Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer

Takuya Kawahara, Kojiro Shimozuma, Takeru Shiroiwa, Yasuhiro Hagiwara, Yukari Uemura, Takanori Watanabe, Naruto Taira, Takashi Fukuda, Yasuo Ohashi, Hirofumi Mukai

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial. Methods: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months. We conducted a responder analysis for the QLQ-C30 and PNQ and created cumulative distribution function (CDF) plots as a sensitivity analysis. Results: The questionnaire response rates were over 80% from 386 patients, who completed at least one baseline questionnaire. S-1 was significantly superior to taxane with respect to 6 scales (physical functioning [p = 0.03], role functioning [p = 0.04], social functioning [p < 0.01], financial difficulties [p = 0.01], global health status [p = 0.02], and constipation [p < 0.01]) and sensory neuropathy (p = 0.01). The CDF plots partially supported the conclusions and their robustness. Conclusion: First-line S-1 therapy has clinical benefits with respect to many aspects of health-related quality of life for metastatic breast cancer patients.

Original languageEnglish
JournalOncology (Switzerland)
DOIs
Publication statusAccepted/In press - Nov 17 2017

Fingerprint

Breast Neoplasms
Quality of Life
Therapeutics
Constipation
Fluorouracil
Health Status
Surveys and Questionnaires
Patient Reported Outcome Measures
Neoplasm Metastasis
Recurrence
taxane

Keywords

  • Adjuvant chemotherapy
  • Chemotherapy-induced peripheral neuropathy
  • Clinical trials
  • Health-related quality of life
  • Metastatic breast cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer. / Kawahara, Takuya; Shimozuma, Kojiro; Shiroiwa, Takeru; Hagiwara, Yasuhiro; Uemura, Yukari; Watanabe, Takanori; Taira, Naruto; Fukuda, Takashi; Ohashi, Yasuo; Mukai, Hirofumi.

In: Oncology (Switzerland), 17.11.2017.

Research output: Contribution to journalArticle

Kawahara, Takuya ; Shimozuma, Kojiro ; Shiroiwa, Takeru ; Hagiwara, Yasuhiro ; Uemura, Yukari ; Watanabe, Takanori ; Taira, Naruto ; Fukuda, Takashi ; Ohashi, Yasuo ; Mukai, Hirofumi. / Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer. In: Oncology (Switzerland). 2017.
@article{08c7087287084948bdd9879b1f19816a,
title = "Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer",
abstract = "Objective: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial. Methods: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months. We conducted a responder analysis for the QLQ-C30 and PNQ and created cumulative distribution function (CDF) plots as a sensitivity analysis. Results: The questionnaire response rates were over 80{\%} from 386 patients, who completed at least one baseline questionnaire. S-1 was significantly superior to taxane with respect to 6 scales (physical functioning [p = 0.03], role functioning [p = 0.04], social functioning [p < 0.01], financial difficulties [p = 0.01], global health status [p = 0.02], and constipation [p < 0.01]) and sensory neuropathy (p = 0.01). The CDF plots partially supported the conclusions and their robustness. Conclusion: First-line S-1 therapy has clinical benefits with respect to many aspects of health-related quality of life for metastatic breast cancer patients.",
keywords = "Adjuvant chemotherapy, Chemotherapy-induced peripheral neuropathy, Clinical trials, Health-related quality of life, Metastatic breast cancer",
author = "Takuya Kawahara and Kojiro Shimozuma and Takeru Shiroiwa and Yasuhiro Hagiwara and Yukari Uemura and Takanori Watanabe and Naruto Taira and Takashi Fukuda and Yasuo Ohashi and Hirofumi Mukai",
year = "2017",
month = "11",
day = "17",
doi = "10.1159/000484142",
language = "English",
journal = "Oncology",
issn = "0030-2414",
publisher = "S. Karger AG",

}

TY - JOUR

T1 - Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer

AU - Kawahara, Takuya

AU - Shimozuma, Kojiro

AU - Shiroiwa, Takeru

AU - Hagiwara, Yasuhiro

AU - Uemura, Yukari

AU - Watanabe, Takanori

AU - Taira, Naruto

AU - Fukuda, Takashi

AU - Ohashi, Yasuo

AU - Mukai, Hirofumi

PY - 2017/11/17

Y1 - 2017/11/17

N2 - Objective: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial. Methods: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months. We conducted a responder analysis for the QLQ-C30 and PNQ and created cumulative distribution function (CDF) plots as a sensitivity analysis. Results: The questionnaire response rates were over 80% from 386 patients, who completed at least one baseline questionnaire. S-1 was significantly superior to taxane with respect to 6 scales (physical functioning [p = 0.03], role functioning [p = 0.04], social functioning [p < 0.01], financial difficulties [p = 0.01], global health status [p = 0.02], and constipation [p < 0.01]) and sensory neuropathy (p = 0.01). The CDF plots partially supported the conclusions and their robustness. Conclusion: First-line S-1 therapy has clinical benefits with respect to many aspects of health-related quality of life for metastatic breast cancer patients.

AB - Objective: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial. Methods: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months. We conducted a responder analysis for the QLQ-C30 and PNQ and created cumulative distribution function (CDF) plots as a sensitivity analysis. Results: The questionnaire response rates were over 80% from 386 patients, who completed at least one baseline questionnaire. S-1 was significantly superior to taxane with respect to 6 scales (physical functioning [p = 0.03], role functioning [p = 0.04], social functioning [p < 0.01], financial difficulties [p = 0.01], global health status [p = 0.02], and constipation [p < 0.01]) and sensory neuropathy (p = 0.01). The CDF plots partially supported the conclusions and their robustness. Conclusion: First-line S-1 therapy has clinical benefits with respect to many aspects of health-related quality of life for metastatic breast cancer patients.

KW - Adjuvant chemotherapy

KW - Chemotherapy-induced peripheral neuropathy

KW - Clinical trials

KW - Health-related quality of life

KW - Metastatic breast cancer

UR - http://www.scopus.com/inward/record.url?scp=85034852081&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85034852081&partnerID=8YFLogxK

U2 - 10.1159/000484142

DO - 10.1159/000484142

M3 - Article

JO - Oncology

JF - Oncology

SN - 0030-2414

ER -