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

Research output: Contribution to journalArticle

99 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

Fingerprint

Carboplatin
Paclitaxel
Epidermal Growth Factor Receptor
Lung Neoplasms
Quality of Life
Mutation
Therapeutics
Odds Ratio
gefitinib
Neoplasms
Quality Improvement
Population
Confidence Intervals

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

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

In: Journal of Thoracic Oncology, Vol. 6, No. 11, 01.01.2011, p. 1872-1880.

Research output: Contribution to journalArticle

Thongprasert, S, Duffield, E, Saijo, N, Wu, YL, Yang, JCH, Chu, DT, Liao, M, Chen, YM, Kuo, HP, Negoro, S, Lam, KC, 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, vol. 6, no. 11, pp. 1872-1880. https://doi.org/10.1097/JTO.0b013e31822adaf7
Thongprasert, Sumitra ; Duffield, Emma ; Saijo, Nagahiro ; Wu, Yi Long ; Yang, James Chih Hsin ; Chu, Da Tong ; Liao, Meilin ; Chen, Yuh Min ; Kuo, Han Pin ; Negoro, Shunichi ; Lam, Kwok Chi ; Armour, Alison ; Magill, Patrick ; Fukuoka, Masahiro. / 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). In: Journal of Thoracic Oncology. 2011 ; Vol. 6, No. 11. pp. 1872-1880.
@article{908c2f65b20a4f8f8704b1f94447ce84,
title = "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)",
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.",
keywords = "Gefitinib, Non-small cell lung cancer, Quality-of-life",
author = "Sumitra Thongprasert and Emma Duffield and Nagahiro Saijo and Wu, {Yi Long} and Yang, {James Chih Hsin} and Chu, {Da Tong} and Meilin Liao and Chen, {Yuh Min} and Kuo, {Han Pin} and Shunichi Negoro and Lam, {Kwok Chi} and Alison Armour and Patrick Magill and Masahiro Fukuoka",
year = "2011",
month = "1",
day = "1",
doi = "10.1097/JTO.0b013e31822adaf7",
language = "English",
volume = "6",
pages = "1872--1880",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "11",

}

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

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

UR - http://www.scopus.com/inward/record.url?scp=80054882063&partnerID=8YFLogxK

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

VL - 6

SP - 1872

EP - 1880

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 11

ER -