scholarly journals Phase II trial of concurrent chemoradiotherapy with L-asparaginase and MIDLE chemotherapy for newly diagnosed stage I/II extranodal NK/T-cell lymphoma, nasal type (CISL-1008)

Oncotarget ◽  
2016 ◽  
Vol 7 (51) ◽  
pp. 85584-85591 ◽  
Author(s):  
Dok Hyun Yoon ◽  
Seok Jin Kim ◽  
Seong Hyun Jeong ◽  
Dong-Yeop Shin ◽  
Sung Hwa Bae ◽  
...  
Keyword(s):  
T Cell ◽  
Phase Ii ◽  
Concurrent Chemoradiotherapy ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Stage I ◽  
Newly Diagnosed ◽  
Nasal Type ◽  
Nk T Cell

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

Preliminary Results Of Treatment Extranodal NK/T-Cell Lymphoma, Nasal Type Stage I-II AT K Hospital

2020 ◽  
Author(s):  
Linh Phan Van
Keyword(s):  
T Cell ◽  
Partial Response ◽  
Concurrent Chemoradiotherapy ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Stage I ◽  
Female Ratio ◽  
Nasal Type ◽  
Results Of Treatment ◽  
Nk T Cell

Background: Extranodal NK/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma, origin from natural killer (NK) cells and T cells. This is a rare, fast-growing and poor prognosis disease. Currently there have been not many studies in Vietnam on this issue. We conduct this research with two objects: to describe characteristics of patients and evaluate premininary results of treatment extranodal NK/T cell lymphoma, nasal type, stage I to II at K hospital. Methods: Retrospective study. From January 2017 to June 2020, we enrolled 26 patients with extranodal NK/T cell lymphoma, nasal type, stage I to II. Patients were treated concurrent chemoradiotherapy with cisplatin, followed by 3 cycles of VIPD adjuvant regimen. Results: Patient characteristics: The average age was 43.2. Male/female ratio was 1.36. The most common symptoms were stuffy of nose 84.6%; runny nose 65.4%. Peripheral lymph nodes observed in 19.2%; 50% with B symptom. Staged I was dominated with 73.1%. Treatment results: Concurrent chemoradiotherapy phase: completed response was 26.9%, partial response 53.8% and progression disease 19.2%. At the end of treatment course, the overall response rate was 73% (including 61.5% completed response and 11.5% partial response), 26.9% cases with disease progression. Toxicity: Leukopenia was the most common toxicity (61.1%). Grade III and IV leukopenia were observed in 18.4%. Conclusions: Concurrent chemoradiotherapy followed by adjuvant VIPD regimen with stage I, II is effective regimen and acceptable toxicity.

A phase II trial of bevacizumab-GemAOD regimen for newly diagnosed extranodal NK/T cell lymphoma.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 7564-7564
Author(s):  
Zhiming Li ◽  
Yu Wang ◽  
Jia Jia Huang ◽  
Tian Xiao Gao ◽  
Ke Wu ◽  
...  
Keyword(s):  
T Cell ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Nk T Cell

scholarly journals A Phase II Study of MESA Chemotherapy for Newly Diagnosed, Relapsed or Refractory Extranodal Natural Killer (NK)/T-Cell Lymphoma, Nasal Type: A Multicenter Trial of Northern-West of China

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3945-3945
Author(s):  
Rong Liang ◽  
Gao Guangxun ◽  
Chen Jie Ping ◽  
Jishi Wang ◽  
Xiao min Wang ◽  
...  
Keyword(s):  
T Cell ◽  
Natural Killer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Nasal Type ◽  
Nk T Cell ◽  
Grade 3

