Cargando…
Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we repor...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617295/ https://www.ncbi.nlm.nih.gov/pubmed/31248142 http://dx.doi.org/10.3390/jcm8060877 |
_version_ | 1783433659752120320 |
---|---|
author | Conticello, Concetta Romano, Alessandra Del Fabro, Vittorio Martino, Enrica Antonia Calafiore, Valeria Sapienza, Giuseppe Leotta, Valerio Parisi, Marina Silvia Markovic, Uros Garibaldi, Bruno Leotta, Salvatore Cotzia, Emilia Innao, Vanessa Mannina, Donato Neri, Santo Musso, Maurizio Scalone, Renato Cangialosi, Clotilde Acquaviva, Francesco Cardinale, Giovanni Merenda, Anxur Maugeri, Cinzia Uccello, Giuseppina Poidomani, Massimo Longo, Giuseppe Carlisi, Melania Tibullo, Daniele Di Raimondo, Francesco |
author_facet | Conticello, Concetta Romano, Alessandra Del Fabro, Vittorio Martino, Enrica Antonia Calafiore, Valeria Sapienza, Giuseppe Leotta, Valerio Parisi, Marina Silvia Markovic, Uros Garibaldi, Bruno Leotta, Salvatore Cotzia, Emilia Innao, Vanessa Mannina, Donato Neri, Santo Musso, Maurizio Scalone, Renato Cangialosi, Clotilde Acquaviva, Francesco Cardinale, Giovanni Merenda, Anxur Maugeri, Cinzia Uccello, Giuseppina Poidomani, Massimo Longo, Giuseppe Carlisi, Melania Tibullo, Daniele Di Raimondo, Francesco |
author_sort | Conticello, Concetta |
collection | PubMed |
description | Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we report real life results of KRd given to 130 RRMM patients from 12 Sicilian Centers. Results: Median age was 62 years; patients had received a median of two previous lines of treatment (range 1–10) and 52% were refractory to previous treatment. Median number of KRd cycles was 12 (2–29), with a mean duration of treatment of 12 months; 21 patients had received at least 18 cycles. Overall response rate was 61%, including 18% complete response. Median PFS was 22.9 months, median OS was not reached. Creatinine clearance >30 mL/min, quality of the best achieved response and standard Fluorescence In Situ Hybridization (FISH) risk were independent predictors of favorable outcome. Patients who received the full-dosage of carfilzomib in the first two cycles had a better outcome. Conclusions: KRd was effective and well tolerated and in a considerable proportion of patients, therapy continued beyond the 18th cycle. The finding of a better outcome in patients with the higher cumulative dose of carfilzomib in the first two cycle encourages to maintain the maximum tolerated dose. |
format | Online Article Text |
id | pubmed-6617295 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-66172952019-07-18 Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network Conticello, Concetta Romano, Alessandra Del Fabro, Vittorio Martino, Enrica Antonia Calafiore, Valeria Sapienza, Giuseppe Leotta, Valerio Parisi, Marina Silvia Markovic, Uros Garibaldi, Bruno Leotta, Salvatore Cotzia, Emilia Innao, Vanessa Mannina, Donato Neri, Santo Musso, Maurizio Scalone, Renato Cangialosi, Clotilde Acquaviva, Francesco Cardinale, Giovanni Merenda, Anxur Maugeri, Cinzia Uccello, Giuseppina Poidomani, Massimo Longo, Giuseppe Carlisi, Melania Tibullo, Daniele Di Raimondo, Francesco J Clin Med Article Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we report real life results of KRd given to 130 RRMM patients from 12 Sicilian Centers. Results: Median age was 62 years; patients had received a median of two previous lines of treatment (range 1–10) and 52% were refractory to previous treatment. Median number of KRd cycles was 12 (2–29), with a mean duration of treatment of 12 months; 21 patients had received at least 18 cycles. Overall response rate was 61%, including 18% complete response. Median PFS was 22.9 months, median OS was not reached. Creatinine clearance >30 mL/min, quality of the best achieved response and standard Fluorescence In Situ Hybridization (FISH) risk were independent predictors of favorable outcome. Patients who received the full-dosage of carfilzomib in the first two cycles had a better outcome. Conclusions: KRd was effective and well tolerated and in a considerable proportion of patients, therapy continued beyond the 18th cycle. The finding of a better outcome in patients with the higher cumulative dose of carfilzomib in the first two cycle encourages to maintain the maximum tolerated dose. MDPI 2019-06-19 /pmc/articles/PMC6617295/ /pubmed/31248142 http://dx.doi.org/10.3390/jcm8060877 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Conticello, Concetta Romano, Alessandra Del Fabro, Vittorio Martino, Enrica Antonia Calafiore, Valeria Sapienza, Giuseppe Leotta, Valerio Parisi, Marina Silvia Markovic, Uros Garibaldi, Bruno Leotta, Salvatore Cotzia, Emilia Innao, Vanessa Mannina, Donato Neri, Santo Musso, Maurizio Scalone, Renato Cangialosi, Clotilde Acquaviva, Francesco Cardinale, Giovanni Merenda, Anxur Maugeri, Cinzia Uccello, Giuseppina Poidomani, Massimo Longo, Giuseppe Carlisi, Melania Tibullo, Daniele Di Raimondo, Francesco Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title | Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title_full | Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title_fullStr | Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title_full_unstemmed | Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title_short | Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network |
title_sort | feasibility, tolerability and efficacy of carfilzomib in combination with lenalidomide and dexamethasone in relapsed refractory myeloma patients: a retrospective real-life survey of the sicilian myeloma network |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617295/ https://www.ncbi.nlm.nih.gov/pubmed/31248142 http://dx.doi.org/10.3390/jcm8060877 |
work_keys_str_mv | AT conticelloconcetta feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT romanoalessandra feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT delfabrovittorio feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT martinoenricaantonia feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT calafiorevaleria feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT sapienzagiuseppe feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT leottavalerio feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT parisimarinasilvia feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT markovicuros feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT garibaldibruno feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT leottasalvatore feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT cotziaemilia feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT innaovanessa feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT manninadonato feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT nerisanto feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT mussomaurizio feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT scalonerenato feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT cangialosiclotilde feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT acquavivafrancesco feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT cardinalegiovanni feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT merendaanxur feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT maugericinzia feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT uccellogiuseppina feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT poidomanimassimo feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT longogiuseppe feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT carlisimelania feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT tibullodaniele feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork AT diraimondofrancesco feasibilitytolerabilityandefficacyofcarfilzomibincombinationwithlenalidomideanddexamethasoneinrelapsedrefractorymyelomapatientsaretrospectivereallifesurveyofthesicilianmyelomanetwork |