| Background and PurposeExtranodal natural killer/T-cell lymphoma is a relatively rare malignant lymphoma with high invasion.Its clinical classification is mainly divided into nasal and nasal type.ENKTCL has different clinical manifestations according to the different organs involved.Currently,there is no standard treatment for ENKTCL,and all the major guidelines recommend clinical trials first.Our center finally worked out DDGP regimen(gemcitabine,permentase,cisplatin and dexamethasone)to treat advanced NK/T cell lymphoma through preliminary experiments.This study was conducted to further evaluate the efficacy and safety of DDGP regimen in advanced ENKTCL patients.Epstein-Barr virus is a DNA virus that infects about 90% humans and is associated with many diseases.Previous studies have indicated that Epstein-Barr virus plays a key role in the occurrence of ENKTCL,but the exact etiology has not yet been determined.EBV-DNA is a key index to evaluate the clinical prognosis of ENKTCL patients.However,the relationship between the dynamic change of EBV-DNA and the clinical efficacy of ENKTCL has not been reported during the treatment.This study investigated the relationship between EBV-DNA transformation and clinical efficacy in patients with advanced ENKTCL after treated with DDGP regimen.Materials and MethodsThe 64 newly diagnosed patients with advanced NK/T cell lymphoma recruited in this clinical trial were all admitted to the First Affiliated Hospital of Zhengzhou University from March 2011 to April 2018.The diagnosis of ENKTL was validated by more than two experienced professors from the Department of Pathology,All of them were in accordance with WHO classification of tumor lymphopoietic system in2008.All patients were given DDGP regimen for 6 cycles after comprehensive evaluation of their conditions by relevant examinations,then the short-term and long-term efficacy of DDGP regimen in patients with advanced ENKTCL was evaluated.During the treatment,the quantitative transformation of EBV-DNA after treatment was monitored,and the effect of EBV-DNA transformation on the clinical efficacy of ENKTCL was evaluated.Statistical MethodsSPSS 21.0 statistical software was utilized for data analysis.Kaplan-Meier survival analysis was performed.Fisher’s exact test was used for statistical processing.The ORR and DCR among different EBV-DNA copy number groups were statistically compared by the χ2 test.A value of P<0.05 was considered statistically significant.ResultsInfection rate of EBV-DNA: 28 among 64 patients were positive and 36 were negative in EBV-DNA levels.The infection rate was 43.75%(28/64).2.Short-term clinical efficacy of DDGP: The short-term clinical efficacy in 64 ENKTL patients was assessed,including 39 cases of CR(39/64,60.94%),12 PR(12/64,18.75%),2 SD(2/64,3.13%)and 11 PD(11/64,17.18%).The ORR was calculated as 79.69%(51/64)and 82.81%(53/64)for DCR.The results of subgroup analysis showed that the ORR in the EBV-DNA-positive group and the EBV-DNA-negative group were 78.57%(22/28)and 80.56%(29/36),respectively.No significant difference was observed between the two groups(P=0.845).The DCR was 78.57%(22/28)in the EBV-DNA-positive group and86.11%(31/36)in the EBV-DNA-negative group,with no significant difference(P=0.428).In the EBV-DNA-positive group,the copy number of EBV-DNA decreased within normal range included 15 cases after the DDGP regimen.The negative conversion ratio was 53.57%(15/28).The ORR of the negative group was93.33%(14/15),which significantly differed from 61.53%(8/13)for the positive group(P=0.041),and the DCR was the same.2.Long-term clinical efficacy of DDGP: The final date of follow-up was in April 2018.The median follow-up was 40 months.Among the 64 ENKTL patients,The 1-,2-and 3-year PFS was 77.00%,67.80% and 62.00%,respectively,and the 1-,2-and 3-year OS was 81.50% 74.9% and 74.90%,respectively.In the EBV-DNA-positive group,the 1-,2-and 3-year PFS was 70.30%,67.50% and67.50%,respectively.In the EBV-DNA-negative group,the 1-,2-and 3-year PFS was 79.90%,68.80% and 58.6%,respectively.No significant difference was noted in PFS between the two groups(P=0.812).In the EBV-DNA-positive group,the 1-,2-and 3-year OS was 73.75%,62.6% and 62.60%,respectively.In the EBV-DNA-negative group,the 1-,2-and 3-year OS was 89.90%,85.4% and 85.40%,respectively.A significant difference was noted in OS between the two groups(P=0.046).In the EBV-DNA-positive group,the 1-year PFS of the negative group was 90.90%,which was significantly higher than that(43.1%)in the positive group(P=0.003).Moreover,the 1-year OS was 93.30% and 44.90% in the negative and positive groups,respectively,which were significantly different(P=0.017)).3.Adverse reactions of DDGP regimen: Adverse reactions mainly included bone marrow suppression,digestive tract reactions,coagulation dysfunction,etc.Among the 64 patients,48.4%(31/64)presented with grade Ⅲ-Ⅳ leukopenia;62.5%(40/64)with grade Ⅰ-Ⅱ anemia;42.2%(27/64)with grade Ⅲ-Ⅳ thrombocytopenia;65.6%(42/64)with digestive tract reactions;and 37.5%(24/64)with slight coagulation dysfunction.ConclusionIn patients with advanced ENKTCL,DDGP regimen showed significant efficacy and tolerable adverse reactions.The transformation of EBV-DNA after treatment is closely related to the efficacy of patients. |
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