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High dose chemotherapy for breast cancer queried

Deborah Josefson, San Francisco

No evidence exists to support high dose chemotherapy rather than standard regimens for treating breast cancer, according to a report in the Lancet (1998;352:515-21).

Despite recent advances in detection, breast cancer recurrence is common. Some reports have suggested that high dose chemotherapy might be superior to standard treatments, and several small scale reports have also suggested an increase in disease free survival with high dose regimens compared with conventional treatments. Some centres routinely offer high dose, neoadjuvant chemotherapy to patients.

The Lancet report queries this trend. Ninety seven premenopausal women with node positive breast cancer and the presumed absence of visceral metastases were enrolled in a trial directed by Dr Sjoerd Rodenhuis at the Netherlands Cancer Institute in Amsterdam. The mean age of the study participants was 41. Node positivity was determined by infraclavicular node biopsy. Blood tests and liver ultrasound examinations were performed to exclude metastatic disease. A total of 81 patients ultimately participated in the trial, and 35 of them remained in the high dose group. All the women underwent three cycles of presurgical conventional chemotherapy with cyclophosphamide, epirubicin, and fluorouracil every week for three weeks. Most patients elected to undergo modified radical mastectomy with axillary node dissection, but 16 had lumpectomy and axillary node dissection instead.

Surgery was followed by randomisation into two groups. In one surgery was followed by a fourth course of conventional chemotherapy and two years of tamoxifen; the other received this treatment followed by a fifth course of high dose chemotherapy. The high dose group also received tamoxifen for two years.

Both standard and high dose treatments were moderately well tolerated. All of the patients who received high dose chemotherapy, however, became irreversibly infertile. Follow up continued for up to 72 months, with a mean of 49 months. During that time no significant differences were detected in either overall survival or disease free survival. Forty nine patients relapsed during treatment, half having received conventional treatment and half high dose treatment. Twenty nine patients died--10 had received high dose treatment and 11 conventional treatment. (The remaining eight were not randomised.)

The authors concluded that high dose chemotherapy should be given only in the setting of a randomised clinical trial.
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