Men with prostate cancer can avoid radiotherapy after surgery, according to the latest results of the RADICALS-RT trial, presented at the Congress of the European Society of Medical Oncology (ESMO), celebrated in Barcelona and published in the magazine Annals of Oncology.
RADICALS-RT, the largest trial of postoperative radiotherapy in prostate cancer, found no differences in disease recurrence at five years between men who received routine radiotherapy shortly after surgery and men who received more radiotherapy. late if the cancer reappeared.
The first author of the study, Professor Chris Parker, of the Foundation Royal Marsden NHS Trust from London (United Kingdom), explains that “the results suggest that radiotherapy is equally effective if it is administered to all men shortly after surgery or later to those with recurrent disease.
“The good news is that in the future, many men will avoid the side effects of radiation therapy, he adds. These include urine leaks and narrowing of the urethra, which can make urination difficult. Both are potential complications of surgery but the risk increases if radiotherapy is also used. ”
The findings were confirmed in a collaborative meta-analysis, also presented at the ESMO Congress 2019, which combines the results of RADICALS with two similar trials, RAVES and GETUG-AFU17.
The author of the analysis, Dr. Claire Vale, of the Clinical Trials Unit of Medical Research Council, from University College London, stresses that “the results of the ARTISTIC meta-analysis confirm those of RADICALS and provide more evidence to support the routine use of observation and early rescue radiotherapy.”
“The meta-analysis provides the best opportunity to assess whether adjuvant radiotherapy can still play a role in some groups of men and investigate the results in the longer term,” Vale adds.
Commenting on the data, Dr. Xavier Maldonado, from Vall d’Hebron University Hospital, from Barcelona, states that “these are the first results that suggest that postoperative radiotherapy for prostate cancer could be omitted or delayed in some patients. This will shorten the duration of the treatment and allow a better use of the resources, since the current radiotherapy is technically sophisticated and, therefore, expensive, but a strict follow-up will be needed to identify the patients who need rescue radiotherapy ”.
RADICALS-RT enrolled 1,396 patients after prostate cancer surgery in the United Kingdom, Denmark, Canada and Ireland. The men were randomly assigned to postoperative radiotherapy or the standard observation approach only, and radiotherapy remained an option if the disease reappeared.
At a median five-year follow-up, progression-free survival was 85 percent in the radiotherapy group and 88 percent in the standard care group. Self-reported urinary incontinence was worse per year in 5.3 percent of patients who received radiotherapy compared with 2.7 percent who had standard care. Longer follow-up is needed to report survival and the primary outcome of the absence of distant metastases.
Regarding the collaborative meta-analysis, ARTISTIC included three randomized trials comparing adjuvant radiotherapy with early rescue radiotherapy after prostatectomy for men with localized prostate cancer: RADICALS, GETUG-AFU 17 and RAVES. The analysis was planned before the test results were known.
The results are based on the 2,151 men included in the three trials, of which 1,074 were randomized to adjuvant radiotherapy and 1,077 men were randomized to early rescue radiotherapy; Of these, 395 men (37 percent) have begun rescue treatment to date.
The analysis found no evidence that adjuvant radiotherapy improves event-free survival compared to early rescue radiation therapy. Based on these results, the difference in five-year event-free survival is likely to be only around 1 percent