PMID- 33565004
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210528
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 8
IP  - 2
DP  - 2021 Jun
TI  - Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered 
      in a Community Setting: A Retrospective Observational Study.
PG  - 187-195
LID - 10.1007/s40801-020-00226-3 [doi]
AB  - 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.
FAU - Gordan, Lucio
AU  - Gordan L
AD  - Florida Cancer Specialists, Gainesville, FL, USA.
FAU - Chang, Melody
AU  - Chang M
AD  - Florida Cancer Specialists, Gainesville, FL, USA.
FAU - Lafeuille, Marie-Helene
AU  - Lafeuille MH
AD  - Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 
      1500, Montreal, QC, H3B 0G7, Canada. Marie-Helene.Lafeuille@analysisgroup.com.
FAU - Romdhani, Hela
AU  - Romdhani H
AD  - Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 
      1500, Montreal, QC, H3B 0G7, Canada.
FAU - Paramasivam, Fuad
AU  - Paramasivam F
AD  - Analysis Group, Inc., 1190 avenue des Canadiens-de-Montreal, Tour Deloitte Suite 
      1500, Montreal, QC, H3B 0G7, Canada.
FAU - Maiese, Eric M
AU  - Maiese EM
AD  - Janssen Scientific Affairs, LLC, Horsham, NJ, USA.
FAU - McKay, Caroline
AU  - McKay C
AD  - Janssen Scientific Affairs, LLC, Horsham, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20210209
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC8128966
COIS- LG is president and managing physician at Florida Cancer Specialists & Research 
      Institute, president of American Oncology Partners, and a board member of 
      Community Oncology Alliance and Florida Society of Clinical Oncology (FLASCO). MC 
      is director of pharmacy operations at Florida Cancer Specialists & Research 
      Institute, director of pharmacy operations at American Oncology Network, 
      pharmacist liaison at the board of directors of FLASCO, and member of the 
      Oncology Pharmacy Education Network Advisory Committee of the Association of 
      Community Cancer Centers. CM is a former employee of Janssen Scientific Affairs, 
      LLC and may own stocks or stock options. EMM is a former employee of Janssen 
      Scientific Affairs, LLC and may own stocks or stock options. MHL, HR, and FP are 
      employees of Analysis Group, Inc., which provided paid consulting services to 
      Janssen Scientific Affairs, LLC for the conduct of the present study.
EDAT- 2021/02/11 06:00
MHDA- 2021/02/11 06:01
PMCR- 2021/02/09
CRDT- 2021/02/10 05:59
PHST- 2020/12/29 00:00 [accepted]
PHST- 2021/02/11 06:00 [pubmed]
PHST- 2021/02/11 06:01 [medline]
PHST- 2021/02/10 05:59 [entrez]
PHST- 2021/02/09 00:00 [pmc-release]
AID - 10.1007/s40801-020-00226-3 [pii]
AID - 226 [pii]
AID - 10.1007/s40801-020-00226-3 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2021 Jun;8(2):187-195. doi: 
      10.1007/s40801-020-00226-3. Epub 2021 Feb 9.