Randomized Phase II Study of PET Response–Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial

作者：Karyn A. Goodman, Fang‐Shu Ou, Nathan C. Hall, Tanios Bekaii‐Saab, Briant F. Fruth, Erin L. Twohy, Michael O. Meyers, Daniel J. Boffa, Kisha Anne Mitchell, Wendy L. Frankel, Donna Niedzwiecki, Anne M. Noonan, Yelena Yuriy Janjigian, Paul J. Thurmes, Alan Paul Venook, Jeffrey A. Meyerhardt, Eileen Mary O'Reilly, David H. Ilson · 发表于：Journal of Clinical Oncology · 年份：2021 · DOI：10.1200/jco.20.03611 · 被引用次数：133 · 研究领域：Esophageal Cancer Research and Treatment、Pancreatic and Hepatic Oncology Research、Head and Neck Cancer Studies

PURPOSE: To evaluate the use of early assessment of chemotherapy responsiveness by positron emission tomography (PET) imaging to tailor therapy in patients with esophageal and esophagogastric junction adenocarcinoma. METHODS: After baseline PET, patients were randomly assigned to an induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP). Repeat PET was performed after induction; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders (< 35% decrease in SUV) crossed over to the alternative chemotherapy during chemoradiation (50.4 Gy/28 fractions). PET responders (≥ 35% decrease in SUV) continued on the same chemotherapy during chemoradiation. Patients underwent surgery at 6 weeks postchemoradiation. Primary end point was pathologic complete response (pCR) rate in nonresponders after switching chemotherapy. RESULTS: Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET. The pCR rates for PET nonresponders after induction FOLFOX who crossed over to CP (n = 39) or after induction CP who changed to FOLFOX (n = 50) was 18.0% (95% CI, 7.5 to 33.5) and 20% (95% CI, 10 to 33.7), respectively. The pCR rate in responders who received induction FOLFOX was 40.3% (95% CI, 28.9 to 52.5) and 14.1% (95% CI, 6.6 to 25.0) in responders to CP. With a median follow-up of 5.2 years, median overall survival was 48.8 months (95% CI, 33.2 m...