A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254).
A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254).
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DOI：
10.1016/j.ygyno.2018.05.029
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发表时间：
2018-08
影响因子：
4.7
通讯作者：
Gershenson DM
中科院分区：
文献类型：
--
作者：
Chan JK;Brady W;Monk BJ;Brown J;Shahin MS;Rose PG;Kim JH;Secord AA;Walker JL;Gershenson DM
确定舒尼替尼在复发性或持续性卵巢透明细胞癌患者中的疗效和耐受性。所有患者都有一个或两个可测量疾病的既往治疗方案。肿瘤至少有50%的透明细胞组织形态学和阴性WT-1抗原和雌激素受体表达的免疫组织化学。舒尼替尼50 mg/天，持续4周，重复6周周期，直至疾病进展或出现抑制性毒性。主要终点是6个月时的无进展生存期（PFS）和临床反应。该研究旨在确定药物的缓解率是否至少为20%或6个月PFS是否至少为25%。在入组的35例患者中，30例接受了治疗且符合条件（中位年龄：51岁，范围：27-73岁）。25例（83%）为白色，4例（13%）为亚洲人，1例（3%）未知。大多数28例（83%）患者接受了≤3个疗程的研究治疗，但2例（7%）患者接受了16个疗程的研究治疗。5例（16.7%）患者的PFS ≥6个月（90% CI：6.8%-31.9%）。2例（6.7%）患者部分或完全缓解（90% CI：1.2%-19.5%）。中位PFS为2.7个月。中位总生存期为12.8个月。最常见的3级不良事件为疲乏（4）、高血压（4）、中性粒细胞减少症（4）、贫血（3）、腹痛（3）和白细胞减少症（3）。4-5级不良事件包括：血小板减少症（5）、贫血（2）、急性肾损伤（1）、中风（1）和过敏反应（1）。舒尼替尼在持续性或复发性透明细胞卵巢癌的二线和三线治疗中表现出最小的活性。
To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20% or 6-month PFS of at least 25%. Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83%) were White, 4 (13%) Asian, and 1 (3%) unknown. The majority 28 (83%) patients, underwent ≤3 but 2 (7%) had 16 courses of study therapy. Five (16.7%) patients had PFS ≥6 months (90% CI: 6.8%−31.9%). Two (6.7%) patients had a partial or complete response (90% CI: 1.2%–19.5%). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma.
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影响因子：
4.7
作者：
Chan, John K.;Tian, Chunqiao;Bell, Jeffrey
通讯作者：
Bell, Jeffrey
DOI：
10.1056/nejmoa1510665
发表时间：
2015-11-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Motzer RJ;Escudier B;McDermott DF;George S;Hammers HJ;Srinivas S;Tykodi SS;Sosman JA;Procopio G;Plimack ER;Castellano D;Choueiri TK;Gurney H;Donskov F;Bono P;Wagstaff J;Gauler TC;Ueda T;Tomita Y;Schutz FA;Kollmannsberger C;Larkin J;Ravaud A;Simon JS;Xu LA;Waxman IM;Sharma P;CheckMate 025 Investigators
通讯作者：
CheckMate 025 Investigators
影响因子：
45.3
作者：
Motzer, RJ;Michaelson, MD;Rini, BI
通讯作者：
Rini, BI
DOI：
10.1097/00004347-198906000-00001
发表时间：
1989-06-01
影响因子：
2.4
作者：
MONTAG, AG;JENISON, EL;KNAPP, RC
通讯作者：
KNAPP, RC
影响因子：
50.5
作者：
Biagi, J. J.;Oza, A. M.;Eisenhauer, E. A.
通讯作者：
Eisenhauer, E. A.