Abstract
BackgroundMantle cell lymphoma (MCL) is an aggressive and incurable lymphoma. Standard of care for younger patients with MCL is induction chemotherapy followed by autologous stem cell transplantation (auto-HCT). Rituximab maintenance after auto-HCT has been shown to improve progression-free survival (PFS) and overall survival (OS) in MCL. Bortezomib maintenance therapy has also been shown to be tolerable and feasible in this setting. However, the combination of bortezomib and rituximab as maintenance therapy post-auto-HCT has not been studied.MethodsWe conducted a multicenter, phase II trial of bortezomib given in combination with rituximab as maintenance in MCL patients after consolidative auto-HCT. Enrolled patients (n = 23) received bortezomib 1.3 mg/m2 subcutaneously weekly for 4 weeks every 3 months (up to 24 months) and rituximab 375 mg/m2 intravenously weekly for 4 weeks every 6 months (up to 24 months) for a total duration of 2 years. The primary study endpoint was disease-free survival (DFS).ResultsWith a median follow-up of 35.9 months, the 2-year DFS probability was 90.2% (95% CI 66–97), and 2-year OS was 94.7% (95% CI 68–99). The most frequent grade 3/4 toxic events were neutropenia (in 74% of patients) and lymphopenia (in 35%). The incidence of peripheral neuropathy was 48% for grade 1, 9% for grade 2, and 0% for grade 3/4. We also examined the role of quantitative cyclin D1 (CCND1) mRNA in monitoring minimal residual disease.ConclusionCombined bortezomib and rituximab as maintenance therapy in MCL patients following auto-HCT is an active and well-tolerated regimen.Trial registrationClinicalTrials.govNCT01267812, registered Dec 29, 2010.
Highlights
Mantle cell lymphoma (MCL) is an aggressive and incurable lymphoma
The 2-year disease-free survival (DFS) was 93.8% and the 2-year overall survival (OS) was 92.3% for the 19 patients who received induction therapy followed by auto-HCT and rituximab/bortezomib maintenance in CR1
In this multicenter phase II prospective trial, we showed that the combination of rituximab and bortezomib as maintenance therapy post-consolidative auto-HCT is feasible, well tolerated, and yielded a 2-year DFS of 90.2%
Summary
Mantle cell lymphoma (MCL) is an aggressive and incurable lymphoma. Standard of care for younger patients with MCL is induction chemotherapy followed by autologous stem cell transplantation (auto-HCT). Mantle cell lymphoma (MCL) is an aggressive lymphoma characterized by chromosomal translocation t(11;14) (q13;q32) resulting in overexpression of cyclin D1. It accounts for approximately 6% of all non-Hodgkin lymphomas and has a median overall survival of less than 10 years [1]. Consolidative autologous stem cell transplantation (auto-HCT) following induction chemotherapy has been shown to prolong progression-free survival (PFS) and is currently the standard of care for younger patients with MCL [2,3,4,5]. Le Gouill et al showed in a randomized trial that rituximab maintenance can prolong PFS and overall survival (OS) in patients with MCL post consolidative auto-HCT [7]. We explored the use of quantitative CCND1 mRNA values to monitor disease
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