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European Trials Show Dose-Related Efficacy of Docetaxel In Metastatic Breast Cancer, Value of Steroid Pretreatment

European Trials Show Dose-Related Efficacy of Docetaxel In Metastatic Breast Cancer, Value of Steroid Pretreatment

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 (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, 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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