依托泊苷胶囊在晚期非小细胞肺癌维持治疗临床观察  

Oral etoposide as maintenance therapy in patients with previously untreated advanced non-small cell lung cancer receiving induction chemotherapy with gemcitabine and cisplatin

作　　者：刘冬英[1] 陈世文[2] 吴海鹰[3] 李明毅[1] LIU Dong-ying CHEN Shi-wen WU Hai-ying LI Ming-yi(Jiangmen Central Hospital, Jiangmen, 529030, P. R. China Department of Medical Oncology , Cancer Center of Sun Yat-Sen University, State Key Laboratory of Oncology in South China ,Guangzhou,51OO60,China. P. R. China)

机构地区：[1]江门市中心医院肿瘤科,广东江门529030 [2]江门市中心医院神经内科,广东江门529030 [3]中山大学附属肿瘤医院肿瘤内科,华南肿瘤学国家重点实验室,广东广州510060

出　　处：《中华肿瘤防治杂志》2017年第17期1228-1231,共4页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的肺癌是我国发病率和死亡率最高的恶性肿瘤之一。近年来含铂双药化疗后的维持化疗是晚期肺癌的研究热点之一,然而维持治疗的最佳模式仍有争议。本研究回顾性分析晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者GP方案(吉西他滨+顺铂)化疗后依托泊苷胶囊换药维持治疗的近期疗效和不良反应。方法选取江门市中心医院肿瘤科2012-07-01-2015-01-31收治的200例初诊晚期NSCLC患者作为研究对象,患者表皮生长因子受体(epithelial growth factor receptor,EGFR)突变均为野生型。200例患者均接受GP方案诱导化疗,吉西他滨1 350mg/m2,d1;顺铂25mg/m2,d1~d2,14d为1个周期,总共6个周期。3和6个周期化疗后复查CT,按RECIST标准评价疗效。无疾病进展的患者共115例,均签署知情同意书,按1∶1分配至两组:A组55例随访观察;B组60例接受依托泊苷胶囊维持治疗,25mg/d,连续口服14d,21d为1个周期,至少服药3个周期,直至肿瘤进展或出现不可耐受停药。两组均每2个月复查CT评价疗效至肿瘤进展或患者死亡。结果 200例患者均可评价,客观缓解率为28.0%(56/200),疾病控制率为57.5%(115/200);中位随访期16.8个月,总体的中位无进展生存期为5.4个月。符合入组的115患者的中位PFS为8.2个月,其中A组和B组的中位PFS分别为7.8和9.0个月,差异有统计学意义,χ2=4.971,P=0.027。不良反应方面,两组的血液学毒性相似,主要为Ⅰ~Ⅱ度的白细胞、血小板下降和贫血,差异均无统计学意义,P>0.05;非血液学毒性主要为Ⅰ~Ⅱ度恶心呕吐,A、B组的发生率分别为20.0%(11/55)和36.7%(22/60),差异有统计学意义,χ2=3.896,P=0.048。结论依托泊苷胶胶囊换药维持可显著延长晚期无EGFR突变的NSCLC患者的无进展生存期,且不良反应轻微,值得进一步研究。OBJECTIVE Lung cancer is one of the most common cancer in terms of both incidence and mortality in China. In recent years, maintenance chemotherapy after initial induction platium-base doublet in patients with advanced non-small cell lung cancer （NSCLC） has been extensively investigated. However, the optimal maintenance strategy remains controversial. The objective of this retrospective study was designed to assess the efficacy and toxicities of oral etoposide as maintenance therapy for epidermal growth factor receptor （EGFR） mutation-negative advanced NSCLC treated with gemcitabine （GEM） plus cisplatih （DDP） as first-line induction chemotherapy. METHODS From July 2012 to Jan uary 2015, a total of 200 chemotherapy-naive advanced NSCLC patients were included at the Department of Medical Oncology,Jiangmen Central Hospital of Sun Yat-Sen University. Eligible patients received induction chemotherapy with GEM at a dose of 1 350 mg/m^2 ,administered intravenously on dl and DDP at a dose of 25 mg/m^2 ,administered intravenously on d1 to d2. The regimen was repeated every 14 days for a total of six cycles. Each patient received at least 3 cycles of chemotherapy unless there was evidence of disease progression or intolerance of the study treatment. Tumor response rate was evaluated with computed tomography scanning （CT scan） according to RECIST criteria at the third and sixth cycles, respectively. A total of 115 non-progressive patients following 6 cycles of induction chemotherapy were assigned to observation or oral etoposide group according to 1 ： 1. All patients were informed consents. Fifty-five patients in the group A were observed, while sixty patients in group B received switch maintenance treatment with oral etoposide at a dose of 25 mg daily for 14 days, repeated every 21 days. All patients were accessed every 2 months by CT scan. RESULTS All of 200 patients were evaluated. The median follow-up time was 16.8 months. For 200 patients,the rate of objective response disease control rate was 28.

关 键 词：非小细胞肺癌 维持治疗 吉西他滨 依托泊苷 

分 类 号：R734.2[医药卫生—肿瘤]