Barcelona, Spain (UroToday.com) There are three randomized RADICALS studies (ISRCTN40814031),1GETUG-AFU 17 (NCT00667069) and RAVES (NCT00860652); recently presented at ASTRO 2019, which compared complementary radiotherapy with emergency radiotherapy policy in the event of PSA failure after radical prostatectomy in men with local prostate cancer. However, these tests have limited power in terms of long-term results. At the ESMO 2019 prostate cancer session, Claire Vale presented the preliminary results of a previously planned meta-analysis of the above studies. As part of ARTISTIC collaboration, a series of meta-analyzes were prospectively planned for each result.
Preliminary discussions on meta-analysis took place in 2011. With the RADICALS-RT and RAVES groups. In 2014, ARTISTIC cooperation officially began. The authors applied the adaptive meta-analysis (FAME) framework, prospectively defining their methods, including a coherent definition of PSA-dependent event-free survival, prior to reviewing research results (CRD42019132669). Event-free survival was defined as the time from randomization to any of (i) PSA> = 0.4 ng / ml and increasing after radiotherapy, (ii) clinical / radiological progression, (iii) initiation of treatment without trial, (iv) death due to prostate cancer after radiotherapy or (v) PSA> = 2.0 ng / ml at any time after randomization. They predicted 240 events in all trials by fall 2019, giving 90% power to detect 5% of the absolute difference in 5-year event-free survival.
In three studies, 1074 men were randomly assigned to complementary radiotherapy and 1077 to emergency radiotherapy. The tests are comparable, but with the subtleties described below:
To date, 395 men (37%) have started emergency radiotherapy. Patient characteristics were balanced throughout research and in general. The median age of men was 65 years, and the majority (77%) had a combined Gleason score of 7. The mean follow-up was 47 to 61 months. In August 2019, RADICALS and GETUG-AFU 17 provided non-event survival results for meta-analysis (temporarily for GETUG-AFU 17). RAVES can currently only ensure freedom from the results of biochemical failures. However, since the vast majority of the first events in all studies are biochemical failures, these results were collected in a preliminary meta-analysis of event-free survival. Based on 245 events, the meta-analysis shows no evidence that event-free survival is improved by adjuvant radiotherapy compared to emergency radiotherapy (HR 1.09, 95% CI 0.86-1.39, p = 0.47).
Professor Vale concluded that this joint, prospective and early meta-analysis of all men from three randomized trials suggests that rescue and complementary radiotherapy offer similar results in event-free survival. Importantly, rescue radiotherapy saves many men from receiving radiation therapy and associated side effects. Final data from GETUG-AFU 17 and RAVES can help determine if some subsets of men can benefit from any of the treatments. Finally, longer follow-up is needed to meta-analyze metastasis-free survival. The current analysis is the simultaneous publication of results for three trials.
Clinical trial identification
ISRCTN40814031; NCT00667069; NCT00860652
Presented by: Dr. Claire Vale, MRC Clinical Trials Unit, University College London, Institute of Clinical Trials and Methodology-UCL, United Kingdom
Co-authors: M. Brihoum,2) S. Chabaud,3) Cook,1 D. Fisher,1 S. Forcat,4 C. Fraser-Browne,5 A. Herschtal,6 A. Kneebone,7 S. Nénan,2) C. Parker,8 M. Parmar,9 M. Pearse,5 P. Richaud,10 E. Rogozińska,4 P. Sargos,11 M. Sydes,9 J. Tierney1
1. Institute of Clinical Trials and Methodology-UCL, London, United Kingdom
2. Unicancer, Paris, FR
3. Center Léon Bérard, Lyon, FR
4. Institute of Clinical Trials and Methodology, UCL, London, United Kingdom
5. Auckland City Hospital, Auckland, NZ
6. Peter MacCallum Cancer Center, Melbourne, AU
7. Northern Sydney Cancer Center, Sydney, AU
8. The Institute of Cancer Research / Royal Marsden NHS Foundation Trust, Sutton, United Kingdom
9. MRC Clinical Trials Unit at UCL, London, United Kingdom
10. Institut Bergonie, Bordeaux, FR
11. Institute Bergonié, Bordeaux, FR
Written by: dr n. Med. Zachary Klaassen – Assistant Professor of Urology, Georgia Cancer Center, Augusta University / Medical College of Georgia Twitter: @zklaassen_md at the annual meeting of the European Society of Medical Oncology 2019, ESMO 2019 # ESMO19, 27 September – 1 Oct 2019 in Barcelona, Spain