Low Absolute Lymphocyte Count Predicts Chemotherapy Response and Survival In Peripheral T-Cell Lymphoma, NOS

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3135-3135
Author(s):  
Yu Ri Kim ◽  
yun Deok Kim ◽  
Jin Seok Kim ◽  
June-Won Cheong ◽  
soo Jeong Kim ◽  
...  
Keyword(s):  
T Cell ◽  
Prognostic Factor ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Prognostic Index ◽  
Independent Prognostic Factor ◽  
T Cell Lymphoma ◽  
Peripheral T Cell Lymphoma ◽  
Overall Response

Abstract Abstract 3135 Peripheral T cell lymphoma, not otherwise specified (PTCL, NOS) is heterogenous groups of aggressive T-cell lymphoma and treatment outcome is dismal. Lymphopenia is an independent prognostic factor for survival for B-cell lymphoma. The ALC at diagnosis on survival in T-cell lymphoma has not been studied. Thus, we studied the role of ALC at diagnosis on clinical outcome in patients with PTCL, NOS. Between 2001 and 2009, 32 patients with PTCL, NOS reviewed for the study. Median patient age was 57 (range 34–78) years. Median ALC at the time of diagnosis was 1.54 (range 0.41–12.64×109/L). Patients were divided two groups according to ALC count 1.0 ×109/L. Ten patients (31%) had lower ALC at diagnosis. Median follow up duration was 299 days (range 11–2164 days). Overall response rate was 61.5% (16 of 26 patients) and complete response (CR) rate was 42% (11 of 26 patients). Only two patients reached CR in low ALC group.There was no significant difference in overall response rate because of small number of patients. Superior overall survival was observed with an ALC 1.0 × 109/L (N = 22) versus an ALC < 1.0 × 109/L (N=10) (median OS: not reached vs 242 days, OS rates at 5 years, 57% vs 0%, p =0.016, respectively). Multivariate analysis demonstrated ALC to be an independent prognostic indicator for OS (Hazard Ratio 3.5, 95% confidence intervals 1.2–10.2; p<0.019) when compared to the International prognostic index (IPI) and Prognostic Index for PTCLU (PIT). This study suggested that low ALC is an independent prognostic factor for survival in patients with PTCL, NOS. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

2019 ◽  
Vol 37 (8) ◽  
pp. 613-623 ◽  
Author(s):  
Owen A. O’Connor ◽  
Muhit Özcan ◽  
Eric D. Jacobsen ◽  
Josep M. Roncero ◽  
Judith Trotman ◽  
...  
Keyword(s):  
T Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
T Cell Lymphoma ◽  
Phase Iii ◽  
Lower Percentage ◽  
Peripheral T Cell Lymphoma ◽  
Overall Response

PURPOSE The aim of this open-label, first-in-setting, randomized phase III trial was to evaluate the efficacy of alisertib, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). PATIENTS AND METHODS Adult patients with relapsed/refractory PTCL—one or more prior therapy—were randomly assigned 1:1 to receive oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m2 (once per week for 6 weeks; 7-week cycle), or intravenous gemcitabine 1,000 mg/m2 or intravenous romidepsin 14 mg/m2 (days 1, 8, and 15; 28-day cycle). Tumor tissue (disease subtype) and imaging were assessed by independent central review. Primary outcomes were overall response rate and progression-free survival (PFS). Two interim analyses and one final analysis were planned. RESULTS Between May 2012 and October 2014, 271 patients were randomly assigned (alisertib, n = 138; comparator, n = 133). Enrollment was stopped early on the recommendation of the independent data monitoring committee as a result of the low probability of alisertib achieving PFS superiority with full enrollment. Centrally assessed overall response rate was 33% for alisertib and 45% for the comparator arm (odds ratio, 0.60; 95% CI, 0.33 to 1.08). Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178). The most common adverse events were anemia (53% of alisertib-treated patients v 34% of comparator-treated patients) and neutropenia (47% v 31%, respectively). A lower percentage of patients who received alisertib (9%) compared with the comparator (14%) experienced events that led to study drug discontinuation. Of 26 on-study deaths, five were considered treatment related (alisertib, n = 3 of 11; comparator, n = 2 of 15). Two-year overall survival was 35% for each arm. CONCLUSION In patients with relapsed/refractory PTCL, alisertib was not statistically significantly superior to the comparator arm.

