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Cetuximab plus chemoradiation failed to improve OS in esophageal cancer

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CHICAGO — The addition of cetuximab to chemotherapy and radiation did not extend OS in patients with non-operative esophageal carcinoma, according to results of a phase 3 study presented at the 2014 ASCO Annual Meeting.

David H. Ilson, MD, PhD, a medical oncologist with Memorial Sloan Kettering Cancer Center’s Gastrointestinal Oncology Service and a HemOnc Today editorial board member, and colleagues evaluated data from 328 patients with biopsy-proven squamous cell (n=125) or adenocarcinoma (n=203) of the esophagus. Eighty percent of patients had T3/T4 disease, 66% had N1 disease and 19% had celiac nodal involvement.

 

David H. Ilson

All patients received 50 mg/m² cisplatin and 25 mg/m² paclitaxel concurrently for 6 weeks, as well as daily radiation in 1.8 Gy fractions totaling 50.4 Gy.

Ilson and colleagues randomly assigned patients to cetuximab (Erbitux; Bristol-Myers Squibb, Eli Lilly) or no cetuximab. Those in the cetuximab arm received 400 mg/m² on day 1 followed by 250 mg/m² weekly for 6 weeks.

OS served as the primary endpoint. Median follow-up was 15.4 months.

Overall, the confirmed complete response rate was similar among patients who did and did not receive cetuximab (56% vs. 59%; P=.72). Researchers observed no differences in response based on histology.

The rates of 12-month OS (79% vs. 53%) and 24-month OS (58% vs. 30%; P˂.0001 for both) were significantly higher among patients who achieved complete response than those who had residual disease.

Outcomes did not vary based on treatment assignment. Researchers reported comparable 12-month OS (64% for cetuximab vs. 65% for no cetuximab) and 24-month OS (44% vs. 42%; P=.7 for both) between study arms.

Researchers also observed no survival differences based on histology. Among patients with adenocarcinoma, 12-month OS was 65% for cetuximab vs. 64% for no cetuximab, and 24-month OS was 43% for cetuximab vs. 41% for no cetuximab (P=.37). Among patients with squamous cell histology, 12-month OS was 62% for cetuximab vs. 67% for no cetuximab, and 24-month OS was 46% for cetuximab vs. 43% for no cetuximab (P=.97).

Toxicity was comparable between the two groups, with expected higher rates of dermatologic toxicity with cetuximab. Researchers also reported a slightly higher but nonsignificant number of therapy-related deaths in the cetuximab arm.

“These results add to the growing body of literature indicating no benefit for current EGFR-targeted therapies in the treatment of unselected patients with esophageal carcinoma,” Ilson and colleagues concluded.

For more information:

Ilson DH. Abstract #4007. Presented at: 2014 ASCO Annual Meeting; May 30-June 3, 2014; Chicago.

Disclosure: Ilson reports research funding from Bristol-Myers Squibb. The study was funded in part by Bristol-Myers Squibb and grants from the NCI.