Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer

D. Khayat, P. Chollet, E. C. Antoine, S. Monfardini, G. Ambrosini, A. Benhammouda, M. F. Mazen, R. Sorio, O. Borg-Olivier, A. Riva, C. Ramazeilles, N. Azli

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Abstract

Purpose: To evaluate the feasibility and efficacy of a sequential administration of four cycles of docetaxel (100 mg/m2 every 3 weeks) followed by four cycles of doxorubicin and cyclophosphamide (AC; 60/600 mg/m2 every 3 weeks), with subsequent consolidation with docetaxel or AC, as first-line chemotherapy in patients with metastatic breast cancer (MBC). Patients and Methods: Forty-eight patients received 443 cycles of chemotherapy (median, 11 cycles/patient; range, 1 to 13 cycles). A total of 267 cycles of docetaxel (60.3%) and 176 of AC (39.7%) were given. Consolidation therapy was given to 33 patients (29 with docetaxel). Results: Grade 4 neutropenia was the most frequent toxicity (83% of patients). This was not cumulative and was rarely complicated by febrile neutropenia or severe infection. The nonhematologic safety profile was favorable: there were no grade 4 adverse events, and grade 3 episodes were infrequent. Docetaxel-specific toxicities were generally not severe. With a median cumulative doxorubicin dose of 397 mg/m2 (range, 150 to 543 mg/m2), two incidences of unrelated congestive heart failure after further treatment with anthracyclines and two of asymptomatic left ventricular ejection fraction decrease were observed. Among the 42 assessable patients, five (12%) had complete and 25 (60%) had partial responses, for an overall response rate of 71% (95% confidence interval, 55% to 84%). Median duration of response was 53 weeks (range, 12 to 72 weeks), and median time to progression was 46 weeks (range, 3 of 72 weeks). With a median follow-up of 40.4 months, median survival was 32 months (range, 2 to 55 months). Conclusion: This docetaxel-based sequential schedule is safe and effective in first-line therapy for MBC, without incurring cumulative toxicity, and provides a feasible chemotherapeutic option in this clinical setting.

Original languageEnglish
Pages (from-to)3367-3375
Number of pages9
JournalJournal of Clinical Oncology
Volume19
Issue number14
Publication statusPublished - Jul 15 2001

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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