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Bortezomib, Melphalan, and Dexamethasone for Light-Chain Amyloidosis.
Kastritis, Efstathios; Leleu, Xavier; Arnulf, Bertrand; Zamagni, Elena; Cibeira, María Teresa; Kwok, Fiona; Mollee, Peter; Hájek, Roman; Moreau, Philippe; Jaccard, Arnaud; Schönland, Stefan O; Filshie, Robin; Nicolas-Virelizier, Emmanuelle; Augustson, Bradley; Mateos, María-Victoria; Wechalekar, Ashutosh; Hachulla, Eric; Milani, Paolo; Dimopoulos, Meletios A; Fermand, Jean-Paul; Foli, Andrea; Gavriatopoulou, Maria; Klersy, Catherine; Palumbo, Antonio; Sonneveld, Pieter; Johnsen, Hans Erik; Merlini, Giampaolo; Palladini, Giovanni.
Afiliación
  • Kastritis E; Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
  • Leleu X; Hopital Huriez Centre Hospitalier Régional Universitaire, Lille, France.
  • Arnulf B; Immunohematology Unit, Hospital Saint-Louis, Assistance Publique - Hôpitaux de Paris, Paris, France.
  • Zamagni E; Bologna University School of Medicine, Bologna, Italy.
  • Cibeira MT; Amyloidosis and Myeloma Unit, Hospital Clinic of Barcelona, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.
  • Kwok F; Westmead Hospital, Sydney, New South Wales, Australia.
  • Mollee P; Princess Alexandra Hospital and University of Queensland, Brisbane, Queensland, Australia.
  • Hájek R; Department of Hemato-oncology, University Hospital, Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
  • Moreau P; Centre Hospitalier Universitaire Hotel Dieu, Nantes, France.
  • Jaccard A; Centre Hospitalier Universitaire, Limoges, France.
  • Schönland SO; Medical Department V, Amyloidosis Centre, University Hospital, Heidelberg, Germany.
  • Filshie R; St Vincent's Hospital, Melbourne, Victoria, Australia.
  • Nicolas-Virelizier E; Centre Leon Berard, Lyon, France.
  • Augustson B; Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
  • Mateos MV; University Hospital of Salamanca, Instituto de Investigación Biosanitaria de Salamanc, Institute of Cancer Molecular and Cellular Biology, Salamanca, Spain.
  • Wechalekar A; University College London Medical School, Royal Free Hospital Campus, London, United Kingdom.
  • Hachulla E; Hopital Huriez Centre Hospitalier Régional Universitaire, Lille, France.
  • Milani P; Amyloidosis Research and Treatment Center "Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo," Pavia, Italy.
  • Dimopoulos MA; Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
  • Fermand JP; Immunohematology Unit, Hospital Saint-Louis, Assistance Publique - Hôpitaux de Paris, Paris, France.
  • Foli A; Amyloidosis Research and Treatment Center "Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo," Pavia, Italy.
  • Gavriatopoulou M; Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
  • Klersy C; Clinical Epidemiology and Biometry Service, "Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo," Pavia, Italy.
  • Palumbo A; University of Torino, Torino, Italy.
  • Sonneveld P; Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
  • Johnsen HE; Aalborg University Hospital, Aalborg, Denmark.
  • Merlini G; Amyloidosis Research and Treatment Center "Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo," Pavia, Italy.
  • Palladini G; Department of Molecular Medicine, University of Pavia, Pavia, Italy.
J Clin Oncol ; 38(28): 3252-3260, 2020 10 01.
Article en En | MEDLINE | ID: mdl-32730181
PURPOSE: Oral melphalan and dexamethasone (MDex) were considered a standard of care in light-chain (AL) amyloidosis. In the past decade, bortezomib has been increasingly used in combination with alkylating agents and dexamethasone. We prospectively compared the efficacy and safety of MDex and MDex with the addition of bortezomib (BMDex). METHODS: This was a phase III, multicenter, randomized, open-label trial. Patients were stratified according to cardiac stage. Patients with advanced cardiac stage (stage IIIb) amyloidosis were not eligible. The primary end point was hematologic response rate at 3 months. This trial is registered with ClinicalTrials.gov identifier NCT01277016. RESULTS: A total of 109 patients, 53 in the BMDex and 56 in the MDex group, received ≥ 1 dose of therapy (from January 2011 to February 2016). Hematologic response rate at 3 months was higher in the BMDex arm (79% v 52%; P = .002). Higher rates of very good partial or complete response rates (64% v 39%; hazard ratio [HR], 2.47; 95% CI, 1.30 to 4.71) and improved overall survival, with a 2-fold decrease in mortality rate (HR, 0.50; 95% CI, 0.27 to 0.90), were observed in the BMDex arm. Grade 3 and 4 adverse events (the most common being cytopenia, peripheral neuropathy, and heart failure) were more common in the BMDex arm, occurring in 20% versus 10% of cycles performed. CONCLUSION: BMDex improved hematologic response rate and overall survival. To our knowledge, this is the first time a controlled study has demonstrated a survival advantage in AL amyloidosis. BMDex should be considered a new standard of care for AL amyloidosis.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Amiloidosis de Cadenas Ligeras de las Inmunoglobulinas Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 2020 Tipo del documento: Article País de afiliación: Grecia Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Amiloidosis de Cadenas Ligeras de las Inmunoglobulinas Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 2020 Tipo del documento: Article País de afiliación: Grecia Pais de publicación: Estados Unidos