The mTOR Inhibitor Temsirolimus Added to Rituximab Combined With Dexamethasone, Cytarabine, and Cisplatinum (R-DHAP) for the Treatment of Patients With Relapsed or Refractory DLBCL – Results From the Phase-II STORM Trial

There is a high need for novel treatment options in relapsed and refractory diffuse large B-cell lymphoma. Single agent mammalian target of rapamycin (mTOR) inhibitor has shown promising efficacy this entity. Here, we report on the results mTOR-inhibitor temsirolimus combined to standard rituximab-DHAP salvage regimen prospective, multicenter, phase II, open-label study. The STORM consisted rituximab 375 mg/m2 (day 2) DHAP (dexamethasone 40 mg day 3-6, cisplatinum 100 3, cytarabine 2 × g/m2 4) with added 1 8 21-day cycle, 4 cycles planned. In part I, dose levels 25, 50, 75, were predefined. Based observed toxicity profile, 25 was defined as recommended II extension cohort trial. intention-to-treat comprised 53 patients. Median age 63 years median number prior 1. All but patient had exposure. Temsirolimus 50 6 patients from I trial remaining 47 general, well tolerated leucopenia thrombocytopenia most frequent severe adverse events. overall response rate after last cycle R-DHAP 66% 24% complete responses. ability mobilize stem cells not impaired by regimen. Twenty-eight received consolidation high-dose therapy (HDT) cell transplantation. duration reached. total 2-year progression-free survival (PFS) (OS) 53% 59%. Patients who consolidated HDT achieved PFS OS 77.8% 82.1%, respectively. We conclude that can be safely activity.