Department of Gynecologic Oncology and Reproductive Sciences, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cancer. 2014 Feb 1;120(3):344-51. doi: 10.1002/cncr.28421. Epub 2013 Oct 24.
The Gynecologic Oncology Group conducted this phase 2 trial to estimate the antitumor activity of bevacizumab and to determine the nature and degree of toxicity in patients with recurrent sex cord-stromal tumors of the ovary.
A prospective, multi-institutional cooperative group trial was performed in women with recurrent, measurable ovarian stromal tumors. Patients were allowed to have unlimited prior therapy, excluding bevacizumab. Bevacizumab 15 mg/kg was administered intravenously on day 1 of every 21-day cycle until patients developed disease progression or adverse effects that prohibited further treatment. The primary endpoint was the response rate (RR). Inhibin A and B levels were measured before each cycle, and the values were examined in relation to response and progression.
Thirty-six patients were enrolled, and all were eligible and evaluable. Patients received a median of 9 cycles of treatment (range, 2-37 cycles). Six patients (16.7%) had partial responses (90% confidence interval, 7.5%-30.3%), 28 patients (77.8%) had stable disease, and 2 patients (5.6%) had progressive disease. This met the criterion for declaring the regimen active. The median progression-free survival was 9.3 months, and the median overall survival was not reached in during reporting period. Two grade 4 toxicities occurred, including hypertension and proteinuria; and the most common grade 3 toxicities were hypertension (n = 5) and pain (n = 5). Inhibin A and B values were lower in patients who responded to treatment.
Bevacizumab has activity in the treatment of recurrent sex cord-stromal tumors of the ovary, and its toxicity is acceptable. Further investigation is warranted.
妇科肿瘤学组进行了这项 2 期试验，以评估贝伐珠单抗的抗肿瘤活性，并确定复发性卵巢性索-间质肿瘤患者的毒性性质和程度。
对患有复发性、可测量的卵巢基质肿瘤的女性进行了一项前瞻性、多机构合作组试验。允许患者接受无限期的既往治疗，但不包括贝伐珠单抗。在每个 21 天周期的第 1 天静脉给予贝伐珠单抗 15mg/kg，直到患者出现疾病进展或毒性反应而禁止进一步治疗。主要终点是反应率（RR）。在每个周期前测量抑制素 A 和 B 的水平，并检查其与反应和进展的关系。
共纳入 36 例患者，所有患者均符合条件且可评估。患者接受了中位数为 9 个周期的治疗（范围为 2-37 个周期）。6 例患者（16.7%）有部分缓解（90%置信区间，7.5%-30.3%），28 例患者（77.8%）病情稳定，2 例患者（5.6%）疾病进展。这符合宣布该方案有效的标准。无进展生存期的中位数为 9.3 个月，在报告期内未达到总生存期的中位数。发生了 2 例 4 级毒性，包括高血压和蛋白尿；最常见的 3 级毒性是高血压（n=5）和疼痛（n=5）。对治疗有反应的患者抑制素 A 和 B 的值较低。
贝伐珠单抗在治疗复发性卵巢性索-间质肿瘤中具有活性，其毒性可接受。需要进一步研究。
