title: Phase I/II study of concurrent chemoradiotherapy for localized nasal natural killer/T-cell lymphoma: Japan Clinical Oncology Group Study JCOG0211.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Hematology and Oncology, Mie University Graduate School of Medicine, Tsu, Mie, Japan. myamaguchi@clin.medic.mie-u.ac.jp
authors.forename: Motoko
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Masahiko
authors.initials: M
authors.lastname: Oguchi
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.forename: Yukio
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Isobe
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Nobuo
authors.initials: N
authors.lastname: Maseki
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Noriko
authors.initials: N
authors.lastname: Usui
authors.forename: Izumi
authors.initials: I
authors.lastname: Wasada
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Koichi
authors.initials: K
authors.lastname: Ohshima
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsuno
authors.forename: Takashi
authors.initials: T
authors.lastname: Terauchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nawano
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kagami
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.forename: Kazuo
authors.initials: K
authors.lastname: Oshimi
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D001707:Biopsy, Needle; D016190:Carboplatin; D003131:Combined Modality Therapy; D003907:Dexamethasone; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005047:Etoposide; D005260:Female; D006801:Humans; D007069:Ifosfamide; D007150:Immunohistochemistry; D007564:Japan; D053208:Kaplan-Meier Estimate; D054391:Lymphoma, Extranodal NK-T-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009669:Nose Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011336:Probability; D016016:Proportional Hazards Models; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D020266:Radiotherapy, Conformal; D018570:Risk Assessment; D012737:Sex Factors; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005047:Etoposide; D003907:Dexamethasone; D016190:Carboplatin; D007069:Ifosfamide