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目的评价吉西他滨2小时输注[10 mg/(m2.min)固定剂量输注]联合卡铂一线治疗晚期非小细胞肺癌的有效性和安全性。方法对54例B和期初治非小细胞肺癌患者行化疗。方案为吉西他滨1200 mg/m22小时输注(10 mg/m2.min)第1天、第8天,卡铂AUC 5第1天,每21天重复一周期,共223个化疗周期,中位4个周期(1~6个周期)。结果可评价疗效患者51例,总有效率为41.2%(95%可信区间,28%~57%),完全缓解率(CR)3.9%,部分缓解率(PR)37.3%。中位肿瘤进展时间(TTP)5.0个月(95%可信区间,3.7~6.3个月),中位生存期(OS)11.5个月(95%可信区间,9.9~13.1个月)。1年生存率41.7%。可评价毒性患者54例,主要的3~4度毒性为中性粒细胞减少(55.6%),血小板减少(57.4%)。27个周期(12.1%)需接受血小板输注。56个周期(25.1%)需造血因子支持治疗。无出血事件发生。3度恶心/呕吐发生率为5.6%,1~2度皮疹发生率42.6%。结论延长吉西他滨输注时间联合卡铂毒性可控制,疗效与其它治疗非小细胞肺癌的一线化疗方案相似。
Objective To evaluate the efficacy and safety of gemcitabine 2-hour infusion [10 mg / (m2.min) fixed-dose infusion plus carboplatin in the first-line treatment of advanced non-small cell lung cancer. Methods 54 cases of B and initial non-small cell lung cancer patients underwent chemotherapy. The protocol was gemcitabine 1200 mg / m22 infusion (10 mg / m2.min) on day 1, day 8, carboplatin AUC 5 on day 1, one cycle repeated every 21 days for a total of 223 cycles of chemotherapy, median 4 A cycle (1 to 6 cycles). Results Fifty-one patients were evaluated. The total effective rate was 41.2% (95% confidence interval, 28% -57%). The complete response rate (CR) was 3.9% and partial response rate (PR) was 37.3%. The median time to tumor progression (TTP) was 5.0 months (95% confidence interval, 3.7 to 6.3 months) and 11.5 months (95% confidence interval, 9.9 to 13.1 months) with a median OS. 1 year survival rate of 41.7%. 54 patients were eligible for evaluation of toxicity. The major toxicities of 3-4 degrees were neutropenia (55.6%) and thrombocytopenia (57.4%). 27 cycles (12.1%) required platelet transfusion. 56 cycles (25.1%) required hematopoietic support. No bleeding event occurred. The incidence of nausea / vomiting at 3 degrees was 5.6% and the incidence of rashes at 1 ~ 2 degrees was 42.6%. Conclusion Prolonged gemcitabine infusion time combined with carboplatin toxicity control, efficacy and other treatment of non-small cell lung cancer first-line chemotherapy is similar.