Abstract
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Objectives FDG-PET response was measured in a prospective phase 2 trial of BR in MCL, an aggressive non-Hodgkin lymphoma (NHL). MCL relapse remains high; chemoresistance and comorbidities are common in elderly patients (pts).
Methods This multicenter, open-label, single-arm study included 45 CD20-positive, B-cell MCL pts: median age 70y (range, 48-88y); 71% male; 91% stage III-IV, 47% relapsed, 53% refractory; MCL International Prognostic Index (MIPI) risk category low (n=24), intermediate (n=12), high (n=9). Overall response rate (ORR: complete response [CR]+partial response [PR]) was assessed after six 28-day cycles (C) of BR per 2007 IWG criteria. For all 45 pts, ORR by CT was 82% (40% CR, 42% PR). ORR was similar for MIPI ≤3 and 4-5 (92% for both), but 58% with MIPI ≤3 achieved CR vs 42% with MIPI 4-5. Median progression-free survival (PFS) was 17.2 (range, 0.03-45.4) mo; 1-y PFS was 67%. Toxicities were similar to prior NHL studies. Deauville response criteria were used for centrally read FDG-PET at baseline/after C6; SUVmax was measured in ≤6 index lesions. Univariate/multivariate logistic regression will be used to identify potential predictors for survival.
Results 32 pts had FDG-PET at baseline and C6; all 32 were positive on staging FDG-PET. After 6 C, 24 (75%) had CR, 7 PR, and 1 progressed (ORR 97%). Differences were seen in posttreatment tumor volume, SUVmax, SUVsum, SUVdelta, and response by the Deauville scale. An analysis of baseline and FDG-PET-response characteristics predictive of survival will be presented.
Conclusions BR showed clinically relevant efficacy and adequate tolerability as MCL salvage therapy. Posttreatment FDG-PET may be a more sensitive and accurate indicator of response to therapy in both relapsed/refractory and advanced disease, pending completed analysis of PFS and overall survival. This may provide useful clinical-practice insight.
Research Support Teva BPP R&D, Inc.
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