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 x 6 cycles (CMF); (b) doxorubicin x 4 cycles followed by CMF x 6 cycles (A --> CMF); (c) CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (CMF --> GT); and (d) doxorubicin x 4 cycles followed by CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (A --> CMF --> GT). The study used a 2 x 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..

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 / DE PLACIDO, Sabino; DE LAURENTIIS, Michelino; DE LENA, M; Lorusso, V; Paradiso, A; D'Aprile, M; Pistillucci, G; Farris, A; Sarobba, Mg; Palazzo, S; Manzione, L; Adamo, V; Palmeri, S; Ferrau, F; Lauria, Rossella; Pagliarulo, C; Petrella, Giuseppe; Limite, Gennaro; Costanzo, Raffaele; Bianco, Ar; GOCSI COOPERATIVE, G. R. O. U. P.. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - STAMPA. - 92:(2005), pp. 467-474.

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.

DE PLACIDO, SABINO;DE LAURENTIIS, MICHELINO;LAURIA, ROSSELLA;PETRELLA, GIUSEPPE;LIMITE, GENNARO;COSTANZO, RAFFAELE;
2005

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 x 6 cycles (CMF); (b) doxorubicin x 4 cycles followed by CMF x 6 cycles (A --> CMF); (c) CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (CMF --> GT); and (d) doxorubicin x 4 cycles followed by CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (A --> CMF --> GT). The study used a 2 x 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
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 / DE PLACIDO, Sabino; DE LAURENTIIS, Michelino; DE LENA, M; Lorusso, V; Paradiso, A; D'Aprile, M; Pistillucci, G; Farris, A; Sarobba, Mg; Palazzo, S; Manzione, L; Adamo, V; Palmeri, S; Ferrau, F; Lauria, Rossella; Pagliarulo, C; Petrella, Giuseppe; Limite, Gennaro; Costanzo, Raffaele; Bianco, Ar; GOCSI COOPERATIVE, G. R. O. U. P.. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - STAMPA. - 92:(2005), pp. 467-474.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/103624
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