Patient-reported outcomes in NRG Oncology RTOG 1010: Phase 3 trial evaluating the addition of trastuzumab to trimodality treatment of HER2 overexpressing esophageal adenocarcinoma

Document Type

Article

Publication Date

3-15-2026

Publication Title

Cancer

Keywords

Humans, Esophageal Neoplasms, Trastuzumab, Female, Adenocarcinoma, Erb-b2 Receptor Tyrosine Kinases, Middle Aged, Aged, Antineoplastic Combined Chemotherapy Protocols, Patient Reported Outcome Measures, Male, Paclitaxel, Carboplatin, Adult, Chemoradiotherapy, Disease-Free Survival, Combined Modality Therapy

Abstract

BACKGROUND: NRG/RTOG 1010 evaluated trastuzumab added to trimodality therapy for HER2+ localized esophageal adenocarcinoma (EAC) management. Secondary PRO objectives assessed improvement in the FACT-Esophageal Cancer Subscale (ECS), version 4, with trastuzumab, and if improved ECS correlated with pathologic complete response (pCR).

METHODS: Patients were randomized to weekly paclitaxel/carboplatin/radiation (chemoradiation, CRT) followed by surgery ± trastuzumab (CRT + Tras). Disease-free survival (DFS) was the primary end point. The projected PRO sample size of 158 patients, based on an 80% participation rate of the DFS primary endpoint sample size of 197 HER2+ patients, would provide ≥ 89% power to detect ≥25% increase in the proportion of CRT + Tras patients with ECS improvement from baseline to 6-8 weeks post-CRT; one-sided α = 0.05, using a χ(2) test. Improvement in ECS and its swallowing index (SI) and eating index (EI) was defined as 5-, 2-, and 2-point increases, respectively, from baseline to 6-8 weeks post-CRT. Univariate logistic regression was assessed if pCR was associated with improved ECS.

RESULTS: From 2010 to 2015, 203 HER2+ patients were randomized and 194 were eligible. Of 171 PRO consenting patients, the ECS was completed by 162 (95%) at baseline, 108 (64%) 6-8 weeks, 82 (49%) 1 year, and 55 (33%) at 2 years. The proportion of patients with an improvement in 6-8 weeks ECS was higher on the CRT + Tras arm (46% vs. 38%), although not significantly different (p = .39). There was no correlation between pCR and ECS scores at 1 year, with 39% and 37% of pCR and non-pCR patients, respectively, having improved 1-year ECS scores.

CONCLUSIONS: The addition of trastuzumab to CRT for localized HER2+ EAC did not improve PROs.

Medical Subject Headings

Humans; Esophageal Neoplasms; Trastuzumab; Female; Adenocarcinoma; Erb-b2 Receptor Tyrosine Kinases; Middle Aged; Aged; Antineoplastic Combined Chemotherapy Protocols; Patient Reported Outcome Measures; Male; Paclitaxel; Carboplatin; Adult; Chemoradiotherapy; Disease-Free Survival; Combined Modality Therapy

PubMed ID

41808581

Volume

132

Issue

6

First Page

70345

Last Page

70345

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