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: The majority of ILD cases (58.5%) were reported within 4 weeks of receiving erlotinib. The incidence of ILD (per 100 patient-weeks) was 0.63–0.81 within 4 weeks of the start of erlotinib treatment and 0.09–0.27 from 6 weeks after the start of erlotinib treatment (Fig. 2). Univariate analysis identified patients who were female, patients with non-adenocarcinoma histology, those with a period of treatment from initial NSCLC diagnosis to the start of treatment <360 days, concomitant or previous emphysema or COPD, concomitant or previous ILD, concomitant or previous lung infections, concomitant hepatic disorders, concomitant renal disorders, history of allergies, smoking history, ECOG PS 2–4, prior chest radiotherapy, pre-treatment lactate dehydrogenase, and no previous treatment with gefitinib as risk factors for ILD development (Table 3). Age at start of treatment, body mass index, concurrent cardiovascular disorders, number of chemotherapy regimens and previous treatment with gemcitabine were variables that were not identified as risk factors from the univariate analysis. Multivariate analysis showed that concurrent/previous ILD (HR, 3.19), concurrent/previous emphysema or COPD (HR, 1.86), concurrent/previous lung infection (HR, 1.55), smoking history (HR, 2.25), and period from initial NSCLC diagnosis to the start of treatment (<360 days; HR, 0.58) were identified as significant risk factors for developing ILD by multivariate analysis (Table 3).
Affiliation: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.