3-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer: a pilot study.

Abstract

BACKGROUND:

Docetaxel has proven efficacy in metastatic breast cancer. In this pilot study, we explored the efficacy/feasibility of docetaxel-based sequential and combination regimens as adjuvant therapy of node-positive breast cancer.

PATIENTS AND METHODS:

From March 1996 till March 1998, four consecutive groups of patients with stages II and III breast cancer, aged < or = 70 years, received one of the following regimens: a) sequential Doxorubicin (A) --> Docetaxel (T) --> CMF (Cyclophosphamide+Methotrexate+5-Fluorouracil): A 75 mg/m q 3 wks x 3, followed by T100 mg/m2 q 3 wks x 3, followed by i.v. CMF Days 1+8 q 4 wks x 3; b) sequential accelerated A --> T --> CMF: A and T administered at the same doses q 2 wks with Lenograstin support; c) combination therapy: A 50 mg/m2 + T 75 mg/m2 q 3 wks x 4, followed by CMF x 4; d) sequential T --> A --> CMF: T and A, administered as in group a), with the reverse sequence. When indicated, radiotherapy was administered during or after CMF, and Tamoxifen after CMF.

RESULTS:

Ninety-three patients were treated. The median age was 48 years (29-66) and the median number of positive axillary nodes was 6 (1-25). Tumors were operable in 94% and locally advanced in 6% of cases. Pathological tumor size was >2 cm in 72% of cases. There were 21 relapses, (18 systemic, 3 locoregional) and 11 patients (12%) have died from disease progression. At median follow-up of 39 months (6-57), overall survival (OS) was 87% (95% CI, 79-94%) and disease-free survival (DFS) was 76% (95% CI, 67%-85%).

CONCLUSION:

The efficacy of these docetaxel-based regimens, in terms of OS and DFS, appears to be at least as good as standard anthracycline-based adjuvant chemotherapy (CT), in similar high-risk patient populations.

• Authors: Antonio Fabiano Ferreira Filho, John Crown, Fatima Cardoso, Jean-Marie Nogaret, Karen Duffy, Stella Dolci, Susan Rowan, Niall O'Higgins, Veronique Batter, Marianne Paesmans, Martine J Piccart, Angelo Di Leo
• Journal: Anticancer research (Anticancer Res) 2002 Jul-Aug Vol. 22 Issue 4 Pg. 2471-6 ISSN: 0250-7005 [Print] Greece
• PMID: 12174946 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Tamoxifen
• docetaxel
• Doxorubicin
• Paclitaxel
• Cisplatin
• Fluorouracil
• Methotrexate

Topics

• Adolescent
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Breast Neoplasms (drug therapy, mortality, pathology)
• Chemotherapy, Adjuvant
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Doxorubicin (administration & dosage)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Lymphatic Metastasis
• Methotrexate (administration & dosage)
• Middle Aged
• Paclitaxel (administration & dosage, analogs & derivatives, therapeutic use)
• Phytotherapy
• Pilot Projects
• Survival Rate
• Tamoxifen (administration & dosage)
• Taxoids
• Time Factors
• Treatment Outcome