Song Yu-Chun, Sun Guang-Yi, Fang Hui, Tang Yu, Song Yong-Wen, Hu Chen, Qi Shu-Nan, Chen Bo, Jing Hao, Tang Yuan, Jin Jing, Liu Yue-Ping, Lu Ning-Ning, Li Ye-Xiong, Wang Shu-Lian
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Front Oncol. 2021 Sep 15;11:738318. doi: 10.3389/fonc.2021.738318. eCollection 2021.
To report patients' quality of life (QoL) at 1 year in a phase 2 randomized trial comparing partial breast irradiation (PBI) with whole-breast irradiation (WBI) after breast-conserving surgery (BCS) for breast cancer.
Women aged ≥ 45 years with low-risk breast cancer after BCS were randomly assigned (1:1) to receive PBI (40 Gy in 10 fractions over 2 weeks) or WBI (43.5 Gy in 15 fractions over 3 weeks). The primary endpoint-the incidence of toxicities of grade 2 or higher-will be reported when participants complete 5 years of follow-up. QoL was assessed at baseline (T0), at the end of radiotherapy (RT) (T1), 6 months (T2) and 1 year (T3) after RT by using the EORTC QLQ-C30 and QLQ-BR23 questionnaires. We calculated the scores for all QOL subscales and differences in mean scores were compared. This study was registered at ClinicalTrials.gov (NCT03583619).
Between June 2017 and January 2019, 140 women were randomly assigned to receive PBI or WBI (n = 70 per group). Fifty-nine and 56 patients treated with PBI and WBI, respectively, were eligible for the QoL analysis. There were no significant differences in any subscale scores at T0, T1, T2, or T3 between the PBI and WBI arms. The scores for most QoL subscales that were influenced by RT recovered to a similar or better level relative to T0 scores within 1 year after RT, except for the scores of the dyspnea subscale. Longitudinal analysis showed that time since RT had a significant impact on physical functioning, role functioning, social functioning, fatigue, pain, dyspnea, financial difficulties, body image, and breast and arm symptoms.
PBI using the intensity-modulated RT affords QoL comparable to that provided by WBI. Most QoL subscale scores that were influenced by RT recovered to a similar or better level relative to baseline scores within 1 year after RT.
在一项2期随机试验中，报告乳腺癌保乳手术后1年时患者的生活质量（QoL），该试验比较了局部乳腺照射（PBI）与全乳照射（WBI）。
保乳手术后患有低风险乳腺癌的≥45岁女性被随机分配（1:1）接受PBI（2周内分10次给予40 Gy）或WBI（3周内分15次给予43.5 Gy）。当参与者完成5年随访时，将报告主要终点——2级或更高等级毒性的发生率。在放疗（RT）开始时（T0）、放疗结束时（T1）、放疗后6个月（T2）和1年（T3），使用欧洲癌症研究与治疗组织（EORTC）QLQ-C30和QLQ-BR23问卷评估生活质量。我们计算了所有生活质量子量表的得分，并比较了平均得分的差异。本研究已在ClinicalTrials.gov（NCT03583619）注册。
2017年6月至2019年1月期间，140名女性被随机分配接受PBI或WBI（每组n = 70）。分别有59名接受PBI治疗和56名接受WBI治疗的患者符合生活质量分析的条件。在T0、T1、T2或T3时，PBI组和WBI组在任何子量表得分上均无显著差异。除呼吸困难子量表得分外，大多数受放疗影响的生活质量子量表得分在放疗后1年内恢复到与T0得分相似或更好的水平。纵向分析表明，放疗后的时间对身体功能、角色功能、社会功能、疲劳、疼痛、呼吸困难、经济困难、身体形象以及乳房和手臂症状有显著影响。
使用调强放疗的PBI所提供的生活质量与WBI相当。大多数受放疗影响的生活质量子量表得分在放疗后1年内恢复到与基线得分相似或更好的水平。
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