Phase II study of gemcitabine, cisplatin, and bevacizumab for first recurrent and refractory ovarian clear cell carcinoma Kansai Clinical Oncology Group-G1601

吉西他滨 医学 贝伐单抗 内科学 临床终点 耐火材料(行星科学) 肿瘤科 不利影响 进行性疾病 顺铂 毒性 临床研究阶段 胃肠病学 卵巢癌 卵巢癌 化疗 临床试验 癌症 物理 天体生物学
作者
Kimihiko Ito,Mio Nakagawa,Mototsugu Shimokawa,Kensuke Hori,Lena Tashima,Mayako Goto,Satoshi Yanagida,Jiro Suzuki,Ryusuke Kaya,Ayako Kawabata,Kyosuke Yamada,Jongmyung Park,Hiroki Nasu,Shin Nishio,Eiji Kondo,Michiko Kaneda,Hiroshi Tsubamoto,Atsushi Arakawa,Takayuki Nagasawa,Takashi Motohashi
出处
期刊:Anti-Cancer Drugs [Lippincott Williams & Wilkins]
被引量:3
标识
DOI:10.1097/cad.0000000000001472
摘要

Patients with advanced ovarian clear cell carcinoma (CCC) have a poor prognosis in the absence of an effective standard treatment. Combination therapy with gemcitabine, cisplatin, and bevacizumab (GPBev) is promising for ovarian CCC. Thus, we conducted a multi-institutional, phase II trial in Japan to examine the efficacy and safety of GPBev for CCC. This is the first study on the use of GPBev for CCC. Eighteen patients (median age, 56.5 years) with pathologically confirmed first recurrent or refractory CCC and having evaluable regions, as assessed using RECIST, were recruited between January 2017 and May 2019. Gemcitabine (1000 mg/m 2 ), cisplatin (40 mg/m 2 ), and bevacizumab (10 mg/kg) were administered intravenously on days 1 and 15, every 28 days, for 6–10 cycles, until disease progression or intolerable toxicity. The primary endpoint was overall response rate (ORR). The secondary endpoints included disease control rate (DCR) and adverse events (AEs). Fifteen patients (83.3%) completed 6–10 cycles of treatment; three patients (two with AEs and one with progressive disease) did not. The ORR was 61.1% [complete response (CR) 3 and partial response (PR) 8] and DCR was 88.9% (CR 3, PR 8, and stable disease 5). Grade 3 and 4 hematological AEs were observed in 16.7 and 5.6% of the patients, respectively. Nonhematological AEs of grades 3 and 4 were observed in 27.8 and 5.6% of the patients, respectively. GPBev is a promising therapy for CCC owing to the high ORR and acceptable toxicity for the first recurrence and refractory CCC.
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