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RealGiDo: A Real-World Study of Afatinib Dose Adjustment

Afatinib Dose Adjustment in Clinical Practice

A global, multicentre medical chart review of first-line afatinib* dose adjustment in real-world clinical practice in patients with advanced epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

Trial NCT02751879


Advanced, EGFR mutation-positive, tyrosine kinase inhibitor-naïve NSCLC

Common EGFR mutations (del19, L858R)

Treatment with afatinib according to the approved label



Treatment with afatinib with a reduced starting dose (≤30 mg), dose reduction (<40 mg) or no dose reduction (≥40 mg)


Primary outcome measures:

  • Percentage of patients with adverse drug reactions by severity
  • Time to treatment failure (time on treatment)
  • Time to progression


Secondary outcome measure:

  • Percentage of patients with a modified starting dose, the reason for this and the outcome


  • Real-world afatinib dose adjustments reduced the frequency and intensity of adverse drug reactions without affecting effectiveness
  • In patients who started with ≤30 mg afatinib, the overall incidence of adverse drug reactions was similar to that in patients who started on ≥40 mg, with fewer Grade 3 (17% vs 25%) and no Grade 4 adverse drug reactions
  • Median time on treatment and time to progression was 18.7 and 20.8 months, respectively. This was not affected by reduced starting dose or dose modifications


Real-world afatinib dose adjustment is effective to help manage side effects, without compromising effectiveness.


1 (Accessed: May 2018).


Halmos B, et al. ASCO 2018 (Abstract e21060).


Halmos B, et al. Poster presented at WCLC 2018 (Poster P1.01-28).

*Afatinib is approved in more than 80 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information.


© 2018 Boehringer Ingelheim International GmbH. All rights reserved.


Last updated: October 2018