白蛋白结合型紫杉醇联合吉西他滨一线治疗晚期胰腺癌的疗效观察

Efficacy observation of albumin-bound paclitaxel plus gemcitabine for the treatment of advanced pancreatic cancer

目的探讨白蛋白结合型紫杉醇联合吉西他滨一线治疗晚期胰腺癌的疗效和安全性。方法本院2012年3月至2015年1月收治的27例经病理确诊为晚期转移性胰腺癌患者,接受白蛋白结合型紫杉醇联合吉西他滨一线治疗,具体方案:白蛋白结合型紫杉醇125 mg/m^2静滴,d_1、d_8;吉西他滨1000 mg/m^2静滴,d_1、d_8,每21天为1个周期。2个周期后按照RECIST 1.1版标准评价客观疗效,采用国立癌症研究所毒性判定标准(NCI CTC)3.0评价化疗毒性反应,同时随访其生存情况并比较不同临床病理特征的中位无进展生存期(PFS)和总生存期(OS)。结果所有患者均可评价疗效,无CR病例,PR2例,SD 19例,有效率(RR)和疾病控制率(DCR)分别为7.4%和77.8%。全组患者的中位PFS和OS分别为5.0个月(95%CI:4.0~6.7个月)和8.0个月(95%CI:7.5~13.8个月)。亚组分析显示化疗周期数与患者的PFS和OS有关。主要不良反应为恶心呕吐(48.1%)、疲劳(55.5%)、发热(7.4%)、皮疹(3.7%)及周围神经异常(11.1%);严重不良反应主要为骨髓抑制,其中3~4级血液学毒性包括白细胞减少、血小板减少和血红蛋白减少。结论白蛋白结合型紫杉醇联合吉西他滨治疗国人晚期胰腺癌疗效确切,不良反应可以耐受。

Objective To evaluate the efficacy and safety of albumin-bound paclitaxel plus gemcitabine for the treatment of advanced pancreatic cancer patients in Chinese. Methods From March 2012 to January 2015, 27 patients with advanced pancreatic cancer diagnosed by pathology were assigned to receive albumin-bound paclitaxel plus gemcitabine as first-line therapy. Albumin-bound paclitaxel was administered at a dose of 125 mg/m^2 plus gemcitabine 1000 mg/m^2 on day 1 and 8 of a 21-day cycle. Response to chem-otherapy was assessed by RECIST criteria 1. 1 and toxicity was evaluated according to National Cancer Institute Common Toxicity Crite-ria 3. 0. The clinical follow-up data from chemotherapy were investigated for comparison of median progression-free survival（ PFS） and overall survival（ OS） between different clinicopathologic characteristics. Results All patients were available for evaluation. None got complete response, 2 cases had partial response and 19 cases had stable disease. The response rate（ RR） was 7. 4% and the disease control rate（DCR） was 77. 8%. Of the 27 patients, the median PFS was 5. 0（95%CI：4. 0-6. 7） months and the median OS was 8. 0 （95%CI：7. 5-13. 8） months. The number of chemotherapy cycles were correlated with PFS and OS in pooled treatment arm analyses. The main adverse reactions were nausea and vomiting（ 48. 1%） , fatigue（ 55. 5%） , fever（ 7. 4%） , rash itching（ 3. 7%） and peripheral nerve abnormalities（ 11. 1%） . The major adverse reactions were mainly bone marrow suppression. Among them, grade 3-4 hematologic toxicity included white blood cell reduction, thrombocytopenia and hemoglobin reduction. Conclusion The combination of albumin-bound paclitaxel and gemcitabine is effective and tolerated in the treatment of advanced pancreatic cancer patients in Chinese.