Abstract Purpose/Background: The nasal type of extranodal natural killer NK/T-cell lymphoma (NKTCL) is a rare aggressive lymphoma with poor prognosis. There is currently no standard treatment. To explore a more effective and feasible treatment for newly diagnosed, relapsed, or refractory NKTCL, we conducted a phase II study of the steroid (Methotrexate, etoposide, dexamethasone, Polyehylene glycol-asparaginase, MESA) regimen and investigated its efficacy and toxicity. Patients and Methods: Patients with newly diagnosed, relapsed, or refractory disease were treated in 5 medical centers. The performance status of 0 to 2 were eligible. At least three cycles of MESA chemotherapy + radiotherapy (RT) + three cycles of MESA chemotherapy were administered as the protocol treatment. The primary endpoints were the complete response (CR) rate, partial response (PR), the overall response rate (ORR), and toxicities. Secondary endpoints were overall survival (OS) and progression-free survival (PFS) rate. Results: A total of 46 eligible patients were enrolled. The median age was 46.1 years (range, 16 to 54 years), and the male: female ratio was 36:10. Among the 35 new diagnosed patients with first-line MESA treatment, the CR/PR at 1 cycle, 2 cycle and 3 cycle was 42.4%/55.9%, 46.9%/50% and 64%/32%, respectively; The ORR was 97.1%, 93.9% and 92.3%. Among 11 relapsed or refractory patients with second-line MESA, the CR/PR at 1 cycle, 2 cycle and 3 cycle was 9.1%/90.9%, 20%/80% and 22.2%/55.6%, respectively; The ORR was 100%, 90.9% and 77.8%. For 35 new diagnosed patients , the 0.5 year, 1 year, 1.5 year, 2 year-OS/PFS was 88.6%/75%, 90%/80%, 92.9%/92.9%, 100%/85.7%, respectively. For 11 relapsed or refractory patients, the 0.5 year, 1 year, 1.5 year, 2 year-OS/PFS was 100%/2.17%, 91.7%/8.7%, 40%/4.3%, 0%/0%, respectively. For 8 advance (IV stage newly diagnosed) NKTCL and 8 relapsed/refractory NKTCL, CR rate was 37.5%(n=6) after 3 cycle MESA, which was less than that of other studies such as SMILE and GELA/GOELAMS. However, PR rate 56.3%(n=9),ORR 93.8%(n=15) and 2y OS rate 81.3%(n=13) were higher than that of other studies. It was showed that different stages had different CR rate and PFS rate. However, the OS had no difference. it was also showed that patients with Ki67≥60% had lower 3 cycle-CR rate and 1 year OS/PFS rate than that of Ki67<60%. Grade 1 and 2 toxicities were frequent during MESA treatment. 4 patients developed grade1/2hypofibrinogenemia. 6 patients experienced grade 3 leukopenia or thrombocytopenia and 3 patients suffered from severe infection. 13 patients had a grade 1/2 abnormal liver function and 1 patient had grade 3 without delay in chemotherapy. Pegaspargase was well tolerated in all of them. No patient developed grade 4 adverse effects. There were no treatment-related deaths. Conclusion: The initial results of MESA chemotherapy for aggressive newly diagnosed, relapsed or refractory NKTCL this type of lymphoma were very encouraging with high effect and safety. These results will require further investigation in larger prospective trials. Disclosures No relevant conflicts of interest to declare.

scholarly journals Final Report on Phase II Trial of L-Asparaginase Plus Concurrent Chemoradiotherapy Followed By Midle (Methotrexate, Ifosfamide, Etoposide, Dexamethasone, and L-asparaginase) Chemotherapy for Patients with Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma, Nasal Type

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3942-3942
Author(s):  
Dok Hyun Yoon ◽  
Seok Jin Kim ◽  
Seong Hyun Jeong ◽  
Dong-Yeop Shin ◽  
Sung Hwa Bae ◽  
...  
Keyword(s):  
T Cell ◽  
Concurrent Chemoradiotherapy ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Complete Response ◽  
T Cell Lymphoma ◽  
Stage I ◽  
Nasal Type ◽  
Nk T Cell ◽  
Grade 3

