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目的:观察晚期非小细胞肺癌(NSCLC)患者接受吉非替尼(gefitinib)治疗后的生存期、缓解率、疗效。方法:分析2000年12月-2003年10月美国M.D.Anderson癌症治疗中心与上海市胸科医院接受吉非替尼250 mg/d口服治疗的共175例晚期NSCLC患者。用Kaplan-Meier及logrank进行生存分析和比较,并用Cox多因素回归分析生存相关因素。用χ2检验比较不同因素在缓解率及疾病控制方面有无差异,logistic多因素回归分析疾病控制率、缓解率的相关因素。结果:175名患者的中位生存期(MST)为6.9个月(95%CI:4.19~9.61);中位无疾病进展时间(PFS)为3.47个月(95%CI:2.67~4.27)。Cox多因素分析显示性别(P=0.002)、年龄(P<0.001)、治疗前血红蛋白水平(P=0.034)、PS评分(P=0.019)、既往化疗方案次数(P=0.013)、病理类型(P=0.030)是影响生存的独立因素。性别(P=0.002)、PS评分(P=0.013)是影响PFS的独立因素。所有患者的缓解率为10.14%;疾病控制率为40.54%。影响缓解率与疾病控制率的多因素分析提示性别(P=0.041)、年龄(P=0.035)、吸烟情况(P=0.038)是影响缓解率的独立因素,而性别是影响疾病控制率的独立因素(P=0.036)。结论:吉非替尼治疗复治、晚期NSCLC患者是安全、有效的。
Objective: To observe the survival, response and efficacy of gefitinib after advanced non-small cell lung cancer (NSCLC). METHODS: A total of 175 patients with advanced NSCLC treated with gefitinib 250 mg / day orally at M.D. Anderson Cancer Center and Shanghai Chest Hospital from December 2000 to October 2003 were analyzed. Survival analysis and comparison were performed with Kaplan-Meier and logrank, and survival-related factors were analyzed using Cox multivariate regression. Chi-square test was used to compare the different factors in remission rate and disease control whether there is any difference, logistic multivariate regression analysis of disease control rate, remission rate related factors. Results: The 175 patients had a median survival (MST) of 6.9 months (95% CI: 4.19 to 9.61) and a median progression-free time (PFS) of 3.47 months (95% CI: 2.67 to 4.27). Cox multivariate analysis showed that gender, age (P <0.001), pretreatment hemoglobin level (P = 0.034), PS score (P = 0.019), previous chemotherapy regimen (P = 0.013), pathological type P = 0.030) is an independent factor affecting survival. Gender (P = 0.002), PS score (P = 0.013) were independent factors affecting PFS. The response rate of all patients was 10.14% and the disease control rate was 40.54%. Multivariable analysis of the rate of response and disease control rates suggested that gender (P = 0.041), age (P = 0.035), and smoking (P = 0.038) were independent factors affecting remission rates and that gender was an independent factor affecting disease control rates Factor (P = 0.036). Conclusion: Gefitinib treatment of retreatment, advanced NSCLC patients is safe and effective.