Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial

Abstract

PurposeThe goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial.MethodsIn the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1.ResultsThe number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713–0.769]) in the taxane arm and 0.748 [0.722–0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789–0.834] vs. 0.772 [0.751–0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003).ConclusionsOur findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm.

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study

“…At each point, assessment was conducted before the start of the next treatment cycle. Although the EQ-5D-3L assessment continued beyond 12 months in the SELECT BC study [ 19 ], we excluded that data in the present study because a few patients continued the study treatment during that period.…”

“…The aim of this study was to investigate the impact of AEs on health utility, measured using the EQ-5D-3L, in metastatic breast cancer patients receiving first-line chemotherapy. We previously reported the long-term EQ-5D-3L index results from the SELECT BC study, a Japanese multicenter, open-label, randomized, phase III study comparing the oral fluoropyrimidine derivative drug S-1 with taxane as first-line chemotherapy for metastatic breast cancer [ 19 ]. The results included health utility values before progression, after progression, and immediately before death.…”

Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions

“…Secondary outcomes included changes in patient-reported quality-of-life outcomes, margin status, re-excision rates, procedural time and physician satisfaction with the use of the MOLLI system. Patient-reported quality of life was measured at day 0 prior to implantation and at day 30 after implantation, using the validated EQ 5D-3L and EQ-VAS questionnaires [8,9]. Similarly, breast radiologists, breast surgeons and pathology assistants were asked to complete a short five-point Likert scale questionnaire to evaluate their experience using MOLLI immediately after their interaction with the system, or completion of their respective procedure.…”

Cost-effectiveness analysis of the introduction of S-1 therapy for first-line metastatic breast cancer treatment in Japan: results from the randomized phase III SELECT BC trial

“…Our previous study examined longer-term (60 months) EQ-5D index values [ 26 ] and reported that the values were higher in the S-1 arm than the taxane arm when the analysis was limited to the first 12 months during progression-free survival (PFS). However, the values did not differ between arms when observations were continued up to 60 months.…”