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

This study analyzed patient-reported outcomes (PROs) from NRG/RTOG 1010, a randomized trial adding trastuzumab to standard trimodality therapy (carboplatin/paclitaxel chemoradiation followed by surgery) in patients with localized HER2-positive esophageal adenocarcinoma.

The key PRO endpoint was change in the FACT-Esophageal Cancer Subscale (ECS) from baseline to 6–8 weeks after chemoradiation, with predefined thresholds for meaningful improvement (5 points for ECS overall; 2 points for the swallowing and eating subscales). The study was powered to detect at least a 25% absolute increase in the proportion of patients with ECS improvement in the trastuzumab arm.

• Enrollment and PRO completion: Among 194 eligible patients, 171 consented to PROs. Completion rates were 95% at baseline, 64% at 6–8 weeks, 49% at 1 year, and 33% at 2 years.
• Primary PRO findings at 6–8 weeks: A higher proportion of patients receiving trastuzumab had ECS improvement versus chemoradiation alone (46% vs 38%), but this difference was not statistically significant (p = .39).
• Association with pathologic complete response (pCR): There was no meaningful association between pCR and ECS improvement at 1 year (improvement in 39% of pCR vs 37% of non-pCR patients).

Overall, adding trastuzumab to standard chemoradiation did not translate into better patient-reported esophageal cancer–specific quality of life, and improvement in PROs did not correlate with achieving a pathologic complete response.