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Final Overall Survi...
Final Overall Survival Analysis of the TOURMALINE-MM1 Phase III Trial of Ixazomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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Richardson, Paul G. (author)
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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, Markus (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition
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Pour, Luděk (author)
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Sandhu, Irwindeep (author)
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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 (author)
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Gimsing, Peter (author)
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Garderet, Laurent (author)
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Touzeau, Cyrille (author)
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Buadi, Francis K. (author)
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Laubach, Jacob P. (author)
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Cavo, Michele (author)
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Darif, Mohamed (author)
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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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(creator_code:org_t)
- 2021
- 2021
- English.
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In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 1527-7755. ; 39:22, s. 2430-2442
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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- art (subject category)
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- By the author/editor
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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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show more...
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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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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
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Journal of clini ...
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University of Gothenburg