@article{17caf37101ab4921aa5d62b37bcc3b9e,
title = "Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group",
abstract = "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.",
keywords = "Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Purines, Quinazolinones, Recurrence, Rituximab, Survival Rate, chronic lymphocytic leukemia, idelalisib, real-world evidence, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Purines, Quinazolinones, Recurrence, Rituximab, Survival Rate, chronic lymphocytic leukemia, idelalisib, real-world evidence",
author = "Luca Laurenti and Vincenzo Arena and Crea, {Attilio Elio Giuseppe} and Marino Gentile and Robin Foa and Rigolin, {Gian Matteo} and Francesco Cavazzini and Alfonso Piciocchi and Valentina Arena and Andrea Visentin and Gianluigi Reda and Giulia Zamprogna and Francesca Cibien and Orsola Vitagliano and Marta Coscia and Lucia Farina and Gianluca Gaidano and Roberta Murru and Marzia Varettoni and Rossella Paolini and Paolo Sportoletti and Daniela Pietrasanta and Molinari, {Anna Lia} and Quaglia, {Francesca M.} and Roberto Marasca and Monia Marchetti and Mauro, {Francesca R.} and Enrico Crea and Marco Vignetti and Massimo Gentile and Marco Montillo and Robin Fo{\`a} and Antonio Cuneo and Annalisa Chiarenza and Omar Perbellini and Donato Mannina and Rosaria Sancetta and Attilio Olivieri and Stefano Molica and Fabrizio Pane and Caterina Patti and Fiorella Iliariucci and Alessandro Gozzetti and Catello Califano and Piero Galieni and Augello, {Accursio Fabio} and Daniele Vallisa and Francesca Cura and Frustaci, {Anna Maria} and Paola Fazi and Livio Trentin and Felicetto Ferrara",
year = "2021",
doi = "10.1002/hon.2861",
language = "English",
volume = "39",
pages = "326--335",
journal = "Hematological Oncology",
issn = "0278-0232",
publisher = "[Chichester ; New York] : John Wiley & Sons, Ltd.",
}