Phase I/II Study of Concurrent Chemoradiotherapy for Localized Nasal Natural Killer/T-Cell Lymphoma: Japan Clinical Oncology Group Study JCOG0211
Phase I/II Study of Concurrent Chemoradiotherapy for Localized Nasal Natural Killer/T-Cell Lymphoma: Japan Clinical Oncology Group Study JCOG0211
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DOI：
10.1200/jco.2009.23.8295
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发表时间：
2009-11-20
影响因子：
45.3
通讯作者：
Oshimi, Kazuo
中科院分区：
文献类型：
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作者：
Yamaguchi, Motoko;Tobinai, Kensei;Oshimi, Kazuo
PurposeTo探讨一种更有效的治疗局限性鼻自然杀伤细胞（NK）/T细胞淋巴瘤，我们进行了一项I/II期研究同步放化疗患者和MethodsTreatments包括同步放疗（50戈伊）和3个疗程的地塞米松，依托泊苷，异环磷酰胺，卡铂（DeVIC）。新诊断的IE期或连续性IIE疾病伴颈淋巴结受累且体能状态（PS）为0 - 2的患者有资格入组。II期部分的主要终点是2年的总生存率与推荐剂量治疗的患者。ResultsOf 33例患者参加，10例患者参加了I期部分和三分之二剂量的DeVIC被确立为推荐剂量。接受推荐剂量治疗的27例患者（范围：21 - 68岁;中位数：56岁）显示出以下临床特征：男性：女性，17：10; IE期，18例; IIE期，9例;存在B症状，10例;血清乳酸脱氢酶升高，5例; PS 2，2例。中位随访时间为32个月，2年总生存率为78%（95% CI，57%-89%）。这与单纯放疗的历史对照（45%）相比是有利的。在26例可评估缓解的患者中，20例（77%）达到完全缓解，1例部分缓解。总有效率为81%。最常见的3级非血液学毒性是与放射相关的粘膜炎（30%）。没有治疗相关的死亡observed.ConclusionConcurrent放化疗使用多药耐药非相关药物和依托泊苷是一种安全有效的治疗局部鼻NK/T细胞淋巴瘤，值得进一步调查。
PurposeTo explore a more effective treatment for localized nasal natural killer (NK)/T-cell lymphoma, we conducted a phase I/II study of concurrent chemoradiotherapy.Patients and MethodsTreatments comprised concurrent radiotherapy (50 Gy) and 3 courses of dexamethasone, etoposide, ifosfamide, and carboplatin (DeVIC). Patients with a newly diagnosed stage IE or contiguous IIE disease with cervical node involvement and a performance status (PS) of 0 to 2 were eligible for enrollment. The primary end point of the phase II portion was a 2-year overall survival in patients treated with the recommended dose.ResultsOf the 33 patients enrolled, 10 patients were enrolled in the phase I portion and a two thirds dose of DeVIC was established as the recommended dose. Twenty-seven patients (range, 21 to 68; median, 56 years) treated with the recommended dose showed the following clinical features: male: female, 17: 10; stage IE, 18; stage IIE, 9; B symptoms present, 10; elevated serum lactate dehydrogenase, 5; and PS 2, 2. With a median follow-up of 32 months, the 2-year overall survival was 78% (95% CI, 57% to 89%). This compared favorably with the historical control of radiotherapy alone (45%). Of the 26 patients assessable for a response, 20 (77%) achieved a complete response, with one partial response. The overall response rate was 81%. The most common grade 3 nonhematologic toxicity was mucositis related to radiation (30%). No treatment-related deaths were observed.ConclusionConcurrent chemoradiotherapy using multidrug resistance-nonrelated agents and etoposide is a safe and effective treatment for localized nasal NK/T-cell lymphoma and warrants further investigation.