Kimura Michio, Morihata Kazuyo, Ito Daisuke, Iwai Mina, Okada Kazutomo, Usami Eiseki, Nakao Toshiya, Yoshimura Tomoaki, Yasuda Tadashi
Dept. of Pharmacy, Ogaki Municipal Hospital.
Gan To Kagaku Ryoho. 2010 May;37(5):829-34.
Patients taking more than 8 courses of S-1 were classified in the continuous group (n=30) and those in whom S-1 was discontinued or reduced due to adverse reactions in the discontinuation/reduction group (n=29). Factors affecting the continuous administration of S-1 as the adjuvant chemotherapy were examined in the two groups. 10 cases in the continuous group and 8 cases in the discontinuation/reduction group began with a stage 1 reduction of the S-1 regimen. Significant factors which affected the reduction or discontinuation of S-1 due to adverse reactions were 1) serum albumin value (Alb) (odds ratio 9.227; 95% confidence interval 1.056-80.603, p=0.0196) and 2) creatinine clearance value (Ccr) (odds ratio 5.850; 95% confidence interval 1. 222-27.995, p=0.0221). Among the reasons for reduction or discontinuation, non-hematotoxicities including malaise, nausea and diarrhea accounted for 24/59 cases (40.7%) and hematotoxicities such as leukopenia for 5/59 cases (8.5%). The present study revealed that most of the reduction or discontinuation of S-1 was due to non-hematotoxicity such as malaise and suggested that these risks increased when Alb decreased to less than 3.5 g/dL and Ccr to less than 80 mL/min. Prognosis is reportedly satisfactory when administration of S-1 is continued for one year even if withdrawal or reduction is necessary during the period. Serious adverse reactions will have ill effects on future compliance with to administration in patients who have experienced them. The above results indicate that the occurrence of non-hematotoxicity should be observed carefully in patients with Alb less than 3.5 g/dL and Ccr less than 80 mL/min at the beginning of S-1 administration, and these patients should receive appropriate guidance. Modification or reduction of S-1 regimen at the beginning may be one way to alleviate hematotoxicity.
接受超过8个疗程S-1治疗的患者被归为持续用药组(n = 30),因不良反应而停用或减量S-1的患者归为停药/减量组(n = 29)。在两组中研究了影响S-1作为辅助化疗持续给药的因素。持续用药组中有10例、停药/减量组中有8例最初采用S-1方案的1级减量。因不良反应导致S-1减量或停药的显著因素为:1)血清白蛋白值(Alb)(比值比9.227;95%置信区间1.056 - 80.603,p = 0.0196)和2)肌酐清除率值(Ccr)(比值比5.850;95%置信区间1.222 - 27.995,p = 0.0221)。在减量或停药原因中,包括不适、恶心和腹泻等非血液学毒性占24/59例(40.7%),白细胞减少等血液学毒性占5/59例(8.5%)。本研究表明,S-1的减量或停药大多是由于不适等非血液学毒性,并提示当Alb降至低于3.5 g/dL且Ccr降至低于80 mL/min时,这些风险会增加。据报道,即使在此期间有必要停药或减量,S-1持续给药一年时预后良好。严重的不良反应会对经历过这些反应的患者未来的用药依从性产生不良影响。上述结果表明,在开始使用S-1时,对于Alb低于3.5 g/dL且Ccr低于80 mL/min的患者,应仔细观察非血液学毒性的发生情况,并且这些患者应接受适当指导。在开始时调整或减少S-1方案可能是减轻血液学毒性的一种方法。