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奥拉帕利维持治疗BRCA 1/2突变铂敏感复发性卵巢癌患者(SOLO2/ENGOT-Ov21):一项双盲随机对照Ⅲ期试验的最终分析
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作者 andrés Poveda anne Floquet +22 位作者 jonathan a ledermann Rebecca asher Richard T Penson amit M Oza Jacob Korach Tomasz Huzarski Sandro Pignata Michael Friedlander alessandra Baldoni Tjoung-Won Park-Simon Kenji Tamura Gabe S Sonke alla Lisyanskaya Jae-Hoon Kim Elias abdo Filho Tsveta Milenkova Elizabeth S Lowe Phil Rowe Ignace Vergote Eric Pujade-Lauraine the SOLO/ENGOT-Ovinvestigators 王娟(校) 李征(校) 《肿瘤药学》 CAS 2021年第3期275-279,共5页
背景既往发表的SOLO2/ENGOT-Ov21试验的第一部分研究结果表明,作为BRCA1或BRCA2(BRCA1/2)突变铂敏感型的高级别浆液性或子宫内膜样卵巢癌复发患者使用奥拉帕利可延长无进展生存期。因此,本研究的最终分析目的是研究奥拉帕利对这类患者... 背景既往发表的SOLO2/ENGOT-Ov21试验的第一部分研究结果表明,作为BRCA1或BRCA2(BRCA1/2)突变铂敏感型的高级别浆液性或子宫内膜样卵巢癌复发患者使用奥拉帕利可延长无进展生存期。因此,本研究的最终分析目的是研究奥拉帕利对这类患者总生存期的影响。方法本研究是一项在16个国家123个医疗中心进行的双盲、随机、安慰剂对照、Ⅲ期临床试验。纳入标准包括:年龄≥18岁;ECOG体能状态评分基线水平为0~1分;组织学检查确诊为复发性、高级别浆液性或高级别子宫内膜样卵巢癌,包括原发性腹膜癌或输卵管癌;以及既往接受过2种或2种以上铂类药物的治疗方案。入选患者按2∶1分配到奥拉帕利组(150 mg片剂,每日2次口服,共300 mg)或安慰剂组;根据既往化疗后是否缓解以及无铂治疗间隔时长进行分层;受试者、治疗提供者和数据分析人员在治疗分配时均设盲。主要终点是既往已报道过的无进展生存期;总生存期作为重要的次要终点之一,在所有随机分配的患者中进行分析;安全性评估在至少接受过1次给药的所有患者中进行。结果2013年9月3日—2014年11月21日,共295例患者参与了试验并被随机分到奥拉帕利组(196例,66%)或安慰剂组(99例,34%)治疗。奥拉帕利组患者中位随访时间为65.7个月(IQR:63.6~69.3),安慰剂组为64.5个月(IQR:63.4~68.7)。奥拉帕利组中位总生存期为51.7个月(95%CI:41.5~59.1),安慰剂组为38.8个月(95%CI:31.4~48.6)(HR=0.74,95%CI:0.54~1.00,P=0.054)。安慰剂组38%接受PARP抑制剂治疗的患者未作调整。治疗引发的最常见的Ⅲ级以上不良事件为贫血,奥拉帕利组发生率为21%(41/195),安慰剂组为2%(2/99)。 展开更多
关键词 安慰剂 Ⅲ期临床试验 输卵管癌 铂类药物 患者参与 组织学检查 BRCA SOLO
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Survey of the management of borderline ovarian tumors in the United Kingdom
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作者 amy Winser jonathan a ledermann +2 位作者 Richard Osborne Hani Gabra Mona a El-Bahrawy 《World Journal of Obstetrics and Gynecology》 2012年第2期3-13,共11页
Borderline ovarian tumors (BOTs) represent approxi-mately 10% of ovarian neoplasms and are a heteroge-neous group of tumors with variable biological behav-iour. The majority present with disease confned to the ovary... Borderline ovarian tumors (BOTs) represent approxi-mately 10% of ovarian neoplasms and are a heteroge-neous group of tumors with variable biological behav-iour. The majority present with disease confned to the ovary and have an excellent prognosis after surgical removal. A small proportion subsequently has recur-rent disease or progression to invasive cancer. Tumor recurrence can occur up to 20 years after surgical resection. There are no robust clinical, histological or molecular markers that distinguish high risk cases and no satisfactory treatment for patients with progressive disease. This results in great variability in management in different centres. We conducted a national survey on the management of borderline ovarian tumors in cancer centres representing different regions in the United Kingdom. In this article we review the literature for the current concepts in diagnosis, treatment and follow up of BOTs and we report the results of the survey of current practice in the United Kingdom. On that basis we provide recommendations for the management of patients with BOTs. 展开更多
关键词 BORDERLINE OVARIAN TUMORS SURVEY MANAGEMENT
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