Lymphopenia Predicts Survival in Peripheral T-Cell Lymphoma, Unspecified.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1930-1930
Author(s):  
Brady Beltran ◽  
Domingo Morales ◽  
Pilar Quinones ◽  
Carlos Desposorio ◽  
Eduardo Sotomayor ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
T Cell ◽  
Prognostic Factor ◽  
Lymphocyte Count ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Independent Prognostic Factor ◽  
T Cell Lymphoma ◽  
Peripheral T Cell Lymphoma

Abstract Abstract 1930 Poster Board I-953 Background: Lymphopenia is an independent prognostic factor for survival for different hematological malignancies like follicular lymphoma, Hodgkin lymphoma and diffuse large B-cell lymphoma. The role of lymphopenia at diagnosis on survival in peripheral T-cell lymphoma, unspecified (PTCLU) is not known. Methods: Eighty seven patients with a diagnosis of PTCLU were evaluated at the Edgardo Rebagliati Martins Hospital in Lima, Peru from October 1997 until April 2008. The primary objective of the study was to assess the role of lymphopenia at diagnosis in survival in cases with PTCLU. Lymphocyte count at diagnosis was obtained from the standard complete blood cell count (CBC). Lymphopenia was defined as a lymphocyte count of less than 1 × 109/L. Kaplan-Meier survival estimates and the log-rank test were performed for univariate survival analyses and Cox proportion-hazard regression test was performed for the multivariate analysis. Results: Eighty four patients with a histological diagnosis of PTCLU were included in this study. The median follow-up was 13.4 months (range 1–68 months). The sample population included 54% males and 46% females with a median age of 57 years (range 18–87 years). The median number of lymphocytes at diagnosis was 1.3 × 109/L (range 0.06–5.2 × 109/L). Lymphopenia was present in 37% of cases. In the univariate analysis, lymphopenia was identified as a poor factor for survival (median OS 59 vs. 1 month; p<0.0001). In the multivariate analysis, lymphopenia was compared to the Prognostic Index for PTCLU (PIT) and it remained as an independent predictor for survival (Hazard Ratio 4.8, 95% confidence intervals 2.2–10.6; p<0.0001). Conclusion: This study demonstrates that lymphopenia is an independent prognostic factor for survival in patients with PTCLU, suggesting that the host immune system might play a preponderant role in survival in this group of patients. Disclosures: No relevant conflicts of interest to declare.

Update of the NCI multiinstitutional phase II trial of romidepsin, FK228, for patients with cutaneous or peripheral T-cell lymphoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8027-8027 ◽  
Author(s):  
R. Piekarz ◽  
R. Frye ◽  
J. Wright ◽  
W. Figg ◽  
S. Allen ◽  
...  
Keyword(s):  
T Cell ◽  
Histone Deacetylase Inhibitors ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
T Cell Lymphoma ◽  
Cell Transplant ◽  
Overall Response ◽  
Prior Therapy

8027 Background: The histone deacetylase inhibitors (HDIs) are a class of differentiating agents undergoing clinical testing. Like other HDIs, romidepsin (FK228) modulates expression of genes involved in cell cycle regulation and markers of differentiation in cancer cell lines, leading to induction of differentiation or apoptosis. Romidepsin has demonstrated clinical activity in patients with T-cell lymphoma. Methods: Patients with CTCL (42) or PTCL (36) were enrolled in the NCI multi-institutional trial and assigned to cohorts based on extent of prior therapy and pathology. Romidepsin is administered on days 1, 8, and 15 of a 28 d cycle with a starting dose of 14mg/m2. Responses for patients with PTCL are measured using Cheson criteria, and CTCL using RECIST criteria. Results: Cohort one, composed of 27 patients who had previously received no more than 2 prior cytotoxic regimens of chemotherapy, has completed enrollment. Responses observed include 3 patients with CR and 7 patients with partial responses, yielding an overall response rate of 37%. Of note, responses were observed independent of stage of disease. Among 18 patients with stage IV disease, 6 patients had a complete or partial response, including 3 patients with Sézary syndrome. When including patients with greater than 2 prior cytotoxic regimens, the overall response rate was 31%. A replicate arm has been opened with the goal of confirming the response rate observed in the first cohort. Response data have not been evaluated from this arm at this time. Responses observed in 36 patients with refractory or relapsed PTCL includes 3 patients with CR and 8 patients with partial responses, comprising an overall response rate of 30%. Responses were observed independent of prior therapy, with some patients having undergone prior stem-cell transplant. Molecular endpoint analysis was performed on peripheral mononuclear cells (PBMNCs) and tumor biopsies from treated patients evaluating histone acetylation and changes in gene expression. Conclusions: Romidepsin as a single agent appears to have significant single agent activity in patients with CTCL and PTCL. Combination therapy with romidepsin may increase efficacy and should be pursued. This protocol remains open to accrual. No significant financial relationships to disclose.

