{"entity":{"id":"paper-ddgp-vs-smile-nk-t-cell-lymphoma-clin-cancer-res-2016","kind":"paper","name":"DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China","aka":["DDGP versus SMILE, interim report","Li 2016"],"tldr":"The interim report of the Chinese trial comparing two asparaginase regimens in advanced NK/T-cell lymphoma, on its first 42 patients.","summary":"The interim report of the randomised trial registered as NCT01501149, in newly diagnosed stage III to IV NK/T-cell lymphoma with performance status 0 to 2, randomised to six cycles of DDGP or SMILE. Its primary endpoint was progression-free survival. The final analysis appeared in JAMA Oncology in 2022 and is the record to read for the result.","asOf":"2026-11-03","links":[{"label":"Clinical Cancer Research 2016","url":"https://doi.org/10.1158/1078-0432.CCR-16-0153"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/27060152/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/27060152"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["extranodal-nk-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","cisplatin","gemcitabine","asparaginase"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["ddgp-vs-smile-enktl"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Clinical Cancer Research","year":2016,"doi":"10.1158/1078-0432.CCR-16-0153","pmid":"27060152","authors":"Li X, Cui Y, Sun Z, et al.","paperType":"rct","findings":["42 patients enrolled, 21 in each arm.","One-year progression-free survival was 86 per cent with DDGP against 38 per cent with SMILE (p = 0.006), and two-year overall survival 74 against 45 per cent (p = 0.027).","Complete remission was 71 against 29 per cent (p = 0.005) and overall response 95 against 67 per cent (p = 0.018).","SMILE caused more serious leucopenia (p = 0.030) and more severe allergic reactions (p = 0.015); two patients on SMILE had grade 4 mucosal reactions."],"whatItMeans":"An interim look whose direction the final report confirmed with smaller differences. The early figures are larger than the final ones, which is the usual pattern of an interim analysis on a small sample.","caveats":["Interim analysis of 42 patients; superseded by the final report of 80 treated patients in JAMA Oncology 2022."],"participants":42},"route":"/key-papers/paper-ddgp-vs-smile-nk-t-cell-lymphoma-clin-cancer-res-2016/","neighbours":{"cancer":[{"id":"extranodal-nk-t-cell-lymphoma","kind":"cancer","name":"Extranodal NK/T-cell lymphoma","route":"/cancers/extranodal-nk-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":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"trial":[{"id":"ddgp-vs-smile-enktl","kind":"trial","name":"DDGP versus SMILE","route":"/trials/ddgp-vs-smile-enktl/"}]}}