Preoperative cetuximab, irinotecan, cisplatin, and radiation therapy for patients with locally advanced esophageal cancer

Oncologist. 2013;18(3):281-7. doi: 10.1634/theoncologist.2012-0208. Epub 2013 Feb 21.


Purpose: To determine the efficacy and toxicity of weekly neoadjuvant cetuximab combined with irinotecan, cisplatin, and radiation therapy in patients with locally advanced esophageal or gastroesophageal junction cancer.

Methods and materials: Patients with stage IIA-IVA esophageal or gastroesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received weekly cetuximab on weeks 0-8 and irinotecan and cisplatin on weeks 1, 2, 4, and 5, with concurrent radiotherapy (50.4 Gy on weeks 1-6), followed by surgical resection.

Results: In the first stage, 17 patients were enrolled, 16 of whom had adenocarcinoma. Because of a low pathologic complete response (pCR) rate in this cohort, the trial was discontinued for patients with adenocarcinoma but squamous cell carcinoma patients continued to be enrolled; two additional patients were enrolled before the study was closed as a result of poor accrual. Of the 19 patients enrolled, 18 patients proceeded to surgery, and 16 patients underwent an R0 resection. Three patients (16%) had a pCR. The median progression-free survival interval was 10 months, and the median overall survival duration was 31 months. Severe neutropenia occurred in 47% of patients, and severe diarrhea occurred in 47% of patients. One patient died preoperatively from sepsis, and one patient died prior to hospital discharge following surgical resection.

Conclusions: This schedule of cetuximab in combination with irinotecan, cisplatin, and radiation therapy was toxic and did not achieve a sufficient pCR rate in patients with localized esophageal adenocarcinoma to undergo further evaluation.

Publication types

  • Clinical Trial, Phase II
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Cetuximab
  • Chemoradiotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / radiotherapy*
  • Esophageal Neoplasms / surgery
  • Esophagogastric Junction / pathology
  • Female
  • Humans
  • Irinotecan
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Preoperative Care
  • Prospective Studies
  • Stomach Neoplasms / drug therapy
  • Stomach Neoplasms / radiotherapy
  • Stomach Neoplasms / surgery
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • Irinotecan
  • Cetuximab
  • Cisplatin
  • Camptothecin