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

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

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2833-2844
Number of pages12
JournalQuality of Life Research
Volume33
Issue number10
DOIs
StatePublished - Oct 2024

Keywords

  • Chemoradiation
  • Clinical trial
  • Esophageal cancer
  • NRG Oncology RTOG 0436
  • Patient-reported outcomes
  • Quality of life

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