Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: A Gynecologic oncology group study
Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: A Gynecologic oncology group study
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DOI：
10.1200/jco.2007.11.5345
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发表时间：
2007-11-20
影响因子：
45.3
通讯作者：
Sorosky, Joel I.
中科院分区：
文献类型：
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作者：
Burger, Robert A.;Sill, Michael W.;Sorosky, Joel I.
血管内皮生长因子（VEGF）可能是卵巢上皮性癌（EOC）和原发性腹膜癌（PPC）肿瘤进展的促进因子。我们进行了第二阶段的试验，以评估单药贝伐单抗，抗VEGF单克隆antibody.Patients和方法的疗效和耐受性符合条件的患者有持续性或复发性卵巢癌/PPC后，一至两个先前的细胞毒性方案，可测量的疾病，妇科肿瘤组的性能状态至少2。治疗包括贝伐珠单抗15 mg/kg静脉注射，每21天一次，直至疾病进展或出现抑制性毒性。主要终点是6个月时的无进展生存期（PFS）和临床反应。结果该研究包括62名符合条件且可评估的患者，中位年龄57岁，其中41名（66.1%）接受过两种既往方案，26名（41.9%）被认为对铂类药物耐药。至少可能与贝伐珠单抗相关的3级不良事件包括血液学（1）、GI（3）、高血压（6）、血栓栓塞（1）、过敏（2）、肝脏（1）、疼痛（3）、凝血（1）、体质（1）和呼吸困难（1）。4级不良事件包括肺栓塞（1例）、呕吐和便秘（1例）以及蛋白尿（1例）。13例患者（21.0%）出现临床缓解（2例完全缓解，11例部分缓解;中位缓解持续时间为10个月），25例（40.3%）无进展生存至少6个月。中位PFS和总生存期分别为4.7和17个月。既往铂类药物敏感性、年龄、既往化疗方案数量或体力状态与进展或死亡风险无显着相关性。结论贝伐珠单抗似乎在EOC/PPC患者的二线和三线治疗中耐受性良好且有效，值得III期研究。
Purpose Vascular endothelial growth factor (VEGF) seems to be a promoter of tumor progression for epithelial ovarian cancer (EOC) and primary peritoneal cancer (PPC). We conducted a phase II trial to assess the efficacy and tolerability of single-agent bevacizumab, an anti-VEGF monoclonal antibody.Patients and Methods Eligible patients had persistent or recurrent EOC/PPC after one to two prior cytotoxic regimens, measurable disease, and Gynecologic Oncology Group performance status of at least 2. Treatment consisted of bevacizumab 15 mg/kg intravenously every 21 days until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response.Results The study consisted of 62 eligible and assessable patients, median age 57 years, 41 (66.1%) having received two prior regimens and 26 (41.9%) considered platinum resistant. Grade 3 adverse events at least possibly related to bevacizumab were hematologic (1), GI (3), hypertension (6), thromboembolism (1), allergy (2), hepatic (1), pain (3), coagulation (1), constitutional (1), and dyspnea (1). Grade 4 adverse events included pulmonary embolus (1), vomiting and constipation (1), and proteinuria (1). Thirteen patients (21.0%) experienced clinical responses (two complete, 11 partial; median response duration, 10 months), and 25 (40.3%) survived progression free for at least 6 months. Median PFS and overall survival were 4.7 and 17 months, respectively. There was no significant association of prior platinum sensitivity, age, number of prior chemotherapeutic regimens, or performance status with the hazard of progression or death.Conclusion Bevacizumab seems to be well tolerated and active in the second- and third-line treatment of patients with EOC/PPC and merits phase III investigation.