一项关于培门冬酶-COEP联合放疗用于新诊断的结外NK/T细胞淋巴瘤患者的前瞻性II期研究。
A Prospective Phase II Study of Pegaspargase-COEP Plus Radiotherapy in Patients With Newly Diagnosed Extra-Nodal NK/T-Cell Lymphoma.
作者信息
Hu Shaoxuan, Lin Ningjing, Liu Jiaxin, Sun Yan, Liu Weiping, Wang Xiaopei, Xie Yan, Song Yuqin, Wen Yi, Zhu Jun
机构信息
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
出版信息
Front Oncol. 2022 Feb 25;12:839252. doi: 10.3389/fonc.2022.839252. eCollection 2022.
BACKGROUND
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.
METHODS
Our study is a prospective, open-label clinical trial. Patients with newly diagnosed ENKTL and an ECOG performance status of 0 to 2 were eligible for enrollment. For patients with stage I/II nasal ENKTL, treatment included 2 cycles of induction COEPL regimen followed by concurrent chemoradiotherapy, then by 2 cycles of COEPL regimen as consolidation. For patients with stage III/IV or primary extra-nasal ENKTL, treatment included 6-8 cycles of COEPL regimen with or without radiotherapy to local sites, and autologous stem cell transplantation was given in selected patients.
RESULTS
A total of 80 patients were enrolled. The median age was 41 years (range, 15-76 years). Sixteen patients (20%) had stage III/IV disease, and 10 (12.5%) had a PINK score≥2. Complete response and overall response rates were 75.9% and 87.3%, respectively. With a median follow-up of 41.4 months (range 2.7-76.2 months), the 3-year progression-free survival (PFS) and overall survival (OS) rates were 71.3% (95%CI 61.1-81.5%) and 73.3% (95%CI 63.1-83.5%), respectively. For patients with stage I/II nasal ENKTL (n=62), the 3-year PFS and OS were 78.1% and 81.2%, respectively. For patients with stage III/IV or primary extra-nasal ENKTL (n=18), 3-year PFS and OS were 48.1% and 45.7%, respectively. Major grade 3-4 adverse events were anemia (21.3%), leucopenia (22.5%), neutropenia (18.8%), and thrombocytopenia (7.6%). No treatment-related death was observed.
CONCLUSIONS
Pegaspargase-COEP chemotherapy in combination with radiotherapy is highly effective and safe for patients with newly diagnosed ENKTL.
背景
结外NK/T细胞淋巴瘤（ENKTL）的最佳一线治疗方案尚未明确。本研究旨在评估聚乙二醇天冬酰胺酶、环磷酰胺、长春新碱、依托泊苷和泼尼松（COEPL）方案联合放疗对新诊断的ENKTL患者的疗效和安全性。
方法
我们的研究是一项前瞻性、开放标签的临床试验。新诊断的ENKTL且东部肿瘤协作组（ECOG）体能状态为0至2的患者符合入组条件。对于I/II期鼻型ENKTL患者，治疗包括2个周期的诱导COEPL方案，随后进行同步放化疗，然后再进行2个周期的COEPL方案巩固治疗。对于III/IV期或原发鼻外型ENKTL患者，治疗包括6 - 8个周期的COEPL方案，可联合或不联合局部放疗，部分患者接受自体干细胞移植。
结果
共纳入80例患者。中位年龄为41岁（范围15 - 76岁）。16例（20%）患者为III/IV期疾病，10例（12.5%）患者PINK评分≥2。完全缓解率和总缓解率分别为75.9%和87.3%。中位随访41.4个月（范围2.7 - 76.2个月），3年无进展生存期（PFS）和总生存期（OS）率分别为71.3%（95%CI 61.1 - 81.5%）和73.3%（95%CI 63.1 - 83.5%）。对于I/II期鼻型ENKTL患者（n = 62），其3年PFS和OS分别为78.1%和81.2%。对于III/IV期或原发鼻外型ENKTL患者（n = 18），3年PFS和OS分别为48.1%和45.7%。主要3 - 4级不良事件为贫血（21.3%）、白细胞减少（22.5%）、中性粒细胞减少（18.8%）和血小板减少（7.6%）。未观察到与治疗相关的死亡。
结论
聚乙二醇天冬酰胺酶 - COEP化疗联合放疗对新诊断的ENKTL患者高效且安全。
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