EAU 2017: Observation or active surveillance or curative treatment: What do PIVOT data tell us?

London, England (UroToday.com) Dr. Wilt presented the Prostate Cancer Intervention Versus Observation Trial (PIVOT) study. This multicenter randomized controlled trial was initiated in 1994, comparing radical prostatectomy (RP) with watchful waiting in men with clinically localized prostate cancer. In total, 13 022 men with prostate cancer at 52 medical centers in the US were considered for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. Mean patient age was 67 years and almost one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL and in three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was elevated PSA. It was demonstrated that approximately 40% had low-risk disease, 34% had medium-risk, and 21% had high-risk prostate cancer. Comparison to men enrolled in the Scandinavian SPCG-4 trial indicated that PIVOT patients are representative of men being diagnosed and treated in the United States and quite different from men in the Scandinavian trial and more racially diverse.

During the median follow-up of 10 years, 47% assigned to RP died while 49.9% assigned to observation died (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P=0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to RP, 5.8% died from prostate cancer or treatment, as compared with 8.4% assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P=0.09; absolute risk reduction, 2.6 percentage points). The treatment effect on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions,
self-reported performance status, or histologic features of the tumor. RP was associated with reduced all-cause mortality among men with intermediate-risk or high-risk tumors (P=0.07 for interaction).

To conclude, observation and PSA monitoring is preferred in low risk and low PSA disease and in men over the age of 65 with life limiting comorbidities even with higher PSA or higher risk disease. Among men with localized prostate cancer detected during the early era of PSA testing,
RP did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. More effective and safer therapies are needed for younger men with higher risk disease.

Presented by: Dr. Timothy J. Wilt, Minneapolis (US)

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto

Twitter: @GoldbergHanan

at the #EAU17 -March 24-28, 2017- London, England

Login