Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer

W Koizumi, N Boku, K Yamaguchi, Y Miyata, A Sawaki, T Kato, Y Toh, I Hyodo, T Nishina, T Furuhata, K Miyashita, Y Okada, W Koizumi, N Boku, K Yamaguchi, Y Miyata, A Sawaki, T Kato, Y Toh, I Hyodo, T Nishina, T Furuhata, K Miyashita, Y Okada

Abstract

Background: S-1, a novel oral fluoropyrimidine, is well tolerated in patients with metastatic colorectal cancer (mCRC). The response rate of S-1 for colorectal cancer is high, ranging from 35% to 40%. This study aimed to evaluate the safety and efficacy of S-1 combined with oral leucovorin (LV) to enhance antitumor activity in chemotherapy-naive patients with mCRC.

Patients and methods: S-1 was given orally twice daily for two consecutive weeks at a daily dose of 80-120 mg, followed by a 2-week rest period, within a 4-week cycle. LV was given orally twice a day at a daily dose of 50 mg, simultaneously with S-1.

Results: Of the 56 patients with previously untreated mCRC, 32 (57%) had partial responses. The median follow-up period was 27.2 months. The median time to progression was 6.7 months (95% confidence interval 5.4-7.9). The median survival time was 24.3 months. There was no treatment-related death or grade 4 toxicity. The most common grade 3 toxic effects were diarrhea (32%), anorexia (21%), stomatitis (20%), and neutropenia (14%).

Conclusion: S-1 combined with LV therapy demonstrated promising efficacy and acceptable safety in chemotherapy-naive patients with mCRC without the concurrent use of irinotecan, oxaliplatin, or molecular-targeted drugs.

Figures

Figure 1.
Figure 1.
Kaplan–Meier curve of time to progression.
Figure 2.
Figure 2.
Kaplan–Meier curve of overall survival.

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