Is ultra-hypo-fractionated radiotherapy more cost-effective relative to conventional fractionation in treatment of prostate cancer? A cost-utility analysis alongside a randomized HYPO-RT-PC trial.

BACKGROUND: Economic evidence for comparing low fraction with ultra-hypo fractionated (UHF) radiation therapy in the treatment of intermediate-to-high-risk prostate cancer (PC) is lacking, especially in Europe. This study presents an economic evaluation performed alongside an ongoing clinical trial. AIM: To investigate up to 6 years' follow-up whether conventional fractionation (CF, 78.0 Gy in 39 fractions, 5 days per week for 8 weeks) is more cost-effective than UHF (42.7 Gy in 7 fractions, 3 days per week for 2.5 weeks inclusive of 2 weekends) radiotherapy in treatment for patients with intermediate-to-high-risk PC. METHOD: HYPO-RT-PC trial is an open-label, randomized, multicenter (10 in Sweden; 2 in Denmark) phase-3 trial. Patients from Sweden (CF 434; UHF 445) were included in this study. The trial database was linked to the National Patient Registry (NPR). Costs for inpatient/non-primary outpatient care for each episode were retrieved. For calculating Quality-adjusted life years (QALYs), the EORTC QLQ-C30 questionnaire was mapped to the EQ-5D-3L index. Multivariable regression analyses were used to compare the difference in costs and QALYs, adjusting for age and baseline costs, and health status. The confidence interval for the difference in costs, QALYs and incremental cost-effectiveness ratio effectiveness ratio (ICER) was estimated by the bootstrap percentile method. RESULTS: No significant differences were found in ICER between the two arms after 6 years of follow-up. CONCLUSION: The current study did not support that the ultra-hypo-fractionated treatment was more cost-effective than the conventional fraction treatment up to the sixth year of the trial.

Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer.

BACKGROUND: The majority of patients with newly diagnosed metastatic prostate cancer (PC) initially respond to androgen deprivation therapy (ADT) and are classified as metastatic castration-sensitive PC (mCSPC). Following months to years of ADT, the disease tends to become resistant to ADT. Recent randomized phase-III trials demonstrated a survival benefit with the addition of upfront docetaxel to ADT in mCSPC. Following its implementation in routine care, this combined treatment strategy requires more detailed evaluation in a real-world setting. AIM: To assess the real-world outcome and safety of upfront docetaxel treatment in mCSPC. METHODS: A multicenter retrospective cohort study in the Southeast Health Care Region of Sweden was performed. This region includes approximately 1.1 million citizens and the oncology departments of Linköping, Jönköping, and Kalmar. All patients given upfront docetaxel for mCSPC from July 2015 until December 2017 were included. The primary endpoint was progression-free survival (PFS) at 12 mo, and the secondary endpoints were PFS at 24 mo, overall survival (OS), treatment intensity, adverse events, and unplanned hospitalizations. Exploratory analyses on potential prognostic parameters were performed. RESULTS: Ninety-four patients were eligible and formed the study cohort. PFS at 12 and 24 mo was 75% (95%CI: 66-84) and 58% (46-70), respectively. OS at 12 and 24 mo was 93% (87-99) and 86% (76-96). A total of 91% of patients (n = 86) were given docetaxel according to the standard protocol of 75 mg/m2 every 3 wk (6 cycles), while 9% (n = 8) received a modified protocol of 50 mg/m2 every 2 wk (9 cycles). The average overall dose intensity for those commencing standard treatment was 91%. Univariate Cox regression analyses show that baseline PSA > 180 vs < 180 and the presence of distant metastases vs locoregional lymph node metastases were only negative prognostic factors (HR 2.86, 95%CI: 1.39-5.87, P = 0.0041 and 3.36, 95%CI: 1.03-10.96, P = 0.045). Following multivariate analysis, statistical significance remained for PSA (2.51, 95%CI: 1.21-5.19, P = 0.013) but not for metastatic status (2.60, 95%CI: 0.78-8.65, P = 0.12). Febrile neutropenia was recorded in 21% (n = 20) of patients, and 26% (n = 24) had at least one episode of unplanned hospitalization under and up to 30 d after the treatment course. CONCLUSION: Results from this study support the implementation of upfront docetaxel plus ADT as part of the standard of care treatment strategy in mCSPC.