. According to a new study in the August 18 issue of the Journal of the National Cancer Institute, they may have higher health care expenditures than previously estimated.

Drug-related side effects account for an estimated 6.5% of all hospitalizations in the United States and 100,000 deaths per year. Some researchers believe that these effects are not adequately reported in clinical trials.

Michael J. Hassett, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues identified 12, 239 breast cancer patients age 63 and under through a database of medical claims made through employer-sponsored health insurance plans. They narrowed the poor to 7,052 patients who had made claims during hospitalizations and emergency room visits for side effects from chemotherapy and health care expenditures. Half received chemotherapy and half did not.

The authors observed that women who received chemotherapy were more likely to be hospitalized for side effects than those who did not. Chemotherapy recipients, on average, incurred $1,271 more per year in costs for medical expenses related to side effects and $17,617 more per year in costs for ambulatory care than women who did not receive chemotherapy.

The authors write, "Our results suggest that breast cancer chemotherapy may cause more patient suffering and higher health care costs than previously estimated. […] Health care providers must carefully decide whether trial results can be applied to routine clinical practice."

In an accompanying editorial, John K. Erban, M.D., and Joseph Lau, M.D., of Tufts New England Medical Center and Tufts University School of Medicine in Boston, suggest that the study's methodology may have excluded under-represented populations and racial and ethnic minorities but note that the results are "important and intriguing." They write, "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. […] Without careful long term tracking of late adverse effects, there is a risk that very important toxicity events will occur unnoticed."

  • Article: Bill Schaller, 617-632-5357,
  • Editorial: Catherine Bromberg,

    Citations: •

  • adverse effects in a population sample of women with breast cancer. J Natl Cancer Inst 2006;98:1108-1117.
  • Editorial: Erban JK, Lau J. On the toxicity of chemotherapy for breast cancer –the need for vigilance. J Natl Cancer Inst 2006;98:1096-1097.

    Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at

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