Study design   |   Safety   |   TTF

 

RealGiDo real-world evidence study

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

The RealGiDo study is a global study of afatinib 1st-line which analysed the impact of afatinib dose adjustments on effectiveness and safety in EGFR M+ NSCLC patients.3

It confirmed the results seen in clinical trials, demonstrating that afatinib dose adjustments reduce AEs without affecting efficacy.35

 

Learn more about how real-world evidence can complement clinical trial data.

Read the full RealGiDo study publication.


Study design

Global, non-interventional, observational study assessing afatinib dose modification effectiveness as a means of reducing ADRs and impact on outcome. Medical records of 228 patients with EGFR mutations prescribed afatinib 1st-line as part of routine care were assessed. Primary outcomes were to assess the effects of afatinib dose modification on the frequency and severity of ADRS, time on treatment and time to progression with afatinib in the real-world setting and compare with data from the LUX-Lung 3 trial in a descriptive manner. Secondary outcomes were the percentage of patients receiving a modified starting dose of afatinib, and reasons for modifying the starting dose.3

Study population

 

  • 44% (n=100), 42% (n=96), 1% (n=3) and 13% (n=29) of patients were of Asian, Caucasian, other or had missing ethnicity, respectively3
  • 12% (n=19) of all patients had an ECOG PS score of 2–33
  • 32% (n=73) of patients had a modified starting dose of afatinib: 1% (n=2), 30% (n=69) and 1% (n=2) starting on a 50 mg/day, 30 mg/day and 20 mg/day dose, respectively3*

Safety

Afatinib dose modifications reduced the incidence and severity of ADRs in real-world clinical practice3

RealGiDo study: incidence of ADRs before and after dose modification3

Adapted from Halmos B, et al. 2018.3


TTF

Afatinib maintained consistent effectiveness regardless of dose modification3

RealGiDo study: median time to treatment failure with afatinib3

Adapted from Halmos B, et al. 2018.3

  • Median TTF was 18.7 months, which was not impacted by starting dose or dose modifications3*

* The recommended starting dose for afatinib is 40mg once daily

AEs=adverse events, ECOG PS=Eastern Cooperative Oncology Group performance status; EGFR M+=epidermal growth factor receptor mutation positive; ADR=adverse drugs reaction; mTTF=median time to treatment failure


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
Halmos B, et al. Lung Cancer 2018;127:103–111.
4
Yang JC, et al. Ann Oncol 2016;27(11):2103–2110.
5
Hirsh V, et al. First-line afatinib versus gefitinib for patients with EGFR mutation-positive NSCLC (LUX-Lung 7): patient-reported outcomes and impact of dose modifications on efficacy and adverse events. ASCO. 3–7 June 2016. Chicago, IL, USA. Poster: 369.