Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial

T. Shiroiwa, T. Fukuda, K. Shimozuma, M. Mouri, Y. Hagiwara, Hiroyoshi Doihara, H. Akabane, M. Kashiwaba, T. Watanabe, Y. Ohashi, H. Mukai

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Purpose: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial. Methods: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1. Results: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713–0.769]) in the taxane arm and 0.748 [0.722–0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789–0.834] vs. 0.772 [0.751–0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003). Conclusions: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalQuality of Life Research
DOIs
Publication statusAccepted/In press - Aug 12 2016

Fingerprint

Health Status
Breast Neoplasms
docetaxel
Least-Squares Analysis
Drug Therapy
Quality-Adjusted Life Years
Therapeutics
Random Allocation
Paclitaxel
Quality of Life
Survival
taxane

Keywords

  • Breast cancer
  • EQ-5D
  • Health-related quality of life
  • Randomized controlled trial
  • S-1
  • Taxane

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Long-term health status as measured by EQ-5D among patients with metastatic breast cancer : comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. / Shiroiwa, T.; Fukuda, T.; Shimozuma, K.; Mouri, M.; Hagiwara, Y.; Doihara, Hiroyoshi; Akabane, H.; Kashiwaba, M.; Watanabe, T.; Ohashi, Y.; Mukai, H.

In: Quality of Life Research, 12.08.2016, p. 1-9.

Research output: Contribution to journalArticle

Shiroiwa, T. ; Fukuda, T. ; Shimozuma, K. ; Mouri, M. ; Hagiwara, Y. ; Doihara, Hiroyoshi ; Akabane, H. ; Kashiwaba, M. ; Watanabe, T. ; Ohashi, Y. ; Mukai, H. / Long-term health status as measured by EQ-5D among patients with metastatic breast cancer : comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. In: Quality of Life Research. 2016 ; pp. 1-9.
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abstract = "Purpose: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial. Methods: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1. Results: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 {\%} CI [0.713–0.769]) in the taxane arm and 0.748 [0.722–0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789–0.834] vs. 0.772 [0.751–0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003). Conclusions: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm.",
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AU - Fukuda, T.

AU - Shimozuma, K.

AU - Mouri, M.

AU - Hagiwara, Y.

AU - Doihara, Hiroyoshi

AU - Akabane, H.

AU - Kashiwaba, M.

AU - Watanabe, T.

AU - Ohashi, Y.

AU - Mukai, H.

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