Cetuximab as second-line therapy in patients with metastatic esophageal adenocarcinoma: A phase II southwest oncology group study (S0415)

Philip J. Gold, Bryan Goldman, Syma Iqbal, Lawrence P. Leichman, Wu Zhang, Heinz Josef Lenz, Charles D. Blanke

Research output: Contribution to journalArticlepeer-review

53 Scopus citations


Introduction: Esophageal adenocarcinomas commonly express the epidermal growth factor receptor. This trial assessed the 6-month overall survival probability in metastatic esophageal cancer patients treated with cetuximab as second-line therapy. Methods: This was a multicenter, open-label phase II study of single-agent cetuximab for metastatic esophageal adenocarcinoma patients who failed one prior chemotherapy regimen. Adequate organ function and Zubrod performance status of 0 to 2 were required. Patients received cetuximab 400 mg/m2 intravenously (IV) on week 1 and 250 mg/m2 IV weekly thereafter. The primary objective was to determine 6-month overall survival. Secondary end points included progression-free survival, response rate, and toxicity. Tumor tissue was collected for correlative studies. Results: Sixty-three patients were registered, with eight ineligible or never treated. Fifty-five eligible patients (49 men, 6 women; median age = 61.2 years [range, 30.7-88.5]) were enrolled. Twenty patients survived more than 6 months for a 6-month overall survival rate of 36% (95% confidence interval [CI]: 24-50%). The median overall survival was 4.0 months (95% CI: 3.2-5.9). Median progression-free survival was 1.8 months (95% CI: 1.7-1.9). One partial response and two unconfirmed partial responses were observed. Two patients experienced grade 4 fatigue. There was one treatment-related death due to pneumonitis. Germline polymorphisms of epidermal growth factor receptor, epidermal growth factor, interleukin (IL)-8, cyclooxygenase (COX)-2, vascular epidermal growth factor receptor (VEGF), CCND1, neuropilin 1 (NRP1), and K-ras mutational status were not associated with response or survival. Conclusions: The 6-month overall survival rate of 36% observed on this study failed to meet the primary survival objective. Thus, cetuximab alone cannot be recommended in the second-line treatment of metastatic esophageal cancer.

Original languageEnglish (US)
Pages (from-to)1472-1476
Number of pages5
JournalJournal of Thoracic Oncology
Issue number9
StatePublished - Sep 2010
Externally publishedYes


  • Cetuximab
  • Esophageal cancer
  • Second-line therapy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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