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Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study)
Annals of Oncology, 11/06/09

Koizumi W et al. – The efficacy and safety of oxaliplatin combined with S-1 (SOX regimen) for unresectable advanced or recurrent gastric cancer were investigated. These findings indicate that SOX regimen with oxaliplatin at a dose of 100 mg/m2 is feasible and shows promising efficacy against advanced gastric cancer.

Methods

Oxaliplatin administered i.v. (100 mg/m2) on day 1, while S-1 was administered orally (80 mg/m2/day, b.i.d.) for 14 days followed by 7-day rest
Schedule repeated every 3 weeks

Results

Among 55 patients enrolled, 1 patient received oxaliplatin for other study, and 3 patients were considered unsuitable against inclusion criteria
51 patients assessable for efficacy
Response rate 59%
Disease control rate 84%
Median PFS time 6.5 months
1-year survival rate 71%
Median survival time 16.5 months
In 54 patients assessed for safety, the major grade 3/4 toxic effects were neutropenia (22%), thrombocytopenia (13%), anemia (9%), anorexia (6%), fatigue (6%), and sensory neuropathy (4%)

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