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目的:观察评价新一代铂类抗癌药物洛铂(LBP)联合长春瑞滨(NVB)组成的LN方案治疗国人晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法:开放性、单试验组、多中心Ⅱ期临床研究,共入组40例NSCLC,均为初治患者,其中男性26例,女性14例;年龄31～77岁(中位年龄58岁)。病理类型为肺腺癌31例,鳞癌9例;TNM分期:ⅢA期2例,ⅢB期8例,Ⅳ期30例。应用LN方案,即LBP30mg/m2,静滴,d1;NVB25mg/m2,静滴,d1,d8,21天为1周期。至少接受2个周期化疗,按照WHO标准评价客观疗效和毒性,定期随访。结果:40例患者中,可评价疗效患者有37例,其中CR1例,PR12例,NC16例,PD8例,有效率(RR)为35.1%;疾病控制率(DCR)为78.4%。其中腺癌的有效率为37.9%,DCR为82.8%;鳞癌的有效率为25.0%,DCR为62.5%。TTP为42～362天,中位TTP为152天,1年生存率为64.9%。主要毒性反应为可逆性的骨髓抑制和胃肠道反应,未见明显肝肾毒性。结论:LBP联合NVB组成LN方案治疗国人初治的晚期NSCLC的疗效较好,毒性反应可以耐受,值得进一步研究观察。
OBJECTIVE: To evaluate the efficacy and safety of LN regimen in the treatment of advanced non-small cell lung cancer (NSCLC) in Chinese population by evaluating a new generation of platinum anticancer drug LBP combined with vinorelbine (NVB). Methods: A total of 40 NSCLC patients were enrolled in this study. They were all untreated patients, including 26 males and 14 females, aged 31-77 years (median age 58 years) . Pathological types were 31 cases of lung adenocarcinoma and 9 cases of squamous cell carcinoma. The TNM stage was stage IIA in 2 cases, stage IIIB in 8 cases and stage IV in 30 cases. Application of LN program, LBP30mg / m2, intravenous infusion, d1; NVB25mg / m2, intravenous drip, d1, d8, 21 days for a cycle. At least 2 cycles of chemotherapy were performed, and objective efficacy and toxicity were evaluated according to WHO criteria and followed up on a regular basis. Results: Among the 40 patients, there were 37 evaluable patients, of which CR1, PR12, NC and PD8 had an effective rate (RR) of 35.1% and a disease control rate (DCR) of 78.4%. The effective rate of adenocarcinoma was 37.9% and DCR was 82.8%. The effective rate of squamous cell carcinoma was 25.0% and the DCR was 62.5%. TTP was 42 to 362 days, median TTP was 152 days, and 1-year survival was 64.9%. The main toxicity was reversible myelosuppression and gastrointestinal reactions, no significant liver and kidney toxicity. CONCLUSION: The combination of LBP and NVB in the treatment of advanced NSCLC patients with advanced NSCLC has a good curative effect and tolerable toxicity. It deserves further study.