Authors: 335 111 RIVER ST, HOBOKEN 07030-5774, NJ USA; 2-s2.0-85112378393 33739461

Journal: Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy||Italy

Published: cc-by

DOI: University of Ferrara||University of Ferrara||GIMEMA Foundation||GIMEMA Foundation||University of Padua||Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano||ASST Grande Ospedale Metropolitano Niguarda||Ospedale Ca’ Foncello||Cardarelli Hospital||A.O.U. Città della Salute e della Scienza di Torino||Milano||Università del Piemonte Orientale||ARNAS “G. Brotzu”||Fondazione IRCCS Policlinico San Matteo||Rovigo General Hospital||Ospedale S. Maria della Misericordia||Dipartimento Internistico Struttura Complessa di Ematologia Ospedale civile SS Antonio e Biagio||Ospedale degli Infermi||University of Verona||Fondazione Policlinico Universitario A Gemelli. Roma IRCCS||University of Modena and Reggio Emilia||Cardinal Massaia Hospital||‘Sapienza’ University||GIMEMA Foundation||GIMEMA Foundation||A.O. of Cosenza||ASST Grande Ospedale Metropolitano Niguarda||‘Sapienza’ University||University of Ferrara||Azienda Universitaria Ospedaliera Policlinico Vittorio Emanuele||San Bortolo Hospital||A.O. Ospedali Riuniti Papardo-Piemonte||Hematology Unit Ospedale dell’Angelo||Università Politecnica delle Marche||Azienda Ospedaliera Pugliese-Ciaccio||Federico II Università||Ospedale V. Cervello||Azienda USL-IRCCS||Hematology Unit Azienda Ospedaliera Universitaria Senese University of Siena||Hospital “A.Tortora,”||“Ospedale C. e G. Mazzoni”||Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS||Guglielmo da Saliceto Hospital||St. Anna University Hospital||ASST Grande Ospedale Metropolitano Niguarda||GIMEMA Foundation||University of Padua||Cardarelli Hospital

Volume: Rigolin G.M.; Cavazzini F.; Piciocchi A.; Arena V.; Visentin A.; Reda G.; Zamprogna G.; Cibien F.; Vitagliano O.; Coscia M.; Farina L.; Gaidano G.; Murru R.; Varettoni M.; Paolini R.; Sportoletti P.; Pietrasanta D.; Molinari A.L.; Quaglia F.M.; Laurenti L.; Marasca R.; Marchetti M.; Mauro F.R.; Crea E.; Vignetti M.; Gentile M.; Montillo M.; Foa R.; Cuneo A.; Chiarenza A.; Perbellini O.; Mannina D.; Sancetta R.; Olivieri A.; Molica S.; Pane F.; Patti C.; Iliariucci F.; Gozzetti A.; Califano C.; Galieni P.; Augello A.F.; Vallisa D.; Cura F.; Frustaci A.M.; Fazi P.; Trentin L.; Ferrara F., Issue: 2021, Pages: Rigolin||Cavazzini||Piciocchi||Arena||Visentin||Reda||Zamprogna||Cibien||Vitagliano||Coscia||Farina||Gaidano||Murru||Varettoni||Paolini||Sportoletti||Pietrasanta||Molinari||Quaglia||Laurenti||Marasca||Marchetti||Mauro||Crea||Vignetti||Gentile||Montillo||Foà||Cuneo||Chiarenza||Perbellini||Mannina||Sancetta||Olivieri||Molica||Pane||Patti||Iliariucci||Gozzetti||Califano||Galieni||Augello||Vallisa||Cura||Frustaci||Fazi||Trentin||Ferrara-Because the efficacy of new drugs reported in trials may not translate into similar results when used in the real-life, we analyzed the efficacy of idelalisib and rituximab (IR) in 149 patients with relapsed/refractory chronic lymphocytic leukemia treated at 34 GIMEMA centers. Median progression-free survival (PFS) and overall survival were 22.9 and 44.5 months, respectively; performance status (PS) ≥2 and ≥3 previous lines of therapy were associated with shorter PFS and overall survival (OS). 48% of patients were on treatment at 12 months; the experience of the centers (≥5 treated patients) and PS 0–1 were associated with a significantly longer treatment duration (p = 0.015 and p = 0.002, respectively). TP53 disruption had no prognostic significance. The overall response rate to subsequent treatment was 49.2%, with median OS of 15.5 months and not reached in patients who discontinued, respectively, for progression and for toxicity (p < 0.01). Treatment breaks ≥14 days were recorded in 96% of patients and adverse events mirrored those reported in trials. In conclusion, this real-life analysis showed that IR treatment duration was longer at experienced centers, that the ECOG PS and ≥3 lines of previous therapy are strong prognostic factor and that the overall outcome with this regimen was superimposable to that reported in a randomized trial.