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Final Overall Survi...
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Richardson, Paul G.
(author)
Final Overall Survival Analysis of the TOURMALINE-MM1 Phase III Trial of Ixazomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- Article/chapterEnglish2021
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LIBRIS-ID:oai:gup.ub.gu.se/310977
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https://gup.ub.gu.se/publication/310977URI
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https://doi.org/10.1200/JCO.21.00972DOI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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PURPOSE: The double-blind, placebo-controlled, phase III TOURMALINE-MM1 study demonstrated a statistically significant improvement in progression-free survival with ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd in patients with relapsed or refractory multiple myeloma. We report the final analyses for overall survival (OS). PATIENTS AND METHODS: Patients were randomly assigned to ixazomib-Rd (n = 360) or placebo-Rd (n = 362), stratified by number of prior therapies (1 v 2 or 3), previous proteasome inhibitor (PI) exposure (yes v no), and International Staging System disease stage (I or II v III). OS (intent-to-treat population) was a key secondary end point. RESULTS: With a median follow-up of 85 months, median OS with ixazomib-Rd versus placebo-Rd was 53.6 versus 51.6 months (hazard ratio, 0.939; P = .495). Lower hazard ratios, indicating larger magnitude of OS benefit with ixazomib-Rd versus placebo-Rd, were seen in predefined subgroups: refractory to any (0.794) or last (0.742) treatment line; age > 65-75 years (0.757); International Staging System stage III (0.779); 2/3 prior therapies (0.845); high-risk cytogenetics (0.870); and high-risk cytogenetics and/or 1q21 amplification (0.862). Following ixazomib-Rd versus placebo-Rd, 71.7% versus 69.9% of patients received ≥ 1 anticancer therapy, of whom 24.7% versus 33.9% received daratumumab and 71.8% versus 76.9% received PIs (next-line therapy: 47.5% v 55.8%). Rates of new primary malignancies were similar with ixazomib-Rd (10.3%) and placebo-Rd (11.9%). There were no new or additional safety concerns. CONCLUSION: Median OS values in both arms were the longest reported in phase III studies of Rd-based triplets in relapsed or refractory multiple myeloma at the time of this analysis; progression-free survival benefit with ixazomib-Rd versus placebo-Rd did not translate into a statistically significant OS benefit on intent-to-treat analysis. OS benefit was greater in subgroups with adverse prognostic factors. OS interpretation was confounded by imbalances in subsequent therapies received, especially PIs and daratumumab.
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Kumar, Shaji K.
(author)
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Masszi, Tamás
(author)
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Grzasko, Norbert
(author)
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Bahlis, Nizar J.
(author)
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Hansson, MarkusGothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition(Swepub:gu)xhmarn
(author)
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Pour, Luděk
(author)
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Sandhu, Irwindeep
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Ganly, Peter
(author)
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Baker, Bartrum W.
(author)
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Jackson, Sharon R.
(author)
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Stoppa, Anne Marie
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Gimsing, Peter
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Garderet, Laurent
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Touzeau, Cyrille
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Buadi, Francis K.
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Laubach, Jacob P.
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Cavo, Michele
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Darif, Mohamed
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Labotka, Richard
(author)
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Berg, Deborah
(author)
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Moreau, Philippe
(author)
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Göteborgs universitetInstitutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition
(creator_code:org_t)
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In:Journal of clinical oncology : official journal of the American Society of Clinical Oncology39:22, s. 2430-24421527-7755
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Richardson, Paul ...
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Kumar, Shaji K.
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Masszi, Tamás
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Grzasko, Norbert
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Bahlis, Nizar J.
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Hansson, Markus
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Pour, Luděk
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Sandhu, Irwindee ...
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Ganly, Peter
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Baker, Bartrum W ...
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Jackson, Sharon ...
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Stoppa, Anne Mar ...
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Gimsing, Peter
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Garderet, Lauren ...
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Touzeau, Cyrille
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Buadi, Francis K ...
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Laubach, Jacob P ...
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Cavo, Michele
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Darif, Mohamed
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Labotka, Richard
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Berg, Deborah
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Moreau, Philippe
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University of Gothenburg