Lenalidomide may be safe and effective for patients with relapsed or refractory mantle cell lymphoma ineligible to receive intensive chemotherapy or hematopoietic cell transplantation (HCT) compared with investigator’s choice of monotherapy, a study published in the journal The Lancet Oncology has shown.1
Lenalidomide is a thalidomide analogue already indicated for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after 2 prior therapies, including bortezomib. For this phase 2 study, researchers sought to evaluate the efficacy and safety of lenalidomide vs investigator’s choice of single-agent therapy in the relapsed or refractory setting.
In the SPRINT trial, researchers enrolled 254 patients with relapsed or refractory mantle cell lymphoma who were ineligible to undergo intensive chemotherapy or HCT and had an ECOG performance status of 0 to 2. Patients had received a median of 2 previous regimens.
Participants were randomly assigned 2:1 to receive lenalidomide 25 mg orally on days 1-21 every 28 days until disease progression or unacceptable toxicity, or single-agent investigator’s choice of chlorambucil, cytarabine, fludarabine, gemcitabine, or rituximab.
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Results of the prespecified primary analysis showed that after a median follow-up of 15.9 months, median progression-free survival was 8.7 months (95% CI, 5.5 – 12.1) compared with 5.2 months (95% CI, 3.7 – 6.9) with investigator’s choice (HR, 0.61; 95% CI, 0.44 – 0.84; P = .004).
In terms of safety, the most common grade 3 or 4 adverse events were neutropenia (without increased risk of infection), thrombocytopenia, leukopenia, and anemia.
- Trnĕný M, Lamy T, Walewski J, et al. Lenalidomide versus investigator’s choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial [published online ahead of print February 15, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00559-8.