scholarly journals EFFICACY AND SAFETY OF PEGASPARGASE, GEMCITABINE, DEXAMETHASONE, AND CISPLATIN COMBINED CHEMOTHERAPY IN NEWLY DIAGNOSED EXTRANODAL NK/T CELL LYMPHOMA

2017 ◽  
Vol 35 ◽  
pp. 393-393
Author(s):  
L. Zhang ◽  
T. Liu ◽  
F. Zhu ◽  
Y. Xiao ◽  
Q. Li ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Combined Chemotherapy ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Nk T Cell

scholarly journals Analysis of the efficacy and safety of a combined gemcitabine, oxaliplatin and pegaspargase regimen for NK/T-cell lymphoma

Oncotarget ◽  
2016 ◽  
Vol 7 (23) ◽  
pp. 35412-35422 ◽  
Author(s):  
Jing-hua Wang ◽  
Hua Wang ◽  
Yan-jun Wang ◽  
Zhong-jun Xia ◽  
Hui-qiang Huang ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Efficacy And Safety ◽  
Nk T Cell

Efficacy of Pegaspargase, Etoposide, Methotrexate and Dexamethasone (PEMD) in Newly-Diagnosed Advanced-Stage Extra-Nodal Natural Killer (NK)/T-Cell Lymphoma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4148-4148
Author(s):  
Wei Xu ◽  
Jin-Hua Liang ◽  
Li Wang ◽  
Lei Fan ◽  
Hua-Yuan Zhu ◽  
...  
Keyword(s):  
T Cell ◽  
Conflicts Of Interest ◽  
Cell Lymphoma ◽  
Elevated Serum ◽  
Early Death ◽  
T Cell Lymphoma ◽  
Advanced Stage ◽  
Newly Diagnosed ◽  
Muscle Involvement ◽  
Nk T Cell

Abstract Objective: Determine efficacy and safety of PEMD (pegaspargase, etoposide, methotrexate, dexamethasone) in persons with newly-diagnosed advanced-stage extra-nodal NK/T-cell lymphoma. Subjects and methods: Twenty-seven consecutive subjects with newly-diagnosed advanced-stage (stage III-IV) extra-nodal NK/T-cell lymphoma were prospectively studied from July, 2010 to August, 2015. All subjects received PEMD (methotrexate, 3.0 g/m2 IV over 6 h on day 1, etoposide, 100 mg/m2 IV on days 2-4, dexamethasone, 40 mg IV on days 1-4 and pegaspargase, 2500 U/m2 IM on day 2). Courses were given every 3 week. Primary co-endpoints were response and survival. Secondary endpoints were proportion of subjects completing planned therapy (4 to 6 cycles of PEMD regimen) and frequencies of adverse events. Results: Median age was 46 y (range, 17-73 y). There were 21 males (78%). Nine subjects (33%) had non-nasal NK/T-cell lymphoma including 5 of the skin involvement, 1 of the testis involvement, 1 of the muscle involvement and 2 of the gastrointestinal tract involvement. Thirteen subjects (48%) had elevated serum LDH levels. Eleven subjects (41%) had higher level of EBV-DNA in blood (>5000 copies/mL). Twenty-one subjects (78%) had B-symptoms and 13 (48%) had an IPI score of 3-5. Subjects received a median of 4 courses of PEMD (range, 1-6). Median follow-up is 48 mo (range, 13-74 mo). Three patients had early death (within 3 mo after the diagnosis). Overall response rate (ORR) was 74% (95%CI 54%-89%) in the 27 subjects with advanced-stage disease including complete response (CR)/unconfirmed CR (CRu) in 12 (44% [95%CI 26%-65%]) and a partial response (PR) in 8 (30% [95%CI 14%-50%]). Four-year progression-free survival (PFS) was 44% (95%CI 25%-63%) and overall survival (OS) 51% (95%CI 32%-70%) (Figure 1). PFS and OS were not correlated between nasal and non-nasal types of ENKTL. There was no treatment-related death or serious allergic reactions. The most common grade-3/-4 hematologic complication was neutropenia (37% [95%CI 19%-58%]). The most common non-hematologic complications were infection (16% [95%CI 4%-34%]) and hypo-fibrinogenemia (12% [95%CI 2%-29%]). Conclusion: PEMD is effective and safe in persons with newly-diagnosed advanced-stage extra-nodal NK/T-cell lymphoma. Figure 1. PFS and OS for all the patients (N=27). Figure 1. PFS and OS for all the patients (N=27). Disclosures No relevant conflicts of interest to declare.

