Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group
- 7 September 2005
- journal article
- research article
- Published by Elsevier BV in Annals of Oncology
- Vol. 16 (11), 1762-1771
- https://doi.org/10.1093/annonc/mdi366
Abstract
Purpose: The aim of this study was to explore the effect of dose-dense sequential chemotherapy with or without paclitaxel primarily on disease-free survival (DFS) and secondarily on overall survival (OS) in patients with high-risk operable breast cancer. Patients and methods: From June 1997 until November 2000, 604 patients with T1–3N1M0 or T3N0M0 tumors were randomized to three cycles of epirubicin 110 mg/m2 followed by three cycles of paclitaxel 250 mg/m2 followed by three cycles of ‘intensified’ CMF (cyclophosphamide 840 mg/m2, methotrexate 47 mg/m2 and fluorouracil 840 mg/m2) (group A), or to four cycles of epirubicin followed by four cycles of CMF, as in group A (group B). All cycles were given every 2 weeks with granulocyte colony-stimulating factor support. Results: A total of 595 patients were eligible. Median follow-up was 61.7 months for group A and 62 months for group B. The 3-year DFS was 80% in group A and 77% in group B. Survival rates were 93% and 90%, respectively. The effect of treatment on the hazard of death was different according to hormonal receptor status. More specifically, in patients with negative receptor status the hazard of death was significantly higher for group B (hazard ratio 2.42). Both regimens were well tolerated and severe acute side-effects were infrequent. No cases of severe cardiotoxicity or acute leukemia were recorded. Conclusions: The present study failed to demonstrate a significant difference in DFS or OS between the two treatment groups. However, our study has shown clearly that high-dose paclitaxel can be safely incorporated to dose-dense sequential chemotherapy.Keywords
This publication has 19 references indexed in Scilit:
- Systematic review of taxane-containing versus non-taxane-containing regimens for adjuvant and neoadjuvant treatment of early breast cancerThe Lancet Oncology, 2004
- Randomized Trial of Dose-Dense Versus Conventionally Scheduled and Sequential Versus Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer: First Report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741Journal of Clinical Oncology, 2003
- Docetaxel and Doxorubicin Compared With Doxorubicin and Cyclophosphamide as First-Line Chemotherapy for Metastatic Breast Cancer: Results of a Randomized, Multicenter, Phase III TrialJournal of Clinical Oncology, 2003
- Are Anthracycline-Taxane Regimens the New Standard of Care in the Treatment of Metastatic Breast Cancer?Journal of Clinical Oncology, 2003
- Theoretical Concepts and the Emerging Role of Taxanes in Adjuvant TherapyThe Oncologist, 2001
- Dose-Dense Sequential Adjuvant Chemotherapy with Epirubicin, Paclitaxel and CMF in High-Risk Breast CancerOncology, 2001
- Dose-Dense Adjuvant Chemotherapy with Epirubicin Monotherapy in Patients with Operable Breast Cancer and ≥10 Positive Axillary Lymph NodesOncology, 1998
- Polychemotherapy for early breast cancer: an overview of the randomised trialsThe Lancet, 1998
- Ovarian ablation in early breast cancer: overview of the randomised trialsThe Lancet, 1996
- Sequential or Alternating Doxorubicin and CMF Regimens in Breast Cancer With More Than Three Positive NodesJama-Journal Of The American Medical Association, 1995