scholarly journals The mTORC1 inhibitor everolimus has antitumor activity in vitro and produces tumor responses in patients with relapsed T-cell lymphoma

Blood ◽  
2015 ◽  
Vol 126 (3) ◽  
pp. 328-335 ◽  
Author(s):  
Thomas E. Witzig ◽  
Craig Reeder ◽  
Jing Jing Han ◽  
Betsy LaPlant ◽  
Mary Stenson ◽  
...  
Keyword(s):  
T Cell ◽  
Antitumor Activity ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Mtor Pathway ◽  
T Cell Lymphoma ◽  
Overall Response ◽  
Key Points

Key Points The mTOR pathway is constitutively activated in the TCL cells and is responsible for TCL proliferation. This is first trial to demonstrate that mTORC1 inhibitors (everolimus) have substantial antitumor activity (44% overall response rate) in patients with relapsed TCL.

scholarly journals The Neutrophil-to-Lymphocyte Ratio Is Prognostic in Patients with Early Stage Peripheral T-Cell Lymphoma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5346-5346
Author(s):  
Brady E Beltran ◽  
Denise Castro ◽  
Rodrigo Motta ◽  
Sally Paredes ◽  
Jose M Malaga ◽  
...  
Keyword(s):  
T Cell ◽  
Prognostic Factor ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Early Stage ◽  
Prognostic Index ◽  
T Cell Lymphoma ◽  
Neutrophil To Lymphocyte Ratio ◽  
Peripheral T Cell Lymphoma ◽  
Lymphocyte Ratio

Abstract Introduction: Peripheral T-cell lymphoma (PTCL) encompasses a group of rare and aggressive lymphomas. PTCL, unspecified (PTCLU) is the most common subtype of PTCL, and carries a poor prognosis. The International Prognostic Index (IPI) and the Prognostic Index for PTCLU (PIT) scoring systems are powerful risk-stratification tools in patients with PTCL. The neutrophil-to-lymphocyte ratio (NLR) has shown to be prognostic in patients with advanced stage PTCLU (Beltran Leuk Lymphoma 2016). The aim of this study was to evaluate whether the NLR is a prognostic factor in patients with early stage PTCLU. Methods: We included patients with a pathological diagnosis of PTCLU who were diagnosed and treated at our institution between 2001-2016. We excluded cases with stage 3 or 4 disease. IRB approval was obtained prior to research. Pathological samples were reviewed by hematopathologists to confirm the diagnosis. Pertinent clinicopathological data were collected through chart review, and are presented using descriptive statistics. The NLR was calculated by dividing the neutrophil by the lymphocyte count, and dichotomized in NLR>=4 and NLR<4. Survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. Univariate Cox models were fitted to evaluate hazard ratios (HR) for overall survival (OS). Results: 48 patients with a diagnosis of early stage PTCL were included in this analysis. Histologically, 40 patients (83%) were PTCL, unspecified, 7 (15%) were anaplastic large cell lymphoma, and 1 (2%) was enteropathy-associated T-cell lymphoma. The median age at diagnosis was 60 years (range 18-83 years) with a slight male predominance (82%). Clinically, 49% of patients were 60 or older, 34% presented with ECOG>1, 36% with elevated LDH, and 65% with extranodal disease; 44% had stage II and 56% had stage I disease. No patient had bone marrow involvement. 30% of patients presented with high/high-intermediate IPI score and 34% with high/high-intermediate PIT score. 27% of patients had a NLR >=4. There were no differences in age, LDH levels, extranodal involvement and stage between NLR>=4 and NLR<4. There was a trend towards worse ECOG performance status in NLR>=4 patients (p=0.06). The 3- and 5-year OS rates were 67% (95% CI 50-80%) and 52% (95% CI 29-71%), respectively. High/high-intermediate IPI score was associated with a worse outcome (HR 4.9, 95% CI 1.7-14.2; p=0.004), as well as high-high-intermediate PIT score (HR 3.9, 95% CI 1.2-12.7; p=0.03). According to NLR, NLR>=4 patients had a higher risk of death (HR 9.9, 95% CO 3.2-30.1; p<0.001). In a multivariate analysis adjusting for IPI and PIT scores, NLR>=4 was the only independent factor associated with a worse survival (HR 6.2, 95% CI 1.9-20.9; p=0.003). Conclusion: The NLR appears as a novel and easy to use prognostic factor for OS in previously untreated patients with early-stage PTCL. Our findings support the need for validation of the NLR in larger retrospective or prospective studies in patients with PTCL. Disclosures Castillo: Otsuka: Consultancy; Pharmacyclics: Honoraria; Abbvie: Research Funding; Millennium: Research Funding; Janssen: Honoraria; Biogen: Consultancy.

