NRG Oncology RTOG 0436 中的患者报告结果 (PROs)：一项评估在紫杉醇、顺铂和放射治疗食管癌的基础上加用西妥昔单抗的 III 期试验，不进行手术治疗

IF 3.3 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES Quality of Life Research Pub Date : 2024-07-27 DOI:10.1007/s11136-024-03736-7

Lisa A. Kachnic, Kathryn Winter, Mohan Suntharalingam, David Ilson, André Konski, Shane Lloyd, Sarah A. McAvoy, Thomas Lad, Olugbenga Gbenga Olowokure, Pamela Samson, Elizabeth M. Gore, Joshua E. Meyer, Gregory M. M. Videtic, David A. Clump, Adam Raben, Omar Kayaleh, Jerry Barker, Michael G. Haddock, Judith O. Hopkins, Deborah W. Bruner

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引用次数: 0

摘要

目的/目标NRG/RTOG 0436 评估了西妥昔单抗加入化疗 (CRT) 用于食管癌非手术治疗的情况。PRO目标评估西妥昔单抗对第4版FACT-食管癌子量表（ECS）的改善情况，以及ECS的改善是否与临床完全应答（cCR）相关。总生存期（OS）是主要终点，目标患者人数为 420 人，这也提供了 82% 的功率来检测西妥昔单抗患者 ECS 从基线到 CT 后 6-8 周改善比例的增加≥15；使用 χ2 检验，α = 0.05。ECS及其吞咽和进食指数（SI、EI）的改善定义为从基线到CRT术后6-8周分别增加5、4和2个点。单变量逻辑回归评估了 cCR 是否与 ECS 的改善有关。结果这项研究因未达到预先指定的 OS 终点而提前结束，且未显示出生存获益。在计划的 420 例患者中，344 例入组，281 例同意进行 PROs。261人（93%）完成了基线ECS，173人（66%）完成了CRT后6-8周的ECS，117人（64%）完成了1年的ECS。6-8周时，接受CRT+西妥昔单抗治疗的患者ECS没有改善；与标准CRT相比，他们改善的比例较低（37% vs. 53%; P = 0.04）。与西妥昔单抗相比，CRT患者SI改善的比例高出9%，但无统计学意义（39% vs. 30%，P = 0.22）。治疗与 EI 之间没有关联。如果按cCR与残留疾病来检查1年后的ECS评分，cCR患者的改善比例较高，但无统计学意义（48% vs. 45%，P = 0.74）。

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Patient-reported outcomes (PROs) in NRG Oncology RTOG 0436: a phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin, and radiation for esophageal cancer treated without surgery

Purpose/objectives

NRG/RTOG 0436 evaluated cetuximab added to chemoradiation (CRT) for non-operative esophageal cancer management. PRO objectives assessed improvement in the FACT-Esophageal cancer subscale (ECS), version 4, with cetuximab, and if improved ECS correlated with clinical complete response (cCR).

Materials/methods

Patients were randomized to cisplatin/paclitaxel/radiation ± cetuximab. Overall survival (OS) was the primary endpoint, with a 420 patient target, which also provided 82% power to detect ≥ 15 increase in the proportion of cetuximab patients with ECS improvement from baseline to 6–8 weeks post-CRT; α = 0.05, using a χ² test. Improvement in ECS and its Swallowing and Eating Indices (SI, EI) was defined as 5, 4 and 2 point increases, respectively, from baseline to 6–8 weeks post-CRT. Univariate logistic regression assessed if cCR was associated with improved ECS.

Results

This study was stopped early for not meeting a pre-specified OS endpoint and did not show survival benefit. Of 420 planned patients, 344 enrolled and 281 consented to PROs. ECS was completed by 261 (93%) at baseline, 173 (66%) 6–8 weeks post-CRT, and 117 (64%) at 1 year. At 6–8 weeks, patients receiving CRT + Cetuximab didn’t have improved ECS; they experienced a lower proportion of improvement compared to standard CRT (37% vs. 53%; P = 0.04). The proportion of CRT patients with improvement in SI was 9% higher than with cetuximab, but not statistically significant (39% vs. 30%, P = 0.22). There was no association between treatment and EI. When examining ECS scores at 1 year by cCR vs. residual disease, a higher proportion of cCR patients improved, but not statistically significant (48% vs. 45%, P = 0.74).

Conclusions

The addition of cetuximab to CRT for the nonoperative management of esophageal cancer did not improve PROs.

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来源期刊

Quality of Life Research 医学-公共卫生、环境卫生与职业卫生

CiteScore

6.50

自引率

8.60%

发文量

224

审稿时长

3-8 weeks

期刊介绍： Quality of Life Research is an international, multidisciplinary journal devoted to the rapid communication of original research, theoretical articles and methodological reports related to the field of quality of life, in all the health sciences. The journal also offers editorials, literature, book and software reviews, correspondence and abstracts of conferences. Quality of life has become a prominent issue in biometry, philosophy, social science, clinical medicine, health services and outcomes research. The journal''s scope reflects the wide application of quality of life assessment and research in the biological and social sciences. All original work is subject to peer review for originality, scientific quality and relevance to a broad readership. This is an official journal of the International Society of Quality of Life Research.