Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma

被引:1
作者
Feng, Demei [1 ]
Yan, Zhimin [2 ]
Fu, Bibo [1 ]
Bai, Shenrui [1 ]
Zhu, Lewei [3 ]
Gale, Robert Peter [4 ]
Xia, Zhongjun [1 ]
Liang, Yang [1 ]
Wang, Hua [1 ]
机构
[1] Sun Yat Sen Univ, Guangdong Prov Clin Res Ctr Canc, Canc Ctr, State Key Lab Oncol South China, Guangzhou, Peoples R China
[2] Gannan Med Coll, Affiliated Hosp 1, Ganzhou, Peoples R China
[3] First Peoples Hosp Foshan, Dept Breast Surg, Foshan, Peoples R China
[4] Imperial Coll London, Haematol Res Ctr, Dept Immunol & Inflammat, London, England
基金
中国国家自然科学基金;
关键词
Extra-nodal NK/T-cell lymphoma; pegaspargase; etoposide; gemcitabine; radiotherapy; SEQUENTIAL CHEMOTHERAPY; T-CELL; NASAL; RADIOTHERAPY; IE;
D O I
10.1080/16078454.2024.2402102
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective:The prognosis of extra-nodal NK/T cell lymphoma (ENKTL) is poor, and the optimal therapy remains controversial. This study aims to evaluate the safety and efficacy of a new combined modality therapy.Methods:Phase-2 study of pegaspargase, etoposide and gemcitabine (PEG) combined with involved field radiation therapy (IFRT) in newly-diagnosed patients with early-stage ENKTL. Patients received 4 course of PEG followed by IFRT. The primary endpoints were complete response (CR), partial response (PR), and objective response rate (ORR) after IFRT. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events.Results:34 consecutive patients with Ann Arbor stage I/II were enrolled. 3 patients progressed on PEG, while the remaining 31 received IFRT. The ORR was 88.2% (30/34), included 28 (82.4%) complete and 2 (5.8%) partial responses. With a median follow-up of 56.0 months (Interquartile Range [IQR], 36.0-66.9 months), the estimated 5-year PFS and OS were 87.4% (95% Confidence Interval [CI],69.5%-94.8%) and 97.1% (95%CI, 80.1%-99.6%), respectively. Most adverse events were hematological and easily managed.Conclusions:PEG followed by IFRT is a safe and effective initial therapy for early-stage ENKTL, demonstrating impressive PFS and OS rates. This promising approach warrants further validation in a randomized controlled trial (Registered at Clinicaltrials.gov NCT02705508).Trial registration: ClinicalTrials.gov identifier: NCT02705508.Conclusions:PEG followed by IFRT is a safe and effective initial therapy for early-stage ENKTL, demonstrating impressive PFS and OS rates. This promising approach warrants further validation in a randomized controlled trial (Registered at Clinicaltrials.gov NCT02705508).Trial registration: ClinicalTrials.gov identifier: NCT02705508.
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页数:6
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