Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences
British Journal of Haematology, 08/10/2012
Eve HE et al. – The authors confirm the activity, safety and immunomodulatory properties of lenalidomide in mantle cell lymphoma (MCL) and highlight its potential as a low–dose maintenance agent.Methods
- Twenty-six patients received lenalidomide 25mg/d (days 1–21 of a 28-d cycle) for up to 6 cycles followed by low-dose maintenance lenalidomide (15mg) in responding patients.
- Eight patients achieved complete or partial response to give an overall response rate of 31% with median response duration of 22.2months [95% confidence interval (CI) 0.0–53.6] and median progression-free survival (PFS) of 3.9months (95% CI 0.0–11.1).
- An additional six patients (23%) achieved stable disease.
- Eleven patients received maintenance with median PFS of 14.6 months (95% CI 7.3–21.9).
- Correlative studies showed that peripheral T and Natural Killer (NK) cells increased in responding patients by 40–60% over the first 6 cycles with an initial dip in NK cells suggestive of tumour infiltration.
- Peripheral regulatory T cells were increased in MCL patients (P=0.001) and expanded further following lenalidomide.
- Sequential plasma analysis showed increased IL12 p40 and IL7 alongside decreased MMP9, IL10, and adiponectin.
- Finally, a significant correlation (P=0.02) between gender and response suggested that female MCL patients were more sensitive to lenalidomide than males.