Publicaciones científicas
Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: a subanalysis of OPTIMISMM by clinical characteristics
Paul G Richardson 1 , Fredrik Schjesvold 2 , Katja Weisel 3 , Philippe Moreau 4 , Larry D Anderson Jr 5 , Darrell White 6 , Paula Rodriguez-Otero 7 , Pieter Sonneveld 8 , Monika Engelhardt 9 , Matthew Jenner 10 , Alessandro Corso 1 11 , Jan Dürig 12 , Michel Pavic 13 , Morten Salomo 14 , Meral Beksac 15 , Albert Oriol 16 , Jindriska Lindsay 17 , Anna Marina Liberati 18 , Monica Galli 19 , Pawel Robak 20 , Alessandra Larocca 21 , Munci Yagci 22 , Filiz Vural 23 , Abraham S Kanate 24 , Ruiyun Jiang 25 , Lara Grote 25 , Teresa Peluso 26 , Meletios Dimopoulos 27
Objective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients at first relapse.
Methods: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).
Results: Overall, 226 patients had one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤ 65 years (median, 22.0 vs 13.1 months; P = 0.0258) and > 65 years (median, 17.6 vs 9.9 months; P = 0.0369). Median PFS in patients with renal impairment (RI; creatinine clearance < 60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]).
In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.
Conclusions: These findings confirm that benefits of PVd at first relapse, including in patients with poor prognostic factors.
CITA DEL ARTÍCULO Eur J Haematol. 2022 Jan;108(1):73-83.
doi: 10.1111/ejh.13706. Epub 2021 Sep 22.
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