For treatment-naive patients with metastatic esophageal or gastroesophageal junction cancer, FOLFOX (oxaliplatin, leucovorin, and bolus and infusional fluorouracil) in combination with cetuximab appeared to be the least toxic of 3 chemotherapy backbone regimens, a study published in the Journal of Clinical Oncology has shown.1
To determine the optimal chemotherapy backbone for testing in future United States cooperative group studies for patients with metastatic esophageal and gastroesophageal junction cancers, investigators randomly assigned 245 patients 1:1:1 to receive 1 of 3 chemotherapy regimens, plus weekly cetuximab intravenously.
Of the 245 patients, 222 had adenocarcinoma histology. Participants received either FOFLOX, IC (irinotecan plus cisplatin), or ECF (epirubicin, cisplatin, and continuous-infusion fluorouracil).
Among the patients with adenocarcinoma, 60.9% (95% CI, 47.9-72.8) of patients who received ECF plus cetuximab achieved a response, compared with 45.0% (95% CI, 33.0-57.0) for IC plus cetuximab, and 54.3% (95% CI, 42.0-66.2) for FOLFOX plus cetuximab.
Median progression-free survival was 7.1 months for ECF, 4.9 months for IC, and 6.8 months for FOLFOX. Median overall survival was 11.6, 8.6, and 11.8 months, respectively.
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In contrast with the ECF and IC groups, fewer patients in the FOLFOX arm required treatment modifications (P = .013), fewer patients required treatment discontinuation due to an adverse event, and fewer treatment-related deaths were recorded.
The findings demonstrated that while differences in efficacy between the 3 backbone regimens were nonsignificant, FOLFOX was the best tolerated of tested regimens.
1. Enzinger PC, Burtness BA, Niedzwiecki D, et al. CALGB 80403 (Alliance)/E1206: A randomized phase II study of three chemotherapy regimens plus cetuximab in metastatic esophageal and gastroesophageal junction cancers. J Clin Oncol. 2016 Jul 5. doi: 10.1200/JCO.2015.65.5092 [Epub ahead of print].