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

  • M. Martin-Richard
  • R. Gallego
  • C. Pericay
  • J. Garcia Foncillas
  • B. Queralt
  • E. Casado
  • J. Barriuso
  • V. Iranzo
  • I. Juez
  • L. Visa
  • E. Saigi
  • A. Barnadas
  • X. Garcia-Albeniz
  • J. Maurel
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

Authors and Affiliations

  • M. Martin-Richard
    • 1
  • R. Gallego
    • 2
  • C. Pericay
    • 3
  • J. Garcia Foncillas
    • 4
  • B. Queralt
    • 5
  • E. Casado
    • 6
  • J. Barriuso
    • 7
  • V. Iranzo
    • 8
  • I. Juez
    • 9
  • L. Visa
    • 2
  • E. Saigi
    • 3
  • A. Barnadas
    • 1
  • X. Garcia-Albeniz
    • 10
  • J. Maurel
    • 2
  1. 1.Department of Medical OncologyHospital de la Santa Creu I Sant PauBarcelonaSpain
  2. 2.Department of Medical OncologyHospital ClinicBarcelonaSpain
  3. 3.Department of Medical OncologyCOrporación Parc TauliBarcelonaSpain
  4. 4.Department of Medical OncologyClínica Universitaria de NavarraPamplonaSpain
  5. 5.Department of Medical OncologyHospital Josep TruetaGironaSpain
  6. 6.Department of Medical OncologyFundación AlthaiaBarcelonaSpain
  7. 7.Department of Medical OncologyHospital La PazMadridSpain
  8. 8.Department of Medical OncologyHospital GeneralValenciaSpain
  9. 9.MD AndersonMadridSpain
  10. 10.Department of EpidemiologyHarvard School of Public HealthBostonUSA