LISBON, Portugal--Studies from the Breast Cancer Cooperative Group and the Clinical Screening Group of the Euro-pean Organization for Research and Treatment of Cancer (EORTC) have spotlighted docetaxel(Drug information on docetaxel) (Taxotere) as a promising second- and first-line treatment for metastatic breast cancer. What's more, the EORTC findings indicate that steroid premedication can delay the fluid retention that frequently limits therapy with this taxoid.
[See "FDA Oncology Drugs Committee Fails to Recommend Taxotere and Ethyol" for a report on the recent decision by the FDA's Oncology Drugs Advisory Committee not to recommend docetaxel for approval.]
Dr. Martine J. Piccart, of Institut Jules Bordet, Brussels, who chairs the EORTC Breast Cancer Cooperative Group, explained that the Group's objective was twofold: to assess the efficacy of a new docetaxel schedule, 50 mg/m² on days 1 and 8 every 3 weeks, in women who had previously undergone therapy for advanced or metastatic disease, and to compare the incidence of fluid retention and dermatologic side effects with and without premedication.
Thus, the 70 participants were randomized to receive an antihistamine alone or in combination with methylprednisolone(Drug information on methylprednisolone), 40 mg orally for 3 days, starting the day before each docetaxel dose.
"The interesting finding of this study," Dr. Piccart said, "was that corticosteroids do make a difference in the onset of the fluid retention phenomenon." Steroid pretreatment significantly delayed the development of docetaxel-associated edema and pleural effusion.
Dr. Piccart also noted that premed-ication with steroids appeared to blunt the severity of pleural effusion and reduce the need for pleural drainage. However, steroids had no impact on the incidence of hematologic toxicity, which was not pronounced, or on the frequency of nonhematologic side effects, including skin and nail reactions.
"The good news is the antitumor activity of the drug," Dr. Piccart said. Intention-to-treat analysis revealed a response rate of 37.1% (95% confidence interval, 25% to 49%) in these heavily pretreated patients, with a 7½-month median duration of response and a 5-month time-to-progression interval.
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