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.
Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group / 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.. - In: HEMATOLOGICAL ONCOLOGY. - ISSN 0278-0232. - 39:3(2021), pp. 326-335. [10.1002/hon.2861]
Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group
Marasca R.;
2021
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.File | Dimensione | Formato | |
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