保乳手术后超大分割与中度大分割辅助放疗的 MC1635 III 期试验的医生和患者报告的结果。
Physician and Patient-Reported Outcomes of the MC1635 Phase III Trial of Ultra-Hypofractionated Versus Moderate Hypofractionated Adjuvant Radiotherapy After Breast-Conserving Surgery.
发表日期:2023 Oct 30
作者:
Brady S Laughlin, Kimberly A Corbin, Diego Augusto Santos Toesca, Cameron S Thorpe, Michael A Golafshar, Barbara Pockaj, Patricia Cronin, Lisa A McGee, Michele Y Halyard, Robert W Mutter, Sameer R Keole, Sean S Park, Dean A Shumway, Tamara Z Vern-Gross, Laura Vallow, William W Wong, Todd A DeWees, Carlos E Vargas
来源:
Int J Radiat Oncol
摘要:
报告医生和患者报告的局限性乳腺癌患者在保乳手术 (BCS) 后接受中度与超大分割全乳放疗 (WBI) 治疗的结果。2018 年 2 月至 2020 年 2 月期间,局限性乳腺癌患者(pT0-3 pN0-1 M0) 被邀请参加一项 3 期随机临床试验,该试验评估 BCS 后辅助中度大分割 (MHF) 至 40 Gy(15 次分割)与超大分割 (UHF) 至 25 Gy(5 次分割),其中可选的同时集成升压。使用经过验证的度量工具在基线、治疗结束 (EOT)、照射后 3 个月、1 年、2 年和 3 年时评估毒性、美容和生活质量。 107 名患者被随机分配至 MHF (n=54)或 UHF (n=53) 佐剂 WBI。中位随访时间为 42.8 个月。 EOT 时,MHF 组有 4 名患者 (7.4%) 和 UHF 组有 2 名患者 (3.7%) 出现 2 级放射性皮炎 (p=0.726)。未观察到 3 级或更高级别的毒性。根据医生评估,在 EOT 时,UHF 组中有 2 名 (6.7%) 患者和 MHF 组中有 1 名 (1.9%) 患者出现美容效果恶化 (p=0.534)。而在 3 个月时,仅 1 名 (1.8%) 接受 MHF 组治疗的患者表现出美容效果恶化 (p=0.315)。在 EOT 时,接受 MHF 和 UHF 方案治疗的患者中,分别有 91% 和 94% 的患者报告称其美容效果极佳(p=0.550)。 3 个月时,与 UHF 组相比,MHF 组中更多的患者报告称具有出色/良好的美容效果(100% vs. 91%,p=0.030)。然而,患者报告的美容效果差异在 1 年、2 年和 3 年时间点消失。在 BCS 后辅助治疗的患者中,与中度大分割放疗相比,UHF WBI 显示出相似的治疗相关晚期毒性和相似的提供者评分美容效果。版权所有 © 2023。由爱思唯尔公司出版。
To report physician and patient-reported outcomes of patients with localized breast cancer treated with moderate versus ultra-hypofractionated whole breast irradiation (WBI) after breast-conserving surgery (BCS).Between 02/2018 and 02/2020, patients with localized breast cancer (pT0-3 pN0-1 M0) were offered participation in a phase 3 randomized clinical trial assessing adjuvant moderate hypofractionation (MHF) to 40 Gy in 15 fractions versus ultra-hypofractionation (UHF) to 25 Gy in 5 fractions after BCS, with an optional simultaneously integrated boost. Toxicities, cosmesis, and QoL were assessed at baseline, end of treatment (EOT), 3 months, 1 year, 2 years, and 3 years from irradiation utilizing validated metric tools.One hundred seven patients were randomized to MHF (n=54) or UHF (n=53) adjuvant WBI. The median follow-up was 42.8 months. Grade 2 radiation dermatitis was experienced by 4 patients (7.4%) in the MHF arm and 2 patients (3.7%) in the UHF arm at EOT (p=0.726). No grade 3 or higher toxicities were observed. Deterioration of cosmesis by physician assessment was observed in 2 (6.7%) patients treated in the UHF arm and 1 (1.9%) patient treated in the MHF arm at EOT (p=0.534). Whereas at 3 months, only 1 (1.8%) patient treated at MHF arm demonstrated deterioration of cosmesis (p=0.315). At EOT, 91% and 94% of patients reported excellent/good cosmesis among those treated with MHF and UHF regimens, respectively (p=0.550). At 3 months, more patients within the MHF arm reported excellent/good cosmesis compared to those within the UHF arm (100% vs. 91%, p=0.030). However, the difference in patient-reported cosmesis disappeared at 1-, 2- and 3-year time points.UHF WBI showed similar treatment-related late toxicities and similar provider-scored cosmesis compared to moderately hypofractionated radiation in patients treated adjuvantly after BCS.Copyright © 2023. Published by Elsevier Inc.