CMF VS ALTERNATING CMF/EV IN THE ADJUVANT TREATMENT OF OPERABLE BREAST-CANCER - A SINGLE-CENTER RANDOMIZED CLINICAL-TRIAL (NAPLES GUN-3 STUDY)

被引：24

作者：

DEPLACIDO, S

PERRONE, F

CARLOMAGNO, C

MORABITO, A

PAGLIARULO, C

LAURIA, R

MARINELLI, A

DELAURENTIIS, M

VARRIALE, E

PETRELLA, G

GALLO, C

BIANCO, AR

机构：

[1] UNIV NAPLES FEDERICO II, SCH MED, DIV SURG ONCOL, I-80131 NAPLES, ITALY

[2] UNIV NAPLES 2, SCH MED, INST MED STAT & BIOMETRY, I-80138 NAPLES, ITALY

[3] CNR, CLIN DATA ANAL CTR SO ITALY, SPECIAL PROJECT CLIN APPLICAT ONCOL RES, I-80131 NAPLES, ITALY

来源：

BRITISH JOURNAL OF CANCER | 1995年 / 71卷 / 06期

关键词：

EARLY BREAST CANCER; ADJUVANT CHEMOTHERAPY; GOLDIE-COLDMAN HYPOTHESIS; ALTERNATING REGIMENS; RANDOMIZED CLINICAL TRIAL;

D O I：

10.1038/bjc.1995.248

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The aim of this study was to test the hypothesis of Goldie and Coldman that the use of non-cross-resistant regimens of chemotherapy could lead to maximal anti-tumour effect. We compared standard CMF (cyclophosphamide, methotrexate, fluorouracil) with alternating CMF/EV (epirubicin, vincristine) in the adjuvant therapy of early breast cancer. Stage II premenopausal node-positive or post-menopausal node-positive oestrogen receptor-negative and stage III breast cancer patients were eligible for the study. From January 1985 to December 1990, 220 patients were randomised (115 to CMF and 105 to CMF/EV). Toxicity was mild; neurotoxicity, vomiting and hair loss were more frequent in the CMF/EV group, while permanent amenorrhoea, diarrhoea, stomachache and minor infections occurred more often in the CMF arm. At a follow-up of 48 months, 113 patients (51.4%) had had recurrence (62 on CMF and 51 on CMF/EV) and 54 (24.5%) had died (30 on CMF and 24 on CMF/EV): There was no significant difference in disease-free and overall survival between the two arms. After adjusting for menopausal status and stage, the relative risk (RR) of recurrence for CMF/EV patients was 0.93 (95% CL 0.64-1.35), while the RR of death was 0.85 (95% CL 0.49-1.47). In conclusion, the Goldie-Coldman model of alternating therapy is not confirmed in this trial of adjuvant therapy of early breast cancer, although in view of its design a difference of less than 20% in 3 year disease-free survival could not be excluded.

引用

页码：1283 / 1287

页数：5

共 32 条

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