Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study

Yasuhiro Hagiwara, Yasuo Ohashi, Takuji Okusaka, Hideki Ueno, Tatsuya Ioka, Narikazu Boku, Shinichi Egawa, Takashi Hatori, Junji Furuse, Kazuhiro Mizumoto, Shinichi Ohkawa, Taketo Yamaguchi, Kenji Yamao, Akihiro Funakoshi, Ann Lii Cheng, Kiyohiro Kihara, Atsushi Sato, Masao Tanaka

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objective: This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL. Methods: Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed. Results: Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference,-0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores. Conclusions: GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.

Original languageEnglish
Article numbere000151
JournalESMO Open
Volume2
Issue number1
DOIs
Publication statusPublished - Apr 2017

Fingerprint

gemcitabine
Pancreatic Neoplasms
Quality of Life
Anorexia
Fatigue

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer : GEST study. / Hagiwara, Yasuhiro; Ohashi, Yasuo; Okusaka, Takuji; Ueno, Hideki; Ioka, Tatsuya; Boku, Narikazu; Egawa, Shinichi; Hatori, Takashi; Furuse, Junji; Mizumoto, Kazuhiro; Ohkawa, Shinichi; Yamaguchi, Taketo; Yamao, Kenji; Funakoshi, Akihiro; Cheng, Ann Lii; Kihara, Kiyohiro; Sato, Atsushi; Tanaka, Masao.

In: ESMO Open, Vol. 2, No. 1, e000151, 04.2017.

Research output: Contribution to journalArticle

Hagiwara, Y, Ohashi, Y, Okusaka, T, Ueno, H, Ioka, T, Boku, N, Egawa, S, Hatori, T, Furuse, J, Mizumoto, K, Ohkawa, S, Yamaguchi, T, Yamao, K, Funakoshi, A, Cheng, AL, Kihara, K, Sato, A & Tanaka, M 2017, 'Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study', ESMO Open, vol. 2, no. 1, e000151. https://doi.org/10.1136/esmoopen-2016-000151
Hagiwara, Yasuhiro ; Ohashi, Yasuo ; Okusaka, Takuji ; Ueno, Hideki ; Ioka, Tatsuya ; Boku, Narikazu ; Egawa, Shinichi ; Hatori, Takashi ; Furuse, Junji ; Mizumoto, Kazuhiro ; Ohkawa, Shinichi ; Yamaguchi, Taketo ; Yamao, Kenji ; Funakoshi, Akihiro ; Cheng, Ann Lii ; Kihara, Kiyohiro ; Sato, Atsushi ; Tanaka, Masao. / Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer : GEST study. In: ESMO Open. 2017 ; Vol. 2, No. 1.
@article{bfe8aeb37e0245e7b590d3ba7d8cbe68,
title = "Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study",
abstract = "Objective: This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL. Methods: Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed. Results: Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference,-0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores. Conclusions: GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.",
author = "Yasuhiro Hagiwara and Yasuo Ohashi and Takuji Okusaka and Hideki Ueno and Tatsuya Ioka and Narikazu Boku and Shinichi Egawa and Takashi Hatori and Junji Furuse and Kazuhiro Mizumoto and Shinichi Ohkawa and Taketo Yamaguchi and Kenji Yamao and Akihiro Funakoshi and Cheng, {Ann Lii} and Kiyohiro Kihara and Atsushi Sato and Masao Tanaka",
year = "2017",
month = "4",
doi = "10.1136/esmoopen-2016-000151",
language = "English",
volume = "2",
journal = "ESMO Open",
issn = "2059-7029",
publisher = "BMJ Publishing Group",
number = "1",

}

TY - JOUR

T1 - Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer

T2 - GEST study

AU - Hagiwara, Yasuhiro

AU - Ohashi, Yasuo

AU - Okusaka, Takuji

AU - Ueno, Hideki

AU - Ioka, Tatsuya

AU - Boku, Narikazu

AU - Egawa, Shinichi

AU - Hatori, Takashi

AU - Furuse, Junji

AU - Mizumoto, Kazuhiro

AU - Ohkawa, Shinichi

AU - Yamaguchi, Taketo

AU - Yamao, Kenji

AU - Funakoshi, Akihiro

AU - Cheng, Ann Lii

AU - Kihara, Kiyohiro

AU - Sato, Atsushi

AU - Tanaka, Masao

PY - 2017/4

Y1 - 2017/4

N2 - Objective: This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL. Methods: Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed. Results: Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference,-0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores. Conclusions: GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.

AB - Objective: This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL. Methods: Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed. Results: Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference,-0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores. Conclusions: GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.

UR - http://www.scopus.com/inward/record.url?scp=85032747275&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85032747275&partnerID=8YFLogxK

U2 - 10.1136/esmoopen-2016-000151

DO - 10.1136/esmoopen-2016-000151

M3 - Article

AN - SCOPUS:85032747275

VL - 2

JO - ESMO Open

JF - ESMO Open

SN - 2059-7029

IS - 1

M1 - e000151

ER -