{"entity":{"id":"paper-ddgp-vs-smile-nk-t-cell-lymphoma-jama-oncol-2022","kind":"paper","name":"Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial","aka":["DDGP versus SMILE, final report","Wang 2022"],"tldr":"The final report of the Chinese randomised trial in which a pegaspargase regimen, DDGP, kept advanced NK/T-cell lymphoma controlled for longer than SMILE, with less toxicity to the blood count.","summary":"An open-label, multicentre randomised trial at 12 hospitals in China from January 2011 to February 2019, in patients aged 14 to 70 with newly diagnosed stage III or IV extranodal natural killer/T-cell lymphoma and performance status 0 to 2. Patients were randomised evenly to DDGP (dexamethasone, cisplatin, gemcitabine and pegaspargase) or SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase and etoposide), every 21 days for six cycles. The primary endpoint was progression-free survival.","asOf":"2026-11-03","links":[{"label":"JAMA Oncology 2022","url":"https://doi.org/10.1001/jamaoncol.2022.1968"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/35708709/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/35708709"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["extranodal-nk-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","cisplatin","gemcitabine","asparaginase","methotrexate","ifosfamide","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["ddgp-vs-smile-enktl","smile-enktl"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"JAMA Oncology","year":2022,"doi":"10.1001/jamaoncol.2022.1968","pmid":"35708709","authors":"Wang X, Zhang L, Liu X, et al.","paperType":"rct","findings":["87 patients were randomised and 80 treated, 40 in each arm; median age 43, 64 per cent male.","At a median follow-up of 41.5 months, median progression-free survival was not reached with DDGP against 6.8 months with SMILE (hazard ratio 0.42, 95 per cent confidence interval 0.23 to 0.77, p = 0.004).","Median overall survival was not reached against 75.2 months (hazard ratio 0.41, 95 per cent confidence interval 0.19 to 0.89, p = 0.02).","Three-year progression-free survival was 56.6 against 41.8 per cent, and five-year overall survival 74.3 against 51.7 per cent.","Overall response was 90.0 against 60.0 per cent (p = 0.002).","Grade 3 and 4 leukopenia occurred in 62.5 per cent with DDGP against 85.0 per cent with SMILE, and neutropenia in 65.0 against 85.0 per cent."],"whatItMeans":"A randomised comparison between two asparaginase regimens in advanced NK/T-cell lymphoma, and the evidence for using a pegaspargase-and-gemcitabine regimen rather than SMILE. In the authors' words, the DDGP regimen showed promising preliminary results and a confirmation trial based on a larger population is warranted.","caveats":["80 treated patients from one national group; the trial has not been repeated.","Open label, and run over eight years.","The registry record lists the study as phase 4, with 80 enrolled and its status unknown."],"participants":87},"route":"/key-papers/paper-ddgp-vs-smile-nk-t-cell-lymphoma-jama-oncol-2022/","neighbours":{"cancer":[{"id":"extranodal-nk-t-cell-lymphoma","kind":"cancer","name":"Extranodal NK/T-cell lymphoma","route":"/cancers/extranodal-nk-t-cell-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"drug":[{"id":"asparaginase","kind":"drug","name":"Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)","route":"/drugs/asparaginase/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"ifosfamide","kind":"drug","name":"Ifosfamide","route":"/drugs/ifosfamide/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"}],"trial":[{"id":"ddgp-vs-smile-enktl","kind":"trial","name":"DDGP versus SMILE","route":"/trials/ddgp-vs-smile-enktl/"},{"id":"smile-enktl","kind":"trial","name":"SMILE","route":"/trials/smile-enktl/"}]}}