The European Commission has approved the mTOR (mammalian target of rapamycin) inhibitor TORISEL(R) (temsirolimus) for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL)in August, 2009. This is based on on results of a phase 3 clinical study that showed patients with relapsed and/or refractory MCL treated with TORISEL experienced a statistically significant improvement in median progression-free survival, compared with single-agent therapy selected by the investigator (4.8 months vs. 1.9 months, P=0.0009). The most frequently occurring severe or life-threatening (Grade 3 or 4) adverse events in patients with relapsed MCL treated with TORISEL included thrombocytopenia, anemia,
With a confirmatory phase III trial, phase II trials and the European Comminsion’s approval, it should not be considered experimental.
Hess G, Herbrecht R, Romaquera R, et al. Phase III study to evaluate temsirolimus compared to investigator’s choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. Journal of Clinical Oncology. 2009;27:3822-3829.
Witzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. Journal of Clinical Oncology. 2005;23:5347-5356.
Ansell SM, Inwards DJ, Rowland KM, et al. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 study trial in the North Central Cancer Treatment Group. Cancer. 2008;113:508-514