1. Health-Related Quality-of-Life in a Randomized Phase III First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients from Asia with Advanced NSCLC (IPASS) 
Sumitra Thongprasert, MD, Emma Duffield, MSc, Nagahiro Saijo, MD, Yi-Long Wu, MD, James Chih-Hsin Yang, MD, Da-Tong Chu, MD, Meilin Liao, MD, Yuh-Min Chen, MD, Han-Pin Kuo, MD, Shunichi Negoro, MD, Kwok Chi Lam, MD, Alison Armour, MD, Patrick Magill, MD, Masahiro Fukuoka, MD 
Journal of Thoracic Oncology 
Volume 6, Issue 11, Pages (November 2011)
DOI: /JTO.0b013e31822adaf7
Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

2. FIGURE 1.
CONSORT diagram.a Among the 112 patients who failed screening, the main reasons for exclusion were abnormal serum creatinine (>1.5 times upper limit of reference range)/creatinine clearance (≤60 mL/min) levels; untreated central nervous system metastases; or low neutrophil (<2.0 × 109/L), platelet (<100 × 109/L), or hemoglobin (<10 g/dL) counts. bAll patients who were randomly assigned to a study group were included in the ITT analysis. c All patients who received at least one dose of study treatment were included in the safety analysis. dAll patients with a baseline and at least one postbaseline quality-of-life assessment that could be evaluated were included in the health-related quality-of-life analysis. eAll patients in the intent-to-treat population with an evaluable tumor sample. Of 683 (56%) patients who provided samples, 118 were cytology samples, and 128 histologic samples were of insufficient quality, and were therefore not included in the main analysis. fAll patients in the evaluable-for-quality-of-life population with an evaluable tumor sample. ITT, intent-to-treat; EFQ, evaluable-for-quality-of-life; EGFR, epidermal growth factor receptor; n, number of patients.
Journal of Thoracic Oncology 2011 6, DOI: ( /JTO.0b013e31822adaf7)
Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

3. FIGURE 2.
HRQoL and symptom improvement for FACT-L, TOI, and LCS for (A) patients with EGFR mutation-positive tumors and (B) patients with EGFR mutation-negative tumors (EFQ population). Posthoc analyses. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; CI, confidence interval; OR, odds ratio.
Journal of Thoracic Oncology 2011 6, DOI: ( /JTO.0b013e31822adaf7)
Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

4. FIGURE 3.
Time-to-worsening in HRQoL and symptoms for (A) FACT-L in patients with EGFR mutation-positive tumors, (B) FACT-L in patients with EGFR mutation-negative tumors, (C) TOI in patients with EGFR mutation-positive tumors, (D) TOI in patients with EGFR mutation-negative tumors, (E) LCS in patients with EGFR mutation-positive tumors, and (F) LCS in patients with EGFR mutation-negative tumors (EFQ population). Posthoc calculations. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; M+, mutation-positive; n, number of patients; G, gefitinib; CI, confidence interval; NC, not calculated; C/P, carboplatin/paclitaxel; M−, mutation negative.
Journal of Thoracic Oncology 2011 6, DOI: ( /JTO.0b013e31822adaf7)
Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

5. FIGURE 4.
Mean change from baseline in HRQoL and symptoms for (A) FACT-L in patients with EGFR mutation-positive tumors, (B) FACT-L in patients with EGFR mutation-negative tumors, (C) TOI in patients with EGFR mutation-positive tumors, (D) TOI in patients with EGFR mutation-negative tumors, (E) LCS in patients with EGFR mutation-positive tumors, and (F) LCS in patients with EGFR mutation-negative tumors (EFQ population). Posthoc calculations. Error bars are 95% CI of the mean. Data after week 54 (EGFR M+) and week 30 (EGFR M−) not presented as <20 patients remain. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; M+, mutation-positive; n, number of patients at baseline; M−, mutation-negative; CI, confidence interval.
Journal of Thoracic Oncology 2011 6, DOI: ( /JTO.0b013e31822adaf7)
Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions