Phase I/II study of concurrent chemoradiotherapy for localized nasal natural killer/T-cell lymphoma: Japan Clinical Oncology Group Study JCOG0211

J Clin Oncol. 2009 Nov 20;27(33):5594-600. doi: 10.1200/JCO.2009.23.8295. Epub 2009 Oct 5.

Abstract

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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols*
  • Biopsy, Needle
  • Carboplatin
  • Combined Modality Therapy
  • Dexamethasone
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Etoposide
  • Female
  • Humans
  • Ifosfamide
  • Immunohistochemistry
  • Japan
  • Kaplan-Meier Estimate
  • Lymphoma, Extranodal NK-T-Cell / diagnosis
  • Lymphoma, Extranodal NK-T-Cell / drug therapy*
  • Lymphoma, Extranodal NK-T-Cell / mortality
  • Lymphoma, Extranodal NK-T-Cell / radiotherapy*
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Staging
  • Nose Neoplasms / drug therapy*
  • Nose Neoplasms / mortality
  • Nose Neoplasms / pathology
  • Nose Neoplasms / radiotherapy*
  • Probability
  • Proportional Hazards Models
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Radiotherapy, Conformal
  • Risk Assessment
  • Sex Factors
  • Survival Analysis
  • Treatment Outcome
  • Young Adult

Substances

  • Etoposide
  • Dexamethasone
  • Carboplatin
  • Ifosfamide

Supplementary concepts

  • ICE protocol 2