https://scholars.lib.ntu.edu.tw/handle/123456789/637968
標題: | Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study | 作者: | Kim, Won Seog Fukuhara, Noriko Yoon, Dok Hyun Yamamoto, Kazuhito Uchida, Toshiki Negoro, Eiju Izutsu, Koji Terui, Yasuhito Nakajima, Hideaki Ando, Kiyoshi Suehiro, Youko Kang, Hye Jin Ko, Po Shen Nagahama, Fumiko Sonehara, Yusuke Nagai, Hirokazu HWEI-FANG TIEN Kwong, Yok Lam Tobinai, Kensei |
公開日期: | 12-九月-2023 | 卷: | 7 | 期: | 17 | 起(迄)頁: | 4903 | 來源出版物: | Blood Advances | 摘要: | Darinaparsin is a novel organic arsenical compound of dimethylated arsenic conjugated to glutathione, with antitumor activity and a mechanism of action markedly different from other available agents. This phase 2, nonrandomized, single-arm, open-label study evaluated the efficacy and safety of intravenous darinaparsin (300 mg/m2 over 1 hour, once daily for 5 consecutive days, per 21-day cycle) and its pharmacokinetics at multiple doses in 65 Asian patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary end point was the overall response rate (ORR). The ORR based on central assessment was 19.3% (90% confidence interval, 11.2-29.9), which was significantly higher than the predefined threshold of 10% (P = .024). The ORR was 16.2% in patients with PTCL- not otherwise specified and 29.4% in patients with angioimmunoblastic T-cell lymphoma. Tumor size decreased in 62.3% of patients. Treatment-emergent adverse events (TEAEs) were observed in 98.5% of patients. Grade ≥3 TEAEs with an incidence rate of ≥5% included anemia (15.4%), thrombocytopenia (13.8%), neutropenia (12.3%), leukopenia (9.2%), lymphopenia (9.2%), and hypertension (6.2%). Darinaparsin is effective and well tolerated, with TEAEs that were clinically acceptable and manageable with symptomatic treatment and dose reductions. |
URI: | https://pubmed.ncbi.nlm.nih.gov/36661315/ https://scholars.lib.ntu.edu.tw/handle/123456789/637968 |
ISSN: | 24739529 | DOI: | 10.1182/bloodadvances.2022008615 |
顯示於: | 醫學系 |
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