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Plasma Cell Disorders
Carfilzomib, cyclophosphamide and dexamethasone for newly diagnosed, high-risk myeloma patients not eligible for transplant: a pooled analysis of two studies
Ferrata Storti Foundation
1Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero- Universitaria Città della Salute e della Scienza di Torino, Torino; 2Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome; 3Università degli Studi di Perugia, Struttura Complessa Universitaria Oncoematologia - Azienda Ospedaliera Santa Maria di Terni, Terni; 4Division of Hematology, AOU Policlinico-OVE, University of Catania, Catania; 5Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia; 6Hematology Unit, IRCCS- CROB, Rionero in Vulture (PZ); 7Clinica di Ematologia, Università Politecnica delle Marche, Ancona; 8Hematology, Città della Salute e della Scienza, Turin; 9Division of Hematology, Ospedale “C. e G. Mazzoni”, ASUR Marche-AV5, Ascoli Piceno; 10"Seràgnoli" Institute of Hematology, Bologna University School of Medicine, Bologna; 11UOC Ematologia, Ospedale S. Eugenio, ASLRM2, Rome; 12Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milano and 13Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy
Roberto Mina,1 Francesca Bonello,1 Maria Teresa Petrucci,2
Anna Marina Liberati,3 Concetta Conticello,4 Stelvio Ballanti,5
Pellegrino Musto,6° Attilio Olivieri,7 Giulia Benevolo,8 Andrea Capra,1
Milena Gilestro,1 Piero Galieni,9 Michele Cavo,10 Agostina Siniscalchi,11
Antonio Palumbo,1° Vittorio Montefusco,12 Gianluca Gaidano,13 111
Haematologica 2021 Paola Omedé, Mario Boccadoro and Sara Bringhen Volume 106(4):1079-1085
°PM is currently at the Department of Emergency and Organ Transplantation, "Aldo Moro" University School of Medicine, Unit of Hematology and Stem Cell Transplantation, AOU Consorziale Policlinico, Bari.
°AP is currently a GlaxoSmithKline AG employee.
ABSTRACT
Despite remarkable advances in the treatment of multiple myeloma (MM) in the last decades, the prognosis of patients harboring high- risk cytogenetic abnormalities remains dismal as compared to that of standard-risk patients. Proteasome inhibitors have been demonstrated to partially ameliorate the prognosis of high-risk patients. We pooled together data from two phase I/II trials on transplant-ineligible patients with MM receiving upfront carfilzomib cyclophosphamide and dexamethasone fol- lowed by carfilzomib maintenance. The aim of this analysis was to com- pare treatment outcomes in patients with standard-risk versus high-risk cytogenetic abnormalities detected by fluorescence in situ hybridization (FISH) analysis. High risk was defined by the presence of at least one chro- mosomal abnormality, including t(4;14), del17p and t(14;16). Overall, 94 patients were included in the analysis: 57 (61%) in the standard-risk and 37 (39%) in the high-risk group. Median follow-up was 38 months. In stan- dard-risk versus high-risk patients, we observed similar progression-free sur- vival (PFS) (3-year PFS: 52% vs. 43%, respectively; P=0.50), overall survival (OS) (3-year OS: 78% vs. 73%; P=0.38), and overall response rate (88% vs. 95%; P=0.47), with no statistical differences between the two groups. No difference in terms of PFS was observed between patients with or without del17p. Carfilzomib, used both as induction and maintenance agent for transplant-ineligible newly diagnosed MM patients, mitigated the poor prognosis carried by high-risk cytogenetics and resulted in similar PFS and OS as in standard-risk patients. (Registered at clinicaltrials.gov identifiers: NCT01857115 [IST-CAR-561] and NCT01346787 [IST-CAR-506].)
Correspondence:
SARA BRINGHEN
sarabringhen@yahoo.com
Received: November 21, 2019. Accepted: February 19, 2020. Pre-published: February 27, 2020.
https://doi.org/10.3324/haematol.2019.243428
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