5-year outcomes data from a French series of HIFU patients

A new report from a French research team has provided detailed 5-year data on the oncological outcomes of a series of low- and intermediate-risk prostate cancer patients treated with high-intensity ultrasound (HIFU) using second-generation Ablatherem™ equipment.

Ripert et al. have carried out a retrospective analysis of oncologic data from all eligible patients given first-line HIFU treatment with second-generation Ablatherm equipment at their institution and followed for up to 6 years. They calculated the 5-year biochemical progression-free and the 5-year disease-free survival rates for this series of 53 patients.

Oncological failure was defined by one or other of two criteria:

  • Biochemical failure based on the “Stuttgart definition,” which is specific to HIFU and states that biochemical failure is a 1.2 ng/ml rise a patient’s PSA above the lowest or “nadir” level achieved after initial therapy.
  • Initiation of salvage therapy because of a persistently positive biopsy after initial HIFU.

The results of their analysis are as follows:

  • The average (mean) age of the 53 patients was 72.5 ± 4.5 years (range 60-79 years)
  • 28/53 patients (52.8 percent) had low-risk and 25/53 patients (47.2 percent) had intermediate-risk disease.
  • The average (mean) PSA of patients prior to treatment was 8.5 ± 4.0 ng/ml (range, 0.29-18.0 ng/ml)
  • No patient had been given hormonal therapy prior to HIFU.
  • The average (mean) follow-up was 45.4 ± 15.5 months (range 16-71 months).
  • The average (median) PSA nadir value was 1.0 ng/ml (range, 0.01-14.0 ng/ml) and occurred at a mean of 5.09 months post-HIFU (range 3-24 months).
  • Overall, 36/53 patients (67.9 percent) experienced oncological failure, among whom 33 patients (62.2 percent) demonstrated biochemical failure according to the Stuttgart definition.
  • PSA nadir values of ≤ 0.2, 0.21-1.0, and > 1 ng/ml were achieved in 20.8, 30.2, and 49.0 percent of patients, respectively, and were associated with biochemical failure in 9.1, 30.3, and 60.6 percent of patients achieving these nadir values, respectively.
  • The 5-year biochemical-free survival rate was just 21.7 percent.
  • The 5-year disease-free survival rate was even lower, at 13.5 percent.
  • A nadir PSA value > 1 ng/ml was significantly associated with a risk of biochemical and oncological failure.
  • Oncological failure was not associated with any specific risk group.
  • No patient in this study died from prostate cancer within the follow-up period.

The authors conclude that HIFU as first-line treatment for clinically localized prostate cancer in men with low- and intermediate-risk, localized prostate cancer, when carried out using second-generation Ablatherm equipment at their institution, was associated with a high rate of biochemical failure as determined by the Stuttgart definition, and did not achieve effective cancer control. They further note that the PSA nadir value after HIFU treatment was a significant predictor of treatment failure.

The “New” Prostate Cancer InfoLink wishes to be clear that this report does not “sound a death knell” for HIFU as a treatment for carefully selected patients with early stage, localized prostate cancer. It is, however,  a clear set-back — most specifically for HIFU using the Ablatherm technology. We need detailed follow-up data from other — preferably larger — series before we can have a good understanding of the long-term value of HIFU, and we would have liked to see any early adverse events data from this series of patients. Since >80 percent of this group of patients had biochemical progression and required further therapy, any long-term adverse events data would have been relatively meaningless with regard to HIFU.

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