The neutrophil-to-lymphocyte ratio is an independent prognostic factor in patients with peripheral T-cell lymphoma, unspecified

2015 ◽  
Vol 57 (1) ◽  
pp. 58-62 ◽  
Author(s):  
Brady E. Beltran ◽  
Christian Aguilar ◽  
Pilar Quiñones ◽  
Domingo Morales ◽  
Julio C. Chavez ◽  
...  
Keyword(s):  
T Cell ◽  
Prognostic Factor ◽  
Cell Lymphoma ◽  
Independent Prognostic Factor ◽  
T Cell Lymphoma ◽  
Neutrophil To Lymphocyte Ratio ◽  
Peripheral T Cell Lymphoma ◽  
Lymphocyte Ratio

Fasting Blood Glucose As Prognostic Factor In Peripheral T-Cell Lymphoma: A Study Of 250 Cases

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5080-5080
Author(s):  
Brady E Beltran ◽  
Jorge J Castillo
Keyword(s):  
Blood Glucose ◽  
T Cell ◽  
Prognostic Factor ◽  
Who Classification ◽  
Cell Lymphoma ◽  
Fasting Blood Glucose ◽  
Prognostic Index ◽  
T Cell Lymphoma ◽  
Peripheral T Cell Lymphoma ◽  
Anaplastic Lymphoma

