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Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma.
Hájek, Roman; Minarík, Jirí; Straub, Jan; Pour, Ludek; Jungova, Alexandra; Berdeja, Jesus G; Boccadoro, Mario; Brozova, Lucie; Spencer, Andrew; van Rhee, Frits; Vela-Ojeda, Jorge; Thompson, Michael A; Abonour, Rafat; Chari, Ajai; Cook, Gordon; Costello, Caitlin L; Davies, Faith E; Hungria, Vania Tm; Lee, Hans C; Leleu, Xavier; Puig, Noemi; Rifkin, Robert M; Terpos, Evangelos; Usmani, Saad Z; Weisel, Katja C; Zonder, Jeffrey A; Barinová, Magda; Kuhn, Matyás; Silar, Jirí; Cápková, Lenka; Galvez, Kenny; Lu, Jin; Elliott, Jennifer; Stull, Dawn Marie; Ren, Kaili; Maisnar, Vladimír.
Afiliação
  • Hájek R; University Hospital Ostrava & Faculty of Medicine, University of Ostrava, Ostrava, 703 00, Czech Republic.
  • Minarík J; Palacky University & University Hospital Olomouc, Olomouc, 771 47, Czech Republic.
  • Straub J; General Teaching Hospital, Prague, 128 08, Czech Republic.
  • Pour L; University Hospital, Brno, 625 00, Czech Republic.
  • Jungova A; Faculty Hospital Pilsen, Pilsen, 301 00, Czech Republic.
  • Berdeja JG; Sarah Cannon Research Institute, Nashville, TN 37203, USA.
  • Boccadoro M; University of Torino, Torino, 10124, Italy.
  • Brozova L; Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic.
  • Spencer A; Alfred Health-Monash University, Melbourne, 3004, Australia.
  • van Rhee F; University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.
  • Vela-Ojeda J; UMAE Especialidades Centro Medico La Raza IMSS, Ciudad de México, 02990, Mexico.
  • Thompson MA; Advocate Aurora Research Institute, Advocate Aurora Health, Milwaukee, WI 53227, USA.
  • Abonour R; Indiana University School of Medicine, Indianapolis, IN 46202, USA.
  • Chari A; Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
  • Cook G; Leeds Teaching Hospital, Leeds, LS1 3EX, UK.
  • Costello CL; Moores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA.
  • Davies FE; Perlmutter Cancer Center, NYU Langone, New York, NY 10016, USA.
  • Hungria VT; Clinica São Germano & Santa Casa Medical School, São Paulo, 04537-081, Brazil.
  • Lee HC; M.D. Anderson Cancer Center, Houston, TX 77030, USA.
  • Leleu X; Pôle Régional de Cancérologie, CHU de Poitiers, Poitiers, 86000, France.
  • Puig N; Department of Hematology, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC (CB16/12/00233), Salamanca, 37007, Spain.
  • Rifkin RM; Rocky Mountain Cancer Centers US Oncology Research, Denver, CO 80218, USA.
  • Terpos E; National & Kapodistrian University of Athens, School of Medicine, Athens, 115 27, Greece.
  • Usmani SZ; Levine Cancer Institute, Charlotte, NC 115 27, USA.
  • Weisel KC; University Medical Center Hamburg-Eppendorf, Hamburg, 20251, Germany.
  • Zonder JA; Barbara Ann Karmanos Cancer Institute / Wayne State University School of Medicine, Detroit, MI 48201, USA.
  • Barinová M; Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic.
  • Kuhn M; Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic.
  • Silar J; Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic.
  • Cápková L; Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic.
  • Galvez K; Hospital Pablo Tobón Uribe, Medellin, 11001, Colombia.
  • Lu J; Peking University People's Hospital, National Clinical Research Center for Hematologic Disease, Beijing, 100044, China.
  • Elliott J; Millennium Pharmaceuticals, Inc., Cambridge, MA 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
  • Stull DM; Millennium Pharmaceuticals, Inc., Cambridge, MA 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
  • Ren K; Millennium Pharmaceuticals, Inc., Cambridge, MA 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
  • Maisnar V; Charles University Hospital & Faculty of Medicine, Hradec Králové, 121 08, Czech Republic.
Future Oncol ; 17(19): 2499-2512, 2021 Jul.
Article em En | MEDLINE | ID: mdl-33769076
ABSTRACT

Aim:

To evaluate the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory multiple myeloma in routine clinical practice. Patients &

methods:

Patient-level data from the global, observational INSIGHT MM and the Czech Registry of Monoclonal Gammopathies were integrated and analyzed.

Results:

At data cut-off, 263 patients from 13 countries were included. Median time from diagnosis to start of IRd was 35.8 months; median duration of follow-up was 14.8 months. Overall response rate was 73%, median progression-free survival, 21.2 months and time-to-next therapy, 33.0 months. Ixazomib/lenalidomide dose reductions were required in 17%/36% of patients; 32%/30% of patients discontinued ixazomib/lenalidomide due to adverse events.

Conclusion:

The effectiveness and safety of IRd in routine clinical practice are comparable to those reported in TOURMALINE-MM1. Clinical trial registration NCT02761187 (ClinicalTrials.gov).
Lay abstract Proteasome inhibitors are drugs used in multiple myeloma (MM), a blood cancer that develops from cells in the bone marrow. Ixazomib is the first oral proteasome inhibitor to be approved for use in MM, when given in combination with two other oral drugs, lenalidomide and dexamethasone, to adult patients who have received one prior therapy. Our study, which was conducted in routine clinical practice, found that the effectiveness and safety of ixazomib + lenalidomide + dexamethasone in previously treated MM patients were similar to those seen in the Phase III clinical trial on which approval was based. These findings are important because they suggest that MM patients in everyday practice can achieve the same benefits from this treatment as patients in clinical trials, despite often being in poorer health.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Mieloma Múltiplo / Recidiva Local de Neoplasia Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: República Tcheca

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Mieloma Múltiplo / Recidiva Local de Neoplasia Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: República Tcheca