Abstract Background We previously have shown that concurrent chemoradiotherapy (CCRT) followed by chemotherapy such as VIPD (etoposide, ifosfamide, cisplatin and dexamethasone) or VIDL (etoposide, ifosfamide, dexamethasone and L-asparaginase) is an effective treatment for the management of localized extranodal NK/T-cell lymphoma (ENKTL), nasal type. To further improve efficacy, we designed a new treatment protocol, MIDLE (methotrexate, ifosfamide, dexamethasone, L-asparaginase and etoposide), which incorporates tri-weekly administration of L-asparaginase during CCRT to reduce the probability of systemic progression and high dose methotrexate to intensify chemotherapy based on previous excellent outcomes of methotrexate-containing regimens such as SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, etoposide) and MLD (methotrexate, L-asparaginase, dexamethasone). Methods The treatment scheme of CCRT consisted of radiation 36-45 Gy and weekly administration of cisplatin 30 mg/m2 (total: 4 doses). During the CCRT, tri-weekly 4,000 IU of Escherichia coli L-asparaginase was administered intravenously (IV). The chemotherapy, MIDLE (methotrexate 3 g/m2 on day 1, etoposide 100 mg/m2, Ifosfamide 1000 mg/m2 on day 2-3, dexamethasone 40mg on day 1-4, and L-asparaginase 6000 IU/m2 IV on day 4, 6, 8, 10) was repeated every 28 days for two cycles. All patients provided informed written consents and this trial was registered at www.ClinicalTrials.gov(NCT01238159). Results Twenty-eight patients with stage IE/IIE ENKTL were enrolled, and the median age was 51 years (range, 30-77 years). Twenty four patients were male while only four patients were female. Twenty-two patients had stage IE and six IIE disease. Twenty four were classified as low risk group and the other four intermediate group according to PINK-E (Kim SJ et al., EHA 2015 S110). All but two patients completed CCRT, which resulted in 85.7% of overall response rate including 16 complete responses (57.1%) and 8 partial responses (28.6%). One showed stable disease (SD) and the other one showed progressive disease (PD) with development of new distant lymph node involvement after CCRT. Grade 3 or 4 hematologic toxicity was not common. Only two patients experienced G3 neutropenia during or after CCRT. However, grade 3 non-hematologic toxicities were noted including bilirubin elevation (n = 3), mucositis (n = 1), anorexia (n=5) and nausea/vomiting (n = 11) Two could not complete CCRT according to the protocol due to G3 allergic reaction to L-asparaginase (n=1) and prolonged G3 mucositis (n=1). After the completion of CCRT, 23 out of 28 patients entered the MIDLE chemotherapy as five patients including one disease progression and four withdrawal during (n=2) or after (n=2) CCRT due to toxicities. All those who completed the planned two cycles of MIDLE chemotherapy achieved complete response after chemotherapy including those with PR (n=6) and SD (n=1) after CCRT. Three patients dropped out during or after their first cycle of MIDLE due to non-hematologic toxicities (recurrent G3 bilirubinemia (n=1), G3 increased creatinine (n=1), G5 infection (n=1)). The final complete response rate was 82% (23/28). It was associated with a significant rate of grade 3/4 neutropenia (n=21) and febrile neutropenia (n=10). Two patients experienced acute kidney injury (AKI) during the first cycle of MIDLE and one of them died of pneumonia complicated by sepsis. With a median follow-up of 46 months (95% confidence interval: 39 - 47 months), four patients progressed and five patients died with the estimated 3-year progression-free survival rate of 74.1% and overall survival rate of 81.5%. PINK-E could successfully stratify both time-to-progression (p=003) and overall survival (p=0.006) in this study. Conclusion L-asparaginase plus concurrent chemoradiotherapy followed by MIDLE chemotherapy may be an effective treatment strategy for stage I/II extranodal NK/T-Cell lymphoma, nasal type. However, higher numbers of patients were withdrawn during or after CCRT due to toxicity or poor tolerance than previous study. MIDLE chemotherapy was associated with high rate of G3 or 4 hematologic toxicities. Thus, this approach should be reserved for selected patients such as young fit but high risk of relapse. PINK-E can be a useful prognostic index for stage I/II extranodal NK/T-Cell lymphoma, nasal type. Disclosures No relevant conflicts of interest to declare.

A Prospective Phase II Trial of An L-Asparaginase Containing Regimen in Patients with Refractory or Relapsing Extra Nodal NK/T-Cell Lymphoma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 579-579 ◽  
Author(s):  
Arnaud Jaccard ◽  
Nathalie Gachard ◽  
Paul Coppo ◽  
Franck Morschhauser ◽  
Lionel Galicier ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Cell Transplant ◽  
Nasal Type ◽  
Prospective Phase ◽  
Nk T Cell

