A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer

Sabino De Placido, Michele De Laurentiis, Mario De Lena, Vito Lorusso, Angelo Paradiso, Modesto D'Aprile, Giorgio Pistillucci, Antonio Farris, Maria Giuseppina Sarobba, Salvatore Palazzo, Luigi Manzione, Vincenzo Adamo, Sergio Palmeri, Francesco Ferraù, Rossella Lauria, Clorindo Pagliarulo, Giuseppe Petrella, Gennaro Limite, Raffaele Costanzo, Angelo Raffaele Bianco

Research output: Contribution to journalArticlepeer-review

Abstract

The sequential doxorubicin → CMF (CMF = cyclophosphamide, methotrexate, fluorouracil) regimen has never been compared to CMF in a randomised trial. The role of adding goserelin and tamoxifen after chemotherapy is unclear. In all, 466 premenopausal node-positive patients were randomised to: (a) CMF × 6 cycles (CMF); (b) doxorubicin × 4 cycles followed by CMF × 6 cycles (A → CMF); (c) CMF × 6 cycles followed by goserelin plus tamoxifen × 2 years (CMF → GT); and (d) doxorubicin × 4 cycles followed by CMF × 6 cycles followed by goserelin plus tamoxifen × 2 years (A → CMF → GT). The study used a 2 × 2 factorial experimental design to assess: (1) the effect of the chemotherapy regimens (CMF vs A × CMF or arms a + c vs b + d) and (2) the effect of adding GT after chemotherapy (arms a + b vs c + d). At a median follow-up of 72 months, A → CMF as compared to CMF significantly improved disease-free survival (DFS) with a multivariate hazard ratio (HR) = 0.740 (95% confidence interval (CI): 0.556-0.986; P = 0.040) and produced a nonsignificant improvement of overall survival (OS) (HR = 0.764; 95% CI: 0.489-1.193). The addition of GT after chemotherapy significantly improved DFS (HR = 0.74; 95% CI: 0.555-0.987; P = 0.040), with a nonsignificant improvement of OS (HR = 0.84; 95% CI: 0.54-1.32). A → CMF is superior to CMF. Adding GT after chemotherapy is beneficial for premenopausal node-positive patients.

Original languageEnglish
Pages (from-to)467-474
Number of pages8
JournalBritish Journal of Cancer
Volume92
Issue number3
DOIs
Publication statusPublished - Feb 14 2005

Keywords

  • Adjuvant therapy
  • Anthracyclines
  • Breast cancer
  • Chemoendocrine treatment
  • Premenopausal

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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