A Clinical Study Between L-asparaginase Combined With DGEMOX Regimen Or DICE Regimen In The First-line Treatment For Patients With ENKTL Nasal Type

Background and Objective: L-asparaginasum has been considered as a basic drug for the treatment of extranodal NK/T cell lymphoma.Its combination with other cytotoxic drugs results in the increase of treatment efficacy.However,there is no consensus optimal combination chemotherapy regimen.To explore treatment efficacy,toxicities of L-asparaginasum combined with DGEMOX regimen and DICE regimen which are commonly in the first-line treatment for extranodal NK/T cell lymphoma,nasal type(ENKTL)in order to optimize the therapeutic option.Material and Method: We enrolled fivty-nine patients with newly-diagnosed ENKTL from January 1,2009 to December 1,who consecutively hospitalized in the Affiliated Cancer Hospital of Zhengzhou University and conformed requirement of study.It included 28 cases with DGEMOX regimen and 31 cases with DICE regimen.We compared the objective response rate(ORR),progression-free survival(PFS)rate,overall survival(OS)rate and adverse effects between two groups,then analyzed prognostic factors.The treatment response was assessed according to the Revised Response Criteria for Lymphoma in 2007,while the toxicity grade was evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events v4.0 in 2009.Statistical analysis was applied by SPSS v19.0.The OS and PFS were calculated by using the Kaplan-Meier method.Logrank test wasused for comparison of survival differences.Cox proportional hazards were used for prognostic factors analysis.model.P value less than 0.05 was considered to be significant.Results: 1.The Both regimens achieved high ORR(DGEMOX 92.9%,26/28;DICE96.8%,30/31),whereas the difference was not statistically significant between them(χ2=0.468,P=0.494).2.The median follow-up time was 43 months.The estimated5-year OS of DGEMOX(70.3±9.9%)also showed better than DICE regimen(65.5%±11.1%)without significant difference(χ2=0.355,P=0.551);the estimated5-year PFS of DGEMOX(61.0±10.5%)showed superiority to DICE regimen(47.5±13.4%)without significant difference(χ2=0.845,P=0.358);3.The toxic side effects of both groups can be tolerated without chemotherapy-related death.The results showed that DGEMOX regimen the incidences of grade 3/4 toxicities of hematology,gastrointestinal tract and alopecia were obviously lower in DGEMOX group than in DICE group(P < 0.05).4.Cox univariate analysis revealed that Ann Arbor stage and PINK prognostic score were poor prognostic factors of PFS,while Ann Arbor stage,LDH,plasma EBV-DNA copy number and PINK prognostic score were poor prognostic factors of OS.Cox multivariate analysis showed that Ann Arbor stage and LDH level were OS independently prognostic factors,while Ann Arbor stage was independently prognostic factors of PFS.Conclusions: 1.L-Asparaginase combined with DGEMOX regimen and DICE regimen have excellent efficacy.2.L-asparaginase combined with DGEMOX regimen is superior to DICE regimen with better survival and safety.