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Capecitabine, oxaliplatin and radiotherapy: a phase IB neoadjuvant study for esophageal cancer with gene expression
Milind M Javle1, Gary Yang, Chumy E Nwogu
1Department of Gastrointestinal Medical Oncology, UT-MD Anderson Cancer Institute, Houston, Texas, USA. mjavle@mdanderson.org
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/m(2)) 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/m(2) 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
Conclusion:
The maximal tolerated dose was 85 mg/m(2) of oxaliplatin, 1,250 mg/m(2)/day of capecitabine, and 50.4 Gy of radiation.