PD01.04. Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma: Health-Related Quality-of-Life Results of the HCHTOG1903 Randomized Controlled Trial

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ID: 325738
2026
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Abstract
Abstract Topic Esophageal Cancer: Adjuvant and Neo-Adjuvant Therapies Background Direct comparisons of health-related quality of life (HRQoL) between neoadjuvant chemoradiotherapy (nCRT) with CROSS regimen and neoadjuvant chemotherapy (nCT) with paclitaxel–cisplatin (TP) for resectable, locally advanced esophageal squamous cell carcinoma (ESCC) are limited. In this randomized controlled trial, we compared the effects of different neoadjuvant regimens on HRQoL (NCT04138212). Methods: In this open-label, randomized controlled trial, patients with resectable, locally advanced ESCC were assigned (1:1) to nCRT or nCT followed by planned esophagectomy. HRQoL was assessed using the EORTC QLQ-C30 and QLQ-OES18 at baseline, mid-treatment, preoperative, pre-discharge, 1-, 3-, and 6-month postoperatively, and transformed to a 0-100 scale. Longitudinal HRQoL was analyzed in the intention-to-treat population using linear mixed-effects models (LMMs with a patient-level random intercept. Prespecified key domains (physical functioning [PF], global health status/quality of life [GHS/QoL], OES18 Dysphagia, and OES18 Pain) were prioritized for primary analyses; other domains were exploratory. Multiplicity was controlled using Holm for overall tests and false discovery rate (FDR) for time-specific comparisons and changes from baseline. A 10-point difference defined the minimal clinically important difference (MCID). Results: Among 456 randomized patients (nCRT: 228; nCT: 228), HRQoL questionnaire completion was 100% at baseline and remained above 75% throughout follow-up. In prespecified key domains, LMMsshowed significant group-by-time interactions for PF, GHS/QoL and OES18 pain (all Holm-adjusted P<0.001), whereas no interaction was observed for OES18 Dysphagia (Holm-adjusted P=0.077). Between-group separation peaked at mid-treatment (FDR-adjusted P<0.05) but did not reach the MCID and was no longer evident from discharge through 6 months. Across both groups, HRQoL temporarily deteriorated during neoadjuvant therapy, was worst at the pre-discharge assessment, and then gradually recovered during postoperative follow-up. By 6 months, HRQoL had largely returned to baseline or improved, although statistically significant changes were generally below the MCID. All other QLQ-C30 and OES18 domains were analyzed exploratorily and showed similar trajectories. Conclusion Collectively, these findings indicate that HRQoL outcomes are clinically comparable between CROSS-regimen nCRT and TP-regimen nCT for resectable, locally advanced ESCC. The short-term treatment-related HRQoL burden did not translate into long-term deficits, and patients' HRQoL returned to baseline by 6 months after surgery.
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Authors Haibo Sun, Ya-Xing Ma, Wen-Qun Xing, Xianben Liu, Shilei Liu, Peinan Chen, Xing-Yu Liu, Xin Chen
Journal diseases of the esophagus : official journal of the international society for diseases of the esophagus
Year 2026
DOI
10.1093/dote/doag077.074
URL
https://doi.org/10.1093/dote/doag077.074
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