A phase I study of concurrent chemoradiotherapy and cetuximab for locally advanced esophageal cancer

Cecilie Holländer, Lene Baeksgaard, Morten Sorensen, Per Albertsson, Lars Damstrup, Ulrik Lassen

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
JournalAnticancer Research
Volume32
Issue number9
Pages (from-to)4019-23
Number of pages5
ISSN0250-7005
Publication statusPublished - Sept 2012

Keywords

  • Adult
  • Aged
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols
  • Cetuximab
  • Chemoradiotherapy
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Esophageal Neoplasms
  • Female
  • Humans
  • Male
  • Middle Aged
  • Organoplatinum Compounds
  • Tegafur
  • Uracil
  • Clinical Trial, Phase I
  • Journal Article
  • Research Support, Non-U.S. Gov't

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