{"corpus_id":205099724,"paper_sha":"41ad797a130c75d61f9e714e6a064eaea6d8f85d","doi":"10.1056/NEJMoa1516282","arxiv_id":null,"pmid":27119237,"pmcid":null,"mag_id":2343386476,"dblp_id":null,"acl_id":null,"title":"Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.","year":2016,"publication_date":"2016-04-27","venue":"New England Journal of Medicine","journal":{"name":"The New England journal of medicine","pages":"\n          1621-34\n        ","volume":"374 17"},"journal_issn":null,"journal_title":null,"publication_types":["Study","JournalArticle","ClinicalTrial"],"pubmed_pub_types":["Clinical Trial, Phase III","Comparative Study","Journal Article","Multicenter Study","Randomized Controlled Trial","Research Support, Non-U.S. Gov't"],"s2_fields_of_study":["Medicine"],"reference_count":34,"citation_count":960,"influential_citation_count":51,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Administration, Oral","mj":false,"ui":"D000284"},{"d":"Adult","mj":false,"ui":"D000328"},{"d":"Aged","mj":false,"ui":"D000368"},{"d":"Aged, 80 and over","mj":false,"ui":"D000369"},{"d":"Antineoplastic Combined Chemotherapy Protocols","mj":false,"qs":[{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D000971"},{"d":"Boron Compounds","mj":false,"qs":[{"q":"administration & dosage","mj":true,"ui":"Q000008"},{"q":"adverse effects","mj":false,"ui":"Q000009"}],"ui":"D001896"},{"d":"Dexamethasone","mj":false,"qs":[{"q":"administration & dosage","mj":true,"ui":"Q000008"}],"ui":"D003907"},{"d":"Disease-Free Survival","mj":false,"ui":"D018572"},{"d":"Double-Blind Method","mj":false,"ui":"D004311"},{"d":"Exanthema","mj":false,"qs":[{"q":"chemically induced","mj":false,"ui":"Q000139"}],"ui":"D005076"},{"d":"Glycine","mj":false,"qs":[{"q":"administration & dosage","mj":false,"ui":"Q000008"},{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"analogs & derivatives","mj":true,"ui":"Q000031"}],"ui":"D005998"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Kaplan-Meier Estimate","mj":false,"ui":"D053208"},{"d":"Lenalidomide","mj":false,"ui":"D000077269"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Middle Aged","mj":false,"ui":"D008875"},{"d":"Multiple Myeloma","mj":false,"qs":[{"q":"drug therapy","mj":true,"ui":"Q000188"}],"ui":"D009101"},{"d":"Proportional Hazards Models","mj":false,"ui":"D016016"},{"d":"Quality of Life","mj":false,"ui":"D011788"},{"d":"Thalidomide","mj":false,"qs":[{"q":"administration & dosage","mj":false,"ui":"Q000008"},{"q":"analogs & derivatives","mj":true,"ui":"Q000031"}],"ui":"D013792"},{"d":"Thrombocytopenia","mj":false,"qs":[{"q":"chemically induced","mj":false,"ui":"Q000139"}],"ui":"D013921"}],"chemicals":[{"n":"Boron Compounds","ui":"D001896","reg":"0"},{"n":"Thalidomide","ui":"D013792","reg":"4Z8R6ORS6L"},{"n":"ixazomib","ui":"C548400","reg":"71050168A2"},{"n":"Dexamethasone","ui":"D003907","reg":"7S5I7G3JQL"},{"n":"Lenalidomide","ui":"D000077269","reg":"F0P408N6V4"},{"n":"Glycine","ui":"D005998","reg":"TE7660XO1C"}],"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":"https://www.nejm.org/doi/pdf/10.1056/NEJMoa1516282?articleTools=true","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/41ad797a130c75d61f9e714e6a064eaea6d8f85d","s2_open_access_license":null,"s2_open_access_status":"BRONZE","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"BACKGROUND: Ixazomib is an oral proteasome inhibitor that is currently being studied for the treatment of multiple myeloma. METHODS: In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had relapsed, refractory, or relapsed and refractory multiple myeloma to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomide-dexamethasone (placebo group). The primary end point was progression-free survival. RESULTS: Progression-free survival was significantly longer in the ixazomib group than in the placebo group at a median follow-up of 14.7 months (median progression-free survival, 20.6 months vs. 14.7 months; hazard ratio for disease progression or death in the ixazomib group, 0.74; P=0.01); a benefit with respect to progression-free survival was observed with the ixazomib regimen, as compared with the placebo regimen, in all prespecified patient subgroups, including in patients with