TY - JOUR
T1 - Patient-reported outcomes (PROs) in NRG Oncology RTOG 0436
T2 - a phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin, and radiation for esophageal cancer treated without surgery
AU - Kachnic, Lisa A.
AU - Winter, Kathryn
AU - Suntharalingam, Mohan
AU - Ilson, David
AU - Konski, André
AU - Lloyd, Shane
AU - McAvoy, Sarah A.
AU - Lad, Thomas
AU - Olowokure, Olugbenga Gbenga
AU - Samson, Pamela
AU - Gore, Elizabeth M.
AU - Meyer, Joshua E.
AU - Videtic, Gregory M.M.
AU - Clump, David A.
AU - Raben, Adam
AU - Kayaleh, Omar
AU - Barker, Jerry
AU - Haddock, Michael G.
AU - Hopkins, Judith O.
AU - Bruner, Deborah W.
N1 - Publisher Copyright:
© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2024.
PY - 2024/10
Y1 - 2024/10
N2 - 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.
AB - 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.
KW - Chemoradiation
KW - Clinical trial
KW - Esophageal cancer
KW - NRG Oncology RTOG 0436
KW - Patient-reported outcomes
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85200043165&partnerID=8YFLogxK
U2 - 10.1007/s11136-024-03736-7
DO - 10.1007/s11136-024-03736-7
M3 - Article
C2 - 39066879
AN - SCOPUS:85200043165
SN - 0962-9343
VL - 33
SP - 2833
EP - 2844
JO - Quality of Life Research
JF - Quality of Life Research
IS - 10
ER -