S-1 Plus Leucovorin, Oxaliplatin Active in Advanced Gastric Cancer

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S-1 plus leucovorin and oxaliplatin was more active than S-1 plus leucovorin or S-1 plus cisplatin with acceptable adverse effects in gastric cancer.
S-1 plus leucovorin and oxaliplatin was more active than S-1 plus leucovorin or S-1 plus cisplatin with acceptable adverse effects in gastric cancer.

S-1 plus leucovorin and oxaliplatin was more active than S-1 plus leucovorin or S-1 plus cisplatin with acceptable adverse effects in patients with advanced gastric cancer, a new study published online ahead of print in the journal The Lancet Oncology.1

Although previous research has demonstrated that leucovorin enhances the efficacy of fluorouracil in advanced gastric cancer, the antitumor activity of S-1 and leucovorin in combination with oxaliplatin in patients with advanced gastric cancer has not been studied.

Therefore, researchers sought to compare the activity and safety of S-1 plus leucovorin, S-1 plus leucovorin and oxaliplatin, and S-1 plus cisplatin as first-line chemotherapy.

For the multicenter, open-label, phase 2 trial, researchers enrolled 145 chemotherapy-naïve patients with unresectable or recurrent gastric cancer from 25 institutions in Japan.

Patients were randomly assigned 1:1:1 to receive S-1 40-60 mg orally plus leucovorin 25 mg orally twice daily for 1 week, every 2 weeks; S-1 plus leucovorin and oxaliplatin 85 mg/m2 intravenously on day 1, every 2 weeks; or S-1 40-60 mg orally twice daily for 3 weeks plus cisplatin 60 mg/m2 intravenously on day 8, every 5 weeks.

Results showed that the objective response rate was 43% (95% CI, 28.3 - 57.8) in the S-1 plus leucovorin group, 66% (95% CI, 50.7 - 79.1) in the S-1 plus leucovorin and oxaliplatin group, and 46% (95% CI, 31.4 - 60.8) in the S-1 plus cisplatin group. S-1 plus leucovorin and oxaliplatin was significantly more active than S-1 plus cisplatin (P = .063) and S-1 plus leucovorin (P = .038).

RELATED: Dietary Factors Linked With Gastric Cancer Risk Identified

In regard to safety, the most common grade 3 to 4 adverse effects were neutropenia, decreased appetite, anemia, and hyponatremia.

A phase 3 trial evaluating S-1 plus leucovorin and oxaliplatin compared with S-1 plus cisplatin is underway.

Reference

  1. Hironaka S, Sugimoto N, Yamaguchi K, et al. S-1 plus leucovorin versus S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer: a randomised, multicentre, open-label, phase 2 trial [published online ahead of print November 27, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00410-6.

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