Abstract Extra nodal NK/T-cell lymphoma, nasal type, is an EBV-related highly aggressive disease with a poor outcome, especially when disseminated or recurrent after radiotherapy. L-Asparaginase seems to have a particular efficacy in this disease (Jaccard, 2008, Ann oncol). Nineteen patients with relapsing or refractory extra nodal NK/T-Cell Lymphoma, nasal type, were included in a multicentric prospective phase II trial using the Aspametdex regimen (E coli-L-asparaginase (Kidrolase®) 6000 UI/m2 IM at day 2,4,6,8, methotrexate 3 gr/m2 at day 1 and dexamethasone 40 mg at day 1 to 4 with 3 weeks cycles). Patients below 65 years of age and with a good performance status received 3 cycles and, in case of good response, an intensive treatment with the BEAM regimen and stem cell rescue. Other patients received up to 6 cycles of the Aspametdex protocol. Patients with localized disease received irradiation if not performed before inclusion. The histology was centrally reviewed and EBV viremia was regularly and centrally monitored. The response after 3 cycles was the primary end point. There were 14 men and 4 women (1 patient was excluded after pathologic review), median age was 59.5 (45 to 76), 7 were primary refractory, 11 were in relapse, 6 were in stage IV. Median number of cycles was 3 (1 to 6). Three patients who had an allergic reaction with L-asparaginase received further courses of Erwinia-asparaginase (Erwiniase®) (n= 3). Toxicity related to L-asparaginase was mild, mainly brief leucopenia (n=2), elevation of alanine aminotransferase (n=2) and venous thrombosis (n=1). Response was documented in 17/18 patients, 10 patients were in complete remission (CR) after treatment with L-asparaginase and 5 patients in partial remission. Five patients died of unrelated causes (n=1) or progression of disease (n=4). Thirteen patients are still alive with a median follow-up of 8 months (1 to 29), 5 responding patients progressed at 4, 5, 8, 8 and 22 months after treatment. Six patients are in persistent CR, 2 of these patients had received high dose therapy with autologous stem cell transplant and 1 patient received irradiation after L-asparaginase treatment. These data confirm the excellent activity of L-asparaginase-containing regimens in extranodal NK/T-cell lymphoma. This must be known because of the very poor prognosis of patients with disseminated or relapsing disease with conventional chemotherapy. First-line L-asparaginase combination therapy for extranodal NK/T-cell lymphoma should be tested in prospective trials.

Phase II Trial of Concurrent Radiation and Weekly Cisplatin Followed by VIPD Chemotherapy in Newly Diagnosed, Stage IE to IIE, Nasal, Extranodal NK/T-Cell Lymphoma: Consortium for Improving Survival of Lymphoma Study

2009 ◽  
Vol 27 (35) ◽  
pp. 6027-6032 ◽  
Author(s):  
Seok Jin Kim ◽  
Kihyun Kim ◽  
Byung Soo Kim ◽  
Chul Yong Kim ◽  
Cheolwon Suh ◽  
...  
Keyword(s):  
T Cell ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Early Stage ◽  
Survival Rates ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Nk T Cell ◽  
Experienced Grade

Purpose On the basis of the benefits of frontline radiation in early-stage, extranodal, natural killer (NK)/T-cell lymphoma (ENKTL), we conducted a phase II trial of concurrent chemoradiotherapy (CCRT) followed by three cycles of etoposide, ifosfamide, cisplatin, and dexamethasone (VIPD). Patients and Methods Thirty patients with newly diagnosed, stages IE to IIE, nasal ENKTL received CCRT (ie radiation 40 to 52.8 Gy and cisplatin 30 mg/m2 weekly). Three cycles of VIPD (etoposide 100 mg/m2 days 1 through 3, ifosfamide 1,200 mg/m2 days 1 through 3, cisplatin 33 mg/m2 days 1 through 3, and dexamethasone 40 mg days 1 through 4) were scheduled after CCRT. Results All patients completed CCRT, which resulted in 100% response that included 22 complete responses (CRs) and eight partial responses (PRs). The CR rate after CCRT was 73.3% (ie, 22 of 30 responses; 95% CI, 57.46 to 89.13). Twenty-six of 30 patients completed the planned three cycles of VIPD, whereas four patients did not because they withdrew (n = 2) or because they had an infection (n = 2). The overall response rate and the CR rate were 83.3% (ie; 25 of 30 responses; 95% CI, 65.28 to 94.36) and 80.0% (ie, 24 of 30 responses; 95% CI, 65.69 to 94.31), respectively. Only one patient experienced grade 3 toxicity during CCRT (nausea), whereas 12 of 29 patients experienced grade 4 neutropenia. The estimated 3-year, progression-free and overall survival rates were 85.19% (95% CI, 72.48 to 97.90) and 86.28% (95% CI, 73.97 to 98.59), respectively. Conclusion Patients with newly diagnosed, stages IE to IIE, nasal ENKTL are best treated with frontline CCRT.

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