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Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study.
Gordan, Lucio; Chang, Melody; Lafeuille, Marie-Hélène; Romdhani, Hela; Paramasivam, Fuad; Maiese, Eric M; McKay, Caroline.
Affiliation
  • Gordan L; Florida Cancer Specialists, Gainesville, FL, USA.
  • Chang M; Florida Cancer Specialists, Gainesville, FL, USA.
  • Lafeuille MH; Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 1500, Montreal, QC, H3B 0G7, Canada. Marie-Helene.Lafeuille@analysisgroup.com.
  • Romdhani H; Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 1500, Montreal, QC, H3B 0G7, Canada.
  • Paramasivam F; Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 1500, Montreal, QC, H3B 0G7, Canada.
  • Maiese EM; Janssen Scientific Affairs, LLC, Horsham, NJ, USA.
  • McKay C; Janssen Scientific Affairs, LLC, Horsham, NJ, USA.
Drugs Real World Outcomes ; 8(2): 187-195, 2021 Jun.
Article in En | MEDLINE | ID: mdl-33565004
BACKGROUND: Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. OBJECTIVE: This study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions. METHODS: Electronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition. RESULTS: In total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%). CONCLUSIONS: This study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials.

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Guideline / Observational_studies Language: En Journal: Drugs Real World Outcomes Year: 2021 Type: Article Affiliation country: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Guideline / Observational_studies Language: En Journal: Drugs Real World Outcomes Year: 2021 Type: Article Affiliation country: United States