If a patient could not tolerate 15 mg/day, treatment was discontinued. If a patient tolerated treatment well at the reduced level, the dose could be increased to the next dose level. Dacomitinib dose reductions were permitted to manage treatment-related toxicity a maximum of 2 dose level reductions were allowed, the first to 30 mg/day, and the second to 15 mg/day. Randomization by a central computer system was stratified by race, as reported by the patient, and EGFR mutation type (exon 19 deletion mutation or exon 21 L858R substitution mutation). ConclusionĮligible patients were randomized (1:1) to receive oral dacomitinib 45 mg/day or oral gefitinib 250 mg/day in 28-day cycles. Treatment-related serious AEs were reported in 16 (9.4 %) and 8 (4.5 %) patients treated with dacomitinib and gefitinib, respectively. The most common adverse events (AEs) were diarrhea (154 patients), paronychia (110 ), dermatitis acneiform (96 ), and stomatitis (87 ) with dacomitinib, and diarrhea (100 ), alanine aminotransferase increased (81 ), and aspartate aminotransferase increased (75 ) with gefitinib. The OS benefit was still maintained in those patients who had a stepwise dose reduction of dacomitinib (to 30 and 15 mg/day).
HR for OS with dacomitinib versus gefitinib was 0.759 (95 % CI: 0.578–0.996 median 37.7 months vs.
The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509 (95 % confidence interval : 0.391–0.662 1-sided p < 0.0001 median 16.5 months vs. Of 346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib.
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