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Published on: April 22, 2019
A phase I study of concurrent chemoradiotherapy and cetuximab for locally advanced esophageal cancer
Cecilie Holländer1, Lene Baeksgaard, Morten Sorensen
1Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. c.hollaender@gmail.com
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 3/4 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.
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