high-risk cytogenetic abnormalities. The overall rates of response were 78% in the ixazomib group and 72% in the placebo group, and the corresponding rates of complete response plus very good partial response were 48% and 39%. The median time to response was 1.1 months in the ixazomib group and 1.9 months in the placebo group, and the corresponding median duration of response was 20.5 months and 15.0 months. At a median follow-up of approximately 23 months, the median overall survival has not been reached in either study group, and follow-up is ongoing. The rates of serious adverse events were similar in the two study groups (47% in the ixazomib group and 49% in the placebo group), as were the rates of death during the study period (4% and 6%, respectively); adverse events of at least grade 3 severity occurred in 74% and 69% of the patients, respectively. Thrombocytopenia of grade 3 and grade 4 severity occurred more frequently in the ixazomib group (12% and 7% of the patients, respectively) than in the placebo group (5% and 4% of the patients, respectively). Rash occurred more frequently in the ixazomib group than in the placebo group (36% vs. 23% of the patients), as did gastrointestinal adverse events, which were predominantly low grade. The incidence of peripheral neuropathy was 27% in the ixazomib group and 22% in the placebo group (grade 3 events occurred in 2% of the patients in each study group). Patient-reported quality of life was similar in the two study groups. CONCLUSIONS: The addition of ixazomib to a regimen of lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with this all-oral regimen were limited. (Funded by Millennium Pharmaceuticals; TOURMALINE-MM1 ClinicalTrials.gov number, NCT01564537.).","claims":[{"public_id":"cl_3d837288c85d680a312170f8629747c9","status":"active","text":"At a median follow-up of approximately 23 months, median overall survival had not been reached in either study group, with follow-up ongoing.","confidence":0.6,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["review"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ 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(3c2apqe3ut)","roles":["review"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"}],"url":"https://sah.borca.ai/claims/cl_a9e81c499f3539aee9f6b2531f487e9f"},{"public_id":"cl_a3019c80da37ecabe07f5fbf5f11d18c","status":"active","text":"Rates of serious adverse events (47% vs. 49%) and death during the study (4% vs. 6%) were similar between the ixazomib and placebo groups, though adverse events of at least grade 3 severity were more frequent with ixazomib (74% vs. 69%).","confidence":0.85,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["review"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"}],"url":"https://sah.borca.ai/claims/cl_a3019c80da37ecabe07f5fbf5f11d18c"},{"public_id":"cl_a8d04eba84ae98f94d7c59543e6f1ec9","status":"active","text":"The ixazomib regimen produced a higher overall response rate (78% vs. 72%) and a longer median duration of response (20.5 vs. 15.0 months) than the placebo regimen.","confidence":0.85,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["review"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"}],"url":"https://sah.borca.ai/claims/cl_a8d04eba84ae98f94d7c59543e6f1ec9"},{"public_id":"cl_2017a7ba0d0509b9c61c33ae5603498c","status":"active","text":"Thrombocytopenia, rash, and peripheral neuropathy occurred more frequently in the ixazomib group than in the placebo group (grade 3/4 thrombocytopenia, 12%/7% vs. 5%/4%; rash, 36% vs. 23%; peripheral neuropathy, 27% vs. 22%).","confidence":0.9,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["review"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"}],"url":"https://sah.borca.ai/claims/cl_2017a7ba0d0509b9c61c33ae5603498c"}],"concepts":[{"public_id":"co_1145fbda9e46045372bb4e92fb2efd6a","status":"active","name":"overall response rate","description":"The proportion of patients achieving an objective tumor response, reported as a secondary efficacy outcome.","types":["outcome measure"],"aliases":["rate of response"],"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous 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