“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”

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

Risultato della ricerca: Articlepeer review

24 Citazioni (Scopus)

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. © 2005 Cancer Research UK.
Lingua originaleUndefined/Unknown
pagine (da-a)467-474
RivistaBritish Journal of Cancer
Volume92
Stato di pubblicazionePublished - 2005

All Science Journal Classification (ASJC) codes

  • ???subjectarea.asjc.2700.2730???
  • ???subjectarea.asjc.1300.1306???

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