Research news for health professionals: April 2016

1. Can radium-223 improve quality of life for men with CRPC?

Nillson and colleagues analysed health-related quality of life (QOL) data from the phase III multi-centre ALSYMPCA trial to determine the effects of radium-223 on patient experience of QOL. The ALSYMPCA trial was a randomised, double-blind, placebo-controlled trial which looked at radium-223 dichloride (radium-223) plus standard of care (SOC) compared to a placebo plus SOC for men with castration-resistant prostate cancer (CRPC). The trial demonstrated radium-223 versus placebo prolonged overall survival (OS) by 3.6 months and prolonged time to first symptomatic skeletal event (SSE) by 5.8 months. Radium-223 specifically targets prostate cancers that have spread to the bone. While radium-223 after chemotherapy is available on the NHS in England, NICE are currently considering whether it should also be available pre chemotherapy. In Scotland men with advanced prostate cancer can access the drug whether or not they have had chemotherapy.

For this study, the authors analysed data from two validated QOL questionnaires, the general EuroQoL 5D (EQ-5D) and the prostate-specific Functional Assessment of Cancer-Prostate (FACT-P). The questionnaires were completed by patients at randomisation (0), whilst on treatment at weeks 16 and 24, and at study discontinuation. The authors assessed the data for percentage of patients experiencing improvement, experiencing worsening and mean QOL scores during the study.

Results of the analysis demonstrated in patients receiving radium-223 a significantly higher percentage experienced meaningful improvement in QOL and a lower percentage experienced of pa meaningful worsening in QOL compared to patients who received placebo. Radium-223 treatment appeared to result in higher mean QOL scores on study versus placebo, and appeared to extend across multiple QOL domains. In conclusion, the authors stated their analysis of EQ-5D and FACT-P data from the ALSYMPCA trial demonstrated clinically meaningful QOL benefits, which accompanies improved survival results from analysis of earlier ALSYMPCA trial analysis.

2. Does a shortened radiotherapy schedule benefit low-risk prostate cancer patients?

The aim of this trial, by Lee and colleagues, was to assess the efficacy of a hypofractionated, also known as shortened, radiotherapy (H-RT) treatment schedule compared to a conventional radiotherapy (C-RT) schedule in men with low-risk prostate cancer. Conventional schedules typically require 40 to 45 treatments that take place from 8 to 9 weeks (>73Gy), whilst H-RT involves 28 treatments over 5-6 weeks (70 Gy).

Over 1,000 men with low-risk prostate cancer were enrolled in the study, received radiotherapy and were treated according to the study protocol. 542 men were assigned to C-RT and 550 to the H-RT protocol. The primary aim of the study was to compare disease-free survival rate, including local progression and distant metastatic progression, between H-RT and C-RT. Additionally the study looked at overall survival, prostate cancer-specific survival and time to biochemical recurrence. The authors reported treatment efficacy was similar between the C-RT and H-RT groups. Men treated with the shorter regimen (H-RT) were reported to experience more mild side effects, although late grade 2 and 3 gastrointestinal (GI) and genitourinary adverse events were increased this group compared to C-RT.

In conclusion the authors reported their data on men with low-risk prostate cancer and demonstrated the efficacy of their H-RT schedule was not inferior to C-RT, although an increase in late GI/genitourinary adverse events was observed in patients treated with H-RT.

3. Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer

The main purpose of this study was to investigate the effects of a 12-week, clinician-referred, community-based exercise training program for improving exercise levels and quality of life for men with prostate cancer. The secondary purpose was to determine whether androgen deprivation therapy (ADT) modified responses to exercise training.

119 patients who had been diagnosed with prostate cancer and had completed active treatment within the previous 3-12 months provided data for this analysis. Of these patients, 53 were referred to the intervention (exercise) condition and 66 to the control condition. Outcome measures included fitness and physical function, anthropometrics, resting heart rate, and blood pressure. 85 % of the men in the intervention condition undertook at least 18 of the 24 supervised sessions in their local community gym.

Statistically significant differences between the two conditions were observed, in favour of men in the intervention condition for all measures of physical function. For example, compared to the control condition, men in the intervention significantly improved their 6-min walk distance, leg and chest strength and 30-s sit-to-stand result. The resting heart rates of the men in the intervention condition decreased by 3.76 beats/min more than those of men in the control condition. In addition ADT did not appear to modify responses to exercise training. Anthropometric differences between the conditions were minimal and were not statistically significant.

The authors concluded their analysis demonstrated that the fitness and physical functioning of men with prostate cancer can be enhanced through a community-based exercise training program. IN addition, the authors noted that improvement in strength, physical functioning, and, potentially, cardiovascular health. They also highlighted their findings suggest that favourable outcomes were gained irrespective of whether or not men were treated with ADT. The authors also acknowledged a limitation of their trial was that men recruited were more physically active than those reported in other studies, and this may have lessened the magnitude of the effects that may have other wise been achieved through the exercise training program.

4. Prostate cancer mortality declined along with cigarette smoking in the US

Researchers in the United States examined prostate cancer mortality rates in relation to changes in cigarette smoking. As in the UK, smoking rates in the US have declined and this is associated with a population-level reduction in incidence and mortality from many smoking associated diseases, including cardiovascular disease and lung cancer.

The study included analysis of smoking rates and prostate cancer mortality in men aged 35 years or older in California, Kentucky, Maryland, and Utah from 1999 through to 2010. The data came from the Behavioural Risk Factor Surveillance System and the Centres for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database.

Across the duration of the data analysed smoking rates declined in each of the four states studied (range 3.0-3.5% across states), although this decline was not significant in Maryland. Prostate cancer mortality rates also declined across all four states (2.1-3.5% across states). The researchers further analysis looking at the populations by ethnicity, found that while smoking rates declined significantly among white men in all four states, the prevalence declined significantly among black men in one state (out of three analysed at ethnicity level).

The authors noted that this study was an ecological analysis and was therefore unable to conclude any causal association between smoking and prostate cancer mortality. The authors also highlighted that the decreases in prostate cancer mortality occurred in spite of increasing obesity prevalence over the study period.
In conclusion the authors stated their findings support the need for targeted smoking cessation efforts, which could reduce prostate cancer mortality rates in this population burdened by both higher rates of prostate cancer and an elevated prevalence of cigarette smoking.

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