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RESEARCH PRODUCT

Evaluation of Safety, Tolerability and Efficacy of Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma (REL/REFR MCL) in the Usual Health Care Setting

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ABSTRACT Background Temsirolimus (TEMS), an mTOR-inhibitor, is approved the EU for the treatment of patients (pts) with relapsed or refractory MCL (rel/refr). A pivotal study demonstrated significantly longer progression free survival with TEMS (175mg weekly for 3 weeks followed by 75mg weekly) in rel/refr MCL pts compared to investigatoŕs choice therapy (4.8 mo vs 1.9 mo; P = .0009). To better identify safety and efficacy of TEMS in an unselected patient population during clinical routine a prospective non-interventional study with TEMS in rel/refr MCL-pts was started. Here we report on interim results of the study. Methods A registry for rel/refr MCL pts treated with TEMS was started in Germany in Oct 2009 (NCT00700258). Primary objective: evaluation of the safety profile of TEMS, secondary objectives: tolerability and anti-tumor activity of TEMS, patient's profile and the sequence of systemic therapies. Results 29 pts have been recruited in 12 active centers until Apr 2012. Baseline characteristics are available for 23 pts: 69.6% male; median age 72.1 yrs; ECOG PS 0 or 1 in 74%, ECOG PS 2 in 26% of the pts; MIPI score: 13.0%, 30.4%, and 56.5% of the pts are classified as low, intermediate and high risk at the time of enrollment; Bone marrow involvement: 47.8% of the pts. Median time between diagnosis and start oft treatment with TEMS is 36 months. The median number of prior therapies is 5 with 65.2% treated in ≥5th line. Most frequent adverse events are leucopenia, anaemia and thrombocytopenia. Severe adverse events (drug related) are general, metabolism, psychiatric disorders and infections (in 2 pts each), thrombocytopenia, leukocytosis, skin and renal disorder (in 1 pt each). Preliminary efficacy analyses (n = 18) shows a clinical benefit in 7 pts, PD in 5 pts and 6 pts are not assessable. Median PFS (assessable pts) is 157 days. Conclusions This registry was started to evaluate the safety and efficacy of TEMS in pts with rez/refr MCL in the clinical routine. Though the here included pts are more heavily pretreated TEMS shows a predictable, acceptable toxicity and efficacy remains comparable with phase III-data. Disclosure G. Krekeler: Employee of Pfizer Pharma GmbH Germany C. Herzberg: Employee of Pfizer Pharma GmbH M.H. Dreyling: Pfizer: Scientific advisory Board, speaker's honoraria, support of IITs G. Hess: Research funding and speaker honoraria from Pfizer D. Kalanovic: Employee of Pfizer Pharma GmbH, Germany.