Journal of Clinical Oncology, Vol 13, 314-322, Copyright © 1995 by American Society of Clinical Oncology
Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer
B Chevallier, P Fumoleau, P Kerbrat, V Dieras, H Roche, I Krakowski, N Azli, M Bayssas, MA Lentz and M Van Glabbeke
Centre Regional de Lutte Contre le Cancer Rouen, France.
PURPOSE: This trial investigated the toxicity and efficacy of docetaxel as
first-line chemotherapy in women with heavily pretreated advanced breast
cancer. PATIENTS AND METHODS: From April 1992 to August 1992, 35 patients
with advanced breast cancer from 29 to 65 years of age with a performance
status of 0 to 2 were entered onto the study. Docetaxel 100 mg/m2 was
administered every 3 weeks as a 1-hour infusion on day 1 without routine
premedication for hypersensitivity reactions. Thirty- one patients were
assessable for response. Previous adjuvant chemotherapy had been given to
11 patients. RESULTS: Five complete responses (CRs) and 16 partial
responses (PRs) were observed, for an overall response rate of 67.7% (95%
confidence interval, 49% to 83%). A CR occurred at 13 of 45 assessable
sites (four liver, two lung, three breast, three lymph node, and one skin).
The median duration of response was 44+ weeks, the median time to disease
progression 37+ weeks, and the median overall survival time 16+ months.
Among 34 patients assessable for toxicity (177 cycles; median, five cycles
per patient), the following side effects were reported: nadir neutropenia
grade 3 (three patients); grade 4 (31 patients); no grade 3 to 4 infection,
acute hypersensitivity-like reaction (10 patients); grade 2 to 3 alopecia
(all patients); and grade 2 to 3 nausea and vomiting (six patients). Fluid
retention occurred in 26 patients and consisted of weight gain, edema alone
(15 patients), or edema associated with serous effusion (11 patients). This
side effect led to treatment discontinuation in 16 of 21 responding
patients after a median of five cycles and a median cumulative dose of
docetaxel of 574 mg/m2. CONCLUSION: Our data suggest that docetaxel has
major antitumor activity when used as a single cytotoxic agent as
first-line chemotherapy in advanced breast cancer.
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