培美曲塞联合顺铂或卡铂一线治疗ⅢB/Ⅳ期非小细胞肺癌临床观察
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江苏省自然科学基金资助(BK2009446)


The effect of pemetrexed plus platinum compounds as first-line chemotheraphy on stage ⅢB/Ⅳ non-small-cell lung cancer
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    摘要:

    目的:观察培美曲塞联合铂类一线治疗晚期非小细胞肺癌的临床疗效及不良反应-方法:69例经病理学或细胞学确诊的ⅢB/Ⅳ期初治非小细胞肺癌患者,予以培美曲塞联合顺铂或卡铂方案全身化疗-培美曲塞:500 mg/m2,第1天静脉滴注,顺铂:75 mg/m2,第1天静脉滴注,卡铂剂量AUC=5,第1天静脉滴注,每21 d为1个周期,连用2~6个周期-进行疗效评价-不良反应分级及无进展生存期(progression-free survival,PFS)分析-结果:69例患者中非鳞癌56例,鳞癌13例,无完全缓解(CR)病例,部分缓解(PR)27例,稳定(SD)24例,进展(PD)18例,总有效率(CR+PR)为39.1%,疾病控制率(CR+PR+SD)为73.9%;非鳞癌患者有效率及疾病控制率均高于鳞癌患者(41.1% vs 30.8%和75.0% vs 69.2%),但差异无统计学意义(P > 0.05);不同年龄-不同性别-ⅢB/Ⅳ期及培美曲塞联合顺铂或卡铂治疗组之间在有效率和疾病控制率方面差异无统计学意义-所有患者PFS为5.3个月,非鳞癌患者PFS优于鳞癌患者(5.4个月 vs 4.5个月),但两者之间差异无显著性(P > 0.05),腺癌患者PFS为5.6个月,与鳞癌患者相比差异有统计学意义(P = 0.03);Cox回归多因素生存分析显示病理组织学类型对PFS有影响(P < 0.05)-全组患者不良反应较轻,主要是骨髓抑制-消化道反应及乏力,多为Ⅰ~Ⅱ级-结论:培美曲塞联合联合顺铂或卡铂一线治疗晚期非小细胞肺癌不良反应轻-耐受性好,尤其对非鳞癌患者疗效可能更好-

    Abstract:

    Objective: To assess the overall response rate and toxicity of pemetrexed puls a platinum agent(cisplatin or carboplatin) in the patients with unresectable stage ⅢB/Ⅳ non-small-cell lung cancer(NSCLC). Methods: Sixty-nine chemotherapy-naive patients with stage ⅢB/Ⅳ NSCLC received pemetrexe 500 mg/m2 plus cisplatin 75 mg/m2(n = 47) or pemetrexed 500 mg/m2 plus carboplatin area under the curve of 5 (AUC=5,n = 22) on day 1,one cycle of treatment is 21 days,and the whole treatment lasted 2 to 6 cycles. RECIST 1.0 was used to assess the efficacy of the treatment,and NCI CTC-AE version 3.0 was used to describe adverse events. Results: In the 69 patients,none showed complete response,27 patients showed partial response,24 had stable disease,the overall response rate was 39.1 %,and the disease control rate was 73.9%. There were higher overall response rates and disease control rates in the patients with nonsquamous histology than that of the patients with squamous histology(41.1% vs 30.8% and 76.8% vs 53.8%). Among the 69 patients,the median progression-free survival was 5.3 months,there was no significant difference in progression-free survival (PFS) between the patients with and without squamous histology (4.5 months vs 5.4 months,P > 0.05),but there was a significant difference in PFS between the patients with adenocarcinoma and with squamous cell carcinoma(5.6 months vs 4.5 months,P = 0.03);In multivariate analysis using the Cox regression model,the histology emerged as an independent indicator(P < 0.05). The principal drug-related adverse events were myelosuppression,gastrointestinal response and fatigue,most of which were grade 1 to 2. Conclusion: Pemetrexed plus platinum compunds was safe and efficacious for the treatment of patients with advanced NSCLC,and the nonsquamous histology may be probably associated with better outcomes.

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王 丽,史美祺,夏国豪,陆建伟,冯继锋.培美曲塞联合顺铂或卡铂一线治疗ⅢB/Ⅳ期非小细胞肺癌临床观察[J].南京医科大学学报(自然科学版),2012,(2):241-245

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  • 收稿日期:2011-09-05
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