非小细胞肺癌一线化疗后替吉奥胶囊维持化疗的临床研究

目的 在晚期非小细胞肺癌的一线化疗后用替吉奥胶囊维持治疗,评价其疗效及毒副反应.方法 单药替吉奥胶囊80mg/（m2·d）]口服2周,停1周的用法,直到毒性不能耐受或疾病进展,生存用Kaplan-Meier法.结果 2010年5月到2011年5月,共入组36例一线化疗有效晚期非小细胞肺癌患者,5例（13.9％）部分缓解,19例（52.8％）疾病稳定,疾病控制率66.7％,17例（47.2％）疾病稳定超过3个月.中位无疾病进展时间4.5个月,中位生存时间10.9个月,1年生存率45.2％.毒副反应：未出现4度以上的毒副反应,3度骨髓抑制共2例（5.5％）,其中是嗜中性粒细胞减少共1例（2.8％）和贫血共1例（2.8％）,感染2例（5.5％）,皮肤色素沉着1例（2.8％）,皮疹1例（2.8％）.结论 在晚期非小细胞肺癌一线化疗后用单药替吉奥胶囊维持化疗疗效较好,毒性低.

A Clinical Study of Maintenance Chemotherapy of Gimeracil and Oteracil Potassium Capsules for Advanced Non-small Cell Lung Cancer Patients with Effective First-line Treatment

Objective This study was designed to evaluate the efficacy and safety of maintenance chemotherapy of Gimeracil and Oteraeil Potassium Capsules for advanced non - small cell lung cancer patients with effective first - line treatment. Methods Pa- tients received oral Oteraeil Potassium Capsules （80mg/m2 per day） on days 1 through 14 every 21 days. For patients without dis- ease progression,Oteracil Potassium Capsules were continued until disease progression or unacceptable toxicity developed. Survival used Kaplan - Meier. Results Thirty - six patients were enrolled in the phase 3 study between May 2010 and May 2011 ; of these, 5 patients （ 13.9% ） achieved a partial response and 19 （52.8%） stable disease,for a disease control rate of 66. 7%. 17 （47.2%） patients presented stable disease maintained for more then 3mnoths. Median progression -free survival was 4. 5 months, Median sur- vival time was 10. 9 months, and 1 - year survival rate was 45.2% , No grade 4 toxicities were encountered. Grade 3 hematological toxicities comprised neutropenia in one patient （2.8%） and anemia in one patient （2.8%）. Grade 3 non -hematologicaltoxicities were observed in only four patients （ 13.9% ）. Treatment - related death did not occur. Conclusion The oral Gimeracil and Oter- aeil Potassium Capsules is an active and well - tolerated monotherapy for maintenance chemotherapy of advanced non - small cell lung cancer patients with effective first -line treatment.