medwireNews: Dose intensification does not improve the outcomes of salvage radiotherapy after radical prostatectomy, the SAKK 09/10 investigators have reported at the 2021 Genitourinary Cancers Symposium.
Pirus Ghadjar (Charité Universitätsmedizin Berlin, Germany) said that the open-label phase 3 trial included 350 stage pTa–3b patients with a prostate-specific antigen (PSA) after surgery increase to between 0.1 and 2.0 ng/mL, but without a persistent PSA level above 0.4 ng/mL.
The participants were free from macroscopic local recurrence and lymph node disease, and had not received androgen deprivation therapy (ADT), he explained.
Freedom from biochemical progression did not significantly differ for the 174 patients who were randomly assigned to receive the dose-intensified regimen of 70 Gy given over 35 fractions and the 170 patients given conventional radiation of 64 Gy in 32 fractions, at a median 7.6 and 8.2 years, respectively.
Clinical progression-free survival and time to receipt of ADT were also similar in the treatment arms, and there were no significant differences on EORTC quality of life measures for urinary or bowel symptom changes over time.
However, patients given the dose-intensified regimen had a significantly higher rate of grade 2 late gastrointestinal toxicity than controls (20 vs 7%), although this was not found for grade 3 events (2 vs 4%), or for genitourinary late adverse events at either grade.
Pirus Ghadjar concluded that “[d]ose-intensified salvage radiotherapy was not superior to conventional dose” and “was associated with increased late gastrointestinal toxicity.”
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