PEG-L-CHOP 治疗在成人结外 NK/T 细胞淋巴瘤中安全有效，临床过敏反应发生率低。
PEG-L-CHOP treatment is safe and effective in adult extranodal NK/T-cell lymphoma with a low rate of clinical hypersensitivity.
机构信息
Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian district, Beijing, 100142, People's Republic of China.
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China.
出版信息
BMC Cancer. 2018 Sep 21;18(1):910. doi: 10.1186/s12885-018-4782-y.
BACKGROUND
The combination of chemotherapy and L-asparaginase (L-ASP) treatment significantly increased survival rate in an adult patient with extranodal natural killer (NK)/T-cell lymphoma (NKTCL). However, hypersensitivity reactions of L-ASP in some patients limited its application. Polyethylene glycol-conjugated asparaginase (PEG-ASP) has a lower immunogenicity and longer circulating half-life than unconjugated L-ASP, and has been reported to be effective and well-tolerated in children with acute lymphoblastic leukemia. Cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisolone (CHOP) is the most common chemotherapy for non-Hodgkin lymphoma. In this report, we sought to study the efficacy and safety of PEG-L- CHOP in NKTCL in adult Chinese patients.
METHODS
Our study is a prospective, multi-center, open-label clinical trial. Patients with newly diagnosed adult NKTCL and an ECOG performance status of 0 to 2 were eligible for enrollment. Treatment included six cycles of PEG-L-CHOP regimen. Radiotherapy was scheduled after 2-4 cycles of PEG-L-CHOP regimen, depending on the stage and primary anatomic site.
RESULTS
We enrolled a total of 33 eligible patients. All 33 patients completed 170 cycles of chemotherapy combined with radical radiotherapy. The overall response rate was 96.9% (32/33) with 75.8% (25/33) achieving complete responses and 21.2% (7/33) achieving partial responses. The overall survival (OS) at 1, 2, 3-year were 100, 90.61 and 80.54%, respectively. The major adverse effects were bone marrow suppression, reduction of fibrinogen level, liver dysfunction, and digestive tract toxicities. No allergic reaction and no treatment-related mortality or severe complications were recorded.
CONCLUSIONS
PEG-L-CHOP chemotherapy in combination radiotherapy is safe and durably effective treatment for adult extranodal NK/T-cell lymphoma with fewer allergic reactions. This study was approved by the Peking University Beijing Cancer Hospital Ethics Review Committee (reference number: 2011101104). The clinical trial registration number ChiCTR1800016940 was registered on July 07, 2018 at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/index.aspx ). The clinical trial was registered retrospectively.
背景
化疗联合 L-门冬酰胺酶（L-ASP）治疗显著提高了 1 例结外自然杀伤（NK）/T 细胞淋巴瘤（NKTCL）成年患者的生存率。然而，L-ASP 在一些患者中的过敏反应限制了其应用。聚乙二醇化门冬酰胺酶（PEG-ASP）的免疫原性低于未结合的 L-ASP，半衰期较长，已被报道在儿童急性淋巴细胞白血病中有效且耐受良好。环磷酰胺、羟基柔红霉素（阿霉素）、长春新碱（长春碱）和泼尼松龙（CHOP）是治疗非霍奇金淋巴瘤最常用的化疗药物。在本报告中，我们旨在研究 PEG-L-CHOP 在成人中国 NKTCL 患者中的疗效和安全性。
方法
本研究是一项前瞻性、多中心、开放标签的临床试验。符合条件的患者为新诊断的成年 NKTCL 患者，ECOG 体能状态为 0-2。治疗包括 6 个周期的 PEG-L-CHOP 方案。根据分期和原发解剖部位，在 2-4 个周期的 PEG-L-CHOP 方案后安排放疗。
结果
共纳入 33 例符合条件的患者。所有 33 例患者均完成了 170 个周期的化疗联合根治性放疗。总缓解率为 96.9%（32/33），完全缓解率为 75.8%（25/33），部分缓解率为 21.2%（7/33）。1、2、3 年总生存率（OS）分别为 100%、90.61%和 80.54%。主要不良反应为骨髓抑制、纤维蛋白原水平降低、肝功能异常和消化道毒性。未发生过敏反应，无治疗相关死亡或严重并发症。
结论
PEG-L-CHOP 化疗联合放疗是一种安全且持久有效的治疗成人结外 NK/T 细胞淋巴瘤的方法，过敏反应较少。本研究经北京大学肿瘤医院伦理审查委员会批准（编号：2011101104）。临床试验注册号 ChiCTR1800016940 于 2018 年 7 月 7 日在中国临床试验注册中心（http://www.chictr.org.cn/index.aspx）注册。临床试验是回顾性注册的。
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