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, Emma Duffield, Nagahiro Saijo, Yi Long Wu, James Chih Hsin Yang, Da Tong Chu, Meilin Liao, Yuh Min Chen, Han Pin Kuo, Shunichi Negoro, Kwok Chi Lam, Alison Armour, Patrick Magill, Masahiro Fukuoka

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101 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1872-1880
Number of pages9
JournalJournal of Thoracic Oncology
Volume6
Issue number11
DOIs
Publication statusPublished - Jan 1 2011
Externally publishedYes

Keywords

  • Gefitinib
  • Non-small cell lung cancer
  • Quality-of-life

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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    Thongprasert, S., Duffield, E., Saijo, N., Wu, Y. L., Yang, J. C. H., Chu, D. T., Liao, M., Chen, Y. M., Kuo, H. P., Negoro, S., Lam, K. C., Armour, A., Magill, P., & Fukuoka, M. (2011). 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). Journal of Thoracic Oncology, 6(11), 1872-1880. https://doi.org/10.1097/JTO.0b013e31822adaf7