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Intruduction Extranodal natural killer/T-cell lymphoma (ENKTL) is an uncommon, aggressive form of non-Hodgkin's lymphoma. Optimal therapeutic strategies have not been fully defined yet. Nasal NK/T-cell lymphomas present mostly with stage I/II disease. For stage I/II nasal lymphoma, a combination of chemotherapy and radiotherapy yields optimal results. Concomitant chemoradiotherapy and sequential chemotherapy and radiotherapy give similar response rates and survivals. For stage III/IV nasal, nonnasal, and disseminated ENKTL, systemic chemotherapy is indicated. Conventional anthracycline-based regimens are ineffective. Regimens containing L-asparaginase are most effective. Both AspaMetDex and P-Gemox is recommended as major effective combined chemotherapy regimen by NCCN guideline. Therefore, we try to evaluate the efficacy and toxicity for P-Gemox plus thalidomide and AspaMetDex followed by extensive involved field radiotherapy (EIFRT) as first-line treatment for newly diagnosed stage I/II patients and as salvage regimen for newly diagnosed stage III/IV or relapsed/refractory ENKTL in this clinical study. Methods We initiated a prospective, multicentre, randomized, phase II clinical trial at 12 centers in China at March 2014. Patients were randomly assigned to receive either P-Gemox+thalidomide regimen (Group A: Pegaspargase 2000U/m2; im d1, Gemcitabine 1000mg/m2; ivdrip , d1, d8. Oxaliplatin 130mg/m2; ivdrip, d1, thalidomide 100mg/d po, for one year.) or AspaMetDex regimen ( Group B: Pegaspargase 2000U/m2; im, d1, Methotrexate 3000mg/ m2; civ 6-hour, d1, calcium folinate 30mg iv, q6h, until reach safe serum MTX concentration, Dexamethasone 40mg/d ivdrip, d1-4.). For newly diagnosed stage I/II patients, both regimens were repeated every three weeks for a maximum four cycles as induction chemotherapy and followed by EIFRT at the dosage of 56Gy in 28 fractions over 4 weeks. Primary EIFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformal treatment planning. For newly diagnosed stage III/IV or relapsed/refractory ENKTL, the regimens were repeated every three weeks for a maximum six cycles. Patients underwent autologous hematopoietic stem cell transplantation (ASCT) as consolidation if they achieved response (complete remission,CR or partial remission,PR). The primary endpoint was progression-free survival(PFS). Results Between March 2014 and March 2018, 165 patients were randomly assigned. 85 patients to Group A, 80 patients to Group B. 156 patients were evaluable for response. Investigator-assessed overall response at the end of induction was 88.2% in the Group A and 75.0% in the Group B. Complete remission (CR) rate were 60.0% and 55.0%. Among 107 newly diagnosed stage I/II patients, 54 patients were assigned to Group A (52 assessed), and 53 to Group B (47 assessed). Overall response during induction in Group A and B was similar in both groups, were 64.8% and 64.2%. 58 newly diagnosed stage III/IV or relapsed refractory patients were enrolled. 31 patients were assigned to Group A (30 assessed), and 27 to Group B. The efficacy rate of Group A was higher than that of Group B. Overall response rate were 87.1% and 66.6%, respectively. At median follow-up of 24.6 (1.0-60.9)months, 3-year progression-free survival (PFS) and overall survival (OS) of whole cohort were 61.4% and 63.4%. PFS and OS rate of Group A were similar to Group B(Figure 1). Group B was better tolerated than Group A, with lower rates of agranulocytosis, thrombocytopenia and infections. While anemia,hyperbilirubinemia, edema, and increased BUN/Cr were more common in Group B. Three patients died of treatment related toxicity only in Group B . Two patients died of severe acute renal failure and sepsis at the first cycle, and one patient died of sepsis at the third cycle. CONCLUSION: Induction chemotherapy of both P-Gemox+Thalidomide and AspaMetDex regimen followed by EIFRT yielded promising efficacy for patients with stage I/II ENKTL. There is little difference therapeutic effect between the two regimens. For advanced or relapsed patients, both regimen showed unsatisfied survival outcome. Meanwhile, P-Gemox+ Thalidomide was less toxic with more convenient administration in outpatients clinics in comparison to AspaMetDex. ( ClinicalTrials.gov, NCT 2085655 ). Disclosures Li: Guangdong Province Hospital: Employment.

