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CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
脂质体米托蒽醌单药治疗复发/难治性成熟 T 细胞和 NK 细胞肿瘤患者：一项 2 期、多中心、开放标签、单臂试验
英文原题：Liposomal mitoxantrone monotherapy in patients with relapsed or refractory mature T-cell and natural killer-cell neoplasms: A phase 2, multicenter, open-label, single-arm trial.
查看英文原题
Liposomal mitoxantrone monotherapy in patients with relapsed or refractory mature T-cell and natural killer-cell neoplasms: A phase 2, multicenter, open-label, single-arm trial.
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研究概要
Lipo-MIT 单药治疗显示出强效且持久的抗肿瘤活性，安全性可控，为复发/难治性成熟 T 细胞和 NK 细胞淋巴瘤提供了一种新的治疗选择。
中文摘要
方法
这项II期、多中心、开放标签、单臂研究（NCT03776279）报告脂质体米托蒽醌（Lipo-MIT）单药治疗复发/难治性成熟T细胞和NK细胞淋巴瘤患者的疗效与安全性。Lipo-MIT按20 mg/m²每4周一次静脉给药。主要终点为独立审查委员会（IRC）和研究者评估的客观缓解率（ORR）；次要终点包括缓解持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和安全性。
结果
2018年4月26日至2022年8月10日，共有108名符合条件的患者在中国26个研究中心入组并接受治疗。IRC评估ORR为41.7%（95%置信区间：32.3%–51.5%），研究者评估ORR为46.3%（95%置信区间：36.7%–56.2%）；分别有25名（23.1%）和15名（13.9%）患者达到完全缓解。中位随访29.5个月时，IRC评估的中位PFS为8.5个月（95%置信区间：6.0–11.9）；中位OS为23.3个月（95%置信区间：12.0至尚不可评估）；IRC评估的中位DoR尚未达到。最常见的治疗期间不良事件为白细胞计数降低（75人，69.4%）、中性粒细胞计数降低（73人，67.6%）和血小板计数降低（47人，43.5%）。
结论
Lipo-MIT单药治疗表现出强效且持久的抗肿瘤活性，安全性可管理，可为复发/难治性成熟T细胞和NK细胞淋巴瘤提供一种新治疗选择。
展开英文摘要原文
METHODS
In this phase 2, multicenter, open-label, single-arm study (NCT03776279), the authors report the efficacy and safety of liposomal mitoxantrone (Lipo-MIT) monotherapy in patients with relapsed or refractory mature T- and NK-cell lymphoma. Lipo-MIT was administered intravenously at 20 mg/m 2 once every 4 weeks. The primary end points were the objective response rate (ORR) determined by the independent review committee (IRC) and investigators. Secondary end points included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
From April 26, 2018, to August 10, 2022, 108 eligible patients were enrolled and treated at 26 study centers in China. The ORRs were 41.7% (95% confidence interval [CI], 32.3-51.5%) per IRC and 46.3% (95% CI, 36.7%-56.2%) per investigators; 25 (23.1%) and 15 (13.9%) patients, respectively, achieved complete response. With a median follow-up of 29.5 months, median PFS per IRC was 8.5 months (95% CI, 6.0-11.9); median OS was 23.3 months (95% CI, 12.0-not evaluable); median DoR per IRC was not reached. The most frequent treatment-emergent adverse events were decreased white blood cell count (75, 69.4%), decreased neutrophil count (73, 67.6%), and decreased platelet count (47, 43.5%).
CONCLUSIONS
Lipo-MIT monotherapy showed robust and durable antitumor activity with a manageable safety profile, representing a new therapeutic option in relapsed or refractory mature T- and NK-cell lymphoma.
论文信息
- 作者
- Gao Y、Huang Y、Zhang Q、Yang H、Li Y、Li Y、Zhou M、Yang R
- 单位
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.China
- 文献类型
- II 期临床试验 · 多中心研究
- 期刊
- Cancer2025 Jan 1
- 原文标识
- PubMed 39748491 · DOI 10.1002/cncr.35672
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