Symptom and Quality of Life Benefit of Afatinib in Advanced Non–Small-Cell Lung Cancer Patients Previously Treated with Erlotinib or Gefitinib: Results.

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Symptom and Quality of Life Benefit of Afatinib in Advanced Non–Small-Cell Lung Cancer Patients Previously Treated with Erlotinib or Gefitinib: Results of a Randomized Phase IIb/III Trial (LUX-Lung 1) Vera Hirsh, MD, Jacques Cadranel, MD, Xiuyu Julie Cong, PhD, Diane Fairclough, DrPH, Henrik W. Finnern, MSc, Robert M. Lorence, MD, PhD, Vince A. Miller, MD, Michael Palmer, PhD, James Chih-Hsin Yang, MD Journal of Thoracic Oncology Volume 8, Issue 2, Pages 229-237 (February 2013) DOI: 10.1097/JTO.0b013e3182773fce Copyright © 2013 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 Percentage of patients with improvement in the three prespecified symptoms of cough, dyspnea, and pain. Improvement was defined as ≥ 10-point increase for functioning scales and ≥ 10-point reduction for symptom domains or items from baseline score. The number of patients included in the analysis of each of the listed items/domains was n = 339–359 (afatinib) and n = 153–171 (placebo). Journal of Thoracic Oncology 2013 8, 229-237DOI: (10.1097/JTO.0b013e3182773fce) Copyright © 2013 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Time to deterioration analysis for the three prespecified symptoms of cough, dyspnea, and pain. Time to deterioration was analyzed using log-rank test stratified by baseline ECOG PS and sex. The time to deterioration analysis included all randomized patients, that is, n = 390 (afatinib) and n = 195 (placebo). Patients who did not complete any questionnaires were either censored on day 1 or considered deteriorated if they died within 4 weeks after randomization. Journal of Thoracic Oncology 2013 8, 229-237DOI: (10.1097/JTO.0b013e3182773fce) Copyright © 2013 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3 Results from the longitudinal analysis for the three prespecified symptoms of cough, dyspnea, and pain. The longitudinal analysis uses a mixed-effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model adjusted for baseline ECOG PS and sex. The number of patients included in the analysis for each of the listed items/domains was n = 385–386 (afatinib) and n = 191 (placebo). ECOG PS, Eastern Cooperative Oncology Group performance status. Journal of Thoracic Oncology 2013 8, 229-237DOI: (10.1097/JTO.0b013e3182773fce) Copyright © 2013 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 4 Subgroup analyses with patients with ECOG PS 0 versus ECOG PS 1, 2. A, Proportion of patients improved. The number of patients included in the analysis of the proportion of patients improved for each of the listed items/domains was for baseline ECOG = 0, n = 82 (afatinib) and n = 46 (placebo); for baseline ECOG = 1 or 2, n = 274–277 (afatinib) and n = 125 (placebo). B, Time to deterioration. The time to deterioration analysis included all randomized patients: baseline ECOG = 0, n = 92 (afatinib), and n = 53 (placebo); for baseline ECOG = 1 or 2, n = 298 (afatinib), and n = 142 (placebo). Patients who did not complete any questionnaires were either censored on day 1 or considered deteriorated if they died within 4 weeks after randomization. C, Longitudinal analysis. The number of patients included in the longitudinal analysis of each of the listed items/domains was n = 91 (afatinib) and n = 53 (placebo) for ECOG PS 0, and n = 294–295 (afatinib) and n = 138 (placebo) for ECOG PS 1–2. ECOG PS, Eastern Cooperative Oncology Group performance status. Journal of Thoracic Oncology 2013 8, 229-237DOI: (10.1097/JTO.0b013e3182773fce) Copyright © 2013 International Association for the Study of Lung Cancer Terms and Conditions