An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations

Table 5 PFS in patient subgroups

Category	Patient Subgroup
Age, years	< 65 years	≥ 65 years
N	53	35
Patients who progressed or died, n (%)	42 (79)	28 (80)
Median PFS, months (95% CI)	16.6 (12.5–26.8)	20.1 (12.7–23.9)
Brain metastases at screening	Yes	No
N	27	61
Patients who progressed or died, n (%)	23 (85)	47 (77)
Median PFS, months (95% CI)	14.0 (11.0–22.1)	19.2 (12.8–28.0)
EGFR mutation type^a	Common	Uncommon
N	72	16
Patients who progressed or died, n (%)	56 (78)	14 (88)
Median PFS months, (95% CI)	19.2 (14.2–23.9)	9.0 (5.5–20.2)
Afatinib line of therapy	First-line	Second-line
N	66	22
Patients who progressed or died, n (%)	50 (76)	20 (91)
Median PFS, months (95% CI)	20.2 (14.2–27.0)	12.9 (7.2–26.7)
Patients with an afatinib dose reduction^b	No	Yes
N	54	34
Patients who progressed or died, n (%)	41 (76)	29 (85)
Median PFS, months (95% CI)	20.2 (13.6–31.3)	14.2 (11.7–22.1)

CI confidence interval, EGFR epidermal growth factor receptor, PFS progression-free survival
^aCommon mutations indicates patients whose tumors harbor EGFR exon 19 deletions only or L858R substitutions only: uncommon mutations indicates patients whose tumors harbor EGFR mutation categories other than exon 19 deletions only and L858R only; ^bDose reduction within the first 6 months of treatment

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