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• W2476672392 abstract "8045 Background: The randomized phase 3 ASPIRE trial demonstrated an improvement in median progression-free survival (PFS) for KRd compared with Rd in patients with RMM (26.3 months vs 17.6 months, P = 0.0001) (Stewart AK et al. N Engl J Med. 2015;372:142–52). In this post hoc analysis of ASPIRE, we studied KRd vs Rd in patients with early disease progression in the first prior line. Methods: Patients were ≥ 18 years old, had RMM, and received 1–3 prior lines. Patients were randomized 1:1 to 28-day cycles of KRd or Rd. Carfilzomib was given on days 1, 2, 8, 9, 15, and 16 during cycles 1–12 and days 1, 2, 15, and 16 during cycles 13–18 (27 mg/m2 [20 mg/m2 on days 1, 2 of cycle 1]). Patients in both arms received lenalidomide 25 mg on days 1–21 and dexamethasone 40 mg on days 1, 8, 15, and 22. The following subgroups were analyzed: patients who relapsed ≤ 1 year from starting the first line of prior therapy (early relapsers) and patients who relapsed ≤ 1 year from the first prior transplant (post-transplant early relapsers). Results: Relapse ≤ 1 year from starting the first prior regimen occurred for 87/396 patients in the KRd arm and 72/396 patients in the Rd arm. Median PFS for early relapsers was 24.1 months for KRd vs 12.5 months for Rd (hazard ratio [HR]: 0.75; 95% confidence interval [CI]: 0.50–1.13), and overall response rate (ORR) was 79.3% for KRd vs 61.1% for Rd ( ≥ complete response[CR], 21.8% vs 4.2%). Relapse ≤ 1 year from first prior transplant occurred for 48 KRd and 49 Rd patients. Median PFS for post-transplant early relapsers was 17.3 months for KRd vs 11.1 months for Rd (HR: 0.87; 95% CI: 0.54–1.41), and ORR was 83.3% for KRd vs 61.2% for Rd ( ≥ CR, 12.5% vs 4.1%). Grade ≥ 3 adverse events that occurred ≥ 5% more frequently in KRd than Rd (in either subgroup) were hypokalemia, neutropenia, febrile neutropenia, hypophosphatemia, and respiratory tract infection. Conclusions: In this post hoc subgroup analysis, addition of K to Rd led to clinically meaningful improvements in PFS and ORR in RMM patients who had early progression following prior therapy (including transplant) and may have more aggressive disease. Clinical trial information: NCT01080391." @default.
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• W2476672392 date "2016-05-20" @default.
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• W2476672392 title "Carfilzomib, lenalidomide, and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) in patients with relapsed multiple myeloma (RMM) and early progression during prior therapy: Secondary analysis from the phase 3 study ASPIRE (NCT01080391)." @default.
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