A phase II study of first-line afatinib for patients aged ≥75 years with EGFR mutation-positive advanced non-small cell lung cancer: North East Japan Study Group trial NEJ027

Table 3 Afatinib exposure and treatment adjustment due to treatment-related adverse events

Category	Safety analysis set *N =* 38
Afatinib exposure
Median treatment duration^a, days (range)	494 (8–950)
Median treatment days^b, n (range)	492 (8–932)
Mean afatinib dose^c, mg	29.7 (10.6–40.0)
Median relative dose intensity^d, % (range)	74.2 (26.4–100)
Treatment adjustments, n (%)
Initial treatment dose 40 mg	38 (100)
Dose reduction	30 (78.9)
Final treatment dose
40 mg	8 (21.1)
30 mg	12 (31.6)
20 mg	14 (36.8)
30 mg QOD	1 (2.6)
20 mg QOD	3 (7.9)
Treatment interruption	28 (73.7)
Treatment discontinuation	8 (21.1)

Abbreviation: QOD every other day, TRAE treatment-related adverse events
Data are n (%) unless otherwise stated. In addition to afatinib exposure, data for dose reductions, treatment interruption and discontinuation due to TRAEs are shown
^aFrom start of treatment to discontinuation or censoring, including days of treatment interruption
^bNot including treatment interruption days
^cTotal afatinib dose/treatment duration
^d(mean afatinib dose/40) × 100

ISSN: 1471-2407