Geary R L, Gillham C, McVey G, Armstrong J, Cunningham M, Rangaswamy G, Sharma D, Wallace N, Skourou C, Dunne M, Mahon M, Bradshaw S, O'Sullivan L, Marron J, Parker I, Shannon A M, McDermott R, Toomey S, Hennessy B T, O'Neill B
St Luke's Radiation Oncology Network, Dublin, Ireland.
St Luke's Radiation Oncology Network, Dublin, Ireland.
Clin Oncol (R Coll Radiol). 2025 Jan;37:103695. doi: 10.1016/j.clon.2024.103695. Epub 2024 Nov 20.
Neoadjuvant radiotherapy is an integral part of the management of locally advanced rectal cancer. Radiotherapy can be delivered using three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT) techniques. We herein compare the quality-of-life (QOL) outcomes of patients who received radiotherapy using these techniques in a randomised trial.
A phase II randomised trial was conducted in patients with locally advanced rectal cancer. Patients staged as T3-4, N (any), or circumferential resection margin at risk were eligible. All patients underwent neoadjuvant chemoradiotherapy with 50.4 Gy given in 28 fractions with concomitant fluorouracil or capecitabine. Patients were randomly allocated, in a 1:1 ratio, to 3DCRT or IMRT planning techniques. QOL, a secondary objective of the study, was evaluated using the European Organisation for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and QLQ CR29 questionnaires at baseline, during the final week of radiotherapy and, at six months after radiotherapy. The impact of the treatment arm on QOL scores was evaluated using analysis of covariance after adjusting for the preintervention scores.
94 patients were accrued between October 2014 and March 2020. The trial was terminated early due to futility of the primary outcome, acute gastrointestinal toxicity, at interim analysis. Eighty-six (91%) patients completed the baseline questionnaire and one other timepoint of assessment. Median follow-up was 1.9 years. Overall, both during the final week of radiotherapy and at six months, emotional functioning had improved, but physical, role, and social functionings had declined compared to that at baseline. At baseline, there was no difference in QOL scores between the two arms. During the final week of radiotherapy, the IMRT arm was associated with better adjusted mean physical (p = 0.04) and role functioning (p = 0.01) scores.
IMRT is associated with limited QOL benefits compared to 3DCRT in patients undergoing neoadjuvant chemoradiotherapy for locally advanced rectal cancer.
新辅助放疗是局部晚期直肠癌治疗的一个重要组成部分。放疗可采用三维适形放疗（3DCRT）和调强放疗（IMRT）技术。我们在一项随机试验中比较了使用这些技术接受放疗的患者的生活质量（QOL）结果。
对局部晚期直肠癌患者进行了一项II期随机试验。分期为T3 - 4、N（任意）或存在环周切缘风险的患者符合条件。所有患者均接受新辅助放化疗，给予50.4 Gy，分28次，同时使用氟尿嘧啶或卡培他滨。患者按1:1的比例随机分配至3DCRT或IMRT计划技术组。作为研究的次要目标，在基线、放疗最后一周以及放疗后六个月，使用欧洲癌症研究和治疗组织（EORTC）生活质量问卷（QLQ）C30和QLQ CR29问卷对生活质量进行评估。在对干预前评分进行调整后，使用协方差分析评估治疗组对生活质量评分的影响。
2014年10月至2020年3月期间共纳入94例患者。在中期分析时，由于主要结局急性胃肠道毒性无效，该试验提前终止。86例（91%）患者完成了基线问卷及另一个评估时间点的调查。中位随访时间为1.9年。总体而言，在放疗最后一周和六个月时，与基线相比，情绪功能有所改善，但身体、角色和社会功能有所下降。在基线时，两组的生活质量评分没有差异。在放疗最后一周，IMRT组的调整后平均身体（p = 0.04）和角色功能（p = 0.01）评分更高。
在接受新辅助放化疗的局部晚期直肠癌患者中，与3DCRT相比，IMRT对生活质量的益处有限。
