Evaluating health related quality of life in outpatients receiving anti-cancer treatment: results from an observational, cross-sectional study.

BACKGROUND: The aim of the study was to assess health-related quality of life (HRQOL) in outpatients receiving anti-cancer treatment. METHODS: Observational, cross-sectional, single-center study that assessed HRQOL in cancer patients receiving antineoplastic treatment. RESULTS: A total of 184 patients were included in the study; the median total FACT-G score was 66 ± 12.9; the scores for the physical well-being, social/family well-being, emotional well-being and functional well-being domains were 17.8 + 4.8, 19.1 ± 4.4, 14.8 ± 3.8 and 14.3 ± 4.7 respectively. Patients with adverse events had poorer HRQOL compared to those without them (FACT-G score 62.2 vs. 67.3; p < 0.05). In the multivariate analysis the variables associated with poorer HRQOL in the form of a gradient were tumor stage and performance status (ECOG); female sex was also associated with poorer HRQOL. CONCLUSION: In our study, the neoplastic disease and anti-cancer treatment toxicities had an impact on HRQOL. Patients had poorer scores in the functional well-being domain and higher ones in the social/family well-being domain. Variables associated with worse HRQOL were tumor stage, performance status (ECOG) and female sex.

Prospective Evaluation of Bone Metabolic Markers as Surrogate Markers of Response to Radium-223 Therapy in Metastatic Castration-resistant Prostate Cancer.

PURPOSE: Radium-223 is approved for metastatic castration-resistant prostate cancer (mCRPC) based on improved overall survival, and delay in skeletal related events. However, it is not associated with PSA or radiographic response, which poses a challenge in real-time assessment of its efficacy. Surrogate markers of treatment outcomes may facilitate tailoring treatment duration with radium-223, by limiting the duration of therapy with radium-223 in these patients. Here, we sought to investigate the utility of bone metabolic markers (BMMs) as surrogate markers of response to radium-223 in mCRPC. PATIENTS AND METHODS: A prospective phase II trial of radium-223 plus enzalutamide (RE) versus enzalutamide alone was designed to assess surrogacy of BMMs with respect to response to radium-223. Enzalutamide was used as a comparator in lieu of placebo due to the progressive disease. Co-primary endpoints were relative change in serum BMM N-telopeptide (NTP) levels from baseline to 6 months between the two arms and safety and feasibility of the combination. RESULTS: Thirty-nine men were randomized to RE (n = 27) or enzalutamide (n = 12). Combination was safe and feasible. Primary endpoint was met. A statistically significant relative change to NTP ratios between arms (0.64, 95% confidence interval, 0.51-0.81; P = 0.00048) favored RE versus enzalutamide. Overall, BMMs decreased with the RE therapy compared with enzalutamide. Improved PSA response rate in RE versus enzalutamide (P = 0.024), correlated with decline in BMMs. CONCLUSIONS: BMMs declined significantly with combination therapy, and were associated with improved outcomes. Upon external validation, BMMs may emerge as surrogate markers to monitor treatment with radium-223 in real-time.