PMID- 32844487
OWN - NLM
STAT- MEDLINE
DCOM- 20210709
LR  - 20210709
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 29
IP  - 10
DP  - 2020 Oct
TI  - Real-world effectiveness of pembrolizumab in previously treated non-small cell 
      lung cancer: A population-based cohort study.
PG  - 1295-1302
LID - 10.1002/pds.5091 [doi]
AB  - PURPOSE: Immunotherapy is promising for lung cancer treatment, although at 
      significant financial impact. The aim of this study was to evaluate the 
      effectiveness and the efficacy-effectiveness gap of pembrolizumab in previously 
      treated non-small cell lung cancer (NSCLC). METHODS: A population-based 
      ambispective cohort study was conducted. Cases of interest were identified 
      through the National Cancer Registry database and additional data sources. 
      Patients aged >/=18 years, diagnosed with NSCLC and exposed to pembrolizumab, 
      between 23 June 2016 and 31 October 2018, as second or later lines of treatment 
      for advanced disease were included. Patients were followed-up until death or 
      cut-off date (30 April 2019). Primary outcome was overall survival (OS). 
      Secondary outcomes were progression-free survival (PFS), event-free survival 
      (EFS), and adverse events (AEs) leading to treatment discontinuation. The 
      efficacy-effectiveness gap was evaluated comparing results with clinical trial 
      data. RESULTS: A total of 181 patients were included. Median age was 63 years 
      (range 33-94); 74.6% were male. Median treatment duration was 5.6 months 
      (interquartile range: 1.4-10.4) and, at cut-off date, treatment had been 
      discontinued in 141 patients, mainly due to disease progression. Median OS was 
      13.0 months (95% confidence interval [CI] 9.3-15.9) and 1-year OS was 53.1% (95% 
      CI 45.2%-60.3%). Median PFS was 5.6 months (95% CI 4.6-7.2), median EFS was 
      4.7 months (95% CI 3.2-6.0), and treatment was discontinued due to AE in 8.3% of 
      cases (n = 15). The efficacy-effectiveness gap seems to favor pembrolizumab use 
      in clinical practice. CONCLUSION: Real-world data suggest the performance of 
      pembrolizumab to reflect the clinical trial outcomes in previously treated NSCLC.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Murteira, Rodrigo
AU  - Murteira R
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - Borges, Fabio Cardoso
AU  - Borges FC
AUID- ORCID: 0000-0001-8496-9211
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - Mendes, Goncalo Pinto
AU  - Mendes GP
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - Ramos, Catarina
AU  - Ramos C
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - Ramos, Adriana
AU  - Ramos A
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - Soares, Patricia
AU  - Soares P
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
AD  - Statistics & Epidemiology, National School of Public Health, Lisbon, Portugal.
FAU - Furtado, Claudia
AU  - Furtado C
AD  - Health Technology Assessment Department, National Authority of Medicines and 
      Health Products (INFARMED), Lisbon, Portugal.
FAU - Miranda, Ana
AU  - Miranda A
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
FAU - da Costa, Filipa Alves
AU  - da Costa FA
AUID- ORCID: 0000-0003-0562-2514
AD  - National Cancer Registry (RON), Portuguese Institute of Oncology of Lisbon 
      Francisco Gentil (IPOLFG), Lisbon, Portugal.
AD  - Social Pharmacy Department, Faculty of Pharmacy, University of Lisbon, Lisbon, 
      Portugal.
CN  - RON Network
LA  - eng
PT  - Journal Article
DEP - 20200825
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - DPT0O3T46P (pembrolizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Antineoplastic Agents, Immunological/*administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Cohort Studies
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Immunotherapy/methods
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Survival Rate
MH  - Treatment Outcome
OTO - NOTNLM
OT  - cancer registries
OT  - effectiveness
OT  - non-small cell lung cancer
OT  - pembrolizumab
OT  - pharmacoepidemiology
OT  - real-world data
EDAT- 2020/08/28 06:00
MHDA- 2021/07/10 06:00
CRDT- 2020/08/27 06:00
PHST- 2019/12/30 00:00 [received]
PHST- 2020/05/12 00:00 [revised]
PHST- 2020/07/13 00:00 [accepted]
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2021/07/10 06:00 [medline]
PHST- 2020/08/27 06:00 [entrez]
AID - 10.1002/pds.5091 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1295-1302. doi: 10.1002/pds.5091. 
      Epub 2020 Aug 25.