Originally published as JCO Early Release 10.1200/JCO.2009.23.8295 on October 5 2009

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

From the Department of Hematology and Oncology, Mie University Graduate School of Medicine, Tsu; Hematology and Stem Cell Transplantation Division and the Radiation Oncology Division, National Cancer Center Hospital; Department of Radiation Oncology, Japanese Foundation for Cancer Research Cancer Institute Hospital; Department of Community Health and Medicine, Research Institute International Medical Center of Japan; Department of Hematology, Juntendo University School of Medicine; Division of Hematology and Oncology, Jikei University School of Medicine; Screening Technology and Development Division, Research Center for Cancer Prevention and Screening, National Cancer Center; Center for Radiological Sciences, International University of Health and Welfare Mita Hospital; Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo; Department of Hematology & Rheumatology, Tohoku University Hospital, Sendai; Department of Hematology, Saitama Cancer Center, Ina; Division of Hematology and Oncology, National Cancer Center Hospital East, Kashiwa; Department of Hematology, Tokai University, Isehara; Department of Hematology and Oncology, Nagoya University Graduate School of Medicine; Department of Internal Medicine, National Hospital Organization Nagoya Medical Center, Nagoya; Department of Pathology, Kurume University School of Medicine, Kurume; and the Department of Surgical Pathology, Hokkaido University Hospital, Sapporo, Japan.

Corresponding author: Motoko Yamaguchi, MD, PhD, Department of Hematology and Oncology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan; e-mail: myamaguchi{at}clin.medic.mie-u.ac.jp.

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 Concurrent 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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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