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
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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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