Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study)

C. Pinto, F. Di Fabio, C. Barone, S. Siena, A. Falcone, S. Cascinu, F. L. Rojas Llimpe, G. Stella, G. Schinzari, S. Artale, V. Mutri, S. Giaquinta, L. Giannetta, A. Bardelli, A. A. Martoni

Research output: Contribution to journalArticle

Abstract

Background:The conventional treatment options for advanced gastric patients remain unsatisfactory in terms of response rate, response duration, toxicity, and overall survival benefit. The purpose of this phase II study was to evaluate the activity and safety of cetuximab combined with cisplatin and docetaxel as a first-line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma.Methods:Untreated patients with histologically confirmed advanced gastric or gastro-oesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg m 2 i.v. followed by weekly doses of 250 mg m 2, cisplatin 75 mg m 2 i.v. on day 1, docetaxel 75 mg m 2 i.v. on day 1, every 3 weeks, for a maximum of 6 cycles, and then cetuximab maintenance treatment was allowed in patients with a complete response, partial response, or stable disease.Results:Seventy-two patients (stomach 81.9% and gastro-oesophageal junction 18.1%; locally advanced disease 4.2%; and metastatic disease 95.8%) were enrolled. The ORR was 41.2% (95% CI, 29.5-52.9). Median time to progression was 5 months (95% CI, 3.7-5.4). Median survival time was 9 months (95% CI, 7-11). The most frequent grades 3-4 toxicity was neutropenia (44.4%). No toxic death was observed.Conclusions:The addition of cetuximab to the cisplatin/docetaxel regimen improved the ORR of the cisplatin/docetaxel doublet in the first-line treatment of advanced gastric and gastro-oesophageal junction adenocarcinoma, but this combination did not improve the TTP and OS. The toxicity of cisplatin/docetaxel chemotherapy was not affected by the addition of cetuximab.

Original languageEnglish
Pages (from-to)1261-1268
Number of pages8
JournalBritish Journal of Cancer
Volume101
Issue number8
DOIs
Publication statusPublished - Oct 20 2009

Keywords

  • Advanced gastric cancer
  • Cetuximab
  • Cisplatin/docetaxel

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Pinto, C., Di Fabio, F., Barone, C., Siena, S., Falcone, A., Cascinu, S., Rojas Llimpe, F. L., Stella, G., Schinzari, G., Artale, S., Mutri, V., Giaquinta, S., Giannetta, L., Bardelli, A., & Martoni, A. A. (2009). Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study). British Journal of Cancer, 101(8), 1261-1268. https://doi.org/10.1038/sj.bjc.6605319