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局部晚期直肠癌患者调强放疗剂量增加对生活质量的影响:随机RECTAL-BOOST 试验的 2 年随访结果。

Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial.

机构信息

Department of Radiation Oncology, University Medical Center Utrecht, Utrecht; Department of Surgery, University Medical Center Utrecht, Utrecht.

Department of Radiation Oncology, University Medical Center Utrecht, Utrecht; Department of Surgery, University Medical Center Utrecht, Utrecht.

出版信息

Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):694-703. doi: 10.1016/j.ijrobp.2021.09.052. Epub 2021 Oct 8.

DOI:10.1016/j.ijrobp.2021.09.052
PMID:34634436
Abstract

PURPOSE

Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer did not result in higher complete response rates but initiated more tumor regression in the randomized RECTAL-BOOST trial (Clinicaltrials.gov NCT01951521). This study compared patient reported outcomes between patients who received dose-escalated CRT (5 × 3 gray boost + CRT) or standard CRT for 2 years after randomization.

METHODS AND MATERIALS

Patients with locally advanced rectal cancer who were participating in the RECTAL-BOOST trial filled out European Organisation for Research and Treatment of Cancer QLQ-C30 and CR29 questionnaires on quality of life (QoL) and symptoms at baseline, 3, 6, 12, 18, and 24 months after start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed-effects model and expressed as effect size (ES). Symptom scores were compared using Mann-Whitney U test.

RESULTS

Patients treated with dose-escalated CRT (boost group, n = 51) experienced a significantly stronger decline in global health at 3 and 6 months (ES -0.4 and ES -0.4), physical functioning at 6 months (ES -1.1), role functioning at 3 and 6 months (ES -0.8 and ES -0.6), and social functioning at 6 months (ES -0.6), compared with patients treated with standard CRT (control group, n = 64). The boost group reported significantly more fatigue at 3 and 6 months (83% vs 66% respectively 89% vs 76%), pain at 3 and 6 months (67% vs 36% respectively 80% vs 44%), and diarrhea at 3 months (45% vs 29%) compared with the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group.

CONCLUSIONS

In patients with locally advanced rectal cancer, dose-escalated CRT resulted in a transient deterioration in global health, physical, role, and social functioning and more pain, fatigue and diarrhea at 3 and 6 months after start of treatment compared with standard CRT. From 12 months onwards, the effect of dose-escalated CRT on QoL largely resolved.

摘要

目的

局部晚期直肠癌的剂量递增放化疗(CRT)并未提高完全缓解率,但在随机RECTAL-BOOST 试验(Clinicaltrials.gov NCT01951521)中引发了更多的肿瘤退缩。本研究比较了接受剂量递增 CRT(5×3 灰度加 CRT)或标准 CRT 的患者在随机分组后 2 年的患者报告结果。

方法和材料

参与 RECTAL-BOOST 试验的局部晚期直肠癌患者在治疗开始后基线、3、6、12、18 和 24 个月时填写欧洲癌症研究和治疗组织 EORTC QLQ-C30 和 CR29 问卷,评估生活质量(QoL)和症状。使用线性混合效应模型估计功能 QoL 域的组间差异,并表示为效应大小(ES)。使用 Mann-Whitney U 检验比较症状评分。

结果

接受剂量递增 CRT(升压组,n=51)的患者在 3 和 6 个月时全球健康状况明显下降(ES -0.4 和 ES -0.4),6 个月时身体功能(ES -1.1),3 和 6 个月时角色功能(ES -0.8 和 ES -0.6),6 个月时社会功能(ES -0.6),与接受标准 CRT(对照组,n=64)的患者相比。升压组在 3 和 6 个月时报告的疲劳(分别为 83%和 66%,分别为 89%和 76%)、疼痛(分别为 67%和 36%,分别为 80%和 44%)和腹泻(分别为 45%和 29%)明显多于对照组。从 12 个月开始,两组之间的 QoL 和症状相似,除了升压组粪便中血液/粘液更多。

结论

在局部晚期直肠癌患者中,与标准 CRT 相比,剂量递增 CRT 在治疗开始后 3 和 6 个月时导致全球健康、身体、角色和社会功能明显恶化,以及更多的疼痛、疲劳和腹泻。从 12 个月开始,剂量递增 CRT 对 QoL 的影响在很大程度上得到解决。

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