TY - JOUR
T1 - Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer
AU - Koizumi, W.
AU - Boku, N.
AU - Yamaguchi, K.
AU - Miyata, Y.
AU - Sawaki, A.
AU - Kato, T.
AU - Toh, Y.
AU - Hyodo, I.
AU - Nishina, T.
AU - Furuhata, T.
AU - Miyashita, K.
AU - Okada, Y.
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2009/10/14
Y1 - 2009/10/14
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=77951944265&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77951944265&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdp371
DO - 10.1093/annonc/mdp371
M3 - Article
C2 - 19828562
AN - SCOPUS:77951944265
VL - 21
SP - 766
EP - 771
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 4
ER -