BDR in newly diagnosed patients with WM: final analysis of a phase 2 study after a minimum follow-up of 6 years.

Abstract:

:In this phase 2 multicenter trial, we evaluated the efficacy of the combination of bortezomib, dexamethasone, and rituximab (BDR) in 59 previously untreated symptomatic patients with Waldenström macroglobulinemia (WM), most of which were of advanced age and with adverse prognostic factors. BDR consisted of a single 21-day cycle of bortezomib alone (1.3 mg/m2 IV on days 1, 4, 8, and 11), followed by weekly IV bortezomib (1.6 mg/m2 on days 1, 8, 15, and 22) for 4 additional 35-day cycles, with IV dexamethasone (40 mg) and IV rituximab (375 mg/m2) on cycles 2 and 5, for a total treatment duration of 23 weeks. On intent to treat, 85% responded (3% complete response, 7% very good partial response, 58% partial response). After a minimum follow-up of 6 years, median progression-free survival was 43 months and median duration of response for patients with at least partial response was 64.5 months. Overall survival at 7 years was 66%. No patient had developed secondary myelodysplasia, whereas transformation to high-grade lymphoma occurred in 3 patients who had received chemoimmunotherapy after BDR. Thus, BDR is a very active, fixed-duration, chemotherapy-free regimen, inducing durable responses and with a favorable long-term toxicity profile (www.ClinicalTrials.gov #NCT00981708).

journal_name

Blood

journal_title

Blood

authors

Gavriatopoulou M,García-Sanz R,Kastritis E,Morel P,Kyrtsonis MC,Michalis E,Kartasis Z,Leleu X,Palladini G,Tedeschi A,Gika D,Merlini G,Sonneveld P,Dimopoulos MA

doi

10.1182/blood-2016-09-742411

subject

Has Abstract

pub_date

2017-01-26 00:00:00

pages

456-459

issue

4

eissn

0006-4971

issn

1528-0020

pii

blood-2016-09-742411

journal_volume

129

pub_type

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