New prostate drug offers extended lifespan for men with advanced disease
A phase III study investigating the efficacy of apalutamide for men with an advanced form of prostate cancer has found that it improved survival rates.
A new prostate cancer treatment may offer men with an advanced form of prostate cancer two more years of survival, according to the results from a large international study published in the New England Journal of Medicine (online, 8 February 2018).
The researchers found that patients with non-metastatic disease who had stopped responding to androgen deprivation therapy (ADT) had, on average, 40.5 months progression-free survival after being treated with apalutamide, compared with an average of 16.2 months in those taking placebo.
The phase III study, which involved more than 1,200 men across 23 countries, also found the drug — a competitive inhibitor of the androgen receptor — significantly reduced the time to symptomatic progression.
The results, which were presented at the American Society for Clinical Oncology Genitourinary Cancers Symposium in San Francisco, showed that the effect was seen across all subgroups, including all ages and those with local or regional nodal disease, at trial entry.
Apalutamide was also effective in patients with short prostate-specific antigen (PSA) doubling times — a sign that they are at high risk of their disease spreading and have a shorter lifespan.
However, the drug was associated with higher rates of rash, fatigue, arthralgia, weight loss, falls, and fracture than placebo. The researchers reported that the rate of men taking apalutamide stopping treatment due to adverse effects was 10.6%, compared with 7% in the placebo group.
“Our study found that apalutamide treatment markedly improved metastasis-free survival and other clinical outcomes in men with castration-resistant prostate cancers and no detectable metastases,” said study leader Matthew Smith, director of the genitourinary malignancies programme at Massacheusetts General Hospital Cancer Centre.
“At this time, there are no approved treatments for men in that situation, so we need to wait until their disease progresses to add the standard therapies that have been approved for metastatic disease,” he added.
ADT is the current mainstay of treatment for metastatic prostate cancer and is also used in non-metastatic disease, but it eventually stops working in almost all men receiving it.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204413
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