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背景与目的目前铂类联合第三代化疗药物的方案为晚期非小细胞肺癌的一线治疗方案,但其对中位生存期及1年生存率的改善已达平台期。本研究的目的是探讨含铂方案联合西乐葆一线治疗晚期非小细胞肺癌的疗效、影响因素及不良反应。方法选择免疫组化证实为COX-2阳性的初治晚期非小细胞肺癌患者接受铂类为基础的二联化疗方案(GP方案:吉西他滨1250mg/m2,d1、8+顺铂80mg/m2,分d1、d2给药;NP方案:长春瑞滨25mg/m2,d1、8+顺铂80mg/m2,分d1、d2给药;TP方案:多西紫杉醇75mg/m2,d1+顺铂80mg/m2,分d1、d2给药),同时在化疗开始前5-7天开始口服西乐葆400mg,Bid,直至病情进展或出现不可耐受的副反应。不良反应采用NCI-CTC标准。采用Kaplan-Meier法估计生存,Cox模型分析影响因素。评价终点:中位生存期、1年生存率、无疾病进展生存期、有效率及不良反应。结果2005年2月至2007年3月入组患者可评价者共44例,有效率为45%,疾病控制率为59%。中位无疾病进展生存期为6个月(95%CI:4-8个月),中位生存期为18个月(95%CI:9-27个月),1年生存率为68%。一线周期数和总体评效是影响PFS的预测因素,未发现明确影响生存期的预测因素。白细胞减少和恶心/呕吐为最常见的不良反应,发生率分别为59%和50%,Ⅲ/Ⅳ度不良反应占15%。结论西乐葆联合铂类为基础的化疗作为COX-2筛选阳性的晚期非小细胞肺癌患者一线治疗是有效的,而且毒副反应可以接受。
BACKGROUND & OBJECTIVE: The current platinum-based third-generation chemotherapeutic regimen is the first-line treatment for advanced non-small cell lung cancer. However, its improvement of median survival and 1-year survival has reached a plateau. The purpose of this study was to investigate the efficacy, influencing factors and adverse reactions of platinum-containing regimen combined with Celebrex in the first-line treatment of advanced non-small cell lung cancer. Methods Patients with newly diagnosed advanced non-small cell lung cancer who were confirmed by immunohistochemistry as COX-2 positive received platinum-based dual regimen (GP regimen: gemcitabine 1250mg / m2, d1,8 + cisplatin 80mg / m2, d1, d2; NP regimen: vinorelbine 25mg / m2, d1,8 + cisplatin 80mg / m2, d1, d2 administration; TP program: docetaxel 75mg / m2, d1 + cisplatin 80mg / m2, Sub-d1, d2 administration), and 5-7 days before chemotherapy began oral Celebrex 400mg, Bid, until the disease progression or intolerable side effects. Adverse reactions using NCI-CTC standards. Kaplan-Meier method was used to estimate the survival and Cox model was used to analyze the influencing factors. End of evaluation: median survival, 1-year survival, disease-free survival, efficacy and adverse events. Results A total of 44 evaluable patients were recruited from February 2005 to March 2007, with an effective rate of 45% and a disease control rate of 59%. The median progression-free survival was 6 months (95% CI: 4-8 months), median survival was 18 months (95% CI: 9-27 months), and 1-year survival was 68% . The number of first-line cycles and overall assessment were predictors of PFS, and no predictors of survival were clearly found. Leukopenia and nausea / vomiting were the most common adverse reactions, with rates of 59% and 50%, respectively, and 15% of patients with grade III / IV adverse reactions. Conclusion Celebrex combined with platinum-based chemotherapy as a first-line treatment of advanced non-small cell lung cancer patients with COX-2 screening is effective and toxic side effects are acceptable.