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

  • PHASE II STUDIES
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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.

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Acknowledgments

We thank Carolyn Newey for English review of the work.

This study was performed within the Medical PhD. framework of the Universitat Autònoma de Barcelona.

X Garcia- Albeniz is a recipient of an “ASISA Fellowship”

Ethical standards

This study comply with the current laws of Spain.

Conflict of interest

The authors declare that they have no conflict of interest

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Authors and Affiliations

  1. Department of Medical Oncology, Hospital de la Santa Creu I Sant Pau, carrer de Sant Antoni M. Claret 167, Barcelona, 08025, Spain

    M. Martin-Richard & A. Barnadas

  2. Department of Medical Oncology, Hospital Clinic, Barcelona, Spain

    R. Gallego, L. Visa & J. Maurel

  3. Department of Medical Oncology, COrporación Parc Tauli, Barcelona, Spain

    C. Pericay & E. Saigi

  4. Department of Medical Oncology, Clínica Universitaria de Navarra, Pamplona, Spain

    J. Garcia Foncillas

  5. Department of Medical Oncology, Hospital Josep Trueta, Girona, Spain

    B. Queralt

  6. Department of Medical Oncology, Fundación Althaia, Barcelona, Spain

    E. Casado

  7. Department of Medical Oncology, Hospital La Paz, Madrid, Spain

    J. Barriuso

  8. Department of Medical Oncology, Hospital General, Valencia, Spain

    V. Iranzo

  9. MD Anderson, Madrid, Spain

    I. Juez

  10. Department of Epidemiology, Harvard School of Public Health, Boston, USA

    X. Garcia-Albeniz

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  1. M. Martin-Richard
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Correspondence to M. Martin-Richard.

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Martin-Richard, M., Gallego, R., Pericay, C. et al. Multicenter phase II study of oxaliplatin and sorafenib in advanced gastric adenocarcinoma after failure of cisplatin and fluoropyrimidine treatment. A gemcad study. Invest New Drugs 31, 1573–1579 (2013). https://doi.org/10.1007/s10637-013-0020-2

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  • DOI: https://doi.org/10.1007/s10637-013-0020-2

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