Phase 2 Study of First-line Intensity Modulated Radiation Therapy Followed by Gemcitabine, Dexamethasone, and Cisplatin for High-Risk, Early Stage Extranodal Nasal-Type NK/T-Cell Lymphoma: The GREEN Study.

Abstract

PURPOSE:

To investigate the efficacy and toxicity profile of sequential intensity modulated radiation therapy (IMRT) followed by gemcitabine, dexamethasone, and cisplatin (GDP) on previously untreated high-risk, early stage upper aerodigestive tract natural killer/T-cell lymphoma (UADT-NKTCL).

METHODS AND MATERIALS:

A phase 2 study was designed, and 40 high-risk patients with stage I(E)/II(E) UADT-NKTCL were enrolled between June 2010 and June 2014. High-risk patients were defined as those with at least 1 predefined risk factor: age >60 years, elevated serum lactate dehydrogenase, regional lymph node involvement, B symptoms, and primary tumor invasion. Patients received extended involved-site IMRT and GDP chemotherapy. The primary endpoint was the 2-year progression-free survival rate. Secondary endpoints were the 2-year overall survival rate, overall response rate, and toxicity.

RESULTS:

Median follow-up time was 60.1 months. The overall response rate and complete remission rate were 97.5% and 95.0%, respectively. The 2- and 5-year progression-free survival rates were 84.7% and 79.4%, and the corresponding overall survival rates were 89.9% and 82.1%, respectively. The most frequent radiation-induced toxicities were mild mucositis and skin reaction. Grade 3/4 neutropenia (12 of 40 patients), thrombocytopenia (7 of 40), and anemia (2 of 40) were observed during chemotherapy.

CONCLUSIONS:

First-line IMRT followed by GDP represents an effective and well-tolerated protocol for high-risk, early stage UADT-NKTCL.

• Authors: Fei Qi, Wei-Hu Wang, Xiao-Hui He, Bo Chen, Lin Gui, Hui Fang, Peng Liu, Shu-Lian Wang, Jian-Liang Yang, Yong-Wen Song, Sheng Yang, Shu-Nan Qi, Sheng-Yu Zhou, Ye-Xiong Li, Mei Dong
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 102 Issue 1 Pg. 61-70 (09 01 2018) ISSN: 1879-355X [Electronic] United States
• PMID: 30102205 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Deoxycytidine
• Dexamethasone
• Cisplatin
• Gemcitabine

Topics

• Adult
• Cisplatin (adverse effects, therapeutic use)
• Combined Modality Therapy
• Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
• Dexamethasone (adverse effects, therapeutic use)
• Female
• Humans
• Lymphoma, Extranodal NK-T-Cell (drug therapy, pathology, radiotherapy)
• Male
• Middle Aged
• Neoplasm Staging
• Radiotherapy, Intensity-Modulated
• Recurrence
• Risk
• Safety
• Treatment Outcome
• Gemcitabine