Clinical characteristics and outcomes of advanced EGFR-mutated NSCLC treated with 45 or 30 mg starting doses of dacomitinib: a retrospective multicenter analysis.

BACKGROUND

The evidence from studies comparing 45 and 30 mg starting doses of first-line dacomitinib for advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) remains limited.

OBJECTIVES

This study aimed to compare the clinical efficacy and safety of two starting-dose first-line dacomitinib strategies in patients with advanced EGFR-mutated NSCLC.

DESIGN

This study employed a multicenter retrospective cohort design.

METHODS

A total of 189 patients with stage IIIB/IV EGFR-mutated NSCLC who received first-line dacomitinib between October 2020 and September 2023 at one of four Taiwanese centers were analyzed. Among them, 59 patients started with 45 mg and 130 patients started with 30 mg.

RESULTS

The 45-mg group included significantly more male patients and had higher baseline body weight and body mass index. The objective response rate (ORR) and disease control rate were comparable between the 45-mg (72.9% and 94.9%) and 30-mg (66.9% and 91.5%) groups (p = 0.623). The median progression-free survival was 18.53 months for patients treated with 45 mg dacomitinib and 18.03 months for patients treated with 30 mg dacomitinib (hazard ratio (HR), 0.958; 95% confidence interval (CI), 0.681-1.349; p = 0.807). The median overall survival was 40.4 and 49.97 months, respectively (HR, 1.078; 95% CI, 0.640-1.815; p = 0.778). However, patients receiving a starting dose of 45 mg dacomitinib experienced significantly higher rates of skin toxicity, paronychia, diarrhea, stomatitis, and anorexia and required dose reduction more frequently (all p < 0.05).

CONCLUSION

This study suggests that a 30-mg starting dose of dacomitinib may provide similar efficacy with improved tolerability compared with 45 mg. Prospective noninferiority studies are warranted to confirm these findings.