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目的肺癌是全世界发病率及死亡率最高的恶性肿瘤。非小细胞肺癌(non-small cell lung cancer,NSCLC)约占肺癌的85%,>2/3患者临床确诊时已处于中晚期。近年来晚期NSCLC治疗方法进步很大,但晚期NSCLC的三线治疗尚无标准方案。本研究回顾性分析比较异环磷酰胺(ifosfamide,IFO)、长春瑞滨(vinorelbine,NVB)及顺铂(cisplatin,DDP)组合的INP方案和培美曲塞(pemetrexed,PEM)联合DDP的AP方案三线治疗不可切除的局部晚期或Ⅳ期NSCLC的近期疗效及不良反应。方法 2013-04-01-2015-04-01江门市中心医院肿瘤科共收治经一、二线治疗失败的ⅢB期或Ⅳ期NSCLC患者158例,简单随机分配至INP组78例和AP组80例。2组患者的性别、年龄、ECOG评分、分期、吸烟状况及既往治疗方面均具有良好的可比性。INP组应用IFO 1.2g/m~2,静脉滴入,d1~d2;NVB 20mg/m~2,静脉推注,d1、d8;DDP 25mg/m~2,静脉滴入,d1~d3。AP组应用PEM 500mg/m~2,静脉滴入,d1;DDP 25mg/m~2,静脉滴入,d1~d3。治疗周期为21d,共4个周期。每2及4个周期后复查CT,按RECIST标准评价疗效。无进展生存期(progression free survival,PFS)定义为首次治疗开始之日到疾病进展或患者死亡。结果 158例患者均可评价,中位随访期13个月。INP和AP组的客观缓解率分别为12.8%(10/78)和17.5%(14/80),χ~2=0.671,P=0.413;疾病控制率分别为53.8%(42/78)和57.5%(46/80),χ~2=0.214,P=0.644。PFS分别为153和189d,差异有统计学意义,P=0.027。不良反应可耐受。INP组和AP组的白细胞减少分别为74.4%(58/78)和37.5%(30/80),差异有统计学意义,P<0.001;中性粒细胞减少分别为64.1%(50/78)和37.5%(30/80),差异有统计学意义,P=0.001;血小板减少分别为30.8%(24/78)和40.0%(32/80),P=0.225;贫血分别为59.0%(46/78)和52.5%(42/80),P=0.413;恶心呕吐分别为79.5%(62/78)和55.0%(44/80),差异有统计学意义,P=0.001;周围神经毒性分别为64.1%(50/78)和37.5%(30/80),差异有统计学意义,P=0.001;静脉炎分别为25.6%(20/78)和2.5%(2/80),差异有统计学意义,P<0.001。INP组独有的不良反应尿路刺激征发生率为12.8%(10/78)。血液学及非血液学毒性INP方案明显高于AP方案,P<0.05。结论 INP组和AP组三线治疗晚期NSCLC的疗效相似;但后者的中位PFS较长,且不良反应明显减轻。患者经济条件允许的情况下,三线化疗,尤其是肺腺癌患者,推荐AP方案。
Purpose Lung cancer is the highest morbidity and mortality in the world. Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer,> 2/3 of patients already in the clinical diagnosis of advanced stage. In recent years, the treatment of advanced NSCLC has made great progress, but the third-line treatment of advanced NSCLC has no standard solution. This study retrospectively analyzed and compared the INP regimen of ifosfamide (IFO), vinorelbine (NVB) and cisplatin (DDP) and the AP of pemetrexed (PEM) with DDP Third-line treatment of unresectable locally advanced or stage IV NSCLC in the short term efficacy and adverse reactions. Methods 2013-04-01-2015-04-01 Department of Oncology, Central Hospital of Jiangmen, a total of 158 patients with stage ⅢB or Ⅳ NSCLC who failed the first and second-line therapies were randomly assigned to 78 patients in the INP group and 80 patients in the AP group . There was a good comparability of gender, age, ECOG score, staging, smoking status and previous treatment in both groups. INP group IFO 1.2g / m ~ 2, intravenous drip, d1 ~ d2; NVB 20mg / m ~ 2, intravenous bolus, d1, d8; DDP 25mg / m ~ 2, intravenous infusion, d1 ~ d3. The AP group was treated with PEM 500mg / m ~ 2, intravenous drip, d1; DDP 25mg / m ~ 2, intravenous drip, d1 ~ d3. Treatment period is 21d, a total of 4 cycles. The CT was reviewed after 2 and 4 cycles, and the efficacy was evaluated according to RECIST criteria. Progression-free survival (PFS) is defined as the date of the first treatment until the disease progresses or the patient dies. Results 158 patients were evaluable, with a median follow-up of 13 months. The objective response rates were 12.8% (10/78) and 17.5% (14/80) in the INP and AP groups, respectively, χ ~ 2 = 0.671 and P = 0.413. The disease control rates were 53.8% (42/78) and 57.5 % (46/80), χ ~ 2 = 0.214, P = 0.644. PFS were 153 and 189d, the difference was statistically significant, P = 0.027. Adverse reactions are tolerable. The leukopenia in INP group and AP group were 74.4% (58/78) and 37.5% (30/80), respectively, with a significant difference (P <0.001). Neutropenia was 64.1% (50/78) And 37.5% (30/80) respectively, P = 0.001; thrombocytopenia were 30.8% (24/78) and 40.0% (32/80) respectively, P = 0.225; anemia was 59.0% / 78) and 52.5% (42/80) respectively, P = 0.413; nausea and vomiting were 79.5% (62/78) and 55.0% (44/80) respectively, the difference was statistically significant The difference was statistically significant, P = 0.001; Phlebitis were 25.6% (20/78) and 2.5% (2/80) respectively, the difference was statistically significant Significance, P <0.001. The unique adverse reaction of INP group urinary tract irritation was 12.8% (10/78). The hematological and non-hematologic toxicity of INP was significantly higher than that of AP (P <0.05). Conclusions The efficacy of the third-line treatment of advanced NSCLC is similar between the INP group and the AP group. However, the median PFS of the latter group is longer and the adverse reactions are significantly reduced. Patients under the conditions of economic conditions, the third-line chemotherapy, especially lung adenocarcinoma patients, recommended AP program.