10-YEAR FOLLOW-UP-STUDY OF PREMENOPAUSAL WOMEN WITH METASTATIC BREAST-CANCER - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP STUDY

Purpose: To investigate the long-term survival of premenopausal women with previously untreated first recurrence or metastases of breast can cer entered on Eastern Cooperative Oncology Group (ECOG) study 2177 (E ST 2177), which completed accrual in June 1983, Materials and Methods: One hundred forty-seven premenopausal women with metastatic breast ca ncer were entered onto the study, Eighty-nine patients with estrogen r eceptor (ER)-positive and ER-unknown disease were randomized to receiv e cyclophosphamide (CTX), doxorubicin (ADR), and fluorouracil (FU) (CA F) or surgical oophorectomy plus CAF (O + CAF). Fifty eight patients w ith known ER-negative disease were treated with CAF. Survival time was measured from the time of study entry, Randomization was stratified b y performance status (PS), dominant metastatic site, and ER status, Re sults: One hundred thirty patients were eligible. The median survival time of randomized patients was 35 months (90% confidence interval, 28 .9 to 54.3), with 28% alive at 5 years. The overall median survival du ration, including ER-negative patients, wets 30 months, There was no s ignificant difference in survival time between the randomized treatmen ts (median, 42 months for O + CAF and 30 months for CAF). In models of survival time, age greater than or equal to 45 years and last menstru ation within 1 month were associated with significantly longer surviva l (P < .004 for each). There were also three significant interactions with treatment (even after correction for multiple comparisons): age ( P = .00009; O + CAF associated with longer survival in patients < 45 y ears, CAF associated with longer survival in patients > 45 years), PS (P = .002; O + CAF associated with consistently better survival in PS O patients), and disease-free interval (DFI), Conclusion: Long-term fo llow-vp data of premenopausal women with metastatic breast cancer show ct longer than expected median survival time at 2.5 years overall and close to 5 years for patients treated with O + CAF who were ER-positi ve or had a good PS. (C) 1995 by American Society of Clinical Oncology .