1: Addition of antiandrogen treatment to salvage radiation therapy increases survival

A double-blind, placebo-controlled trial published in the New England Journal of Medicine shows that addition of the antiandrogen bicalutamide to salvage radiotherapy increases overall and prostate cancer specific survival.

Following prostatectomy, 760 men who had T2 or T3 confirmed disease were randomised to receive radiation therapy in combination with 24 months of daily bicalutamide or placebo control. With a median follow up of 13 years, the 12 year actuarial overall survival rate was 76.3% in the bicalutamide group compared to 71.3% in the placebo control group (HR 0.77, p=0.04). In addition, comparing men in the bicalutamide vs control group at 12 years, the rate of prostate specific death was 5.8% vs 13.4% (p<0.001) and the cumulative incidence of metastatic prostate cancer was 14.5% vs 23% (p=0.005). While late adverse effects associated with radiotherapy were similar between the two groups, there was a higher rate of gynecomastia in the bicalutamide group (69.7%) compared to the control group (10.9%).

Of note, since this was a blinded study men did not receive prophylactic radiation prior to beginning antiandrogen treatment, as normally occurs in practice. This trial started in 1998 and bicalutamide has since been superseded by other gonadotrophin-releasing hormone (GnRH) analogues such as goserelin or leuprorelin. While it is predicted that these newer treatments will also increase survival effects of salvage radiation, we look forward to hearing about results from the ongoing RADICALS trial which is addressing this question.

2: Longer-interval dosing of zoledronic acid is effective for patients with bone metastases

Zoledronic acid reduces the incidence and pain of skeletal metastases and is currently administered every three or four weeks.

A randomised study published in JAMA shows that increasing this interval to 12 weeks is just as effective in managing skeletal events. Patients with breast cancer (855), prostate cancer (689) or multiple myeloma (278) who had at least one bone metastasis received zoledronic acid every 4 or 12 weeks for two years. At the end of this period 29.5% of patients in the 4-week dosing and 28.6% of patients in the 12-week dosing groups had at least 1 skeletal-related event (p<0.001 for non-inferiority). Non-inferiority (no significant difference between groups) was also seen when each cancer type was analysed independently.

In addition, while there were no significant differences in pain scores and jaw osteonecrosis, patients who received zoledronic acid every 12 weeks did have higher bone turnover. Interestingly, reducing the number of zoledronic acid treatments to once every 12 weeks increased compliance but did not result in lower toxicity. Taken together, decreasing the frequency of zoledronic acid administration may be an acceptable option for patients with bone metastases.

3: Men with emotional distress are more likely to choose surgery over active surveillance

1531 men with localised prostate cancer participated in this American study, which measured their level of emotional distress using a Distress Thermometer shortly after diagnosis and again after they had made a treatment decision. Most participants had low risk (35.7%) or intermediate risk (49.1%) disease and treatments chosen were surgery (48.4%), radiation (27.4%) or active surveillance (24.2%).

Distress after diagnosis predicted choosing surgery over active surveillance (RR 1.07; p=0.021), while distress after they had made a treatment decision was associated with choosing surgery over active surveillance (RR 1.16; p<0.001) and surgery over radiation (RR 1.12; p=0.001). Distress was not associated with choosing radiation over active surveillance.

Other associations were consistent with previous publications, including that men with higher levels of education are more likely to choose active surveillance, and that married/cohabiting men are more likely to choose surgery over active surveillance. This study demonstrates that distress may affect treatment decisions and may lead to overtreatment. It suggests that intervening early after diagnosis may be a viable strategy to reduce distress and improve the decision making process.

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