Phase II study of SMILE chemotherapy for newly-diagnosed stage IV, relapsed or refractory extranodal NK/T-cell lymphoma, nasal type: NKTSG study.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 8044-8044 ◽  
Author(s):  
M. Yamaguchi ◽  
Y. Kwong ◽  
Y. Maeda ◽  
C. Hashimoto ◽  
W. Kim ◽  
...  
Keyword(s):  
T Cell ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Stage Iv ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Nasal Type ◽  
Nk T Cell

scholarly journals CEOP/IVE/GDP Alternating Regimen Compared with CEOP As the First-Line Therapy for Newly Diagnosed Patients with Peripheral T-Cell Lymphoma: Results from a Phase 2, Multi-Center, Randomized, Controlled Clinical Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1556-1556 ◽  
Author(s):  
Mingci Cai ◽  
Shu Cheng ◽  
Wang Xin ◽  
Jianda Hu ◽  
Yongping Song ◽  
...  
Keyword(s):  
T Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Study Groups ◽  
T Cell Lymphoma ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Peripheral T Cell Lymphoma ◽  
Randomized Controlled

Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) or CHOP-like chemotherapy is widely used for treatment of peripheral T-cell lymphoma (PTCL). Given the poor response to CHOP-based regimens and the potential anti-lymphoma activity by alternating chemotherapy in PTCL, we conducted a phase 2, multi-center, randomized, controlled trial, comparing the efficacy and safety of CEOP/IVE/GDP alternating regimen with CEOP in a Chinese cohort of newly diagnosed patients with PTCL. Methods The primary endpoint of the study was the complete response rate (CRR). Patients with newly diagnosed PTCL, except for anaplastic large cell lymphoma (ALCL)- anaplastic lymphoma kinase (ALK) positive, were 1:1 randomly assigned. Patients in the CEOP/IVE/GDP group received intravenous cyclophosphamide 750 mg/m², epirubicin 70 mg/m², and vincristine 1.4 mg/m² (up to a maximum of 2 mg) on day 1, and oral prednisone 60 mg/m2 (up to a maximum of 100 mg) on day 1-5 every 21 days, at the 1st and 4th cycle with CEOP. Intravenous ifosfamide 2000 mg/m2 on day 1-3, epirubicin 70 mg/m2 on day 1, and etoposide 100 mg/m2 on day 1-4 every 21 days, at the 2nd and 5th cycle with IVE. Intravenous gemcitabine 1000 mg/m² on day 1, and 8, cisplatin 25 mg/m² on day 1-3, and dexamethasone 40mg on day 1-4 every 21 days, at the 3rd and 6th cycle with GDP, for a total of 6 cycles. Patients in the CEOP group received standard CEOP regimen every 21 days for 6 cycles. Analysis of efficacy and safety was of the intent-to-treat population. The study was registered with ClinicalTrials.gov, number NCT02533700. Findings Between Sep 22, 2015 and Sep 23, 2018, 102 patients were randomly assigned to two treatment groups: 51 each to the CEOP/IVE/GDP and the CEOP group. One patient was excluded because of the change of diagnosis and 3 patients withdrew informed consent before treatment in both study groups. 49 patients in the CEOP/IVE/GDP group and 49 patients in the CEOP group were included into efficacy and safety analysis as intent-to-treatment population. CRR at the end of treatment (EOT) in the CEOP/IVE/GDP group was similar as the CEOP group (36.7% vs. 32.7%, OR 0.84, 95% CI 0.36-1.88; p=0.835), while overall response rate (ORR) at EOT was higher in the CEOP/IVE/GDP group (73.5% vs. 51.0%, OR 0.38, 95% CI 0.17-0.86; p=0.037). There was no difference in median progression-free survival (15.4 months [95% CI 9.8-21.1] vs 10.7 months [4.5-16.8]; HR 0.73, 95% CI 0.45-1.18; p=0.20) or overall survival (24.3 months [95% CI 17.0-31.6] vs 21.9 months [7.5-36.2]; HR 0.69, 95% CI 0.41-1.17; p=0.17) between the CEOP/IVE/GDP and the CEOP group. Grade 3-4 hematological and non-hematological adverse events were similar between two study groups. Interpretation CEOP/IVE/GDP regimen showed similar CRR at EOT as CEOP regimen in PTCL. Nevertheless, CEOP/IVE/GDP increased ORR at EOT and could potentially bridge more patients to hematopoietic stem cell transplantation. Disclosures No relevant conflicts of interest to declare.

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