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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.

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Presentation on theme: "Safety and Efficacy of Dacomitinib in Korean Patients with KRAS Wild-Type Advanced Non–Small-Cell Lung Cancer Refractory to Chemotherapy and Erlotinib."— Presentation transcript:

1 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 (October 2014) DOI: /JTO Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

2 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, DOI: ( /JTO ) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

3 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, DOI: ( /JTO ) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

4 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, DOI: ( /JTO ) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

5 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, DOI: ( /JTO ) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

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