التفاصيل البيبلوغرافية
| العنوان: |
Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma. |
| المؤلفون: |
Feng, Demei1 (AUTHOR), Yan, Zhimin2 (AUTHOR), Fu, Bibo1 (AUTHOR), Bai, Shenrui1 (AUTHOR), Zhu, Lewei3 (AUTHOR), Gale, Robert Peter4 (AUTHOR), Xia, Zhongjun1 (AUTHOR) xiazhj@sysucc.org.cn, Liang, Yang1 (AUTHOR) liangyang@sysucc.org.cn, Wang, Hua1 (AUTHOR) wanghua@sysucc.org.cn |
| المصدر: |
Hematology. Dec2024, Vol. 29 Issue 1, p1-6. 6p. |
| مصطلحات موضوعية: |
*COMBINED modality therapy, *OVERALL survival, *PROGRESSION-free survival, *RANDOMIZED controlled trials, *T cells |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |