1. Rituximab-PECC induction followed by Y-90-ibritumomab tiuxetan consolidation in relapsed or refractory DLBCL patients who are ineligible for or have failed ASCT: results from a phase II HOVON study
- Author
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Lugtenburg, Pieternella J., Zijlstra, Josee M., Doorduijn, Jeanette K., Bohmer, Lara H., Hoogendoorn, Mels, Berenschot, Henriette W., Beeker, Aart, van der Burg-de Graauw, Nicole C., Schouten, Harry C., Bilgin, Yavuz M., Kersten, Marie-Jose, Koene, Harry R., Herbers, Alexandra H. E., de Jong, Daphne, Hijmering, Nathalie, Lam, King H., Chitu, Dana, Brouwer, Rolf E., and van Imhoff, Gustaaf W.
- Subjects
relapse ,PLUS RITUXIMAB ,IBRITUMOMAB TIUXETAN ,diffuse large B-cell lymphoma ,MULTICENTER ,B-CELL LYMPHOMA ,PECC ,CHEMOTHERAPY ,OPEN-LABEL ,TRIAL ,Y-90-ibritumomab tiuxetan ,COMBINATION ,consolidation ,ELDERLY-PATIENTS ,CHOP - Abstract
Patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after, or ineligible for, autologous stem cell transplantation (ASCT) have a dismal prognosis. This phase II study evaluated treatment with R-PECC (rituximab, prednisolone, etoposide, chlorambucil, lomustine), every 28 days for 4 cycles in 62 patients, followed by radio-immunotherapy consolidation with Y-90-ibritumomab tiuxetan in responsive patients. Primary endpoints were failure-free survival (FFS) and incidence of grade >= 3 adverse events from start of Y-90-ibritumomab tiuxetan. The overall response rate after R-PECC was 50%. Twenty-nine of 31 responsive patients proceeded to Y-90-ibritumomab tiuxetan. Five out of 15 partial remission patients converted to complete remission after Y-90-ibritumomab tiuxetan. One-year FFS and overall survival (OS) from start of Y-90-ibritumomab tiuxetan was 52% (95% confidence interval [CI], 33-68%) and 62% (95% CI, 42-77%), respectively. One-year FFS and OS from start of R-PECC was 28% (95% CI, 17-39%) and 49% (95% CI, 36-61%), respectively. Toxicities of R-PECC and Y-90-ibritumomab tiuxetan were mainly haematological. In conclusion, for relapsed DLBCL patients the largely oral R-PECC regimen achieves promising response rates, combined with an acceptable safety profile. Consolidation with Y-90-ibritumomab tiuxetan resulted in long-term response durations in approximately one third of the patients that received it.
- Published
- 2019