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伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究 被引量:14

A prospective randomized controlled clinical trial of irinotecan plus cisplatin versus gemcitabine pluscisplatin as a first-line treatment for advanced non-small cell lung cancer
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摘要 目的探讨伊立替康联合顺铂(DDP)方案(IP方案)与吉西他滨联合DDP方案(GP方案)一线治疗晚期非小细胞肺癌(NSCLC)的近期疗效和不良反应。方法采用前瞻性随机对照的临床研究设计,将63例经组织学或细胞学确诊的初治晚期NSCLC患者分为IP方案组和GP方案组,观察其近期有效率(RR)、疾病控制率(DCR)、疾病进展时间(TTP)、中位生存时间(MST)、1年生存率和不良反应。结果IP方案组中,部分缓解(PR)8例,疾病稳定(SD)17例,疾病进展(PO)6例,RR为25.8%(8/31),DCR为80.6%(25/31);TTP为6.7个月,MST为11.2个月,1年生存率为45.2%(14/31)。GP方案组中,PR11例,SD18例,PD3例,RR为34.4%(11/32),DCR为90.6%(29/32),1TP为6.5个月,MST为11.0个月,1年生存率为43.7%(14/32)。两组患者的主要不良反应为血液学毒性、消化道反应和脱发。IP方案组腹泻的发生率高于GP方案组(P〈0.05),而GP方案组血小板减少发生率高于IP方案组(P〈0.01)。结论IP方案和GP方案治疗晚期NSCLC疗效确切,不良反应均可耐受。 Objective To prospectively evaluate the efficacy and toxicity of irinotecan plus cisplatin (IP regimen) compared with gemcitabine plus cisplatin (GP regimen) as a first-line treatment for advanced non-small cell lung cancer (NSCLC). Methods A total of 63 patients were randomly assigned to two regimens. IP Group (31 patients) : ifinoteean 100 mg/m2, iv, dl and d8; cisplatin 25 mg/㎡, iv, dl to d3, and 3 weeks a cycle. GP Group (32 patients) : gemcitabine 1000 mg/㎡, dl and d8 ; cisplatin 25 mg/㎡, iv, dl to d3, and 3 weeks a cycle. All the patients at least received two cycles of therapy. The response rate (RR), disease control rate (DCR), median time to tumor progression (TFP), median survival time ( MST), 1-year survival rate, and side effects were observed. Results Among the 31 cases of IP group, 8 patients had PR, 17 patients had SD and 6 patients had PD. The RR and DCR were 25.8% (8/31) and 80.6% (25/31), respectively. The TFP was 6.7 months, MST was 11.2 months and the 1-year survival rate was 45.2% (14/31). Among 32 cases in the GP group, 11 patients had PR, 18 patients had SD and 3 patients had PD. The RR and DCR were 34.4% (11/32) and 90.6% (29/32), respectively. The TTP was 6.5 months, MST was 11.0 months and the 1-year survival rate was 43.7% (14/32). The main side effects of the two groups included hematologic toxieities, digestive tract reaction and hair loss. The incidence of diarrhea in the IP group was significantly higher than that in the GP group (P 〈 0.05 ), but the incidence of thrombocytopenia in the GP group was significantly higher than that in the IP group ( P 〈 0.01 ). Conclusions Our findings demonstrate that the two regimens have similar efficacy as a first-line treatment for advanced NSCLC. The major toxicities of the two regimens are well tolerable.
出处 《中华肿瘤杂志》 CAS CSCD 北大核心 2012年第10期775-779,共5页 Chinese Journal of Oncology
关键词 非小细胞肺 抗肿瘤联合化疗方案 伊立替康 吉西他滨 顺铂 Carcinoma, non-small cell lung Antineoplastic combined chemotherapy protocols Irinotecan Gemcitabine Cisplatin
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