6533b7d6fe1ef96bd12670e2

RESEARCH PRODUCT

Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma

Wolfram KlapperJohannes AttaUlrich KellerChristian RuckesChristian BuskeSebastian KirscheyChristian ScholzChristoph MedlerGeorg HessC Van OordtMathias Witzens-harigMartin DreylingMatthias Theobald

subject

MaleBendamustineCancer Researchmedicine.medical_specialtyMaximum Tolerated DoseFollicular lymphomaLymphoma Mantle-CellNeutropeniaGastroenterologyAntibodies Monoclonal Murine-Derivedhemic and lymphatic diseasesInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicineMucositisBendamustine HydrochlorideHumansProspective StudiesLymphoma FollicularAgedNeoplasm StagingSirolimusLeukopeniabusiness.industryRemission InductionHematologyMiddle AgedPrognosismedicine.diseaseTemsirolimusSurgerySurvival RateOncologyNitrogen Mustard CompoundsFeasibility StudiesFemaleMantle cell lymphomaRituximabNeoplasm Recurrence LocalSafetymedicine.symptomRituximabbusinessFollow-Up Studiesmedicine.drug

description

In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with r/r follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1-3 prior therapies received Bendamustine (90 mg/m(2), day 1+2) and Rituximab (375 mg/m(2), day 1) with Temsirolimus in doses from 25 to 75 mg added on day 1, 8, 15 of a 28-day cycle. Fifteen (11 MCL, 4 FL) patients were included in the phase I. Median age was 73 years and median pretreatment number was 2. No formal dose-limiting toxicity was observed. Dominant non-hematological side effects were fatigue in 11 (73%), nausea in 9 (60%), mucositis in 7 (47%) and vomiting in 6 patients (40%). Cough, diarrhea, pyrexia and rash were observed in five patients (33%) each. Grade 3/4 events included leukopenia in 6 (40%), neutropenia in 4 (27%) and thrombocytopenia in 2 patients (13%). An objective response was observed in 14/15 patients (93%), including 5 complete response (33%; all MCL). After a median follow-up of 19 months, 67% of patients are without signs of progression. Temsirolimus can be safely added to BR with promising preliminary activity. Recruitment in phase II is ongoing.

yearjournalcountryeditionlanguage
2015-03-13Leukemia
https://doi.org/10.1038/leu.2015.60