• Head & Neck Cancers
• Gastrointestinal Cancers Clinical Trials

• Head & Neck Cancers
• Gastrointestinal Cancers Clinical Trials

Cetuximab plus chemotherapy and radiation therapy does not improve clinical complete response (cCR) rates or overall survival (OS) in patients with locally advanced esophageal cancer. David H. Ilson, MD, PhD, Memorial Sloan-Kettering Cancer Center, New York, New York, USA, presented data from the Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer trial [RTOG 0436; Ilson D et al. Ann Oncol 2014 (abstr O-0005)].

Cetuximab is a monoclonal antibody that blocks the EGFR and inhibits tumor growth by preventing blood flow to the tumor. The purpose of the RTOG 0436 trial was to determine if the addition of cetuximab to paclitaxel and cisplatin plus radiation therapy would improve outcomes in patients with locally advanced esophageal cancer.

In the Phase 3 RTOG 0436 trial, 328 patients with adenocarcinoma or squamous cell carcinoma of the esophagus were randomly assigned to receive paclitaxel plus cisplatin and radiation (50.4 Gy/1.8 Gy fractions) with or without cetuximab. Patients were eligible if their endoscopic ultrasound (EUS) stage was T1N1M0, T2 to T4 any N M0, or any T or N M1a, and patients were stratified by histology, tumor size, and the presence of celiac lymph nodes. The primary end point of the RTOG 0436 trial was OS. Baseline characteristics were similar among treatment arms, with T3/4 disease present in 80% of patients, N1 in 66%, and celiac lymph nodes in 19%.

During the median follow-up period of 15.4 months, cCR rates were similar between both treatment arms (p = .72), regardless of stratification by histology. In patients who achieved cCR, the 12- and 24-m OS rates were, respectively, 79% and 58% compared with 53% and 30% in patients with residual disease (p < .0001); however, there was no significant difference between treatment arms.

Dr. Ilson stated that, in his opinion, the data from the RTOG 0436 trial indicated that the addition of cetuximab to concurrent chemotherapy and radiation therapy does not improve cCR rates or prolong OS in patients with esophageal cancer, regardless of histology. Therefore, the data from this trial suggest that there is currently no evidence for the use of EGFR-targeted therapies in addition to concurrent chemotherapy and radiation therapy for the treatment of esophageal cancer.

• © 2014 MD Conference Express®