4.4 Article

Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group

期刊

HEMATOLOGICAL ONCOLOGY
卷 39, 期 3, 页码 326-335

出版社

WILEY
DOI: 10.1002/hon.2861

关键词

chronic lymphocytic leukemia; idelalisib; real‐ world evidence

资金

  1. Universita degli Studi di Ferrara [FAR 2018, 2019, 2020]
  2. Associazione Italiana Contro le Leucemie -Linfomi e Mieloma

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In a real-life analysis of 149 patients with relapsed/refractory chronic lymphocytic leukemia, the efficacy of idelalisib and rituximab (IR) showed longer progression-free survival at experienced centers, with performance status and number of previous therapy lines being strong prognostic factors.
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.

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