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: A total of 10 708 patients were enrolled in this study. Of these, 9909 patients were evaluated for the final safety analysis and 9663 patients were evaluated for the final efficacy analysis (Fig. 1). Baseline characteristics are shown in Table 1. Of note, more males than females were enrolled; the majority of patients had adenocarcinoma histology (80.9%) and most had ECOG PS 0–1 (74.0%).
Affiliation: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.