PMID- 31282227
OWN - NLM
STAT- MEDLINE
DCOM- 20190904
LR  - 20190904
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 18
IP  - 9
DP  - 2019 Sep
TI  - Oral antineoplastic agents: assessment of safety and dose adjustments in clinical 
      practice.
PG  - 861-868
LID - 10.1080/14740338.2019.1641197 [doi]
AB  - Objectives: Although the safety profile of oral antineoplastic agents (OAAs) is 
      better than that of classic chemotherapy, the rate of severe adverse events (AEs) 
      is high. The objective was to assess the reasons for adjustments to treatment 
      with OAAs during the first 100 days of treatment. Methods: The authors performed 
      a prospective observational study of cancer outpatients who initiated OAAs 
      between November 2015 and October 2017. Dose reductions and treatment 
      interruptions were closely followed-up during the first 100 days after the 
      beginning of treatment with an OAA. The authors described the different safety 
      profile of different OAA classes. Results: The authors included 443 patients (31 
      different OAA assessed), of whom 53.0% required their OAA to be adjusted during 
      the first 100 days of treatment. A total of 151 patients required dose reductions 
      and/or interruptions of OAAs owing to AEs. The authors identified 203 AEs in 
      these patients. Treatment with sorafenib, lower ECOG performance status, and 
      first-line treatment were associated with a higher proportion of treatment 
      adjustments due to AEs. Conclusion: These results in clinical practice could be a 
      first approach to help healthcare professionals to design patient monitoring 
      programs by identifying priority patients and drugs, and remarks the importance 
      of pharmacovigilance in OAAs.
FAU - Escudero-Vilaplana, Vicente
AU  - Escudero-Vilaplana V
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Revuelta-Herrero, Jose Luis
AU  - Revuelta-Herrero JL
AUID- ORCID: 0000-0003-2071-8928
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Collado-Borrell, Roberto
AU  - Collado-Borrell R
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Marzal-Alfaro, Belen
AU  - Marzal-Alfaro B
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Gimenez-Manzorro, Alvaro
AU  - Gimenez-Manzorro A
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Herranz-Alonso, Ana
AU  - Herranz-Alonso A
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
FAU - Sanjurjo-Saez, Maria
AU  - Sanjurjo-Saez M
AD  - a Pharmacy Department, Hospital General Universitario Gregorio Maranon, Instituto 
      de Investigacion Sanitaria Gregorio Maranon , Madrid , Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20190715
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antineoplastic Agents)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug Monitoring/methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - *Pharmacovigilance
MH  - Prospective Studies
MH  - Sorafenib/administration & dosage
OTO - NOTNLM
OT  - Adverse event
OT  - dosage
OT  - oral antineoplastic agent
OT  - pharmacovigilance
OT  - safety
EDAT- 2019/07/10 06:00
MHDA- 2019/09/05 06:00
CRDT- 2019/07/09 06:00
PHST- 2019/07/10 06:00 [pubmed]
PHST- 2019/09/05 06:00 [medline]
PHST- 2019/07/09 06:00 [entrez]
AID - 10.1080/14740338.2019.1641197 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2019 Sep;18(9):861-868. doi: 10.1080/14740338.2019.1641197. 
      Epub 2019 Jul 15.