Ian Davis, MBBS (Hons), PhD, FRACP, FAChPM
The formal discussant of the ARAMIS trial, Ian Davis, MBBS (Hons), PhD, FRACP, FAChPM, of Monash University and Eastern Health, Melbourne, Australia, commented: “ARAMIS is a positive trial with encouraging early results. It has a meaningful endpoint of metastasis-free survival with acceptable toxicity. However, a practice-changing treatment should be cost-effective,” he told listeners.
In addition, he questioned whether nonmetastatic castration-resistant prostate cancer as defined here is important and indeed whether it will continue to exist as an entity. “New, more sensitive imaging techniques, like prostate-specific membrane antigen positron-emission tomography, show that small metastases are often evident in patients with no metastases seen using conventional imaging,” he noted. “Nonmetastatic castration-resistant prostate cancer is not one single disease: it behaves very differently depending on prostate-specific antigen doubling time,” he continued.
“The question of whether ARAMIS should change practice is open. Toxicity seems acceptable, but we have no information on the effects of darolutamide on the efficacy of subsequent treatment, or on cost-effectiveness with respect to survival,” Dr. Davis said. “For full disclosure, I am a believer in universal access to affordable health care.” ■
DISCLOSURE: Dr. Davis has received institutional research funding from Astellas Pharma, Roche/Genentech, MSD Oncology, AstraZeneca, Eisai, Janssen Oncology, and Pfizer, and he has patents/royalties/other intellectual property with the Ludwig Institute for Cancer Research.
Darolutamide—an investigational androgen receptor inhibitor—significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer vs placebo in the large phase III ARAMIS trial.1 Men treated with darolutamide had a median metastasis-free survival...