Published in:
01-05-2008 | Clinical Trial
A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: results of the ERASME 3 study
Authors:
Philippe A. Cassier, Sylvie Chabaud, Véronique Trillet-Lenoir, Pierre-Yves Peaud, Jean-Dominique Tigaud, Hervé Cure, Hubert Orfeuvre, Bruno Salles, Claude Martin, Jean-Philippe Jacquin, Cecile Agostini, Jean-Paul Guastalla, David Pérol, Thomas Bachelot
Published in:
Breast Cancer Research and Treatment
|
Issue 2/2008
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Abstract
Purpose In first-line metastatic breast cancer, both paclitaxel (P)-doxorubicin (A) and docetaxel (D)-doxorubicin (A) combinations have shown superiority over treatments without taxane. The aim of this study was to compare the two combinations. Patients and methods
Chemotherapy-naive (except for adjuvant therapy) metastatic breast cancer patients were randomly assigned to intravenous AD (arm D) or AP (arm P) every 3 weeks for a maximum of four cycles, then four cycles of single agent docetaxel (arm D) or paclitaxel (arm P). Primary endpoint was overall quality of life (QoL) measured by EORTC QLQ-C30 after four courses of doxorubicin–taxane combination. Secondary endpoints were toxicity, overall survival (OS), progression-free survival (PFS), and QoL sub-scores. Results
Between March 2000 and April 2004, 210 patients were randomized: 103 to arm P and 107 to arm D. Patient characteristics were well balanced between arms. After four courses, QoL score differences between groups or compared to baseline scores were not significant. Response rate was 39.6% for AD and 41.8% for AP. After a median follow-up of 50.2 months, median PFS and median OS were 8.7 and 21.4 months in arm D and 8.0 and 27.3 months in arm P (p = 0.977 and 0.081, respectively). Hematological toxicity was significantly more frequent in arm D than in arm P (p < 10−6), as well as grades 3–4 asthenia (p = 0.03). Neuropathy occurred more frequently in arm P (p = 0.03). Conclusion In this study, paclitaxel or docetaxel combined with doxorubicin were not significantly different in terms of QoL scores and efficacy, but had different toxicity profiles.