Falkson G, Holcroft C, Gelman R S, Tormey D C, Wolter J M, Cummings F J
Department of Medical Oncology, University of Pretoria, South Africa.
J Clin Oncol. 1995 Jun;13(6):1453-8. doi: 10.1200/JCO.1995.13.6.1453.
To investigate the long-term survival of premenopausal women with previously untreated first recurrence or metastases of breast cancer entered on Eastern Cooperative Oncology Group (ECOG) study 2177 (EST 2177), which completed accrual in June 1983.
One hundred forty-seven premenopausal women with metastatic breast cancer were entered onto the study. Eighty-nine patients with estrogen receptor (ER)-positive and ER-unknown disease were randomized to receive cyclophosphamide (CTX), doxorubicin (ADR), and fluorouracil (FU) (CAF) or surgical oophorectomy plus CAF (O+CAF). Fifty-eight patients with known ER-negative disease were treated with CAF. Survival time was measured from the time of study entry. Randomization was stratified by performance status (PS), dominant metastatic site, and ER status.
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 duration, including ER-negative patients, was 30 months. There was no significant difference in survival time between the randomized treatments (median, 42 months for O+CAF and 30 months for CAF). In models of survival time, age > or = 45 years and last menstruation within 1 month were associated with significantly longer survival (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 years, 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).
Long-term follow-up data of premenopausal women with metastatic breast cancer show a 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-positive or had a good PS.
调查参加东部肿瘤协作组（ECOG）2177研究（EST 2177）的绝经前首次复发或转移且未经治疗的乳腺癌女性患者的长期生存情况，该研究于1983年6月完成病例入组。
147例绝经前转移性乳腺癌女性患者进入该研究。89例雌激素受体（ER）阳性及ER情况未知的患者被随机分为接受环磷酰胺（CTX）、阿霉素（ADR）和氟尿嘧啶（FU）（CAF）治疗，或手术去势加CAF（O+CAF）治疗。58例已知ER阴性的患者接受CAF治疗。生存时间从研究入组时开始测量。随机分组按体能状态（PS）、主要转移部位和ER状态进行分层。
130例患者符合条件。随机分组患者的中位生存时间为35个月（90%置信区间，28.9至54.3），5年时28%存活。总体中位生存时间，包括ER阴性患者，为30个月。随机分组治疗之间的生存时间无显著差异（中位时间，O+CAF为42个月，CAF为30个月）。在生存时间模型中，年龄≥45岁且末次月经在1个月内与显著更长的生存时间相关（每项P<.004）。治疗还存在三个显著的相互作用（即使在进行多重比较校正后）：年龄（P=.00009；O+CAF与45岁以下患者更长的生存相关，CAF与45岁以上患者更长的生存相关）、PS（P=.002；O+CAF与PS为O的患者持续更好的生存相关）和无病间期（DFI）。
绝经前转移性乳腺癌女性患者的长期随访数据显示，总体2.5年的中位生存时间长于预期，对于ER阳性或PS良好且接受O+CAF治疗的患者接近5年。
