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

Autor: Silvano Palazzo, G Pistillucci, Sergio Palmeri, Rossella Lauria, Vincenzo Adamo, Vito Lorusso, G. Petrella, S. De Placido, C. Pagliarulo, L. Manzione, M. De Lena, M. De Laurentiis, A. Paradiso, M. D'Aprile, Maria Giuseppa Sarobba, Gennaro Limite, Antonio Farris, F. Ferraù, R. Costanzo, Ar Bianco
Přispěvatelé: DE PLACIDO S, DE LAURENTIIS M, DE LENA M, LORUSSO V, PARADISO A, DAPRILE M, PISTILLUCCI G, FARRIS A, SAROBBA MG, PALAZZO S, MANZIONE L, ADAMO V, PALMERI S, FERRAU F, LAURIA R, PAGLIARULO C, PETRELLA G, LIMITE G, COSTANZO R, BIANCO AR
Rok vydání: 2005
Předmět:
Zdroj: British Journal of Cancer
ISSN: 1532-1827
0007-0920
DOI: 10.1038/sj.bjc.6602355
Popis: 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.
Databáze: OpenAIRE