SAN FRANCISCO—Cetuximab does not improve overall survival (OS) or clinical complete response rates for patients with esophageal cancer who undergo chemoradiation without surgery, according to findings from a randomized phase 3 clinical trial presented at the 2014 Gastrointestinal Cancers Symposium.

“The addition of cetuximab to concurrent chemoradiation did not improve OS (overall survival),” reported Mohan Suntharalingam, MD, of the University of Maryland Marlene and Stewart Greenebaum Cancer Center, in Baltimore, MD, and coauthors. “These phase 3 results point to little benefit for current EGFR [epidermal growth factor receptor] targeted agents in the treatment of esophageal cancer.”

RTOG 0436 is a randomized phase 3 trial undertaken to assess potential benefits of adding cetuximab to concurrent chemoradiation for esophageal carcinoma.

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Related: Gastrointestinal Cancers Resource Center

Between 2008 and 2013, a total of 328 eligible patients with pathology-confirmed esophageal squamous cell carcinoma (SCC) or adenocarcinoma were randomly assigned to receive either weekly concurrent cisplatin (50 mg/m2), paclitaxel (25 mg/m2), plus daily radiation (50.4 Gy in 1.8-Gy fractions), with or without weekly cetuximab (400 mg/m2 on day 1, then weekly 250 mg/m2), Dr. Suntharalingam and coauthors reported.

At a median follow-up of 15.4 months, the 12- and 24-month OS rates were 64% and 44% (for patients receiving cetuximab, vs. 65% and 42% for patients not administered cetuximab; P = 0.37, not significant), the coauthors reported.

Interim analysis led to halts of enrollment of new patients with adenocarcinoma in May 2012, and patients with SCC in January 2013. 


  1. Suntharalingam M, Winter K, Ilson D, et al. Abstract LBA6. Presented at: 2014 Gastrointestinal Cancers Symposium. Jan. 16-18, 2014; San Francisco.