Abstract Background Peripheral T-cell lymphoma (PTCL) is a heterogeneous familyof entities with a worse prognosis, stage by stage, than theirB-cell counterparts. Fasting blood glucose (FBG) level at diagnosis has recently been described as a novel, independent prognostic factor for survival in patients with extranodal natural killer/T-cell lymphoma (NKTCL). The goal of this study is to retrospectively investigatethe prognostic value of FBG at lymphoma diagnosis in the survival of patientswith PTCL. Methods A total of 250 cases of aggressive, non-primary cutaneous PTCLdiagnosed at our institution between January 1997 and December 2012 were reviewed,reevaluated according to their morphological, immunologicaland clinical characteristics, and reclassified according tothe 2008 WHO classification of lymphoid neoplasms. Characteristics are presented descriptively. For the evaluation of FBG, patients were divided in 2 categories; those patients with an FBG at diagnosis >100 mg/dl (hyperglycemia) and those with an FBG at diagnosis <100 mg/dl (normoglycemia). Overall survival (OS) was defined as the time elapsed between lymphoma diagnosis and death or last follow-up. The Kaplan-Meiermethod was used to estimate OS curves, which were then comparedusing the log-rank test. P-values less than 0.05 were considered statistically significant. Results According to the new WHO classification, 104 cases (41%) were classified as adult T-cell leukemia/lymphoma (ATLL), 103 cases (41%) as PTCL, unspecified (PTCLU), 26 cases (11%) as anaplastic lymphoma kinase (ALK)-negative anaplastic large cell lymphoma (ALCL), 10 cases (4%) as extranodal NKTCL, nasal type, 4 cases (2%) as angioimmunoblastic lymphoma (AIL), 2 cases (1%) as ALK-positive ALCL, and 1 case (0.4%) as hepatosplenic T-cell lymphoma. The median age at diagnosis was 57 years (range 14-92 years); 47% of patients were >60 years. The male-to-female ratio was 1:1. ECOG performance status >1 was seen in 51%, LDH was elevated in 67%, advanced stage was seen in 73%, and >1 extranodal sites were seen in 22% of the patients. Bone marrow involvement was reported in 30% and B symptoms in 64% of patients. FBG >100 mg/dl was seen in 34% and FBG <100 mg/dl in 66%. An International Prognostic Index (IPI) score 3-5 was seen in 52%, and a Prognostic Index for PTCLU (PIT) score of 2-4 in 62%.  Response evaluation was performed only in patients who received chemotherapy (n=161). The overall response rate (ORR) was 47% (n=76) with complete response (CR) in 32% (n=52) and partial response (PR) in 15% (n=24). FBG was no associated with ORR or CR (p=0.25 and p=0.43, respectively. We then evaluated FBG separately in patients with ATLL and PTCL except ATLL. In ATLL patients, the median OS was 8 months with a 3-year OS of 33%. In PTCL patients, the median OS was 17 months with a 3-year OS of 49%. FBG >100 appeared as an adverse prognostic factor only in PTCL patients with a median OS that was not reached vs. 27 months in patients with FBG <100 mg/dl (Figure; log-rank p=0.035). No difference was seen in patients with ATLL; patients with FBG >100 mg/dl has a median OS of 16 months vs. 18 months in patients with FBG <100 mg/dl (log-rank p=0.95). Conclusions Based on the results of our single-center retrospective study, FBG >100 mg/dl appears as a prognostic factor in PTCL but not in patients with ATLL. Additional studies are needed to investigate the role of hyperglycemia in patients with PTCL, and to evaluate if controlling hyperglycemia during therapy could improve the survival on such patients. Disclosures: No relevant conflicts of interest to declare.

Prognostic Value of Platelet Count in Patients with Peripheral T Cell Lymphoma

2019 ◽  
Vol 141 (3) ◽  
pp. 176-186 ◽  
Author(s):  
Mihong Choi ◽  
Jeong-Ok Lee ◽  
Jongheon Jung ◽  
Ji Yun Lee ◽  
Eunyoung Lee ◽  
...  
Keyword(s):  
Platelet Count ◽  
T Cell ◽  
Prognostic Factor ◽  
Cox Regression ◽  
Cell Lymphoma ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
T Cell Lymphoma ◽  
Peripheral T Cell Lymphoma ◽  
Poor Prognostic Factor

Background: Peripheral T cell lymphoma (PTCL) is a heterogeneous entity with poor survival. We evaluated the neutrophil-to-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and platelet count as new prognostic factors for PTCL. Patients and Methods: We retrospectively analyzed 77 patients with PTCL initially treated with anthracycline-based chemotherapy. Survival curves were compared between groups with different initial NLR (iNLR), end-point NLR (eNLR), initial ALC, and platelet counts. Cox regression was used to analyze the risk factor for survival. Results: Patients with a higher eNLR (≥3), lymphopenia (< 1,000/μL), and thrombocytopenia (< 150 K/μL) had an inferior progression-free survival (PFS) and overall survival (OS) compared to their counterparts, while a higher iNLR (≥3) was predictive of a shorter OS but not PFS. Among these, thrombocytopenia was an independent poor prognostic factor for both PFS and OS, with a hazard ratio of 2.42 (p = 0.012) for PFS and 4.21 (p = 0.006) for OS. The presence of thrombocytopenia further stratified patients with a worse prognosis within overlapping risk-groups by the prognostic index for PTCL. Conclusions: Our study showed that thrombocytopenia at diagnosis was an independent prognostic factor for survival in patients with PTCL.

scholarly journals Efficacy and Survival in Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized, Controlled, Multicenter and Open-Labled Study with Ddgp Regimen Versus SMILE Regimen

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 463-463 ◽  
Author(s):  
Xinhua Wang ◽  
Lei Zhang ◽  
Xiangli Liu ◽  
Xin Li ◽  
Ling Li ◽  
...  
Keyword(s):  
Overall Survival ◽  
T Cell ◽  
Overall Response Rate ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
Overall Response

