BACKGROUND: S-1 is an oral fluoropyrimidine that promises better and accessible treatment. This article identifies the risk factors for severe adverse events of S-1 from nationwide survey data. METHODS: Advanced gastric cancer patients scheduled to receive S-1 monotherapy (80 mg/day for days 1-28, every 6 weeks) were registered throughout Japan between 1999 and 2000 (n = 3758). Univariate and multivariate analyses were performed to explore the risk factors for severe adverse events. RESULTS: A multivariate analysis revealed that grade 3 or 4 neutropenia was significantly associated with baseline renal function [odds ratios (ORs) corresponding to creatinine clearance (ml/min) ranges of 50-79, 30-49, and <30 in reference to >80 increased to 1.21, 1.79, and 2.43, respectively], and the estimated incidence probability of grade 3 or 4 neutropenia ranged from 5.0% to 33.7% depending on the initial status of renal function and baseline neutrophil count. Some prior chemotherapeutic drug use may be implicated in the experience of adverse events; decreases in hemoglobin, nausea/vomiting, and hyperbilirubinemia were observed to be influenced by the previous use of irinotecan (OR = 3.07, P = 0.003), mitomycin (OR = 2.28, P = 0.004), and cisplatin (OR = 1.60, P = 0.007), respectively. CONCLUSION: These findings identified possible risk factors for severe adverse events of S-1 and the patient subgroups at potentially higher risk from its administration. The results will facilitate safer administration of S-1 and thus promote enhanced tolerability and efficacy.
BACKGROUND:S-1 is an oral fluoropyrimidine that promises better and accessible treatment. This article identifies the risk factors for severe adverse events of S-1 from nationwide survey data. METHODS: Advanced gastric cancerpatients scheduled to receive S-1 monotherapy (80 mg/day for days 1-28, every 6 weeks) were registered throughout Japan between 1999 and 2000 (n = 3758). Univariate and multivariate analyses were performed to explore the risk factors for severe adverse events. RESULTS: A multivariate analysis revealed that grade 3 or 4 neutropenia was significantly associated with baseline renal function [odds ratios (ORs) corresponding to creatinine clearance (ml/min) ranges of 50-79, 30-49, and <30 in reference to >80 increased to 1.21, 1.79, and 2.43, respectively], and the estimated incidence probability of grade 3 or 4 neutropenia ranged from 5.0% to 33.7% depending on the initial status of renal function and baseline neutrophil count. Some prior chemotherapeutic drug use may be implicated in the experience of adverse events; decreases in hemoglobin, nausea/vomiting, and hyperbilirubinemia were observed to be influenced by the previous use of irinotecan (OR = 3.07, P = 0.003), mitomycin (OR = 2.28, P = 0.004), and cisplatin (OR = 1.60, P = 0.007), respectively. CONCLUSION: These findings identified possible risk factors for severe adverse events of S-1 and the patient subgroups at potentially higher risk from its administration. The results will facilitate safer administration of S-1 and thus promote enhanced tolerability and efficacy.
Authors: Robert C Kane; Ann T Farrell; Haleh Saber; Shenghui Tang; Gene Williams; Josephine M Jee; Chengyi Liang; Brian Booth; Nallaperumal Chidambaram; David Morse; Rajeshwari Sridhara; Patricia Garvey; Robert Justice; Richard Pazdur Journal: Clin Cancer Res Date: 2006-12-15 Impact factor: 12.531
Authors: T Shirasaka; Y Shimamato; H Ohshimo; M Yamaguchi; T Kato; K Yonekura; M Fukushima Journal: Anticancer Drugs Date: 1996-07 Impact factor: 2.248
Authors: T Taguchi; Y Inuyama; R Kanamaru; K Hasegawa; S Akazawa; H Niitani; H Furue; M Kurihara; K Ota; S Suga; Y Ariyoshi; S Takai; T Shimoyama; T Toge; S Takashima; K Sugimachi; Y Hara; H Fujita; K Kimura; T Saito; S Tsukagoshi; I Nakao Journal: Gan To Kagaku Ryoho Date: 1997-12
Authors: J Cassidy; C Twelves; E Van Cutsem; P Hoff; E Bajetta; M Boyer; R Bugat; U Burger; A Garin; U Graeven; J McKendric; J Maroun; J Marshall; B Osterwalder; G Pérez-Manga; R Rosso; P Rougier; R L Schilsky Journal: Ann Oncol Date: 2002-04 Impact factor: 32.976