Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001).
Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001).
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DOI：
10.1016/j.ygyno.2018.04.572
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发表时间：
2018-07
影响因子：
4.7
通讯作者：
Gershenson DM
中科院分区：
文献类型：
--
作者：
Konstantinopoulos PA;Brady WE;Farley J;Armstrong A;Uyar DS;Gershenson DM
评价卡博替尼在复发性透明细胞卵巢癌、原发性腹膜癌或输卵管癌中的疗效和耐受性。具有至少50%透明细胞组织形态学、可测量疾病、一种或两种先前方案和ECOG体力状态0-2的复发性卵巢、输卵管或原发性腹膜肿瘤的患者接受卡博替尼60 mg口服，每天一次，连续4周，直至疾病进展或不可接受的毒性。主要终点是6个月时的无进展生存期（PFS）和完全或部分肿瘤缓解（根据RECIST 1.1评估）。次要终点包括毒性、PFS和总生存期（OS）。在19个月内，累积了13名患者。54%的患者年龄≥60岁。体能状态为0和1的患者分别为8例和5例。未观察到客观肿瘤缓解。13例患者中有3例（23% [95% CI：5%，54%]）的PFS ≥ 6个月，包括1例接受卡博替尼治疗23个周期且截至数据截止日期仍在接受治疗的患者。中位PFS和OS分别为3.6和8.1个月。1例患者发生5级事件：血栓栓塞事件被认为可能与研究治疗相关;患者死亡原因确定为疾病和方案治疗所致。其他4例患者发生血栓栓塞事件（2例3级，1级和2级各1例）。2例或2例以上患者报告的其他3级或3级以上事件为恶心、呕吐、疲乏、呼吸困难和脱水。卡博替尼在透明细胞卵巢癌、输卵管癌或原发性腹膜癌的二线和三线治疗中表现出最小的活性。
To evaluate the efficacy and tolerability of cabozantinib in recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer. Patients with recurrent ovarian, fallopian or primary peritoneal tumors with at least 50% clear cell histomorphology, measurable disease, one or two prior regimens and ECOG performance status 0–2 received cabozantinib 60 mg orally once daily continuously, in 4-week cycles until disease progression or unacceptable toxicity. Primary endpoints were progression-free survival (PFS) at six months and complete or partial tumor response (as assessed by RECIST 1.1). Secondary endpoints included toxicity, PFS, and overall survival (OS). Over 19 months, 13 patients were accrued. Fifty-four percent of patients were ≥60 years of age. Performance statuses of 0 and 1 comprised 8 and 5 patients. No objective tumor responses were seen. Three (23% [95% CI: 5%, 54%]) of 13 patients had PFS ≥ 6 months, including one patient who received cabozantinib for 23 cycles and was still on treatment as of the data cut-off date. Median PFS and OS were 3.6 and 8.1 months, respectively. There was one patient with a grade 5 event: a thromboembolic event considered possibly related to study therapy; patient’s cause of death was determined to be due to disease and protocol treatment. Four other patients had thromboembolic events (two grade 3 and one each grade 1 and grade 2). Other grade 3 or higher events reported in two or more patients were nausea, vomiting, fatigue, dyspnea, and dehydration. Cabozantinib demonstrated minimal activity in the second- and third-line treatments of clear cell ovarian, fallopian tube or primary peritoneal carcinoma.
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影响因子：
3.7
作者：
Yamashita Y;Akatsuka S;Shinjo K;Yatabe Y;Kobayashi H;Seko H;Kajiyama H;Kikkawa F;Takahashi T;Toyokuni S
通讯作者：
Toyokuni S
DOI：
10.1056/nejmoa1510016
发表时间：
2015-11-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Choueiri TK;Escudier B;Powles T;Mainwaring PN;Rini BI;Donskov F;Hammers H;Hutson TE;Lee JL;Peltola K;Roth BJ;Bjarnason GA;Géczi L;Keam B;Maroto P;Heng DY;Schmidinger M;Kantoff PW;Borgman-Hagey A;Hessel C;Scheffold C;Schwab GM;Tannir NM;Motzer RJ;METEOR Investigators
通讯作者：
METEOR Investigators
影响因子：
1.2
作者：
Alifrangis, C.;Thornton, A.;Gabra, H.
通讯作者：
Gabra, H.
影响因子：
7.5
作者：
Yamamoto, Sohei;Tsuda, Hitoshi;Matsubara, Osamu
通讯作者：
Matsubara, Osamu
影响因子：
3.5
作者：
Itamochi, H;Kigawa, J;Terakawa, N
通讯作者：
Terakawa, N