Pegaspargase Combined with Concurrent Radiotherapy for Early-Stage Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: A Two-Center Phase II Study.
Pegaspargase Combined with Concurrent Radiotherapy for Early-Stage Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: A Two-Center Phase II Study.
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培门冬酶联合同步放疗治疗早期结外自然杀伤/T细胞淋巴瘤，鼻型：双中心II期研究
DOI：
10.1634/theoncologist.2020-0144
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发表时间：
2020-11
期刊：
影响因子：
--
通讯作者：
Lu Y
中科院分区：
文献类型：
--
作者：
Wang H;Wang L;Li C;Wuxiao Z;Chen G;Luo W;Lu Y
同步放化疗（CCRT）有望改善局部和全身疾病控制，并已被确立为几种类型实体瘤的标准疗法。考虑到一线放射和聚乙二醇门冬酶对局限性结外自然杀伤细胞（NK）/鼻型T细胞淋巴瘤（ENKTL）的益处，我们对基于聚乙二醇门冬酶的CCRT进行了II期研究，以探索有效的治疗方法。在这项研究中，30例IE至IIE期新诊断的鼻ENKTL患者接受了CCRT（放疗50戈伊和2个周期的培门冬酶2，500单位/m2，每3周一次）。CCRT后进行了4个疗程的培门冬酶治疗。患者完成了CCRT和4个周期的培门冬酶治疗。CCRT后完全缓解（CR）率为90%，95%可信区间（CI）为73.5%~ 97.9%。治疗结束时CR率为100%（95%CI，88.4%~ 100%）。2年总生存率和无进展生存率分别为90.9%（95% CI，78.4%-100%）和92.8%（95% CI，83.2%-100%）。主要不良事件为1-2级。初步数据表明，培门冬酶联合同步放疗治疗新诊断的鼻ENKTL患者有效且耐受性良好。在www.chictr.org注册。临床试验注册号。ChiCTR‐OIC‐15007662。本临床试验评价了采用培门冬酶单药同步放化疗治疗IE至IIE期结直肠鼻型自然杀伤/T细胞淋巴瘤（ENKTL）患者的疗效和毒性，结果显示培门冬酶联合同步放疗有效且耐受性良好。培门冬酶半衰期长，易于通过肌内注射给药。因此，ENKTL患者的培门冬酶联合同步放疗可在门诊完成。这项II期临床研究评价了使用培门冬酶单药进行同步放化疗治疗鼻型淋巴结NK/T细胞淋巴瘤患者的疗效和毒性。
Concurrent chemoradiotherapy (CCRT) is expected to improve local and systemic disease control and has been established as a standard therapy for several types of solid tumors. Considering the benefits of frontline radiation and pegaspargase in localized extranodal natural killer (NK)/T‐cell lymphoma, nasal type (ENKTL), we conducted a phase II study on pegaspargase‐based CCRT to explore an effective treatment. In this study, 30 patients with newly diagnosed nasal ENKTL in stages IE to IIE received CCRT (radiation 50 Gy and two cycles of pegaspargase 2,500 unit/m2 every 3 weeks). Four courses of pegaspargase were performed after CCRT. The patients completed CCRT and four cycles of pegaspargase. The complete remission (CR) rate was 90%, with a 95% confidential interval (CI) of 73.5%–97.9% after CCRT. The CR rate was 100% (95% CI, 88.4%–100%) at the end of the treatment. The 2‐year overall survival and progression‐free survival rates were 90.9% (95% CI, 78.4%–100%) and 92.8% (95% CI, 83.2%–100%), respectively. The major adverse events were in grades 1–2. Preliminary data indicate that pegaspargase combined with concurrent radiotherapy for newly diagnosed patients with nasal ENKTL was efficacious and well tolerated. Registered at www.chictr.org. Clinical Trial Registration Number. ChiCTR‐OIC‐15007662. This clinical trial, evaluating the efficacy and toxicity of concurrent chemoradiotherapy by using single‐drug pegaspargase for patients with extranodal natural killer/T‐cell lymphoma, nasal type (ENKTL) in stage IE to IIE, showed pegaspargase combined with concurrent radiotherapy was efficacious and well tolerated. Pegaspargase has a long half‐life and is easy to administer via intramuscular injection. Consequently, pegaspargase combined with concurrent radiotherapy for patients with ENKTL can be completed in the outpatient clinic. This phase II clinical study evaluated the efficacy and toxicity of concurrent chemoradiotherapy using single‐drug pegaspargase for patients with nasal‐type extranodal NK/T‐cell lymphoma.
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影响因子：
158.5
作者：
Bernier, J;Domenge, C;van Glabbeke, M
通讯作者：
van Glabbeke, M
影响因子：
20.3
作者：
Chim, CS;Ma, SY;Kwong, YL
通讯作者：
Kwong, YL
淋巴瘤分类更新：T细胞淋巴瘤，霍奇金淋巴瘤和组织细胞/树突状细胞肿瘤。
影响因子：
2.8
作者：
Jiang M;Bennani NN;Feldman AL
通讯作者：
Feldman AL
DOI：
10.1016/j.ijrobp.2003.12.006
发表时间：
2004-07-15
影响因子：
7
作者：
Koom, WS;Chung, EJ;Kim, GE
通讯作者：
Kim, GE
影响因子：
45.3
作者：
Cheson, Bruce D.;Fisher, Richard I.;Lister, T. Andrew
通讯作者：
Lister, T. Andrew