Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide‐pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
Makaleler > Tam Makale · 2021
Yazarlar: Paul G. Richardson, Fredrik Schjesvold, Katja Weisel, Philippe Moreau, Larry D. Anderson, Darrell White, Paula Rodriguez-Otero, Pieter Sonneveld, Monika Engelhardt, Matthew Jenner, Alessandro Corso, Jan Duerig, Michel Pavic, Morten Salomo, MERAL BEKSAÇ, Albert Oriol, Jindriska Lindsay, Anna Marina Liberati, Monica Galli, Pawel Robak, Alessandra Larocca, Munci Yagci, Filiz VURAL, Abraham S. Kanate, Ruiyun Jiang, Lara Grote, Teresa Peluso, Meletios Dimopoulos
European Journal of Haematology, SCI Expanded İndekslerine Giren Dergi, Uluslararası, Wos, 2021, cilt 108, ss 73-83
DOI: 10.1111/ejh.13706
Özet
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 with multiple myeloma 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 received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .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 confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.