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

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.
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.
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%).
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.
AuthorsAntonio 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
JournalAnticancer research (Anticancer Res) 2002 Jul-Aug Vol. 22 Issue 4 Pg. 2471-6 ISSN: 0250-7005 [Print] Greece
PMID12174946 (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
  • 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

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