Capecitabine, Oxaliplatin and Radiotherapy: A Phase IB Neoadjuvant Study for Esophageal Cancer with Gene Expression Analysis

Milind M. Javle Department of Gastrointestinal Medical Oncology, UT-MD Anderson Cancer Institute, Houston, Texas, USA; Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Gary Yang Department Radiation, Roswell Park Cancer Institute, Buffalo, New York, USA

Chumy E. Nwogu Department of Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA

Gregory E. Wilding Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, New York, USA

Linda O'Malley Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Sanjay Vinjamaram Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Michael D. Schiff Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Hector R. Nava Department of Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA

Charles LeVea Department of Pathology, Roswell Park Cancer Institute, Buffalo, New York, USA

Kimberly R. Clark Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Joshua D. Prey Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

Patrick F. Smith Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA; Roche Pharmaceuticals, Nutley, New Jersey, USA

Lakshmi Pendyala Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA

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Abstract

Purpose: To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer. Patients and Methods: Oxaliplatin (85 mg/m²) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m² with 50.4 Gy radiation. Results: Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p ≤ 0.05). Conclusion: The maximal tolerated dose was 85 mg/m² of oxaliplatin, 1,250 mg/m²/day of capecitabine, and 50.4 Gy of radiation.

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Capecitabine, Oxaliplatin and Radiotherapy: A Phase IB Neoadjuvant Study for Esophageal Cancer with Gene Expression Analysis

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Capecitabine, Oxaliplatin and Radiotherapy: A Phase IB Neoadjuvant Study for Esophageal Cancer with Gene Expression Analysis

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