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Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR.
Chng, W-J; Goldschmidt, H; Dimopoulos, M A; Moreau, P; Joshua, D; Palumbo, A; Facon, T; Ludwig, H; Pour, L; Niesvizky, R; Oriol, A; Rosiñol, L; Suvorov, A; Gaidano, G; Pika, T; Weisel, K; Goranova-Marinova, V; Gillenwater, H H; Mohamed, N; Feng, S; Aggarwal, S; Hájek, R.
Afiliación
  • Chng WJ; Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.
  • Goldschmidt H; Department of Haematology-Oncology, Cancer Science Institute of Singapore, National University of Singapore, Singapore, Singapore.
  • Dimopoulos MA; Department of Internal Medicine, Heidelberg Medical University, Heidelberg, Germany.
  • Moreau P; School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Joshua D; Department of Haematology, University of Nantes, Nantes, France.
  • Palumbo A; Department of Haematology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
  • Facon T; Department of Oncology, University of Torino, Torino, Italy.
  • Ludwig H; Department of Haematology, CHRU Lille Hôpital Claude Huriez, Lille, France.
  • Pour L; Department of Medicine, Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.
  • Niesvizky R; Myeloma Group, University Hospital Brno, Brno, Czech Republic.
  • Oriol A; Multiple Myeloma Center, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, USA.
  • Rosiñol L; Department of Clinical Haematology, Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.
  • Suvorov A; Department of Haematology, Hospital Clínic de Barcelona, Barcelona, Spain.
  • Gaidano G; Hematological Department, First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.
  • Pika T; Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.
  • Weisel K; Department of Hematooncology, University Hospital Olomouc, Olomouc, Czech Republic.
  • Goranova-Marinova V; Myeloma Clinic, Universitatsklinikum Tubingen, Tubingen, Germany.
  • Gillenwater HH; Haematooncology Clinic, University Multiprofile Hospital for Active Treatment 'Sveti Georgi' and Medical University, Plovdiv, Bulgaria.
  • Mohamed N; Onyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA, USA.
  • Feng S; Onyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA, USA.
  • Aggarwal S; Onyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA, USA.
  • Hájek R; Onyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA, USA.
Leukemia ; 31(6): 1368-1374, 2017 06.
Article en En | MEDLINE | ID: mdl-28025582
The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd, n=97 (25%); Vd, n=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd, n=284 (75%); Vd, n=291 (72%)). Median PFS in the high-risk group was 8.8 months for Kd vs 6.0 months for Vd (hazard ratio (HR), 0.65; 95% confidence interval (CI), 0.45-0.92; P=0.0075). Median PFS in the standard-risk group was not estimable for Kd vs 10.2 months for Vd (HR, 0.44; 95% CI, 0.33-0.58; P<0.0001). Overall response rates were 72.2% (Kd) vs 58.4% (Vd) in the high-risk group and 79.2% (Kd) vs 66.0% (Vd) in the standard-risk group. In the high-risk group, 15.5% (Kd) vs 4.4% (Vd) achieved a complete response (CR) or better. In the standard-risk group, 13.0% (Kd) vs 7.9% (Vd) achieved ⩾CR. This preplanned subgroup analysis found that Kd was superior to Vd in relapsed or refractory MM, regardless of cytogenetic risk.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Recuperativa / Resistencia a Antineoplásicos / Mieloma Múltiple / Recurrencia Local de Neoplasia Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Leukemia Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2017 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Recuperativa / Resistencia a Antineoplásicos / Mieloma Múltiple / Recurrencia Local de Neoplasia Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Leukemia Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2017 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Reino Unido