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Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post-authorization safety cohort study conducted in Europe and in the United States

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Vera Ehrenstein
  • Kui Huang, Pfizer
  • ,
  • Johnny Kahlert
  • Shahram Bahmanyar, Karolinska Institutet
  • ,
  • Pär Karlsson, Karolinska Institutet
  • ,
  • Lukas Löfling, Karolinska Institutet
  • ,
  • Anthony P. Nunes, Optum
  • ,
  • Cheryl Enger, Optum
  • ,
  • Irene D. Bezemer, PHARMO Institute, Utrecht
  • ,
  • Josephina G. Kuiper, PHARMO Institute, Utrecht
  • ,
  • Fabian Hoti, EPID Research
  • ,
  • Rosa Juuti, EPID Research
  • ,
  • Pasi Korhonen, EPID Research
  • ,
  • Jingping Mo, Pfizer
  • ,
  • Stephen E. Schachterle, Pfizer, City University of New York
  • ,
  • Keith D. Wilner, Pfizer
  • ,
  • Mikael Rørth
  • Henrik T. Sørensen

Purpose: We examined safety outcomes of interest (SOI) and overall survival (OS) among lung cancer patients initiating crizotinib and erlotinib in routine clinical practice. Methods: This descriptive cohort study used routinely collected health data in Denmark, Finland, Sweden, the Netherlands, and the United States (US) during 2011–2017, following crizotinib commercial availability in each country. Among crizotinib or erlotinib initiators, we reported baseline characteristics and incidence rates and cumulative incidences of the SOI – hepatotoxicity, pneumonitis/interstitial lung disease, QT interval prolongation-related events, bradycardia, vision disorders, renal cysts, edema, leukopenia, neuropathy, photosensitivity, malignant melanoma, gastrointestinal perforation, cardiac failure and OS. Results from the European Union (EU) countries were combined using meta-analysis; results from the US were reported separately. Results: There were 456 patients in the crizotinib cohort and 2957 patients in the erlotinib cohort. Rates of the SOI per 1000 person-years in the crizotinib cohort ranged from 0 to 65 in the EU and from 0 to 374 in the US. Rates of the SOI per 1000 person-years in the erlotinib cohort ranged from 0 to 91 in the EU and from 3 to 394 in the US. In the crizotinib cohort, 2-year OS was ~50% in both EU and US. In the erlotinib cohort, 2-year OS was 21% in the EU and 35% in the US. Conclusions: This study describes clinical outcomes among lung cancer patients initiating crizotinib or erlotinib in routine clinical practice. Differences between SOI rates in EU and US may be partially attributable to differences in the underlying databases.

OriginalsprogEngelsk
TidsskriftPharmacoepidemiology and Drug Safety
Vol/bind30
Nummer6
Sider (fra-til)758-769
Antal sider12
ISSN1053-8569
DOI
StatusUdgivet - jun. 2021

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