NSABP/NRG Oncology, Pittsburgh, PA, USA.
Department of Health Policy and Management, UCLA Fielding School of Public Health, Jonsson Comprehensive Cancer Center, University of California at Los Angeles, 650 Charles Young Drive South, Rm A2-125 CHS, Los Angeles, CA, 90095, USA.
Breast Cancer Res Treat. 2022 Feb;192(1):153-161. doi: 10.1007/s10549-021-06475-2. Epub 2022 Feb 3.
The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.
Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.
FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38).
Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC.
NCT00087178; Date of registration: 07/08/2004.
NSABP B-36 比较了四种周期的多柔比星和环磷酰胺（AC）与六周期的 5-氟尿嘧啶、表柔比星和环磷酰胺（FEC-100）在淋巴结阴性早期乳腺癌中的疗效。B-36 中的一项子研究侧重于症状、生活质量（QOL）、月经史（MH）和心脏功能（CF）。
患者在基线、治疗期间和 36 个月内每 6 个月完成 QOL 问卷。使用重复测量混合模型分析比较两组 FACT-B 试验结局指数（TOI）、症状严重程度和 SF-36 活力和身体功能（PF）量表评分。MH 在基线时收集，如果随机分组前 12 个月内发生月经出血，则随后进行评估。化疗后闭经结果在 18 个月时进行检查，定义为前一年无月经。Logistic 回归用于测试闭经与治疗的相关性。CF 评估在基线和 12 个月时进行。相关性分析用于分析基线和 12 个月 PF 的变化与 LVEF 测量的同期 CF 变化之间的关系。
FEC-100 患者在化疗期间（P=0.02）和 6 个月时（P<0.001）的 TOI 评分显著降低；6 个月时（P<0.01）的活力评分降低，PF 评分在第一年也低于 AC 组。两组在 12 个月后 QOL 评分无统计学差异。两组间症状严重程度无统计学差异。FEC-100 和 AC 的闭经率差异有统计学意义（67.4%比 59.1%，P<0.001）。LVEF 和 PF 的变化之间没有关联（P=0.38）。
两组之间的 QOL 差异具有统计学意义，AC 组更优；然而，这种差异很小，不太可能具有临床意义。AC 组闭经的风险明显更高，具有统计学意义。
NCT00087178；注册日期：2004 年 7 月 8 日。
