European Association of Urology
Guidelines
Education & Events
Join our events Join our events
On-demand education Learn at your own pace
Scholarships Enrich your capabilities
Exchange Programmes Urology beyond Europe
Education Educational Platforms Talent Incubator Programme Accreditation
Science & Publications
Publications Our publications
Research & Science Passionate about research?
About
Who we are Our mission and history
Our Board and Offices How we work
Join the EAU Find out about membership
Vacancies Contact

EMUC19: ARAMIS trial likely to change Guidelines recommendations

The third day of the EMUC meeting (and the second day of the main scientific programme) opened with a two-hour session on new trials.

Sat, 16 Nov 2019
OncologyEMUC 19EMUCEAU Guidelines
Enlarge image

Like all sessions at EMUC19, it was chaired by a multidisciplinary group, in this case Dr. Carl Salembier (radiation oncologist), Prof. Aristotelis Bamias (medical oncologist) and Ass. Prof. Maurer (urologist).

The audience was presented with the most up-to-date statistics and preliminary conclusions from the SPCG4 study, the ARAMIS trial, KEYNOTE 057, with further lectures concerning first-line treatment options for metastatic RCC and the duration of ADT in high-risk PCa. Each presenter was followed by a discussant from a complementary specialty and many further talking points coming from the audience.

ARAMIS

It was Prof. Karim Fizazi’s talk on the ARAMIS trial and the potential for the use of darolutamide for non-metastatic, castration-resistant prostate cancer (m0 CRPC) that led to a lot of discussion. M0 CRPC is considered to be a quite rare situation, so treatment has so far been an unmet need. Primary endpoints were improved overall survival and time to pain progression.

Darolutamide’s structure might be the explanation for its low blood-brain barrier penetration, leading to fewer side effects and better tolerability when compared to enzalutamide and apalutamide (PROSPER and SPARTAN trials respectively).

Fizazi concluded based on the latest results that all three agents showed clear and meaningful improvement of metastasis-free survival, with Darolutamide, in particular, showing a remarkable safety profile. The preliminary results clearly suggested improvement in pain progression and overall survival.

Not only his ‘discussant’ Prof. Maria De Santis added new insights, but the audience too had questions about the potential of darolutamide vs. enzalutamide and apalutamide. While the results of darolutamide and the ARAMIS trial are very good, particulary, the tolerability, the price point may yet be an important factor when choosing between the drugs, Fizazi pointed out.

De Santis pointed out changes in the 2019 EAU Guidelines that gave a strong recommendation for APA or ENZA for patients with m0 CRPC, and expected the 2020 Guidelines to do the same for Darolutamide, based on these new results. This was clearly the “Guideline-changing potential” that Dr. Maurer expected from the session beforehand.

Challenges when comparing trials

Prof. Pär Stattin on the SPCG4 Trial. The trials compared radical prostatectomy vs watchful waiting in early prostate cancer and recruited 695 men between 1989-1999. It spawned five major publications in the New England Journal of Medicine in 2002, 2005, 2011, 2014 and 2018.

At EMUC19, Stattin explored whether the absolute risks of death from the trial were applicable to current patients undergoing radical prostatectomy. Unfortunately, the trial did not collect data on prostate volume (and therefore density), the extent of cancer on biopsy or the comorbidities, making this a challenge.

Further challenges for those wishing to draw lessons out of a twenty-year-old trial are what Stattin referred to as “Gleason grade inflation” that required compensation. Broadly concluded, the absolute risk of PCa death in SPCG-4 is not applicable to men undergoing radical prostatectomy in 2019. Furthermore, comprehensive data on changes in detection, cancer characteristics and work-up have to be considered in order to interpret data in old trials.

Share this article

Suggested for you

See all
About EAU
  • Who we are
  • How we work
  • Become a member
Services
  • MyEAU
  • Congress registrations
  • Abstract submission
Media
  • EAU News
  • EAU Newsletter
  • EAU Press Releases
Contact
  • EAU Central Office
    PO Box 30016
    NL-6803 AA ARNHEM
    The Netherlands

  • Contact us
About EAU
Who we areHow we workBecome a member
Services
MyEAUCongress registrationsAbstract submission
Media
EAU NewsEAU NewsletterEAU Press Releases
Contact

EAU Central Office
PO Box 30016
NL-6803 AA ARNHEM
The Netherlands

Contact us
European Association of Urology
Privacy PolicyDisclaimer