PMID- 29860707
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20210216
IS  - 2210-7711 (Electronic)
VI  - 40
IP  - 4
DP  - 2018 Aug
TI  - Using a cancer registry to capture signals of adverse events following immune and 
      targeted therapy for melanoma.
PG  - 852-861
LID - 10.1007/s11096-018-0665-1 [doi]
AB  - Background Toxicity of oncology treatments in real-life patients is frequently 
      disregarded and hence underreported. Objective To characterize adverse events 
      (AEs) of immunotherapy and targeted therapy reported in patients with locally 
      advanced or metastatic melanoma. Setting District Hospital for Cancer treatment 
      (Instituto Portugues de Oncologia de Lisboa Francisco Gentil). Method A 
      retrospective cohort of melanoma patients was established, comprising adult 
      patients diagnosed with malignant melanoma treated with immunotherapy or targeted 
      therapy. Exposure was characterized by nature, time and intensity of exposure. To 
      account for different exposure periods, person-time was used as unit of analysis. 
      Main outcomes measure Occurrence of AEs. Results Data from 111 patients included 
      in the cohort indicates the majority received immunotherapy regimens (CTLA-4, 
      anti-PD-1 and combination therapy; (n = 70; 63.1%), among which anti-PD-1 were 
      the predominant treatment. Pembrolizumab was the most frequently prescribed drug 
      (n = 30; 45.7%). Three hundred and seventy-one AEs were extracted. The incidence 
      of AEs was lower in the anti-PD-1 mAc group (54 AEs per 1000 person.months) and 
      the number of AEs/patient was also lower (3.1 +/- 2.0). Grade 3 to 4 AEs occurred 
      in 15.3% (n = 17) of the cohort, being more common in the targeted therapy group. 
      Forty-two (11.6%) of the extracted AEs were not described in the Summary of 
      Product Characteristics of the drugs under study. Conclusion This study suggests 
      various known and unknown AEs of immunotherapy and targeted therapy may be 
      identified using the Cancer Registry database. These events should be considered 
      as signals worth further investigation for assessment of causality as the 
      underreporting of AEs in cancer may have potential implications for the patient's 
      quality of life.
FAU - Aguiar, Joao P
AU  - Aguiar JP
AD  - iMED.ULisboa - Research Institute for Medicines, Faculdade de Farmacia, 
      Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003, Lisbon, Portugal.
FAU - Cardoso Borges, Fabio
AU  - Cardoso Borges F
AD  - Registo Oncologico Regional Sul (ROR-Sul), Instituto Portugues de Oncologia de 
      Lisboa Francisco Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - Murteira, Rodrigo
AU  - Murteira R
AD  - Registo Oncologico Regional Sul (ROR-Sul), Instituto Portugues de Oncologia de 
      Lisboa Francisco Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - Ramos, Catarina
AU  - Ramos C
AD  - Registo Oncologico Regional Sul (ROR-Sul), Instituto Portugues de Oncologia de 
      Lisboa Francisco Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - Gouveia, Emanuel
AU  - Gouveia E
AD  - Servico de Oncologia Medica, Instituto Portugues de Oncologia de Lisboa Francisco 
      Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - Passos, Maria Jose
AU  - Passos MJ
AD  - Servico de Oncologia Medica, Instituto Portugues de Oncologia de Lisboa Francisco 
      Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - Miranda, Ana
AU  - Miranda A
AD  - Registo Oncologico Regional Sul (ROR-Sul), Instituto Portugues de Oncologia de 
      Lisboa Francisco Gentil, R. Prof. Lima Basto, Lisbon, Portugal.
FAU - da Costa, Filipa Alves
AU  - da Costa FA
AUID- ORCID: 0000-0003-0562-2514
AD  - Registo Oncologico Regional Sul (ROR-Sul), Instituto Portugues de Oncologia de 
      Lisboa Francisco Gentil, R. Prof. Lima Basto, Lisbon, Portugal. 
      facosta@ipolisboa.min-saude.pt.
AD  - Centro de Investigacao Interdisciplinar Egas Moniz (CiiEM), Campus Universitario, 
      Quinta da Granja, Monte da Caparica, 2829-551, Caparica, Portugal. 
      facosta@ipolisboa.min-saude.pt.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20180602
PL  - Netherlands
TA  - Int J Clin Pharm
JT  - International journal of clinical pharmacy
JID - 101554912
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Protein Kinase Inhibitors)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Immunological/*adverse effects
MH  - Data Mining/methods
MH  - Drug-Related Side Effects and Adverse 
      Reactions/diagnosis/*epidemiology/prevention & control
MH  - Female
MH  - Humans
MH  - Immunotherapy/*adverse effects
MH  - Male
MH  - Melanoma/diagnosis/*drug therapy/epidemiology
MH  - Middle Aged
MH  - Molecular Targeted Therapy/*adverse effects
MH  - Patient Safety
MH  - Portugal/epidemiology
MH  - Protein Kinase Inhibitors/*adverse effects
MH  - Registries
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Skin Neoplasms/diagnosis/*drug therapy/epidemiology
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse drug reactions
OT  - Adverse events
OT  - Drug-related side effects and adverse reactions
OT  - Immunotherapy
OT  - Malignant melanoma
OT  - Pharmacovigilance
EDAT- 2018/06/04 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/06/04 06:00
PHST- 2018/01/09 00:00 [received]
PHST- 2018/05/17 00:00 [accepted]
PHST- 2018/06/04 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/06/04 06:00 [entrez]
AID - 10.1007/s11096-018-0665-1 [pii]
AID - 10.1007/s11096-018-0665-1 [doi]
PST - ppublish
SO  - Int J Clin Pharm. 2018 Aug;40(4):852-861. doi: 10.1007/s11096-018-0665-1. Epub 
      2018 Jun 2.