Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma
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 invo...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2024-12-01
|
| Series: | Hematology |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/16078454.2024.2402102 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850061170458755072 |
|---|---|
| author | Demei Feng Zhimin Yan Bibo Fu Shenrui Bai Lewei Zhu Robert Peter Gale Zhongjun Xia Yang Liang Hua Wang |
| author_facet | Demei Feng Zhimin Yan Bibo Fu Shenrui Bai Lewei Zhu Robert Peter Gale Zhongjun Xia Yang Liang Hua Wang |
| author_sort | Demei Feng |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7e33d77bc4194755b3e45e5b4156abc0 |
| institution | DOAJ |
| issn | 1607-8454 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Hematology |
| spelling | doaj-art-7e33d77bc4194755b3e45e5b4156abc02025-08-20T02:50:19ZengTaylor & Francis GroupHematology1607-84542024-12-0129110.1080/16078454.2024.2402102Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphomaDemei Feng0Zhimin Yan1Bibo Fu2Shenrui Bai3Lewei Zhu4Robert Peter Gale5Zhongjun Xia6Yang Liang7Hua Wang8State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaDepartment of Hematology, the First Affiliated Hospital of Gannan Medical College, Ganzhou, People’s Republic of ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaDepartment of Breast Surgery, The First People’s Hospital of Foshan, Foshan, People’s Republic of ChinaDepartment of Immunology and Inflammation, Haematology Research Centre, Imperial College London, London, UKState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of ChinaObjective: 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.https://www.tandfonline.com/doi/10.1080/16078454.2024.2402102Extra-nodal NK/T-cell lymphomapegaspargaseetoposidegemcitabineradiotherapy |
| spellingShingle | Demei Feng Zhimin Yan Bibo Fu Shenrui Bai Lewei Zhu Robert Peter Gale Zhongjun Xia Yang Liang Hua Wang Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma Hematology Extra-nodal NK/T-cell lymphoma pegaspargase etoposide gemcitabine radiotherapy |
| title | Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma |
| title_full | Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma |
| title_fullStr | Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma |
| title_full_unstemmed | Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma |
| title_short | Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma |
| title_sort | phase ii study of pegaspargase etoposide gemcitabine peg followed by involved field radiation therapy in early stage extranodal natural killer t cell lymphoma |
| topic | Extra-nodal NK/T-cell lymphoma pegaspargase etoposide gemcitabine radiotherapy |
| url | https://www.tandfonline.com/doi/10.1080/16078454.2024.2402102 |
| work_keys_str_mv | AT demeifeng phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT zhiminyan phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT bibofu phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT shenruibai phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT leweizhu phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT robertpetergale phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT zhongjunxia phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT yangliang phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma AT huawang phaseiistudyofpegaspargaseetoposidegemcitabinepegfollowedbyinvolvedfieldradiationtherapyinearlystageextranodalnaturalkillertcelllymphoma |