Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer.
Bottom Line: Interstitial lung disease was confirmed in 429 (4.3%) patients.These data confirm the well-characterized safety profile of erlotinib.Interstitial lung disease is still an adverse drug reaction of interest in this population, and these results, including ILD risk factors, give helpful information for treatment selection and monitoring.
Affiliation: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.Show MeSH
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Mentions: Median OS was 277 days (95% CI, 264–292), with a 6-month survival rate of 62.6% and a 12-month survival rate of 42.8% (Fig. 3a). Median PFS was 67 days (95% CI, 64–70), with a 6-month progression-free rate of 25.8% and a 12-month progression-free rate of 10.6% (Fig. 3b). Compared with the overall population, median OS and PFS appeared to be longer in female patients, non-smokers, patients with ECOG PS 0–1, and patients with grade ≥2 rash (Fig. 3c,d).
Affiliation: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.