Investigational New Drugs

, Volume 31, Issue 6, pp 1573–1579

Multicenter phase II study of oxaliplatin and sorafenib in advanced gastric adenocarcinoma after failure of cisplatin and fluoropyrimidine treatment. A gemcad study

Authors

    • Department of Medical OncologyHospital de la Santa Creu I Sant Pau
  • R. Gallego
    • Department of Medical OncologyHospital Clinic
  • C. Pericay
    • Department of Medical OncologyCOrporación Parc Tauli
  • J. Garcia Foncillas
    • Department of Medical OncologyClínica Universitaria de Navarra
  • B. Queralt
    • Department of Medical OncologyHospital Josep Trueta
  • E. Casado
    • Department of Medical OncologyFundación Althaia
  • J. Barriuso
    • Department of Medical OncologyHospital La Paz
  • V. Iranzo
    • Department of Medical OncologyHospital General
  • I. Juez
    • MD Anderson
  • L. Visa
    • Department of Medical OncologyHospital Clinic
  • E. Saigi
    • Department of Medical OncologyCOrporación Parc Tauli
  • A. Barnadas
    • Department of Medical OncologyHospital de la Santa Creu I Sant Pau
  • X. Garcia-Albeniz
    • Department of EpidemiologyHarvard School of Public Health
  • J. Maurel
    • Department of Medical OncologyHospital Clinic
PHASE II STUDIES

DOI: 10.1007/s10637-013-0020-2

Cite this article as:
Martin-Richard, M., Gallego, R., Pericay, C. et al. Invest New Drugs (2013) 31: 1573. doi:10.1007/s10637-013-0020-2

Summary

Background Cisplatin and fluoropyrimidine (CF) are standard first- line treatment in advanced gastric cancer, but no second-line treatment has yet been established. We present a phase II study in which we evaluated the efficacy and toxicity of the combination of Sorafenib (S), and Oxaliplatin as second-line therapy. Methods Patients with progressive gastric adenocarcinoma after CF- first-line, ECOG 0–2, and measurable disease were included. The primary objective was PFS. Treatment doses were Oxaliplatin 130 mg/m2/3 weeks and Sorafenib 800 mg/bid/d. Results We included 40 patients. CR was 2.5 % and SD was 47.2 %. Grade 3–4 toxic effects were neutropenia (9.8 %), thrombocytopenia (7.3 %), neurotoxicity (4.9 %) and diarrhea (4.9 %). Median PFS was 3 months (95 %CI: 2.3–4.1) and median OS was 6.5 months (95 % CI: 5.2–9.6). Time to progression (TTP) to first line therapy was a prognosis factor. Median OS was 9.7 months when time-to-progression during first-line chemotherapy was >6 months and 5.6 m when it was <6 months (p = 0.04). Conclusions Time-to-progression under a CF-based first-line therapy determines subgroups of GC patients with different prognosis. The combination of Oxaliplatin-Sorafenib in advanced GC patients previously treated with CF appears safe, but our results do not support the implementation of a phase III trial.

Keywords

Advanced gastric adenocarcinomaSecond-line treatmentAntitarget therapiesOxaliplatinSorafenib

Copyright information

© Springer Science+Business Media New York 2013