培美曲塞或吉西他滨联合顺铂——线治疗晚期非小细胞肺癌的临床随机对照研究  

A Randomized Clinical Study of Comparing Pemetrexed plus Cisplatin with Gemcitabine plus Cisplatin as First-line Treatment in Patients with Advanced Non-small Cell Lung Cancer

作　　者：杨新杰[1] 张卉[1] 张权[1] 王敬慧[1] 农靖颖[1] 张树才[1] 朱晓丽（编辑）[1] 

机构地区：[1]首都医科大学附属北京胸科医院肿瘤内科,北京101149

出　　处：《结核病与胸部肿瘤》2012年第1期38-41,共4页Tuberculosis and Thoracic Tumor

摘　　要：目的本研究为比较培美曲塞联合顺铂（pemetrexedpluscisplatin，PEM）方案与吉西他滨联合顺铂（gemcitabinepluscisplatin，GEM）方案一线治疗晚期非小细胞肺癌（non．smalllungcancer，NSCLC）的近期疗效、远期生存及毒副反应。方法30例经病理学或细胞学证实的Ⅲ b期或Ⅳ期初治非小细胞肺癌患者随机分成培美曲塞，顺铂（PEM）组和吉西他滨川哽铂（GEM）组，每组各15例。主要研究终点为无进展生存期（（progression．freesurvival，PFS），次要研究终点为总生存（overallsurvival，OS），客观反应率（responserate，RR），疾病控制率和毒副反应。结果PEM组RR为40．0％，疾病控制率为86．7％；GEM组RR为20．O％，疾病控制率为86．7％，两组比较无统计学意义（只=0．182，P=1．000）。PEM组中位PFS为5．6个月（95％CI3．473-7．727），中位OS为18．07个月（95％C17．620．28．520）；GEM组中位PFS为6．5个月（95％CI5．767．7．233），中位OS为18．10个月（95％CI8．243．35．957），两组比较均无统计学差异（P=O．431；P=0．516）。两组主要毒副反应均为骨髓抑制和胃肠道反应，PEM组患者Ⅲ／IV度血液学毒性发生率均低于GEM组患者，且GEM组中2例患者因严重血小板减低而退组。但无论是血液学毒性还是非血液学毒性，两组均未见明显统计学差异（P＞O．05）。结论培美曲塞联合顺铂一线治疗晚期非小细胞肺癌，显示出可靠的耐受性和有效性，且严重血液系统不良反应发生率要略低。Objective To Compare the clinical efficacy and adverse effect of pemetrexed combined with cisplatin （PEM） and gemcitabine combined with cisplatin （GEM） in treating advanced non-small cell lung cancer. Methods Thirty chemotherapy-navie patients with stage IIIb/IV NSCLC were recruited in this study and randomly assigned to either cisplatin and gemcitabine or cisplatin and pemetrexed. The primary end point was progression-free survival （PFS） and secondary end points were overall survival （OS）, response rate （RR）, disease control rate and toxicity. Results In the PEM ann, the overall response rate was 40.0% and disease control rate including tumor response and stable disease was 86.7%. In the GEM arm, the overall response rate was 20.0% and disease control rate was 86.7%. There was no significant difference between the two groups （P=0.182,P=l.000） . Median PFS was 5.6 months （95%CI 3.473-7.727） in the PEM arm and 6.5 months （95%CI 5.767-7.233） in the GEM ann （P=0.431）. Median OS was 18.07 months （95%CI 7.620-28.520） and 18.10 months （95%CI 8.243-35.957） in the PEM and GEM arm （P=0.516）, respectively. No difference was observed. The main common adverse reactions were myelosuppression and gastrointestinal response in both arms. There was no significant difference in the grade 3 and 4 toxicities between the two arms （P〉0.05）. In the PEM arm, hematologic toxicities occurred fewer than in the GEM ann, and 2 patients withdraw because of severe thrombocytopenia in the GEM ann. Conclusion Cisplatin plus pemetrexed regimen is an effective first-line therapy for patients with advanced NSCLC and well tolerated, with fewer severe hematologic side effects.

关 键 词：培美曲塞 癌 非小细胞肺 临床研究 化疗 

分 类 号：R734.2[医药卫生—肿瘤]