Abstract
A phase II trial evaluated safety, feasibility and efficacy of a sequential tandem approach combining myeloablative BEAM chemotherapy and autologous stem cell transplantation (ASCT) with myeloablative radioimmunotherapy (HD-RIT), with (131)I-anti-CD20 antibody ((131)I-rituximab), followed by a second ASCT in patients with relapsed or refractory CD20+ B-cell lymphoma. According to protocol, 16 patients with relapsed (n = 14) and refractory (n = 2) CD20+ B-cell lymphoma received salvage therapy with rituximab and Dexa-BEAM, followed by BEAM (HD chemotherapy) and high-dose myeloablative radioimmunotherapy 2-6 months after BEAM. Nine of 16 patients received HD-RIT; seven patients were excluded before HD-RIT because of toxicity or progressive disease. Disease histologies were follicular lymphoma (FL) grades 1 and 2 (n = 4), transformed follicular (FL 3b; n = 6), diffuse large B-cell (DLBCL; n = 4), mantle cell (n = 1) and marginal zone lymphoma (n = 1). After a median follow-up of 50.4 months for OS and 39.7 months for progression-free survival (PFS), estimated 4-year OS and PFS were 67% and 64%, respectively. The estimated 4-year OS and PFS for patients with FL were 80% and 78%, respectively. Toxicity was significant, including one fatal outcome due to pneumonitis. Tandem transplants consisting of HD chemotherapy followed by HD-RIT with (131)I-coupled anti-CD20 are manageable and effective but toxic treatment modalities for relapsed poor prognosis CD20+ B-NHL.
Highlights
The incorporation of monoclonal anti-CD20 antibody treatment has improved the outcome of patients with B-cell lymphoma [1, 2]; the prognosis of relapsed or refractory B-cell lymphoma patients [3, 4], even in the rituximab era [5, 6], is still poor
high-dose chemotherapy (HDC) as front line consolidation in follicular and mantle cell lymphoma (MCL) leads to a significant improvement of the progression-free survival (PFS), but not to a prolonged overall survival compared to a conventional chemotherapy followed by interferon maintenance [9, 10]
Non-randomized phase II trial, we evaluated the safety and efficacy of a sequential approach of HDC with BEAM and autologous stem cell transplantation (ASCT) followed by a consolidation with myeloablative radioimmunotherapy with 131I-antiCD20 antibody and second ASCT
Summary
The incorporation of monoclonal anti-CD20 antibody treatment has improved the outcome of patients with B-cell lymphoma [1, 2]; the prognosis of relapsed or refractory B-cell lymphoma patients [3, 4], even in the rituximab era [5, 6], is still poor. Complete remissions can be achieved by R-CHOP treatment in approximately 80% of patients with diffuse large B-cell lymphoma (DLBCL). Forty percent of these patients remain in a durable complete remission, 40% experience a relapse and 20% are primary refractory. In relapsed aggressive lymphoma before the era of rituximab, a randomized study of high-dose chemotherapy (HDC) combined with autologous stem cell transplantation (ASCT) versus conventional salvage therapy for patients with chemo-sensitive disease demonstrated a superior 5-year event-free survival for HDC (46% versus 12%, p=0.001). HDC as front line consolidation in follicular and MCL leads to a significant improvement of the PFS, but not to a prolonged overall survival compared to a conventional chemotherapy followed by interferon maintenance [9, 10]
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