铂类耐药复发转移性卵巢癌贝伐单抗联合白蛋白结合型紫杉醇治疗临床观察

Evaluation of efficacy and safety of Bevacizumab combined with Albumin-bound paclitaxel for patients with platinum-resistant or recurrent ovarian cancer

目的在女性生殖系统肿瘤中卵巢癌的发病率及死亡率居于前列，在治疗期间可能出现耐药现象或远处转移，给后续治疗带来困难，影响患者预后，且此时应用传统化疗效果较差。本研究主要观察贝伐单抗联合白蛋白结合型紫杉醇治疗铂类耐药的复发或转移性卵巢癌的临床效果。方法回顾性分析我院2010-09-2013—10经手术确诊为卵巢癌，术后使用以铂类为基础的药物化疗后6个月内复发，且化疗期间病情稳定的58例患者，分为两组，其中28例采用贝伐单抗联合白蛋白结合型紫杉醇方案治疗（联合组），患者d1、d8、d15接受白蛋白结合型紫杉醇100mg／m^2，同时于d1、d15；接受10mg／kg贝伐单抗治疗；30例采用单药白蛋白结合型紫杉醇治疗（单药组），第d1、d8和d15天接受白蛋白结合型紫杉醇100mg／m^2，两种治疗方案均为28d为1个周期。分析两组患者的疗效和不良反应并进行随访。结果联合组与单药组的客观有效率分别为53．57％（15／28）和36．67％（11／30），χ^2=3．425，P=0．025；中位无进展生存期分别为8．9和6．6个月，χ^2=11．892，P=0．001；中位生存期分别为16．8和15．6个月，差异有统计学意义，χ^2=5．376，P=0．02。联合化疗组较单药组增加的不良反应主要有高血压、出血和蛋白尿，发生率分别为14．28％、10．71％和10．71％，但均为Ⅰ～Ⅱ级，经药物治疗后均可控制，不影响后续化疗，两组最常见的不良反应为骨髓抑制及消化道反应，两组出现Ⅲ-Ⅳ级的骨髓抑制之间的差异无统计学意义，P〉0．05。结论贝伐单抗联合白蛋白结合紫杉醇治疗铂类耐药的复发或转移性卵巢癌临床效果较好，较单药化疗组生存期延长，且患者耐受性较好具有很好的临床应用前景。

OBJECTIVE To evaluate the efficacy and safety of Bevacizumab combined with Albumin-bound paclitaxel chemotherapy for patients with platinum-resistant recurrent or metastatic ovarian cancer. METHODS A total of 58 patients were confirmed ovarian cancer by surgery during September 2010 to October 2013 ,these patients had postoperative adjuvant chemotherapy with platinum-based regimens and they were stable disease during the chemotherapy but had recurrence within six months. The 58 patients were separated into two groups, 28 patients received Bevacizumab combined with albumin bound paclitaxel chemotherapy regimen（combined group） ,ab-paclitaxel 100 mg/ms given on days 1, 8, and 15 of a 28 days cycle with bevacizumab 10 mg/kg given on days 1 and 15. The other 30 patients received ab-paclitaxel only 100mg/m^2 on clays 1,8 and 15（single group） of a 28 days cycle, The adverse reactions and efficacy were evaluated after treatment. The patients were followed-up, and the survival was analyzed. RESULTS The objective response rates of combined group and single group were respectively 53.57% （15/28） and 36. 67% （11/30）（P= 0. 025, χ^2 = 3. 425）. The median progression-free survival was 8.9 months and 6.6 months（χ^2=11. 892, P= 0. 001）. The median overall survival was 16.8 months and 15.6 months （χ^2 =5. 376,P=0.02）. The specific toxicities of combined group was hypertension （14.28%） ,haemorrhage （10.71%）, proteinuria（10.71%） within Ⅰ - Ⅱ grade, these adverse reactions could be controlled after medication. The most frequent adverse reactions of the both groups were myelosuppression and gastrointestinal reactions,the grade Ⅲ-Ⅳ myelosuppression occurred in the two groups,but it had no statistical significance. CONCLUSION Bevacizumab with Ab-paclitaxel has antitumor activity with manageable side effects in patients with platinumresistant recurrent or metastatic ovarian carcinoma, and it can prolong survival time compared with the single group, This regimen has good clinical application prospects.