刘隽, 唐勇, 程毅敏, et al. Clinical study on pegaspargase combined with dexamethasone in the treatment of elderly patients with extranodal NK/T-cell lymphoma[J]. China Oncology, 2013, 23(4): 298-301.
刘隽, 唐勇, 程毅敏, et al. Clinical study on pegaspargase combined with dexamethasone in the treatment of elderly patients with extranodal NK/T-cell lymphoma[J]. China Oncology, 2013, 23(4): 298-301. DOI: 10.3969/j.issn.1007-3969.2013.04.010.
Clinical study on pegaspargase combined with dexamethasone in the treatment of elderly patients with extranodal NK/T-cell lymphoma
背景与目的:进展期淋巴结外NK/T细胞淋巴瘤(extranodal NK/T-cell lymphoma,ENKTL)是一种高度侵袭性非霍奇金淋巴瘤,老年患者预后较差,目前仍无标准治疗方案。培门冬酶作为聚乙二醇包裹的天冬酰胺酶可诱导肿瘤性NK细胞凋亡,并且具有良好耐受性。本研究探讨培门冬酶联合地塞米松(pegaspargase combined with dexamethasone,PegAD)方案治疗老年进展期ENKTL (鼻型)的临床疗效和不良反应。方法:15例老年患者均经病理确诊为ENKTL (鼻型),临床分期Ⅲ~Ⅳ期,采用PegAD方案治疗:培门冬酶2 500 U/(m
2
·d),肌内注射,第1天;地塞米松20 mg/d,静脉滴注,第1~4天,21 d为1个疗程。对该方案的临床疗效和安全性进行分析和评估。结果:①15例患者共完成45个疗程PegAD方案化疗,中位化疗3个疗程,2例获得完全缓解,7例达到部分缓解,总有效率为60%,总体平均生存时间10个月。②初治患者有效率75%明显高于诱导化疗失败的难治性患者(75% vs 43%,P0.05),而且初治患者平均生存时间长于难治性患者(14个月 vs 6个月)。③PegAD方案化疗的主要不良反应为肝功能损害和凝血功能异常,其中3~4级肝功能损害发生率为20%,纤维蛋白原含量下降、凝血酶原时间或活化部分凝血酶时间延长的发生率达60%,血液学毒性轻微。结论:PegAD方案是治疗老年进展期ENKTL患者有效,且耐受性较好的化疗方案。
Abstract
Background and purpose: Advanced extranodal NK/T-cell lymphoma is a highly aggressive disease with a grim prognosis in elderly patients. No therapeutic strategy is currently identified in these setting of patients. Pegaspargase formed by covalently attaching polyethylene glycol to asparaginase has been shown to induce apoptosis of tumoral NK cells in vitro and well tolerated. This clinical study was to investigate the clinical efficacy and toxicity of pegaspargase combined with dexamethasone (PegAD) regime
n in the treatment of elderly patients with extranodal NK/T-cell lymphoma
nasal type (ENKTL). Methods: A total of 15 elderly patients with pathologically diagnosed ENKTL and presented with Ann Arbor stage Ⅲ-Ⅳ were treated with PegAD regimen
which consisted of pegaspargase 2 500 U/(m
2
·d) given as intramuscular injection on day 1 and dexamethasone 20 mg/d administered intravenously on day1 through 4. The PegAD regimen was repeated every 21 days. Clinical efficacy and safty profiles of PegAD regimen was systemically reviewed and analysed. Results: ① All the 15 patients received a total of 45 cycles of PegAD regimen. The median cycles was 3. Two patients achieved complete response
while seven cases obtained partial response. The overall response rate was 60%. The median survival time was 10 months. ②In newly diagnosed patients
overall response rate (OR) reached 75%
which was significantly higher than that in refractory cases
whose OR were 43% (P0.05). In addition
the median survival duration of newly diagnosed patients was longer than that of refractory cases
whose median survival time was 14 and 6months
respectively. ③The major adverse events was liver dysfunction and disturbances of blood coagulation with grade 3-4 hepatitis in 20% cases and low levels of fibrinogen as well as prolonged PT and APTT in 60% patients. However
hematologic toxicities were moderate. Conclusion: PegAD regimen was an effective and well tolerated therapeutic schedule for elderly patients with ENKTL.