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The Impact of Taxotere on Adjuvant Breast Cancer
European Oncology Review, 2005:79-82
Adjuvant chemotherapy for breast cancer has undergone a major change over the past two decades. Results from the published update of the overview analysis indicate that administration of adjuvant chemotherapy significantly reduced the risk of recurrence by 23.5% and the risk of death by 15.3%.1 According to the same overview, the 10- year recurrence-free survival for node-positive patients treated with adjuvant chemotherapy was 47.6% for patients younger than 50 years old and 43.6% for those 50 to 69 years old. The 10-year overall survival (OS) was 53.8% and 48.6% respectively.
The recent overview analysis found overall a moderate but highly significant advantage of anthracycline over cyclophosphamide/ methotrexate/5-fluorouracil (5-FL) (CMF) (recurrence rate ratio 0.89 (SE 0.03); breast cancer death ratio 0.84 (SE 0.03)).2 In addition, the allocation of about six months of anthracyclines-based polychemotherapy (e.g. with 5-FL, doxorubicin and cyclophosphamide (FAC) or 5-FL, epirubicin and cyclophosphamide (FEC)) reduces the annual breast cancer death rate by about 38% for women younger than 50 years old when diagnosed and by about 20% for those aged 50 to 69 years old when diagnosed. This is largely irrespective of the use of tamoxifen and of oestrogen receptor status, nodal status or other tumour characteristics. Such regimens are significantly (2p=0.0001 for recurrence, 2p<0.00001 for breast cancer mortality) more effective than CMF chemotherapy.
Two trials provide important confirmatory information regarding the benefit of incorporating four courses of a taxane (paclitaxel) sequentially after four cycles of adjuvant chemotherapy in the adjuvant setting in node-positive patients. Mature results from Cancer and Leukemia Group B (CALGB) 9344 with 69 months of median follow-up demonstrated that the addition of four cycles of paclitaxel given at the dose of 175mg/m2 every three weeks improved recurrence-free survival (reduction in the hazard rate of recurrence, 17%, p=0.0023) and OS (reduction in the hazard rate of death, 18%, p=0.0064).3 The results of the second trial (National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28) have been published very recently.4
- Early Breast Cancer Trialist’s Collaborative Group, “Polychemotherapy for early breast cancer: an overview of the randomized trials”, Lancet (1998);352: pp. 930–942.
- Early Breast Cancer Trialist’s Collaborative Group, “Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials”, Lancet (2005);365: pp. 1,687–1,717.
- Henderson C, Berry D A, Demetri G D, et al., “Improved Outcomes From Adding Sequential Paclitaxel but Not From Escalating Doxorubicin Dose in an Adjuvant Chemotherapy Regimen for Patients With Node-Positive Primary Breast Cancer”, J. Clin. Oncol. (2003);21: pp. 976–983.
- Mamounas E P, Bryant J, Lembersky B, et al., “Paclitaxel. After Doxorubicin Plus Cyclophosphamide As Adjuvant Chemotherapy for Node-Positive Breast Cancer: Results From NSABP B-28”, J. Clin. Oncol. June 1, 2005;23: pp. 3,686–3,696.
- Chevallier B, Fumoleau P, Kerbrat P, et al., “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”, J. Clin. Oncol. (1995) Feb;13 (2): pp. 314–322.
- Fumoleau P, Chevallier B, Kerbrat P, Krakowski Y, Misset J-L, Maugard-Louboutin C, Dieras V, Azli N, Bougon N, Riva A, Roche H, “A multicentre Phase II study of the efficacy and safety of docetaxel as first-line treatment of advanced breast cancer: report of the Clinical Screening Group of the EORTC”, Ann. Oncol. (1996);7: pp. 165–171.
- Nabholtz J M, Falkson C, Campos D, et al., “Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomize multicentre, phase III trial”, J. Clin. Oncol. (2003);21: p. 2,048.
- Mackey J R, Paterson A, Dirix L Y, et al., “Final results of the phase II randomized trial comparing docetaxel (T), doxorubicin (A) and cyclophosphamide (C) to FAC as first line chemotherapy for patients with metastatic breast cancer”, Proc. Am. Soc. Clin. Oncol. (2002);21: p. 35a. abstract.
- Botenbal M, Braun J J, Creemers G J, et al., “Phase III study comparing AT (adriamycin, docetaxel) to FAC (fluorouracil, adriamycin, cyclophosphamide) as first-line chemotherapy in patients with metastatic breast cancer”, Eur. J. Cancer Suppl. (2003);1: p. S201.
- Valero V, Holmes F, Walters R S, et al., “Phase II trial of docetaxel a new highly effective agents in the management of patients with anthracycline-resistant metastatic breast cancer”, J. Clin. Oncol. (1995);13: pp. 2,886–2,894.
- Bellot R, Robert J, Dieras V et al., “Taxotere does not change the pharmacokinetic profile of doxorubicin and doxorubicinol”, Proc. Am. Soc. Clin. Oncol. (1998);17: p. 221a. abstract.
- Martin M, Tadeusz-Pienkowski M, Mackey J, et al., “Adjuvant docetaxel for node-positive breast cancer”, N. Engl. J. Med. (2005);352: pp. 2,302–2,313.
- Roché H, Fumoleau P, Spielmann M, et al., “6 Cycles of FEC 100 vs. 3 FEC 100 Followed by 3 Cycles of Docetaxel for Node-Positive Breast Cancer Patients: Analysis at 5 Years of the Adjuvant PACS 01 Trial”, SABCS (2005);27a abstract p. 27.
- Levine M N, Bramwell V H, Pritchard K I, et al., “Randomized trial of intensive cyclophosphamide, epirubicin and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate and fluorouracil in premenopausal women with node-positive breast cancer.”, J. Clin. Oncol. (1998);16: pp. 2,651–2,658.
- Fumoleau P, Kerbrat P, Romestaing, et al., “Randomized Trial Comparing Six Versus Three Cycles of Epirubicin-Based Adjuvant Chemotherapy in Premenopausal, Node-Positive Breast Cancer Patients: 10-Year Follow-Up Results of the French Adjuvant Study Group 01 Trial J”, Clin. Oncol. (2003);21 (2): pp. 298–305.
- Bonneterre J, Roche H, Kerbrat P, et al., “Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial”, J. Clin. Oncol. (2005);23 (12): pp. 2,686–2,693.
- Citron M L, Berry D A, Cirrincione C, et al., “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 9741”, J. Clin. Oncol. (2003);21 (8) pp. 1,431–1,439.