Web of Science: 2 cites, Scopus: 3 cites, Google Scholar: cites,
Ixazomib as postinduction maintenance for patients with newly diagnosed multiple myeloma not undergoing autologous stem cell transplantation : The phase III TOURMALINE-MM4 trial
Dimopoulos, M.A. (Hematology and Medical Oncology. Department of Clinical Therapeutics. National and Kapodistrian University of Athens. School of Medicine)
Špička, I. (First Department of Medicine. Department of Hematology. First Faculty of Medicine. Charles University. General Hospital in Prague)
Quach, H. (Department of Hematology. University of Melbourne. St Vincent's Hospital)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Hájek, R. (Department of Hemato-oncology. University Hospital Ostrava. University of Ostrava. Faculty of Medicine)
Garg, M. (Hematology. Leicester Royal Infirmary. University Hospitals of Leicester NHS Trust)
Beksac, M. (Department of Hematology. Ankara University)
Bringhen, S. (Division of Hematology. University of Torino. Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino)
Katodritou, E. (Department of Hematology. Theagenion Cancer Hospital)
Chng, W.J. (Department of Hematology-Oncology. National University Cancer Institute. National University Health System. Yong Loo Lin School of Medicine. Cancer Science Institute of Singapore. National University of Singapore)
Leleu, X. (Pôle Régional de Cancérologie. Department of Haematology. Centre Hospitalier Universitaire La Milétrie-Poitiers)
Iida, S. (Department of Hematology and Oncology. Nagoya City University. Graduate School of Medical Sciences)
Mateos, M.V. (Hematology. Hospital Universitario de Salamanca. University Hospital of Salamanca. Centro de Investigación del Cáncer. Instituto de Biología Molecular y Celular del Cáncer. Universitario de Salamanca Consejo Superior de Investigaciones Científicas)
Morgan, G. (Perlmutter Cancer Center. NYU Langone Health)
Vorog, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited)
Labotka, R. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited)
Wang, B. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited)
Palumbo, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited)
Lonial, S. (Department of Hematology and Medical Oncology. Winship Cancer Institute of Emory University)
Universitat Autònoma de Barcelona

Data: 2020
Resum: PURPOSE Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed. PATIENTS AND METHODS The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization. RESULTS Patients were randomly assigned to receive ixazomib (n 5 425) or placebo (n 5 281). TOURMALINEMM4 met its primary endpoint with a 34. 1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17. 4 v 9. 4 months; hazard ratio [HR], 0. 659; 95% CI, 0. 542 to 0. 801; P,. 001; median follow-up, 21. 1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25. 6 v 12. 9 months; HR, 0. 586; P,. 001). With ixazomib versus placebo, 36. 6% versus 23. 2% of patients had grade $ 3 treatment-emergent adverse events (TEAEs); 12. 9% versus 8. 0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26. 8% v 8. 0%), vomiting (24. 2% v 4. 3%), and diarrhea (23. 2% v 12. 3%). There was no increase in new primary malignancies (5. 2% v 6. 2%); rates of on-study deaths were 2. 6% versus 2. 2%. CONCLUSION Ixazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.
Drets: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Llengua: Anglès
Document: article ; recerca ; Versió publicada
Publicat a: Journal of Clinical Oncology, Vol. 38 Núm. 34 (january 2020) , p. 4030-4041, ISSN 1527-7755

DOI: 10.1200/JCO.20.02060
PMID: 33021870

13 p, 861.9 KB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Institut de Recerca contra la Leucèmia Josep Carreras
Articles > Articles de recerca
Articles > Articles publicats

 Registre creat el 2021-02-17, darrera modificació el 2021-05-31

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