Department of Gynecology, Ohki Memorial Kikuchi Cancer Clinic for Women, Tokorozawa, Saitama, Japan.
Gynecol Oncol. 2011 Aug;122(2):233-7. doi: 10.1016/j.ygyno.2011.04.046. Epub 2011 May 23.
Currently, pegylated liposomal doxorubicin (PLD) is regarded as one of the standard treatment options in recurrent ovarian cancers (ROC). Bevacizumab has shown significant antitumor activity for ROC in single-agent or in combination with cytotoxic agents. We have conducted a preliminary study to investigate effects of combination of bevacizumab and PLD for heavily pretreated patients with ROC.
Thirty patients with ROC were treated with combination therapy with weekly bevacizumab and PLD, 2 mg/kg of continuous weekly bevacizumab and 10 mg/m(2) of PLD (3 weeks on, 1 week off). The treatment was continued until development of disease progression, or unmanageable adverse effects. Response evaluation was based upon Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and Gynecologic Cancer Intergroup (GCIG) CA125 response criteria. Adverse effects were analyzed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Overall response rate was 33%, and clinical benefit rate (CR+PD+SD) was 73%. Median progression-free survival was 6 months (range: 2-20 months), and a 6-months progression-free survival was 47%. Any hematological toxicities more than grade 3 were not observed. Two cases developed non-hematologic toxicities more than grade 2; a case with grade 3 hand-foot syndrome, another with grade 3 gastrointestinal perforation (GIP). The case with GIP was conservatively treated and recovered after 2 months, and there was no case with treatment-related death.
The present investigation suggested that combination therapy with bevacizumab and PLD was active and well tolerated for patients with ROC. We recommend the regimen be evaluated in further clinical studies.
目前，聚乙二醇脂质体阿霉素（PLD）被认为是复发性卵巢癌（ROC）的标准治疗选择之一。贝伐单抗单药或联合细胞毒性药物治疗 ROC 显示出显著的抗肿瘤活性。我们进行了一项初步研究，以调查贝伐单抗联合 PLD 治疗复发性卵巢癌的效果。
30 例 ROC 患者接受每周贝伐单抗联合 PLD 治疗，每周 2mg/kg 持续贝伐单抗和 10mg/m² PLD（3 周 ON，1 周 OFF）。治疗持续到疾病进展或不可耐受的不良反应发生。根据实体瘤反应评估标准（RECIST）1.0 版和妇科肿瘤学组（GCIG）CA125 反应标准进行疗效评价。不良反应根据不良事件常用术语标准（CTCAE）3.0 版进行分析。
总缓解率为 33%，临床获益率（CR+PD+SD）为 73%。中位无进展生存期为 6 个月（范围：2-20 个月），6 个月无进展生存率为 47%。未观察到任何 3 级以上的血液学毒性。2 例发生 2 级以上非血液学毒性；1 例出现 3 级手足综合征，另 1 例出现 3 级胃肠道穿孔（GIP）。GIP 患者经保守治疗后 2 个月恢复，无治疗相关死亡病例。
本研究表明，贝伐单抗联合 PLD 治疗 ROC 有效且耐受性良好。我们建议在进一步的临床研究中评估该方案。
