Randomised Trial: One Cycle of Anthracycline-Containing Adjuvant Chemotherapy Compared With Six Cycles of CMF Treatment in Node-Positive, Hormone Receptor-Negative Breast Cancer Patients

Onkologie. 2003 Apr;26(2):115-9. doi: 10.1159/000069831.

Abstract

Aim: A randomised, controlled clinical trial was initiated in 1984 to test whether 1 cycle of anthracycline-containing adjuvant chemotherapy improves the outcome of breast cancer patients presenting with stage II disease and negative oestrogen and progesterone receptors (ER, PgR), as compared with 6 cycles of dose-reduced CMF.

Patients and methods: Within 7 years 263 women with stage II breast cancer were randomised either to receive 1 cycle of doxorubicin, vinblastine, cyclophosphamide, methotrexate and 5- fluorouracil (AV-CMF) or to receive 6 cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF). Patients were stratified for tumour stage, nodal stage, menopausal status, type of surgery and participating centre.

Results: After a median follow-up of 100 months, neither disease-free (DFS) nor overall survival (OS) differed significantly between the two groups.

Conclusions: Compared to 6 cycles of a non-standard low-dose CMF regimen 1 cycle of anthracycline- containing adjuvant chemotherapy failed to improve the outcome in women with stage II receptor-negative breast cancer in terms of DFS and OS.

Publication types

  • Clinical Trial
  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Carcinoma, Ductal, Breast / drug therapy*
  • Carcinoma, Ductal, Breast / mortality
  • Carcinoma, Ductal, Breast / pathology
  • Carcinoma, Lobular / drug therapy*
  • Carcinoma, Lobular / mortality
  • Carcinoma, Lobular / pathology
  • Chemotherapy, Adjuvant
  • Cisplatin / adverse effects
  • Cisplatin / therapeutic use
  • Combined Modality Therapy
  • Cyclophosphamide / adverse effects
  • Cyclophosphamide / therapeutic use
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use
  • Drug Administration Schedule
  • Female
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use
  • Humans
  • Lymphatic Metastasis
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use
  • Middle Aged
  • Neoplasm Staging
  • Receptors, Estrogen / analysis
  • Receptors, Progesterone / analysis
  • Survival Rate
  • Vincristine / adverse effects
  • Vincristine / therapeutic use

Substances

  • Receptors, Estrogen
  • Receptors, Progesterone
  • Vincristine
  • Doxorubicin
  • Cyclophosphamide
  • Cisplatin
  • Fluorouracil
  • Methotrexate

Supplementary concepts

  • CMF protocol
  • CMFDV protocol