Phase I Results from a Study of Crizotinib in Combination with Erlotinib in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer Sai-Hong Ignatius.

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Phase I Results from a Study of Crizotinib in Combination with Erlotinib in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer Sai-Hong Ignatius Ou, MD, PhD, Ramaswamy Govindan, MD, Keith D. Eaton, MD, PhD, Gregory A. Otterson, MD, Martin E. Gutierrez, MD, Alain C. Mita, MD, Athanassios Argiris, MD, Nicoletta M. Brega, MD, PharmD, Tiziana Usari, BSc, Weiwei Tan, PhD, Steffan N. Ho, MD, PhD, Francisco Robert, MD Journal of Thoracic Oncology Volume 12, Issue 1, Pages 145-151 (January 2017) DOI: 10.1016/j.jtho.2016.09.131 Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 Pharmacokinetics of erlotinib and crizotinib administered in combination during cycle 1 of treatment. (A) Erlotinib exposure (by patient and geometric mean [geomean]) when administered alone (day −1) or in combination with crizotinib (days 1 and 15). (B) Crizotinib exposure on day 15. Circles indicate individual values, horizontal white lines indicate medians, boxes indicate 25th to 75th percentiles, and whiskers indicate 1.5× interquartile range. AUCτ, area under the concentration–time curve over the dosing interval (crizotinib, 12 hours; erlotinib, 24 hours). aPfizer Inc., data on file. Journal of Thoracic Oncology 2017 12, 145-151DOI: (10.1016/j.jtho.2016.09.131) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Best overall response in patients who received at least one dose of crizotinib and erlotinib. (A) Waterfall plot of best percent change from baseline in size of target lesions in patients who had at least one follow-up scan (n = 20). (B) Treatment duration, best response, smoking status, and prior EGFR tyrosine kinase inhibitor (TKI) treatment in patients grouped by dose level. aWithdrawn from the study before first scan during treatment. bDuration of treatment at data cutoff (August 2012); this patient ultimately continued treatment for a total of 28 months. Journal of Thoracic Oncology 2017 12, 145-151DOI: (10.1016/j.jtho.2016.09.131) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions