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InOncology.com

Dose modification

Afatinib* dose adjustment may allow patients with non-small cell lung cancer (NSCLC) to remain on treatment longer, thereby maximising clinical benefit. Post-hoc analyses of the LUX-Lung 3, LUX-Lung 6 and LUX-Lung 7 studies were conducted to evaluate the effect of afatinib dose modifications on efficacy.1,2

Of the patients treated with afatinib, dose reductions occurred in 53% of patients in LUX-Lung 3 and in 28% of patients in LUX-Lung 6. Tolerability-guided dose adjustment of afatinib reduced the incidence and severity of treatment-related adverse events (AEs) without affecting efficacy.1 Median progression-free survival (PFS) in patients who had dose reductions in the first 6 months was found to be similar to that in patients who remained on afatinib 40 mg once daily.1

Similarly, in the Phase IIb LUX-Lung 7 trial of afatinib versus gefitinib, 42% of afatinib-treated patients had tolerability-guided dose reductions and experienced fewer treatment-related AEs without any loss in afatinib efficacy.2

In a single-arm, open-label, Phase II study of first-line afatinib in 46 Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC, afatinib was initially prescribed at 20 mg/day and then, if tolerated, the dose was increased in 10 mg increments up to 50 mg/day.3 In patients with Grade ≥3 or selected prolonged Grade 2 drug-related AEs, the afatinib dose could be reduced 10 mg at a time to a minimum of 20 mg every other day.3 In the 44 patients with a target lesion, the objective response rate (ORR) was 82%.3 In the overall patient group, median PFS was 15.2 months (95% confidence interval [CI]: 13.2–not estimable) and median overall survival (OS) had not yet been reached at the data cut-off (median follow-up was 18.9 months).Low-dose afatinib treatment was well tolerated.3

PFS outcomes for patients with and without dose reductions in LUX-Lung 3 and 6

LUX-Lung 3: figure for PFS in patients with and without dose reductions

CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.

LUX-Lung 6: figure for PFS in patients with and without dose reductions

CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.

Treatment-related AEs requiring tolerability-guided dose modification in LUX-Lung 31

LUX-Lung 3: adverse events requiring dose modification

Treatment-related AEs requiring tolerability-guided dose modification in LUX-Lung 61

LUX-Lung 6: adverse events requiring dose modification

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References

1

Yang JC, et al. Ann Oncol 2016;27(11):2103–10.

2

Hirsh V, et al. J Clin Oncol 2016;34(Suppl.):Abstract 9046.

3

Fujimoto D, et al. Poster presented at ESMO Asia 2017 (Poster 465P).

*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 click here. Registration conditions differ internationally; please refer to locally approved prescribing information.

 

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Last updated: October 2018