Afatinib’s real-world evidence

Real-world evidence demonstrates therapy effectiveness under a clinical setting, complementing data obtained from controlled clinical trials.1,2

 

Clinical trials are necessary for establishing comparative efficacy and safety under optimal conditions.However, they can be limited in terms of extrapolation to the general public.This is where real-world evidence is useful, indicating the level of success across the whole patient population without controlled variables.1,2

 

  • Real-world studies include everyday patients with characteristics which might otherwise preclude them from participation in randomised controlled trials3
  • Real-world studies can help to identify rare or late AEs1,3
  • Real-world studies and randomised controlled trials have different set ups and priorities2

 

An overview of some of the studies providing real-world evidence for afatinib are described in the table below. Discover how patients in real-world clinical practice benefited from afatinib.

Description Primary Endpoint Selected

Secondary Endpoint

EGFR M+; 1st-line and 2st-line in patients with T790M resistance

A real-world study of sequencial afatinib and osimertinib treatment

GioTag study4

TTF

Type and proportion of acquired resistance mechanisms after osimertinib treatment

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EGFR M+ advanced NSCLC; 1st-line

A real-world study of the impact of dose modification on afatinib safety and effectiveness

RealGiDo study5

Percentage of patients with ADRs; TTF; TTP

Percentage of patients receiving modified starting dose and the reasons why

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GioTag study

EGFR M+; 1st-line and 2st-line in patients with T790M resistance

A real-world study of sequencial afatinib and osimertinib treatment


Primary Endpoint: TTF

Selected Secondary Endpoint: Type and proportion of acquired resistance mechanisms after osimertinib treatment

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RealGiDo study5

EGFR M+ advanced NSCLC; 1st-line

A real-world study of the impact of dose modification on afatinib safety and effectiveness


Primary Endpoint: Percentage of patients with ADRs; TTF; TTP

Selected Secondary Endpoint: Percentage of patients receiving modified starting dose and the reasons why

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ADRs=adverse drug reactions; EGFR M+=epidermal growth factor receptor mutation positive; TTF=time to treatment failure; TTP=time to progression.


References

1
Khozin S, et al. J Natl Cancer Inst 2017;109(11):1–5.
2
Roche N, et al. Ann Am Thorac Soc 2014;11Suppl2:99–104.
3
Sherman RE et al. N Engl J Med 2016; 375(23):2293–2297.
4
Hochmair MJ, et al. Future Oncol 2018;doi:10.2217/fon-2018-0711.
5
Halmos B, et al. Lung Cancer 2019;127:103–111.