TY - JOUR
T1 - 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)
AU - Thongprasert, Sumitra
AU - Duffield, Emma
AU - Saijo, Nagahiro
AU - Wu, Yi Long
AU - Yang, James Chih Hsin
AU - Chu, Da Tong
AU - Liao, Meilin
AU - Chen, Yuh Min
AU - Kuo, Han Pin
AU - Negoro, Shunichi
AU - Lam, Kwok Chi
AU - Armour, Alison
AU - Magill, Patrick
AU - Fukuoka, Masahiro
N1 - Funding Information:
Disclosure: This study was supported by AstraZeneca. Sumitra Thongprasert has received compensation from AstraZeneca to participate in a scientific symposium; Yi-Long Wu has received compensation from AstraZeneca, Roche, Eli Lilly, Pfizer and Glaxo Smith Kline for services as a speaker; James Chih-Hsin Yang has received compensation from AstraZeneca for services as a speaker and participation in an advisory board; Da-Tong Chu has received compensation from AstraZeneca for services as a speaker and participation in an advisory board; and Emma Duffield, Alison Armour and Patrick Magill are full-time employees of AstraZeneca and hold stock in AstraZeneca. All other authors declare no conflicts of interest.
Funding Information:
Supported by AstraZeneca. The authors thank the patients and investigators for their participation in this study. The authors thank Sarah Lewis, from Complete Medical Communications, who provided medical writing support funded by AstraZeneca.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2011/1/1
Y1 - 2011/1/1
N2 - Introduction: Evaluation of health-related quality-of-life (HRQoL) and symptom improvement were preplanned secondary objectives for the overall population and posthoc analyses for epidermal growth factor receptor (EGFR) mutation-positive/negative subgroups in IPASS. Methods: HRQoL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Trial Outcome Index (TOI); symptom improvement by the Lung Cancer Subscale (LCS). Improvements defined as: 6 or more (FACT-L; TOI), 2 or more (LCS) points increase maintained for 21 or more days. Results: Overall (n = 1151/1217 evaluable), HRQoL improvement rates were significantly greater with gefitinib versus carboplatin/paclitaxel; symptom improvement rates were similar for both treatments. Significantly more patients recorded improvements in HRQoL and symptoms with gefitinib in the EGFR mutation-positive subgroup (n = 259; FACT-L 70.2% versus 44.5%; odds ratio, 3.01 [95% confidence interval, 1.79-5.07]; p < 0.001; TOI 70.2% versus 38.3%; 3.96 [2.33-6.71]; p < 0.001; LCS 75.6% versus 53.9%; 2.70 [1.58-4.62]; p < 0.001), and with carboplatin/paclitaxel in the EGFR mutation-negative subgroup (n = 169; FACT-L 14.6% versus 36.3%; odds ratio, 0.31 [0.15-0.65]; p = 0.002; TOI 12.4% versus 28.8%; 0.35 [0.16-0.79]; p = 0.011; LCS 20.2% versus 47.5%; 0.28 [0.14-0.55]; p < 0.001). Median time-to-worsening (months) FACT-L score was longer with gefitinib versus carboplatin/paclitaxel for the overall population (8.3 versus 2.5) and EGFR mutation-positive subgroup (15.6 versus 3.0), and similar for both treatments in the EGFR mutation-negative subgroup (1.4 versus 1.4). Median time-to-improvement with gefitinib was 8 days in patients with EGFR mutation-positive tumors who improved. Conclusions: HRQoL and symptom endpoints were consistent with efficacy outcomes in IPASS and favored gefitinib in patients with EGFR mutation-positive tumors and carboplatin/paclitaxel in patients with EGFR mutation-negative tumors.
AB - Introduction: Evaluation of health-related quality-of-life (HRQoL) and symptom improvement were preplanned secondary objectives for the overall population and posthoc analyses for epidermal growth factor receptor (EGFR) mutation-positive/negative subgroups in IPASS. Methods: HRQoL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Trial Outcome Index (TOI); symptom improvement by the Lung Cancer Subscale (LCS). Improvements defined as: 6 or more (FACT-L; TOI), 2 or more (LCS) points increase maintained for 21 or more days. Results: Overall (n = 1151/1217 evaluable), HRQoL improvement rates were significantly greater with gefitinib versus carboplatin/paclitaxel; symptom improvement rates were similar for both treatments. Significantly more patients recorded improvements in HRQoL and symptoms with gefitinib in the EGFR mutation-positive subgroup (n = 259; FACT-L 70.2% versus 44.5%; odds ratio, 3.01 [95% confidence interval, 1.79-5.07]; p < 0.001; TOI 70.2% versus 38.3%; 3.96 [2.33-6.71]; p < 0.001; LCS 75.6% versus 53.9%; 2.70 [1.58-4.62]; p < 0.001), and with carboplatin/paclitaxel in the EGFR mutation-negative subgroup (n = 169; FACT-L 14.6% versus 36.3%; odds ratio, 0.31 [0.15-0.65]; p = 0.002; TOI 12.4% versus 28.8%; 0.35 [0.16-0.79]; p = 0.011; LCS 20.2% versus 47.5%; 0.28 [0.14-0.55]; p < 0.001). Median time-to-worsening (months) FACT-L score was longer with gefitinib versus carboplatin/paclitaxel for the overall population (8.3 versus 2.5) and EGFR mutation-positive subgroup (15.6 versus 3.0), and similar for both treatments in the EGFR mutation-negative subgroup (1.4 versus 1.4). Median time-to-improvement with gefitinib was 8 days in patients with EGFR mutation-positive tumors who improved. Conclusions: HRQoL and symptom endpoints were consistent with efficacy outcomes in IPASS and favored gefitinib in patients with EGFR mutation-positive tumors and carboplatin/paclitaxel in patients with EGFR mutation-negative tumors.
KW - Gefitinib
KW - Non-small cell lung cancer
KW - Quality-of-life
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UR - http://www.scopus.com/inward/citedby.url?scp=80054882063&partnerID=8YFLogxK
U2 - 10.1097/JTO.0b013e31822adaf7
DO - 10.1097/JTO.0b013e31822adaf7
M3 - Article
C2 - 22011650
AN - SCOPUS:80054882063
SN - 1556-0864
VL - 6
SP - 1872
EP - 1880
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 11
ER -
