保乳手术后 T1-2N1 乳腺癌辅助区域性淋巴结照射并未改善结局:BIG02/98 和 BCIRG005 试验的倾向评分匹配分析。
Adjuvant regional nodal irradiation did not improve outcomes in T1-2N1 breast cancer after breast-conserving surgery: A propensity score matching analysis of BIG02/98 and BCIRG005 trials.
机构信息
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
出版信息
Breast. 2020 Feb;49:165-170. doi: 10.1016/j.breast.2019.11.001. Epub 2019 Nov 29.
AIM
To determine whether the addition of regional nodal irradiation (RNI) to whole-breast irradiation (WBI) would improve outcomes over WBI alone in T1-2N1 breast cancer after breast-conserving surgery (BCS) and adjuvant systematic therapy.
METHODS
Data were obtained from two randomized controlled trials (NCT00174655 and NCT00312208). Univariate and multivariate Cox-regression analysis were performed to investigate predictors for overall survival and disease-free survival. A 1:1 propensity score matching (PSM) analysis was applied to eliminate selection bias.
RESULTS
With median follow-up 80 months (range: 3-155 months), the 5-year local regional recurrence in the WBI group was 2% vs. 5% (p = 0.28) in the WBI + supraclavicular radiotherapy, and the rate of 5-year distant metastasis in the WBI group was 7% vs. 13% in the WBI + supraclavicular radiotherapy (p = 0.0748); In addition, the 5-year local regional recurrence in the WBI group was 3% vs. 9% (p = 0.19) in the WBI + internal mammary irradiation (IMI); However, the rate of 5-year distant metastasis in the in the WBI group was significantly lower than that in the WBI + IMI (8% vs. 24%, p = 0.036). After PSM, cox-regression analysis indicated that neither RNI nor IMI in combination with WBI in T1-2N1 breast cancer was associated with an improved overall survival and disease-free survival when compared to WBI alone.
CONCLUSION
The addition of RNI to WBI in T1-2N1 breast cancer after BCS and adjuvant systematic therapy did not improve outcomes in comparison with WBI alone. Further studies are still needed to identify patients who would most benefit from RNI in this patient population.
目的
在接受保乳手术(BCS)和辅助系统治疗后,比较 T1-2N1 乳腺癌患者接受全乳照射(WBI)加区域淋巴结照射(RNI)与单纯 WBI 的治疗效果。
方法
数据来源于两项随机对照试验(NCT00174655 和 NCT00312208)。采用单因素和多因素 Cox 回归分析来研究总生存和无病生存的预测因素。应用 1:1 倾向评分匹配(PSM)分析消除选择偏倚。
结果
中位随访 80 个月(范围:3-155 个月),WBI 组的 5 年局部区域复发率为 2%,而 WBI+锁骨上放疗组为 5%(p=0.28),WBI 组的 5 年远处转移率为 7%,而 WBI+锁骨上放疗组为 13%(p=0.0748);此外,WBI 组的 5 年局部区域复发率为 3%,而 WBI+内乳照射(IMI)组为 9%(p=0.19);然而,WBI 组的 5 年远处转移率明显低于 WBI+IMI 组(8% vs. 24%,p=0.036)。PSM 后,Cox 回归分析表明,与单纯 WBI 相比,T1-2N1 乳腺癌患者接受 WBI 加 RNI 或 IMI 治疗,总生存和无病生存均无显著改善。
结论
在接受 BCS 和辅助系统治疗后,T1-2N1 乳腺癌患者接受 WBI 加 RNI 治疗与单纯 WBI 治疗相比,并未改善结局。仍需要进一步研究,以确定在该患者人群中,哪些患者最能从 RNI 中获益。