Safety, compliance, and predictive parameters for dosage modification in adjuvant S-1 chemotherapy for gastric cancer
Safety, compliance, and predictive parameters for dosage modification in adjuvant S-1 chemotherapy for gastric cancer
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DOI：
10.1111/cas.12044
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发表时间：
2013-01-01
期刊：
影响因子：
5.7
通讯作者：
Lee, Keun-Wook
中科院分区：
文献类型：
--
作者：
Kim, Su-Jung;Kim, Yu Jung;Lee, Keun-Wook
本研究旨在研究接受辅助S-1化疗的胃癌患者的依从性、安全性、剂量调整（剂量减少和/或方案改变[包括永久停用S-1]）以及预测S-1剂量调整的临床参数。149例接受根治性D2手术并接受辅助S-1化疗的患者入组。S-1经口给药（40 mg/m2，每日两次，第128天，每6周一次），持续1年。对于无法耐受S-1的患者，减少剂量或将方案变更为3周一次的方案，治疗2周，随后停药1周。73.8%的患者完成了计划的1年治疗; 69例患者因毒性需要调整剂量。剂量调整的最常见原因是小肠结肠炎（37例患者;定义为≥ 2级腹痛和/或≥ 2级腹泻）。大多数剂量调整发生在治疗的早期周期（前3个月内）。严重毒性（≥ 3级）包括中性粒细胞减少（13.4%）、腹痛（8.1%）和腹泻（8.1%）。在多变量分析中，相对剂量强度降低与无病生存率差相关，与分期无关，只有低肌酐清除率预测S-1剂量调整。总之，尽管辅助S-1治疗的依从率较高，但在治疗早期需要对不良事件进行细致的监测。肌酐清除率降低是预测剂量调整的唯一因素。肌酐清除率患者
This study was performed to investigate the compliance, safety, dosage modifications (dose reduction and/or schedule change [including permanent S-1 withdrawal]), and clinical parameters that predict S-1 dosage modification in gastric cancer patients receiving adjuvant S-1 chemotherapy. One hundred and forty-nine patients who underwent curative D2 surgery and received adjuvant S-1 chemotherapy were enrolled. S-1 was administered orally (40 mg/m2 twice daily on days 128 every 6 weeks) for 1 year. For patients unable to tolerate S-1, the dosage was reduced or the schedule was changed to a 3-weekly schedule of 2 weeks on treatment followed by 1 week off treatment. The planned 1-year treatment was completed in 73.8% of patients; 69 patients required dosage modification because of toxicity. The most frequent cause of dosage modification was enterocolitis (37 patients; defined as = grade 2 abdominal pain and/or = grade 2 diarrhea). Most dosage modification occurred during the early cycles of treatment (within the first 3 months). Severe toxicities (= grade 3) included neutropenia (13.4%), abdominal pain (8.1%) and diarrhea (8.1%). In multivariate analyses, decreased relative dose intensity was related to poor disease-free survival independent of stage, and only low creatinine clearance predicted S-1 dosage modification. In conclusion, although adjuvant S-1 therapy has a high compliance rate, meticulous monitoring of adverse events is required in the early period of treatment. Decreased creatinine clearance was the only factor that predicted dosage modification. In patients with creatinine clearance