Safety and Efficacy of Dacomitinib in Korean Patients with KRAS Wild-Type Advanced Non–Small-Cell Lung Cancer Refractory to Chemotherapy and Erlotinib.

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Safety and Efficacy of Dacomitinib in Korean Patients with KRAS Wild-Type Advanced Non–Small-Cell Lung Cancer Refractory to Chemotherapy and Erlotinib or Gefitinib: A Phase I/II Trial Keunchil Park, Byoung C. Cho, Dong-Wan Kim, Myung-Ju Ahn, Sang-Yoon Lee, Diana Gernhardt, Ian Taylor, Alicyn K. Campbell, Hui Zhang, Nagdeep Giri, Stephen P. Letrent, Joseph O’Connell, Dae S. Heo Journal of Thoracic Oncology Volume 9, Issue 10, Pages 1523-1531 (October 2014) DOI: 10.1097/JTO.0000000000000275 Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 Kaplan–Meier plot of (A) progression-free survival and (B) overall survival in the phase II portion, as enrolled. Journal of Thoracic Oncology 2014 9, 1523-1531DOI: (10.1097/JTO.0000000000000275) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Best percent change from baseline in target lesion as assessed by RECIST in the phase II portion. N = 40: One patient with progressive disease in nontarget lesion but no target lesion measurement and two patients without on-study tumor scan were excluded. †Two patients had >30% reduction at one post-treatment assessment, but PR was not confirmed on a follow-up assessment and responses were classified as SD per RECIST v1.0. RECIST, Response Evaluation Criteria in Solid Tumors v1.0; PR, partial response; SD, stable disease. Journal of Thoracic Oncology 2014 9, 1523-1531DOI: (10.1097/JTO.0000000000000275) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3 Mean change from baseline in (A) lung cancer symptoms of cough, pain in chest, and pain in arm or shoulder (EORTC QLQ-C13); (B) class-related adverse events of diarrhea (EORTC QLQ-C30) and sore mouth (EORTC QLQ-LC13); (C) skin toxicity by total scores on DLQI (Dermatology Life Quality Index). Baseline scores and equivalent normative values for the respective symptoms are listed in panel (D). Higher scores indicate higher levels of symptoms or a higher degree of impairment of functioning; lower scores indicate fewer symptoms or a lower degree of impairment of functioning. EORTC scales are scored from 0 to 100; DLQI total scores range from 0 to 30. SD, standard deviation. Journal of Thoracic Oncology 2014 9, 1523-1531DOI: (10.1097/JTO.0000000000000275) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 4 Median dacomitinib plasma concentration–time plots on cycle 0 day −9 (30 mg and 45 mg, single dose) (A); and on cycle 1, day 14 (30 mg and 45 mg, multiple dose), for dose-compliant patients (B). Journal of Thoracic Oncology 2014 9, 1523-1531DOI: (10.1097/JTO.0000000000000275) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions