CMF vs alternating CMF/EV in the adjuvant treatment of operable breast cancer. A single centre randomised clinical trial (Naples GUN-3 study)

S. De Placido, F. Perrone, C. Carlomagno, A. Morabito, C. Pagliarulo, R. Lauria, A. Marinelli, M. De Laurentiis, E. Varriale, G. Petrella, C. Gallo, A. R. Bianco

Research output: Contribution to journalArticle

Abstract

The aim of this study was to test the hypothesis of Goldie and Coldman that the use of non-cross-resistant regimens of chemotherapy could lead to maximal anti-tumour effect. We compared standard CMF (cyclophosphamide, methotrexate, fluorouracil) with alternating CMF/EV (epirubicin, vincristine) in the adjuvant therapy of early breast cancer. Stage II premenopausal node-positive or post-menopausal node-positive oestrogen receptor-negative and stage III breast cancer patients were eligible for the study. From January 1985 to December 1990, 220 patients were randomised (115 to CMF and 105 to CMF/EV). Toxicity was mild; neurotoxicity, vomiting and hair loss were more frequent in the CMF/EV group, while permanent amenorrhoea, diarrhoea, stomachache and minor infections occurred more often in the CMF arm. At a follow-up of 48 months, 113 patients (51.4%) had had recurrence (62 on CMF and 51 on CMF/EV) and 54 (24.5%) had died (30 on CMF and 24 on CMF/EV). There was no significant difference in disease-free and overall survival between the two arms. After adjusting for menopausal status and stage, the relative risk (RR) of recurrence for CMF/EV patients was 0.93 (95% CL 0.64-1.35), while the RR of death was 0.85 (95% CL 0.49-1.47). In conclusion, the Goldie-Coldman model of alternating therapy is not confirmed in this trial of adjuvant therapy of early breast cancer, although in view of its design a difference of less than 20% in 3 year disease-free survival could not be excluded.

Original languageEnglish
Pages (from-to)1283-1287
Number of pages5
JournalBritish Journal of Cancer
Volume71
Issue number6
Publication statusPublished - 1995

Keywords

  • Adjuvant chemotherapy
  • Alternating regimens
  • Early breast cancer
  • Goldie-Coldman hypothesis
  • Randomised clinical trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    De Placido, S., Perrone, F., Carlomagno, C., Morabito, A., Pagliarulo, C., Lauria, R., Marinelli, A., De Laurentiis, M., Varriale, E., Petrella, G., Gallo, C., & Bianco, A. R. (1995). CMF vs alternating CMF/EV in the adjuvant treatment of operable breast cancer. A single centre randomised clinical trial (Naples GUN-3 study). British Journal of Cancer, 71(6), 1283-1287.