Background Extranodal NK/T cell lymphoma (ENKTL) is rare in western countries but rather common in Asia and South America, characterized with Epstein-Barr virus (EBV) infection. Patients with advanced stage (III/IV) ENKTL has a poor survival and low response to conventional CHOP-like chemotherapy, with a 5-year overall survival rate of only 30%. Retrospective study showed that SMILE regimen had a certain effect on ENKTL, but the toxicity limited its further clinical application. More effective treatment regimens are required to be explored for systematic, prospective, controlled, randomized clinical trials. Recently, studies revealed that asparaginase-based combination chemotherapy such as P-Gmox(Pegaspargase, Gemcitabine, Oxaliplatin)is effective in patients of ENKTL. However standard treatment for newly untreated advanced ENKTL is still controversial. We developed a refined chemotherapeutic DDGP (dexamethasone, cisplatin, gemcitabline, and peg-asparaginase) regimen and proceeded a prospective randomized, multicenter and open-label clinical trial to evaluate and compare the efficacy and safety of DDGP with SMILE regimen in patients with newly diagnosed stage III/IV ENKTL in January 2011. Based on the encouraging interim results in 2016(Li, L et al.Clin Cancer Res, 2016), we presented the final results of this clinical investigation (ClinicalTrials.gov, No. NCT01501149). Patients and methods: The study was initiated at 9 centers in China in January 2011. Patients aged 14-70 with newly diagnosed ENKTL in stages III/IV, and ECOG performance score of 0-2 were enrolled. According to a computer-generated randomization schedule, eligible patients were assigned either DDGP regimen (cisplatin 20 mg/m² on day 1-4; dexamethasone 15mg/m2 on d1-5; gemcitabine 800mg/m2 on d1,8; pegaspargase 2500 IU/m2 on d1; 21 days per cycle)or SMILE regimen (methotrexate 2g/m2 on d1; dexamethasone 40mg/m2 on d2-4; ifosfamide 1500mg/m2 on d2-4; L-asparaginase 6000 U/m2 on d3-9; etoposide 100 mg/m2 on d2-4; 21 days per cycle) for up to 6 cycles unless disease progression, unacceptable toxicity or patient rejection. Efficacy was evaluated every two cycles. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall response rate (ORR) and overall survival (OS). In addition we compared the safety and tolerability between DDGP and SMILE regimens. The Kaplan-Merier method was used to evaluate for survival of freedom from events, and the log-rank test was used to evaluate differences among two groups. Results: A total of 87 eligible newly diagnosed advanced ENKTL patients were randomly assigned for the study and 80 patients were included into intention-to-treat population (40 patients in DDGP group and 40 patients in SMILE group). Data were collected from January 2011 to February 2019. Baseline characteristics of the two group patients were well balanced. At median follow-up of 41.5 months, the median PFS and OS in the SMILE group were 6.83 months and 75.2 months, respectively, while the median PFS and OS in the DDGP group have not been reached (Fig 1). The 3-year PFS rate and 5-year OS rate in DDGP group were higher than in SMILE group (56.6% vs. 41.8% for 3-year PFS, P=0.004; 74.3% vs. 51.7% for 5-year OS, P=0.02). No difference of the complete remission (CR) rate was observed between two groups, while overall response rate (ORR) in DDGP group was higher than in SMILE group (90.0% vs. 60.0%, p=0.002) (Table 1). More frequently 3/4 grade hematologic toxicities such as leucopenia and netropenia were observed in SMILE group than in DDGP group (p=0.022, p=0.015). Non-hematologic toxicities included elevated transaminase, mucositis and allergy were higher in SMILE group than in DDGP group(p=0.027, p&lt;0.001, p=0.024). Pancreatitis occurred in 2 patients in SMILE group, but not in DDGP group (Table 2). In addition, treatment-related deaths rate was up to 17.5% in SMILE regimen which was mainly caused by infection and hemorrhage due to bone marrow suppression. Such event was only 10% in DDGP regimen. Conclusion: DDGP regimen produced prolonged survival, better tolerability and safety than SMILE regimen in newly diagnosed advanced ENKTL. Disclosures No relevant conflicts of interest to declare.

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