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.

• Authors: Takuya Kawahara, Kojiro Shimozuma, Takeru Shiroiwa, Yasuhiro Hagiwara, Yukari Uemura, Takanori Watanabe, Naruto Taira, Takashi Fukuda, Yasuo Ohashi, Hirofumi Mukai
• Journal: Oncology (Oncology) Vol. 94 Issue 2 Pg. 107-115 ( 2018) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 29145211 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2017 The Author(s) Published by S. Karger AG, Basel.

Chemical References

• Antineoplastic Agents
• Bridged-Ring Compounds
• Drug Combinations
• Taxoids
• S 1 (combination)
• Tegafur
• taxane
• Oxonic Acid
• Fluorouracil

Topics

• Aged
• Antineoplastic Agents (therapeutic use)
• Breast Neoplasms (drug therapy)
• Bridged-Ring Compounds (therapeutic use)
• Drug Combinations
• Female
• Fluorouracil (therapeutic use)
• Health Status
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Oxonic Acid (therapeutic use)
• Patient Reported Outcome Measures
• Quality of Life
• Surveys and Questionnaires
• Taxoids (therapeutic use)
• Tegafur (therapeutic use)