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LUX-Lung 3, 6 & 7 clinical data
The most common AEs with GIOTRIF® were generally manageable through supportive care1,2

  • In LUX-Lung 3, 6 & 7, the most common AEs with GIOTRIF® were diarrhoea, stomatitis, rash, acne and paronychia1,2,3

Treatment-related discontinuation due to any AE was low1,2

  • Treatment-related discontinuation rate was 8% for GIOTRIF® versus 12% for pemetrexed/cisplatin in LUX-Lung 3 and 6.3% for GIOTRIF® versus 8% for gemcitabine/cisplatin in LUX-Lung 61,3
  • Treatment-related discontinuation rates were equivalent in both arms (6.3%) in LUX-Lung 72,4

 

LUX-Lung 3 & 6 clinical data
GIOTRIF® dose modification was effective at reducing AE incidence and severity4,5

GIOTRIF® has a manageable AE profile with dose modification proven to reduce AEs without compromising efficacy
  • Dose reductions tended to occur in patients who had higher initial GIOTRIF® plasma concentrations, with tolerability-guided dose modification reducing excessive GIOTRIF® exposure5
  • Dose reductions of <40 mg occurred in 53.3% of patients in the LUX-Lung 3 trial and in 28% of patients in the LUX-Lung 6 trial, with the majority occurring in the first 6 months of treatment (86.1% and 82.1%, respectively)5
  • Tolerability-guided dose adjustment reduced the incidence and severity of drug-related AEs5

LUX-Lung 3, 6 & 7 clinical data
GIOTRIF® dose modification does not affect treatment efficacy4,5

  • No significant difference in PFS in patients who dose-reduced in the first 6 months of treatment compared with those who remained on ≥40 mg in either trial5
  • 11.3 versus 11.0 months (HR=1.25; 95% CI, 0.91–1.72; P=0.175) in LUX-Lung 35
  • 12.3 versus 11.0 months (HR=1.00; 95% CI, 0.69–1.46; P=0.982) in LUX-Lung 65
  • 12.8 versus 11.0 months (HR=1.34; 95% CI, 0.90–2.00, P=0.144) in LUX-Lung 74

AE=adverse event; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival.

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Information about dosing and administration

Information about dosing and administration

Recommended dose6

  • The recommended dose is 40mg, taken orally once daily
  • Multiple tablet strengths are available for dose adjustment 

 

Dose escalation with GIOTRIF®6

Dose escalation with GIOTRIF®6

  • The maximum daily dose is 50mg. The dose should not be escalated in any patients with a prior dose reduction.

Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials.

Yang et al., Ann Oncol. 2016 Nov;27(11):2103-2110.

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References

  1. Sequist LV et al. J Clin Oncol. 2013;31(27):3327-3334.
  2. Park K et al. Lancet Oncol. 2016;17(5):577-589.
  3. Wu YL et al. Lancet Oncol. 2014;15(2):213-222.
  4. Hirsch V et al. Poster #369 presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA; 3-7 June 2016.
  5. Yang JCH et al. Ann Oncol. 2016;27(11):2103-2110.
  6. GIOTRIF® (afatinib) Summary of Product Characteristics, 2016.
  7. Yang JC et al. J Clin Oncol. 2013;31(27):3342-3350. Soria JC et al. Lancet Oncol. 2015;16(8):897-907.
  8. Soria JC et al. Lancet Oncol. 2015;16(8):897-907.
  1. Sequist LV et al. J Clin Oncol. 2013;31(27):3327-3334.

  2. Wu YL et al. Lancet Oncol. 2014;15(2):213-222.

  3. Yang JC et al. Lancet Oncol. 2015;16(2):141-151.

  4. Park K et al. Lancet Oncol. 2016;17(5):577-589.

  5. Soria JC et al. Lancet Oncol. 2015;16(8):897-907.

  6. Solca F et al. J Pharmacol Exp Ther. 2012;343(2):342-350.

  7. Yang JC et al. J Clin Oncol. 2013;31(27):3342-3350.

  8. Hirsch V et al. Poster #369 presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA; 3-7 June 2016.

  9. Yang JCH et al. Ann Oncol. 2016;27(11):2103-2110.

  10. Schuler M et al. J Thorac Oncol. 2016;11(3):380-390.

  11. Paz-Arez L et al. Ann Oncol. 2017; doi: 10.1093/annonc/mdw611.

  12. GIOTRIF® (afatinib) Summary of Product Characteristics, 2016.

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