PMID- 35354375
OWN - NLM
STAT- MEDLINE
DCOM- 20220804
LR  - 20240102
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 38
IP  - 8
DP  - 2022 Aug
TI  - Real-world safety and supportive care use of second-line 5-fluorouracil-based 
      regimens among patients with metastatic pancreatic ductal adenocarcinoma.
PG  - 1295-1303
LID - 10.1080/03007995.2022.2059976 [doi]
AB  - OBJECTIVE: Chemotherapy-related adverse events (AEs) can negatively impact the 
      care of patients. The prevention and management of AEs often require additional 
      medications. This study evaluated the percentages of patients with metastatic 
      pancreatic ductal adenocarcinoma (mPDAC) undergoing second-line therapy with 
      5-fluorouracil (5-FU)-based regimens that experienced AEs during treatment and 
      received medication to manage those AEs. METHODS: We conducted a retrospective 
      observational analysis utilizing the Flatiron Health database of adult patients 
      with mPDAC who started second-line therapy between January 2016 and August 2020. 
      The occurrence of diarrhea, fatigue, nausea and vomiting, neuropathy, and 
      hematologic AEs including G3/G4 anemia, neutropenia, and thrombocytopenia was 
      assessed. The use of concomitant medications including atropine and granulocyte 
      colony stimulating factor (G-CSF) was assessed. RESULTS: Of the 825 eligible 
      patients, 29.0% (n = 239) received FOLFIRINOX, 24.0% (n = 198) received FOLFOX, 
      6.8% (n = 56) received FOLFIRI, and 40.2% (n = 332) received liposomal 
      irinotecan-based regimens. FOLFIRI and FOLFIRINOX regimens were associated with 
      the highest rates of anemia (16.1% and 15.5%), neutropenia (19.6% and 22.6%), and 
      thrombocytopenia (14.3% and 9.6%). The liposomal irinotecan and FOLFOX regimens 
      were associated with lower rates of anemia (11.8% and 12.1%), neutropenia (12.4% 
      and 14.7%), and thrombocytopenia (2.4% and 8.1%). G-CSF use was observed among 
      63.6%, 34.9%, 33.9%, and 44.9% of patients treated with FOLFIRINOX, FOLFOX, 
      FOLFIRI, and liposomal irinotecan-based regimens, respectively. Diarrhea was 
      observed among 12.5%, 4.5%, 12.5%, and 10.2% of patients who were treated with 
      FOLFIRINOX, FOLFOX, FOLFIRI, and liposomal irinotecan-based regimens, 
      respectively. Nausea and vomiting occurred in 14.9%, 12.6%, 10.5%, and 13.1% of 
      patients treated with FOLFIRINOX, FOLFOX, FOLFIRI, and liposomal irinotecan-based 
      regimens, respectively. Atropine use was higher in patients treated with 
      FOLFIRINOX and FOLFIRI (90.8% and 94.6%, respectively) than in patients treated 
      with liposomal irinotecan-based regimens (75.6%). CONCLUSIONS: In patients with 
      mPDAC who received second-line therapy, those who received liposomal 
      irinotecan-based regimens had the lowest rates of anemia, neutropenia, and 
      thrombocytopenia compared to FOLFIRI, FOLFIRINOX, and FOLFOX, while requiring a 
      similar or lower level of medication to treat and manage those adverse events. 
      Patients treated with FOLFIRI received the highest dose of pegfilgrastim to 
      manage neutropenia. The results of this real-world analysis are consistent with 
      prior evaluations of patients with mPDAC and highlight the importance of managing 
      adverse events and associated cost implications.
FAU - Kim, George
AU  - Kim G
AD  - Division of Hematology & Oncology, George Washington University, Washington, DC, 
      USA.
FAU - Cockrum, Paul
AU  - Cockrum P
AD  - Ipsen, Cambridge, MA, USA.
FAU - Surinach, Andy
AU  - Surinach A
AD  - Genesis Research, Hoboken, NJ, USA.
FAU - Wang, Shu
AU  - Wang S
AD  - Genesis Research, Hoboken, NJ, USA.
FAU - Wainberg, Zev
AU  - Wainberg Z
AD  - Department of Medicine, University of California Los Angeles, Los Angeles, CA, 
      USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220422
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Atropine Derivatives)
RN  - 0 (folfirinox)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 7673326042 (Irinotecan)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - XT3Z54Z28A (Camptothecin)
SB  - IM
MH  - *Adenocarcinoma
MH  - Adult
MH  - *Anemia/chemically induced/drug therapy/epidemiology
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Atropine Derivatives/therapeutic use
MH  - Camptothecin/adverse effects
MH  - Diarrhea/drug therapy
MH  - Fluorouracil/adverse effects
MH  - Granulocyte Colony-Stimulating Factor/therapeutic use
MH  - Humans
MH  - Irinotecan/adverse effects
MH  - Leucovorin/adverse effects
MH  - Nausea/chemically induced
MH  - *Neutropenia/chemically induced/epidemiology
MH  - Oxaliplatin
MH  - *Pancreatic Neoplasms/drug therapy
MH  - Retrospective Studies
MH  - *Thrombocytopenia/chemically induced/drug therapy
MH  - Vomiting/chemically induced
OTO - NOTNLM
OT  - Metastatic pancreatic cancer
OT  - adverse events
OT  - liposomal irinotecan
OT  - real-world evidence
OT  - systemic therapy
EDAT- 2022/04/01 06:00
MHDA- 2022/08/05 06:00
CRDT- 2022/03/31 05:07
PHST- 2022/04/01 06:00 [pubmed]
PHST- 2022/08/05 06:00 [medline]
PHST- 2022/03/31 05:07 [entrez]
AID - 10.1080/03007995.2022.2059976 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2022 Aug;38(8):1295-1303. doi: 10.1080/03007995.2022.2059976. 
      Epub 2022 Apr 22.