PURPOSE: The aim of this multicentric randomized trial was to determine whether reducing the interval between surgery and chemotherapy improves the outcome of breast cancer patients. PATIENTS AND METHODS: Between June 1985 and July 1992, 600 breast cancer patients, clinical stages T1-3A,N0-2,M0 were randomly assigned to a perioperative cycle (PC) of cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF). Node-negative (N-) patients did not receive any further treatment. Node positive (N+) patients received 11 cycles if previously given PC, or 12 cycles of CEF alternated with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 (CMF). In addition, N+ patients received concomitant or sequential 5-year tamoxifen therapy. RESULTS: At a median follow-up duration of 5.7 years, no significant difference in survival (88% v 84%, P = .3) between the two treatment arms was seen. However, a difference of borderline significance in relapse-free survival (RFS; 76% v 70%, P = .053) was evident. A significant survival advantage for the PC arm was detected only in the estrogen receptor-negative (ER-) patients (P = .003). RFS was significantly improved in N- patients, postmenopausal patients, and ER- patients. Multivariate analyses show that pathologic tumor size, nodal status, receptor status, and treatment (only in ER- patients) are significantly correlated with survival and RFS. PC toxicity did not influence wound healing. CONCLUSION: This study provides preliminary evidence that PC positively affects relapse rate and survival in some subgroups, namely, ER- patients.
RCT Entities:
PURPOSE: The aim of this multicentric randomized trial was to determine whether reducing the interval between surgery and chemotherapy improves the outcome of breast cancerpatients. PATIENTS AND METHODS: Between June 1985 and July 1992, 600 breast cancerpatients, clinical stages T1-3A,N0-2,M0 were randomly assigned to a perioperative cycle (PC) of cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF). Node-negative (N-) patients did not receive any further treatment. Node positive (N+) patients received 11 cycles if previously given PC, or 12 cycles of CEF alternated with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 (CMF). In addition, N+ patients received concomitant or sequential 5-year tamoxifen therapy. RESULTS: At a median follow-up duration of 5.7 years, no significant difference in survival (88% v 84%, P = .3) between the two treatment arms was seen. However, a difference of borderline significance in relapse-free survival (RFS; 76% v 70%, P = .053) was evident. A significant survival advantage for the PC arm was detected only in the estrogen receptor-negative (ER-) patients (P = .003). RFS was significantly improved in N- patients, postmenopausal patients, and ER- patients. Multivariate analyses show that pathologic tumor size, nodal status, receptor status, and treatment (only in ER- patients) are significantly correlated with survival and RFS. PCtoxicity did not influence wound healing. CONCLUSION: This study provides preliminary evidence that PC positively affects relapse rate and survival in some subgroups, namely, ER- patients.
Authors: Davide Bedognetti; Mario Roberto Sertoli; Paolo Pronzato; Lucia Del Mastro; Marco Venturini; Paola Taveggia; Elisa Zanardi; Guido Siffredi; Simona Pastorino; Paola Queirolo; Giovanni Gardin; Ena Wang; Clara Monzeglio; Francesco Boccardo; Paolo Bruzzi Journal: J Natl Cancer Inst Date: 2011-09-15 Impact factor: 13.506
Authors: John K Chan; James J Java; Katherine Fuh; Bradley J Monk; Daniel S Kapp; Thomas Herzog; Jeffrey Bell; Robert Young Journal: Gynecol Oncol Date: 2016-10-19 Impact factor: 5.482
Authors: Soo Young Jeong; Chel Hun Choi; Tae Joong Kim; Jeong Won Lee; Byoung-Gie Kim; Duk Soo Bae; Yoo-Young Lee Journal: J Ovarian Res Date: 2019-12-31 Impact factor: 4.234