Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

Richardson P. G., Schjesvold F., Weisel K., Moreau P., Anderson L. D., White D., ...Daha Fazla

EUROPEAN JOURNAL OF HAEMATOLOGY, cilt.108, sa.1, ss.73-83, 2022 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 108 Sayı: 1
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1111/ejh.13706
  • Dergi Adı: EUROPEAN JOURNAL OF HAEMATOLOGY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, EMBASE, MEDLINE, Veterinary Science Database
  • Sayfa Sayıları: ss.73-83
  • Anahtar Kelimeler: aged, chromosome aberrations, multiple myeloma, pomalidomide, renal insufficiency, RELAPSED/REFRACTORY MULTIPLE-MYELOMA, LOW-DOSE DEXAMETHASONE, HIGH-RISK CYTOGENETICS, COMBINATION
  • Gazi Üniversitesi Adresli: Evet

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.