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

Abstract

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.

• Authors: Michael S Lee, Harvey J Mamon, Theodore S Hong, Noah C Choi, Panagiotis M Fidias, Eunice L Kwak, Jeffrey A Meyerhardt, David P Ryan, Raphael Bueno, Dean M Donahue, Michael T Jaklitsch, Michael Lanuti, David W Rattner, Charles S Fuchs, Peter C Enzinger
• Journal: The oncologist (Oncologist) Vol. 18 Issue 3 Pg. 281-7 ( 2013) ISSN: 1549-490X [Electronic] England
• PMID: 23429739 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

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