Abstract
Simple SummaryIdelalisib, the first-in-class phosphatidylinositol 3-kinase inhibitor, approved by the Italian Medicines Agency for the treatment of relapsed/refractory follicular lymphoma patients, showed high antitumor activity with an acceptable safety profile in a phase II registration trial. A 6-year follow-up of the same trial did not reveal any new safety concerns, confirming the role of idelalisib as an effective option for indolent non-Hodgkin lymphoma, refractory to previous therapies. The aim of this multicenter study is to point out the role of idelalisib in a real-life context, since data from everyday clinical practices are scarce. We report the effective and manageable safety profile of idelalisib in the treatment of 72 relapsed/refractory follicular lymphoma patients, bringing further demonstrations of its role in this setting.Follicular lymphoma (FL) is an indolent hematological disease, often responsive to the first line of treatment, but characterized by repeated relapses. The therapeutic algorithm for relapsed/refractory FL patients comprises phosphatidylinositol 3-kinase inhibitors. Idelalisib showed anticancer activity, while inducing a significant rate of toxicities. Since the evidence in the literature on its use in normal clinical practice is scarce, a retrospective multicenter study was conducted to evaluate effectiveness and tolerability in a real-life context. Seventy-two patients with a median age at diagnosis of 57.2 years—mostly with an advanced stage (88.9%) and relapsed to the most recent therapy (79.1%)—were enrolled. The median number of prior therapies was three (20.8% refractory to the last therapy before idelalisib). With a median number of 4 months of treatment, the overall response rate was 41.7% (20.8% complete responses). Median disease-free survival and overall survival were achieved at 8.4 months and at 4 years, respectively. Forty-four percent of patients experienced at least one drug-related toxicity: 6.9% hematological ones and 43% non-hematological. The study confirmed that idelalisib has anticancer effectiveness and an acceptable safety profile in relapsed/refractory FL with unfavorable prognostic characteristics, even in the context of normal clinical practice.
Highlights
Follicular lymphoma (FL) is the second most frequent lymphoma in Western countries (5–7/100.000 per year), representing about 20% of all non-Hodgkin lymphomas (NHL)and at least 70% of indolent NHL subtypes [1]
Criteria for non-Hodgkin lymphomas [19], and we considered 1 cycle equal to 30 days
Bendamustine was administered in 35 patients; cyclophosphamide was given to 70.8% patients (35 received cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen, and 16 received a cyclophosphamide, vincristine, and prednisone (CVP) regimen)
Summary
Follicular lymphoma (FL) is the second most frequent lymphoma in Western countries (5–7/100.000 per year), representing about 20% of all non-Hodgkin lymphomas (NHL)and at least 70% of indolent NHL subtypes [1]. Despite its indolent course that leads to an excellent overall survival (OS), FL remains in most cases an incurable disease characterized by multiple relapses that require further treatment. In this setting, much remains to be accomplished in order to identify predictive markers that can guide the choice and sequence of treatments. Twentyfour months of maintenance rituximab can prolong progression free survival (PFS), but not OS, in those patients who obtained at least a partial response (PR) with first-line treatment [5]. In the second-line setting, autologous stem cell transplantation (ASCT) still has a role as a consolidation therapy for young patients who obtained a disease remission with salvage chemo-immunotherapy [6]. Lenalidomide in combination with rituximab (R2 ) was approved by the Italian Medicines Agency (AIFA)
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