S-1 plus oxiliplatin may be new first-line standard for advanced gastric cancer
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Patients with advanced gastric cancer who underwent first-line treatment with S-1 plus oxaliplatin demonstrated comparable survival outcomes with less toxicity than those treated with S-1 plus cisplatin, according to results of a randomized phase 3 study.
The results suggest the combination of S-1, an oral fluoropyrimidine derivative, and cisplatin could become the new standard first-line regimen for this patient population, researchers wrote.
The open-label, multicenter study included 685 patients.
Yasuhide Yamada, MD, of the gastrointestinal oncology division at National Cancer Center Hospital in Japan, and colleagues randomly assigned 318 patients to S-1 plus oxaliplatin. Treatment consisted of S-1 80/mg day to 120 mg/day for 2 weeks, plus oxaliplatin 100 mg/m2 on day 1 every 3 weeks.
The other 324 patients received S-1 plus cisplatin. Treatment consisted of S-1 for 3 weeks, plus cisplatin administered at a dose of 60 mg/m2 on day 8 every 5 weeks.
Noninferiority of S-1 plus oxaliplatin as measured by PFS, as well as the combination’s relative efficacy in OS, served as primary endpoints. Researchers also evaluated performance status, as well as unresectable or recurrent disease.
Results of the per-protocol population analysis showed patients assigned S-1 plus oxaliplatin demonstrated comparable PFS as those assigned S-1 plus cisplatin (5.5 months vs. 5.4 months; HR=1.004; 95% CI, 0.84-1.19). The HR met the predefined noninferiority margin of 1.3. Patients assigned S-1 plus oxaliplatin also demonstrated slightly longer OS (14.1 months vs. 13.1 months; HR=0.95; 95% CI, 0.8-1.14).
In the intention-to-treat population, researchers reported HRs of 0.97 (95% CI, 0.82-1.16) for PFS and 0.93 (95% CI, 0.78-1.1) for OS, both in favor of S-1 plus oxaliplatin.
More patients assigned S-1 plus cisplatin developed grade ≥3 neutropenia (41.8% vs. 19.5%), anemia (32.5% vs.15.1%), hyponatremia (13.4% vs. 4.4%) and febrile neutropenia (6.9% vs. 0.9%). More patients assigned S-1 plus oxaliplatin developed grade ≥3 sensory neuropathy (4.7% vs. 0%).
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.