A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study.
A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2012.03.023
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发表时间：
2012-06
影响因子：
4.7
通讯作者：
Howell SB
中科院分区：
文献类型：
--
作者：
Gold MA;Brady WE;Lankes HA;Rose PG;Kelley JL;De Geest K;Crispens MA;Resnick KE;Howell SB
这项多机构II期试验评估了与CD 44结合的抗转移A6肽在持续性或复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌（EOC/FTC/PPC）患者中的活性和耐受性。持续性或复发性EOC/FTC/PPC的女性，如果有RECIST标准定义的可测量疾病、良好的体能状态和良好的整体器官功能，则有资格参与研究。患者必须既往接受过一种含铂化疗方案，并允许接受一种额外的细胞毒性方案以管理复发性或持续性疾病。女性接受150 mg每日两次皮下注射A6，并继续治疗直至疾病进展或出现不可接受的毒性。临床疗效的主要指标是6个月时的客观肿瘤缓解和无进展生存期（PFS）。研究了存档组织标本中CD 44与临床结局的相关性。对31例合格患者进行了评价。未观察到任何反应。2例患者（6.5%）至少6个月无进展。中位PFS为2.0个月，中位总生存期尚未达到。1例患者死于出血，可能与研究相关。无4级毒性。最常见的3级毒性为全身毒性（2/31; 6.5%）。27例患者的存档标本可用，5例（18.5%）免疫组化显示CD 44阳性。CD 44表达与6个月PFS无关（p=0.342）。A6耐受性良好，但在持续性或复发性EOC/FTC/PPC患者中的活性最低。
This multi-institutional phase II trial assessed the activity and tolerability of the anti-metastatic A6 peptide that binds CD44 in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC/FTC/PPC). Women with persistent or recurrent EOC/FTC/PPC were eligible for participation if they had measurable disease defined by RECIST criteria, good performance status, and good overall organ function. Patients must have received one prior platinum-based chemotherapeutic regimen and were allowed to have received one additional cytotoxic regimen for the management of recurrent or persistent disease. Women received a 150 mg twice daily subcutaneous dose of A6 and continued on treatment until disease progression or unacceptable toxicity. Primary measures of clinical efficacy were objective tumor response and progression-free survival (PFS) at 6 months. The association of CD44 in archival tissue specimens with clinical outcome was investigated. Thirty-one eligible patients were evaluated. No responses were observed. Two patients (6.5%) were progression free for at least 6 months. The median PFS was 2.0 months, and median overall survival has not yet been reached. One patient died of hemorrhage which was possibly study related. There were no grade 4 toxicities. The most common grade 3 toxicities were constitutional (2/31; 6.5%). Archival specimens were available for 27 patients, and 5 (18.5%) were CD44 positive by immunohistochemistry. CD44 expression was not associated with the 6-month PFS (p=0.342). A6 was well tolerated but had minimal activity in patients with persistent or recurrent EOC/FTC/PPC.
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