Department of Gynaecology and Obstetrics, University of Ulm, Prittwitzstr. 43, 89075, Ulm, Germany.
Department of Gynaecology and Obstetrics, University of Würzburg, Würzburg, Germany.
Breast Cancer. 2022 May;29(3):429-436. doi: 10.1007/s12282-021-01321-1. Epub 2022 Feb 18.
This study examined 5-year overall, recurrence and distant metastasis-free survival (OS, RFS, MFS) of high- and intermediate-risk breast cancer (BC) patients who declined guideline-recommended adjuvant chemotherapy (CHT).
In the prospective multicenter cohort study BRENDA II, patients with primary BC were sampled over a period of four years (2009-2012). A multi-professional team (tumorboard) discussed recommendation for adjuvant CHT according to the German guideline. Potential differences in 5 year survival were analyzed using Kaplan-Meier curves and Cox regression. The hazard ratios (HR) were adjusted for age, Charlson Comorbidity Score, American Society of Anesthesiologist (ASA) physical status classification, and endocrine therapy.
A total of 759 patients were enrolled of which 688 could receive CHT according to the guidelines (n = 219 had a clear indication, in n = 304 it was possible). For 360 patients, the tumorboard advised to perform CHT, for 304 it advised against and in 24 cases, no decision was documented. Of those with a positive suggestion, 83% received CHT. Until 5 years after diagnosis, 57 patients were deceased, 41 had at least one distant metastasis and 29 a recurrence. There was no evidence for differences in OS and MFS in patients who declined CHT despite tumorboard recommendation (HR 3.5, 95% CI 0.8-15.1 for OS, HR 1.9, 95% 0.6-6.6 for MFS). Patients who received CHT had significantly better 5-year RFS compared to those who declined (HR 0.3, 95% CI 0.1-0.9, p = 0.03). There was no evidence for different survival in those who had no CHT because of comorbidity and those who declined actively, neither for OS, MFS nor RFS.
The prospective BRENDA II study demonstrates benefit in RFS by guideline adherence in adjuvant breast cancer treatment, indicating prospectively the value of internationally validated guidelines in breast cancer care.
本研究调查了拒绝指南推荐的辅助化疗（CHT）的高风险和中风险乳腺癌（BC）患者的 5 年总生存率（OS）、无复发生存率（RFS）和无远处转移生存率（MFS）。
在前瞻性多中心 BRENDA II 队列研究中，在四年期间（2009-2012 年）对原发性 BC 患者进行了抽样。一个多专业团队（肿瘤委员会）根据德国指南讨论了辅助 CHT 的建议。使用 Kaplan-Meier 曲线和 Cox 回归分析了 5 年生存率的潜在差异。风险比（HR）根据年龄、Charlson 合并症评分、美国麻醉医师协会（ASA）身体状况分类和内分泌治疗进行调整。
共纳入 759 例患者，其中 688 例根据指南可接受 CHT（n=219 有明确适应证，n=304 可能接受）。肿瘤委员会建议 360 例患者接受 CHT，建议 304 例患者不接受 CHT，24 例未记录决定。在有阳性建议的患者中，83%接受了 CHT。诊断后 5 年内，57 例患者死亡，41 例至少发生一次远处转移，29 例发生复发。尽管肿瘤委员会建议，但拒绝 CHT 的患者在 OS 和 MFS 方面没有差异（OS 的 HR 为 3.5，95%CI 为 0.8-15.1，MFS 的 HR 为 1.9，95%CI 为 0.6-6.6）。接受 CHT 的患者 5 年 RFS 明显优于拒绝 CHT 的患者（HR 0.3，95%CI 0.1-0.9，p=0.03）。由于合并症而未接受 CHT 的患者和主动拒绝 CHT 的患者在 OS、MFS 和 RFS 方面均无生存差异。
前瞻性 BRENDA II 研究表明，在辅助乳腺癌治疗中遵循指南可提高 RFS 的获益，前瞻性地表明国际验证的指南在乳腺癌治疗中的价值。