Backgroud and Purpose: Extranodal natural killer/T-cell lymphoma (ENKTL) is an uncommon, aggressive form of non-Hodgkin's lymphoma. Optimal therapeutic strategies have not been fully defined yet. We reported the outcome of P-Gemox for the treatment of chemotherapy-naïve, refractory ENKTL in 2013 ASH meeting at the first time. Although several clinical trials have demonstrated the efficacy and tolerability of P-Gemox, we collected and anlyzed the real-world data of P-Gemox in Chinese patients with ENKTL. Patients and methods All cases with ENKTL from 2008 to 2017 were analyzed retrospectively P-Gemox were as follows: gemcitabine 1000 mg/m2; day 1,8; oxaliplatin 130 mg/m2 day 1, pegaspargase 2000-2500 U/m2 im day1. The regimen was repeated every 3 weeks. For newly diagnosed stage I/II patients, P-Gemox regimen was administered as induction chemotherapy for 4-6cycles and followed by involved-field radiotherapy or with"sandwiched" radiotherapy/chemotherapy. Furthermore autologous haematopoietic stem cell transplantation (ASCT) was recommended to chemo-sensitive refractory/relapsed patients as consolidation. All patients come to hospital regularly. Results: 267 patients with ENKTL were treated at the 10 institutions, in the department of Oncology or hematology in China between 2008 and 2017. Patient characteristics are summarized in Table 1. All patients received P-Gemox regimen, 209 patients (78.2%) as first-line therapy and 46 patients (22.0%) as second-line therapy. The median number of treatment cycles was 4.6(1-8) in the first line, 3.3 (2-6) in the second line, 243 patients were evaluable for response. The overall response (OR) rate was 84.8% (206/243), with a complete remission (CR) rate of 59.3% (144/243) (Table2). After the median follow-up time was 43.5 months (range, 1.5-101 months). The median OS of whole group was not reached, the median PFS was 61.0 months. The OS and PFS of the newly diagnosed patients is superior to refractory and relapsed patients (Fig1 A, B, P50%) of rates of grade 1 and 2 adverse events were as follows: hypoproteinemia, 74.1%, neutropenia, 64.4%, fibrinogenopenia 56.2%, transaminase elevated, 52.8%. Grade 3 and 4 adverse reactions (>10%) were thrombocytopenia, 29.2%, neutropenia, 27.7%(Table 3) . Conclusion: P-Gemox regimen followed by EIFRT yielded promising results for patients with stage I/II ENKTL. While for advanced or refractory/relapsed patients, P-Gemox was still unsatisfied . ASCT consolidation for good responders may improve the longterm outcom. Toxicity was moderate and tolerable. Disclosures No relevant conflicts of interest to declare.

Introduction At present, there is no standard of care for patients with relapsed/refractory non-Hodgkin lymphomas (NHL) after autologous stem cell transplantation (ASCT). Though, rituximab maintenance and interferon maintenance have been reported in patients with relapsed/refractory NHL after ASCT. Thalidomide is a kind of immunomodulatory drugs (IMiD) and has been proved to be effective in various NHLs, but the value of IMiD maintenance after ASCT remains to be discussed. In this study, we retrospectively analyzed the efficacy of thalidomide maintenance(TM) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after ASCT, comparing with historical control of patients without TM. Patients and Methods Between January 2013 and December 2017, eighty-eight patients with relapsed/refractory DLBCL undergoing TM after ASCT at the Sun Yat-sen University Cancer Center (SYSUCC) were reviewed. As historical control, ninety-seven patients without TM after ASCT during January 2006 to December 2012 were compared for analyses. All patients achieved CR before ASCT. Patients with transplantation related deaths were excluded. TM were given 100mg daily for one year. If grade III toxicities were observed, thalidomide would be postponed for one week and reduced to 75mg daily, and further 50mg daily in case of recurrence of grade III toxicities. The latest follow-up was updated to June 30th, 2018. Clinical and laboratory information was collected and analyzed. Results Overall, a total of 185 patients were reviewed and 15 of them were excluded due to lost to follow-up. In the TM group(n=81) and the non-TM group(n=89) available for survival analyses, the median age were 44 years (range, 19-72) and 40 years (range, 17-76) respectively, the proportion of male were 55% and 62% respectively, and the median follow-up time were 24 months(range, 6-68 months) and 79 months(range, 5-160 months) respectively. The 3-year overall survival (OS) were 77.8% in the TM group and 64.0% in the non-TM group, respectively (P =0.037). The 3-year progression-free survival (PFS) were 69.8% in the TM group and 61.4% in the non-TM group, respectively. (P=0.094). In multivariate analysis, maintenance therapy was an independent prognostic factor for OS (P < 0.05) . The major toxicities observed in the TM group were as follows: thrombocytopenia(73.2%), leucopenia(50.0%), constipation(53.5%), fatigue(58.5%), Somnolence (38.7%), rash(25.0%), edema(23.0%), and peripheral neuropathy(8.3%). Conclusions Despite the retrospective nature and other limitations of this study, it is suggested that TM might be associates with promising survival benefit of in patients with relapsed/refractory DLBCL after ASCT, comparing with historical controls. It warrants further prospective studies to confirm the efficacy of IMiD maintenance in DLBCL. Figure. Figure. Disclosures No relevant conflicts of interest to declare.