Japanese value set for the EORTC QLU-C10D: A multi-attribute utility instrument based on the EORTC QLQ-C30 cancer-specific quality-of-life questionnaire.

PURPOSE: This study aimed to develop a Japanese value set for the EORTC QLU-C10D, a multi-attribute utility measure derived from the cancer-specific health-related quality-of-life (HRQL) questionnaire, the EORTC QLQ-C30. The QLU-C10D contains ten HRQL dimensions: physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, and bowel problems. METHODS: Quota sampling of a Japanese online panel was used to achieve representativeness of the Japanese general population by sex and age (≥ 18 years). The valuation method was an online discrete choice experiment. Each participant considered 16 choice pairs, randomly assigned from 960 choice pairs. Each pair included two QLU-C10D health states and life expectancy. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Preference weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. RESULTS: A total of 2809 eligible panel members consented, 2662/2809 (95%) completed at least one choice pair, and 2435/2662 (91%) completed all choice pairs. Within dimensions, preference weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Intermediate utility weights were associated with social functioning and nausea; the remaining symptoms and emotional functioning were associated with smaller utility decrements. The value of the worst health state was - 0.221, lower than that seen in most other existing QLU-C10D country-specific value sets. CONCLUSIONS: The Japan-specific QLU-C10D value set is suitable for evaluating the cost and utility of oncology treatments for Japanese health technology assessment and decision-making.

Psychometric properties of the Japanese version of the EQ-5D-Y by self-report and proxy-report: reliability and construct validity.

PURPOSE: This study aimed to assess psychometric properties of the Japanese version of the EQ-5D-Y (3 levels) with a focus on feasibility, reliability, and construct validity. METHODS: Respondents were recruited from the general populations of three cities in Japan. First, children and adolescents responded to the EQ-5D-Y and PedsQL by self-report. Parents were also asked to evaluate the health states of their children/adolescents using proxy versions of these questionnaires. Next, the EQ-5D-Y was mailed to their residence approximately 2 weeks later, and both children/adolescents and their parents responded to the questionnaire. Reliability was confirmed by self-report test-retest methods and a comparison of self-report responses with proxy responses. Spearman's correlation coefficients were calculated between responses to the EQ-5D-Y and both responses to and scores of the PedsQL in order to assess construct validity. RESULTS: A total of 654 children/adolescents from aged 8 to 15 (median age: 11) responded to the questionnaires at both the first- and second-stage surveys. Test-retest agreement was sufficiently high and was influenced by age. Proxy test-retest results revealed that parents' responses were more reliable compared to the self-report results. Some correlations (|r| > 0.3) between items of the EQ-5D-Y and PedsQL were found. Meanwhile, no correlations were found between proxy responses to the EQ-5D-Y and self-report responses to the PedsQL. CONCLUSIONS: The EQ-5D-Y demonstrates reliability and validity among children/adolescents and their parents in Japan. Construct validity of the EQ-5D-Y by self-report was confirmed through comparisons with the PedsQL. Proxy responses to the EQ-5D-Y were more reliable compared to the self-report results, but construct validity was not confirmed in the proxy version.

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.

PURPOSE: The 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. METHODS: In 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. RESULTS: The 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). CONCLUSIONS: Our 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.

Cost-effectiveness analysis of trastuzumab to treat HER2-positive advanced gastric cancer based on the randomised ToGA trial.

BACKGROUND: We performed a cost-effectiveness analysis of trastuzumab plus chemotherapy for human epidermal growth factor type-2 (HER2)-positive advanced gastric cancer (GC) based on data obtained from the Trastuzumab for Gastric Cancer (ToGA) trial from a Japanese perspective. METHODS: The following Japanese and Korean populations of the ToGA trial were analysed to obtain mean overall and progression-free survival times: (1) all HER2-positive populations, (2) immunohistochemical (IHC) 2+/fluorescence in situ hybridisation (FISH)+ or IHC 3+ populations, and (3) IHC 3+ only population. The effect of trastuzumab treatment on mean survival time was estimated by fitting a Weibull parametric function. Costs were calculated from the perspective of health-care payer. Neither costs nor outcomes were discounted because of short life expectancy. RESULTS: In the base-case analysis, the incremental cost-effectiveness ratio was (1) JPY 12 million (€110,000) per quality-adjusted life year (QALY) gained and JPY 8.9 million (€81,000) per life-year gained (LYG) for all HER2-positive populations, (2) JPY 9.1 million (€83,000) per QALY gained and JPY 6.6 million (€60,000) per LYG for the IHC 2+/FISH+ or IHC 3+ population, and (3) JPY 6.1 million (€55,000) per QALY gained and JPY 4.3 million (€39,000) per LYG for the IHC 3+ population. CONCLUSION: Trastuzumab treatment for IHC 3+ populations is cost effective. Our analysis can find a cost-effective subgroup when advanced GC is treated by trastuzumab.

Cost-effectiveness analysis of XELOX for metastatic colorectal cancer based on the NO16966 and NO16967 trials.

BACKGROUND: The purpose of the study was to evaluate the cost-effectiveness of capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX4) as first-line or second-line chemotherapy in patients with metastatic colorectal cancer. METHODS: On the basis of NO16966 and NO16967 trials, mean costs and effectiveness were calculated from patient-level data. Until the disease progressed, the mean costs were calculated from the perspective of health-care payers in Japan. We estimated mean quality-adjusted progression-free survival days (QAPFSD), considering adverse events and patient preference for chemotherapy regimens. Utility scores were obtained by a web-based survey from general people, randomly sampled from a large panel adjusted for sex and age. RESULTS: Incremental effectiveness of XELOX as first-line and second-line chemotherapy for colorectal cancer patients was significantly greater. By use of XELOX, patients gained 10.5 QAPFSD from first-line treatment or 11.3 QAPFSD from second-line treatment. Capecitabine plus oxaliplatin (XELOX) was also proven to significantly reduce treatment costs by 3000 euro (JPY 360,000) and 2300 euro (JPY 270,000) for first-line and second-line treatment, respectively. In health-care settings in the United Kingdom, XELOX decreased medical costs for National Health Service by 7600 pound and 3900 pound for patients who received first-line and second-line treatment, respectively. CONCLUSION: Capecitabine plus oxaliplatin (XELOX) as first-line and second-line chemotherapy was 'dominant'. In terms of effectiveness and cost, XELOX was superior to FOLFOX4.