secondary endpoints. Patients and Methods: Between 8/2011 and 2/2017, 102 pts that received BV were reported. Median age was 32 (range, 16‐73), 56 (55%) were primary refractory. Sixty‐six (65%) received… Click to show full abstract
secondary endpoints. Patients and Methods: Between 8/2011 and 2/2017, 102 pts that received BV were reported. Median age was 32 (range, 16‐73), 56 (55%) were primary refractory. Sixty‐six (65%) received BV after ASCT failure, and 39 of these relapsed in the first year. The median number of previous treatment was 3 (range, 2‐7). At the time of initiation of BV, 79 (77%) were resistant to the last line of therapy. BV was indicted at 1.8 mg/kg as IV infusion. Seventy‐eight (77%) received BV as monotherapy, and 24 (23%) received BV combined with chemotherapy of which 19/24 was with bendamustine (BvB). For the pts that received BV as monotherapy, the median number of cycles was 6.5 (1‐16), only 6 pts received all 16 cycles. The median time of first assessment of response was after 4 cycles. Four patients had dose reduction due to toxicity. Results: Seventy‐one patients treated with Bv as monotherapy were evaluated for response. The most common adverse events (AE) for were nauseas, vomiting and diarrhea (24%), infections (26%), peripheral sensory neuropathy (21%), and neutropenia (16%), 21 Grade 3‐4 AE were reported, including 1 seizure, 1 aseptic meningitis, and 1 cerebral syndrome in 3 pts treatedwith BVB. The overall response (CR + PR) was 60% with 22 (31%) pts achieving a CR, 21 (29.6%) pts a PR, and 8 pts showed progressive disease. With a median follow‐up of 13 months, the PFS and OS at 24 months was 30% and 78% for all pts. For pts in CR, the PFS at 24 months was 82%. In a multivariate analysis for obtaining CR after BV considering: Bulky disease, dose density of treatment, 2 vs more than 2 lines of prior treatment and primary or early relapse vs late relapse, the only significant prognostic factors were being primary refractory or having a first relapse within the first year (P = .019). Of the 19 patients that received BVB, 15 were evaluable at the time of this analysis, and they were analyzed separately. The ORR for this group was 80% with 5pts (33%) achieving a CR and 7 (47%) PR. Conclusions: This is the first and only retrospective multicenter trial showing the Argentine experience with brentuximab. Our findings add to the growing body of evidence supporting the efficacy of Bv as monotherapy and the high ORR and CR of the combination of BvB and warrant a confirmatory randomized trial to re‐ examine the benefit of this drug combination over BV as monotherapy.
               
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