替拉扎明加顺铂对铂敏感的复发卵巢癌或原发性腹膜癌治疗的二期评估:妇产科肿瘤协作组的研究  

A phase II evaluation of tirapazamine plus cisplatin in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer:A Gynecologic Oncology Group study

作　　者：Covens A. Blessing J. BenderD. 吕涛 

机构地区：[1]Division of Gynecology/Oncology, Toronto-Sunny brook Regional Cancer Center, 2075 Bayview Avenue, Toronto, Ont. M4N 3M5, Canada

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2006年第6期54-55,共2页Core Journal in Obstetrics/Gynecology

摘　　要：Objectives. To estimate the anti- tumor activity, nature and degree of toxicity of tirapazamine in combination with cisplatin in patients with recurrent platinum- sensitive ovarian or primary peritoneal cancers. Methods. Eligible consenting patients had to have recurrent epithelial ovarian or primary peritoneal carcinoma with measurable disease. Patients were not allowed to have received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens. Patients must have been platinum- sensitive, meaning a treatment- free interval of >6 months after response to a platinum- based regimen. The RECIST criteria were used for parameters of response. Tirapazamine was administered at a dose of 390 mg/m2 IV over 2 h followed 1 h later by cisplatin 60 mg/m 2 IV every 3 weeks until disease progression or adverse effects prohibited further therapy. Results. Between June 2001 and February 2004, 65 patients were entered onto this study by 27 institutions; one patient was excluded due to ineligible tumor type. Twenty- six patients (41% ) received six or more cycles of therapy; however, 16 (25% ) received one course of therapy (mainly due to side effects or patient request). There were six (9% ) complete responders and 28 (44% ) partial responders for a total response rate of 53% . Only two patients (3% ) developed increasing disease on this protocol, and response could not be assessed in 18 patients (28% ). The median progression- free and overall survival for all patients is 10.9 and 26.4 months, respectively. The regimen did not cause major hematologic toxicity,however, it did cause frequent constitutional (23% ) and gastrointestinal (mostly nausea/vomiting) (44% ) grade 3 or 4 toxicity. Conclusions. The combination of tirapazamine and cisplatin has definite activity in the treatment of recurrent platinum- sensitive ovarian or primary peritoneal cancer. However, toxicity, primarily non- hematologic,was substantial. Reducing the toxicity of a tirObjectives. To estimate the anti-tumor activity, nature and degree of toxicity of tirapazamine in combination with cisplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal cancers. Methods. Eligible consenting patients had to have recurrent epithelial ovarian or primary peritoneal carcinoma with measurable disease. Patients were not allowed to have received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens. Patients must have been platinum-sensitive, meaning a treatment-free interval of 〉 6 months after response to a platinum-based regimen. The RECIST criteria were used for parameters of response. Tirapazamine was administered at a dose of 390 mg/m^2 IV over 2 h followed 1 h later by cisplatin 60 mg/m^ 2 Ⅳ every 3 weeks until disease progression or adverse effects prohibited further therapy. Results. Between June 2001 and February 2004, 65 patients were entered onto this study by 27 institutions; one patient was excluded due to ineligible tumor type. Twenty-six patients （41%） received six or more cycles of therapy; however, 16 （25%） received one course of therapy （mainly due to side effects or patient request）. There were six （9%） complete responders and 28 （44%） partial responders for a total response rate of 53%. Only two patients （3%） developed increasing disease on this protocol, and response could not be assessed in 18 patients （28%）.

关 键 词：原发性腹膜癌 复发卵巢癌 替拉扎明 癌治疗 妇产科肿瘤 顺铂 RECIST标准 静脉内给药 协作 

分 类 号：R735.5[医药卫生—肿瘤] R737.310.5[医药卫生—临床医学]