白蛋白结合型紫杉醇治疗吉西他滨一线化疗失败后晚期胰腺癌的临床观察

Clinical observation of Nab-paclitaxel on patients with advanced pancreatic carcinoma who failed to gemcitabine first-line therapy

目的观察和评价白蛋白结合型紫杉醇（Nab-P）治疗吉西他滨一线化疗失败后晚期胰腺癌的疗效和安全性。方法回顾分析2012年5月至2015年5月接受Nab-P单药或联合方案（Nab-P 110 mg/m^2静滴,第1、8天,21天为1周期）作为二线或二线以上治疗的晚期胰腺癌患者。分别采用RECIST 1.1版与NCI-CTC 4.0版标准评价近期疗效和毒副反应。采用Kaplan-Meier法进行生存分析。结果共纳入13例患者,其中9例可评价疗效和毒副反应。9例患者平均年龄为56.1岁,Nab-P平均治疗2.27个周期。9例患者的疾病控制率（DCR）为55.6%,其中2例获PR,3例SD,4例PD;CA199较基线下降50%者4例（44.4%）;中位疾病进展时间（TTP）为3.3个月（95%CI：2.4~4.2个月）,中位生存时间（OS）为14.2个月（95%CI：2.8~25.6个月）;3个月及6个月生存率分为88.9%和77.8%。常见毒副反应多为1~2级,主要为白细胞减少、中性粒细胞减少、乏力、恶心、呕吐等。结论 Nab-P对国人吉西他滨一线治疗失败后的晚期胰腺癌具有较好的疗效,且耐受性良好。

Objective To evaluate the efficacy and safety of Nab-paclitaxel（ Nab-P） on patients with advanced pancreatic carcinoma who failed to gemcitabine first-line therapy. Methods Patients with advanced pancreatic carcinoma who have failed to firstline therapy from May 2012 to May 2015 were analyzed retrospectively. All the patients received Nab-P-based monotherapy or combination regimens（ Nab-P 110 mg / m^2 iv,d1,d8,every 3 weeks） as second or more line treatments. The efficacy and safety were evaluated by RECIST 1. 1 and NCI-CTC 4. 0 criteria. Median time to disease progression（ TTP） and overall survival（ OS） were analyzed by Kaplan-Meier method. Results Thirteen patients failured to gemcitabine-based regimen were enrolled and 9 of them were evaluatable.The median age was 56. 1 years,and the average treatment cycle was 2. 27. The disease control rate（ DCR） was 55. 6%,including 2cases of PR,3 cases of SD and 4 cases of PD. The number of patients with elevated baseline CA19-9 had 50% decline was 4（ 44. 4%）. The median TTP was 3. 0 months（ 95% CI： 2. 4-4. 2 months） and the median OS was 14. 2 months（ 95% CI： 2. 8-25. 6months）. The 3-month and 6-month survival rate was 88. 9% and 77. 8%,respectively. The major treatment-related side effects including leucopenia,neutropenia,nausea,vomiting,fatigue and etc. were mainly in grade 1-2. Conclusion Nab-paclitaxe is effective and tolerable in Chinese advanced pancreatic carcinoma patients who have progressed on gemcitabine first-line therapy.