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Panobinostat plus bortezomib and dexamethasone in relapsed/relapsed and refractory myeloma: outcomes by prior treatment

02-dic-2015 | Revista: Blood

Richardson PG (1), Hungria VT (2), Yoon SS (3), Beksac M (4), Dimopoulos MA (5), Elghandour A (6), Jedrzejczak WW (7), Guenther A (8), Na Nakorn T (9), Siritanaratkul N (10), Schlossman RL (11), Hou J (12), Moreau P (13), Lonial S (14), Lee JH (15), Einsele H (16), Sopala M (17), Bengoudifa BR (17), Corrado C (17), Binlich F (18), San-Miguel JF (19). (1) Dana-Farber Cancer Institute, Boston, MA, United States; paul_richardson@dfci.harvard.edu.
(2) Irmandade da Santa Casa de Misericordia de Sao Paulo, Sao Paulo, Brazil;
(3) Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, Republic of;
(4) Ankara University School of Medicine, Ankara, Turkey;
(5) National and Kapodistrian University of Athens, Athens, Greece;
(6) Alexandria University, Alexandria, Egypt;
(7) Medical University of Warsaw, Warsaw, Poland;
(8) Division of Stem Cell Transplantation and Immunotherapy, 2nd Department of Medicine, University Hospital Schleswig-Holstein and University of Kiel, Kiel, Germany;
(9) King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand;
(10) Siriraj Hospital, Bangkok, Thailand;
(11) Dana-Farber Cancer Institute, Boston, MA, United States;
(12) Chang Zheng Hospital, Shanghai, China;
(13) University Hospital of Nantes, Nantes, France;
(14) Winship Cancer Institute, Emory University, Atlanta, GA, United States;
(15) Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Korea, Republic of;
(16) Medizinische Klinik und Poliklinik II, University of Wuerzburg, Wuerzburg, Germany;
(17) Novartis Pharma AG, Basel, Switzerland;
(18) Novartis Pharma SAS, Rueil-Malmaison, France;
(19) Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.


RESUMEN

Panobinostat is a potent pan-deacetylase inhibitor that affects the growth and survival of multiple myeloma (MM) cells through alteration of epigenetic mechanisms and protein metabolism. Panobinostat plus bortezomib and dexamethasone (PAN-BTZ-Dex) led to a significant increase in progression-free survival (PFS) vs placebo plus bortezomib and dexamethasone (Pbo-BTZ-Dex) in patients with relapsed or relapsed and refractory MM in the phase 3 PANORAMA 1 trial.

This subgroup analysis evaluated outcomes of patients in the PANORAMA 1 trial based on prior treatment: prior IMiD (n = 485); prior bortezomib plus IMiD (n = 193); and ≥ 2 prior regimens including bortezomib and an IMiD (n = 147). Median PFS for PAN-BTZ-Dex vs Pbo-BTZ-Dex across subgroups were as follows: prior IMiD (12.3 vs 7.4 months; hazard ratio [HR] 0.54; 95% CI, 0.43-0.68), prior bortezomib plus IMiD (10.6 vs 5.8 months; HR 0.52; 95% CI, 0.36-0.76), and ≥ 2 prior regimens including bortezomib and an IMiD (12.5 vs 4.7 months; HR 0.47; 95% CI, 0.31-0.72). Common grade 3/4 adverse events and laboratory abnormalities in patients who received PAN-BTZ-Dex across the prior treatment groups included thrombocytopenia, lymphopenia, neutropenia, diarrhea, and asthenia/fatigue.

Incidence of on-treatment deaths among patients who received prior bortezomib and IMiD (regardless of number of prior regimens) were similar between treatment arms.

This analysis demonstrated a clear PFS benefit of 7.8 months for PAN-BTZ-Dex among patients who received ≥ 2 prior regimens including bortezomib and an IMiD, a population with limited treatment options and poorer prognosis.

CITA DEL ARTÍCULO  Blood. 2015 Dec 2. pii: blood-2015-09-665018.

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