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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.

Authors :
Martin-Richard, M.
Gallego, R.
Pericay, C.
Foncillas, J.
Queralt, B.
Casado, E.
Barriuso, J.
Iranzo, V.
Juez, I.
Visa, L.
Saigi, E.
Barnadas, A.
Garcia-Albeniz, X.
Maurel, J.
Source :
Investigational New Drugs; Dec2013, Vol. 31 Issue 6, p1573-1579, 7p
Publication Year :
2013

Abstract

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/m/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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01676997
Volume :
31
Issue :
6
Database :
Complementary Index
Journal :
Investigational New Drugs
Publication Type :
Academic Journal
Accession number :
91843714
Full Text :
https://doi.org/10.1007/s10637-013-0020-2