A Phase I Study of Concurrent Chemoradiotherapy and Cetuximab for Locally Advanced Esophageal Cancer

作者：Hollander Cecilie^*; Baeksgaard Lene; Sorensen Morten; Albertsson Per; Damstrup Lars; Lassen Ulrik

来源：Anticancer Research, 2012, 32(9): 4019-4023.

• Concurrent chemoradiotherapy
• esophagus cancer
• cetuximab
• phase I study

Aim: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of concurrent chemoradiotherapy and cetuximab in patients with non-resectable locally advanced esophageal cancer. Patients and Methods: Escalating doses of oxaliplatin every second week and daily tegafur/uracil were given concurrently with radiotherapy, 59.4 Gy in 33 fractions. Cetuximab was given on day 15 (400 mg/m(2)) and weekly (250 mg/m(2)) during radiotherapy. Fixed doses of oxaliplatin (130 mg/m(2)) and tegafur/uracil (300 mg/m(2)) were administered before, and after radiotherapy. Results: Eleven patients were included in the study; two were excluded due to allergic reactions to cetuximab. In DL2 (tegafur/uracil 300 mg/m(2), oxaliplatin 30 mg/m(2)) two grade 314 fistula and one grade 3 neuropathy were observed. Six patients were enrolled in DL1 (tegafur/uracil 150 mg/m(2)/, oxaliplatin 30 mg/m(2)) with no DLTs. Four out of 9 patients had complete response. Conclusion: Concomitant chemoradiotherapy and cetuximab had significant activity. DL1 was established as the MTD.

• 出版日期2012-9