Phase I/II Study of Concurrent Chemoradiotherapy for Localized Nasal Natural Killer/T-Cell Lymphoma: Japan Clinical Oncology Group Study JCOG0211

作者：Motoko Yamaguchi, Kensei Tobinai, Masahiko Oguchi, Naoki Ishizuka, Yukio Kobayashi, Yasushi Isobe, Kenichi Ishizawa, Nobuo Maseki, Kuniaki Itoh, Noriko Usui, Izumi Wasada, Tomohiro Kinoshita, Koichi Ohshima, Yoshihiro Matsuno, Takashi Terauchi, Shigeru Nawano, Satoshi Ishikura, Yoshikazu Kagami, Tomomitsu Hotta, Kazuo Oshimi · 发表于：Journal of Clinical Oncology · 年份：2009 · DOI：10.1200/jco.2009.23.8295 · 被引用次数：341 · 研究领域：Lymphoma Diagnosis and Treatment、Immune Cell Function and Interaction、Head and Neck Cancer Studies

PURPOSE: To 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 METHODS: Treatments 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. RESULTS: Of 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. CONCLUSION:...