1. Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer.
- Author
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Kawahara, Takuya, Shimozuma, Kojiro, Shiroiwa, Takeru, Hagiwara, Yasuhiro, Uemura, Yukari, Watanabe, Takanori, Taira, Naruto, Fukuda, Takashi, Ohashi, Yasuo, and Mukai, Hirofumi
- Subjects
ANTINEOPLASTIC agents ,BREAST tumors ,CANCER relapse ,CONSTIPATION ,FLUOROURACIL ,HEALTH status indicators ,METASTASIS ,ORAL drug administration ,HEALTH outcome assessment ,POSTOPERATIVE period ,QUALITY of life ,QUESTIONNAIRES ,FINANCIAL management ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,FUNCTIONAL assessment - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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