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SAKK 09/10 Fails To Show Dose-Intensification Benefit For Post-Prostatectomy Salvage Radiation

Dose-intensified salvage radiotherapy offers no benefit over a conventional regimen for men with rising PSA after radical prostatectomy
18 Feb 2021
Prostate Cancer;  Radiation Oncology

Author: By Lynda Williams, Senior medwireNews Reporter 


medwireNews: A study of dose-intensified salvage radiotherapy reported at the 2021 Genitourinary Cancers Symposium has not demonstrated any benefits over a conventional regimen for patients with a rising prostate-specific antigen (PSA) level after radical prostatectomy. 

Presenting author Pirus Ghadjar, from Charité Universitätsmedizin Berlin in Germany, explained that retrospective comparisons have suggested that biochemical progression-free survival (PFS) with salvage radiotherapy might be improved by a 2.5% per Gy dose intensification. 

To test this hypothesis, the SAKK 09/10 trial investigators designed a phase III, open-label, multicentre study comparing 3D-conformal or intensity-modulated salvage radiotherapy when given as a dose-intensified 70 Gy regimen over 35 daily fractions or a conventional 64 Gy dose regimen over 32 daily fractions. 

The study included 350 patients with pTa–3b disease with a positive or negative resection margin and a rising PSA level after surgery that was above 0.1 ng/mL, but no higher than 2.0 ng/mL, at baseline (median 0.3 ng/mL). 

Pirus Ghadjar added that patients were excluded from the study if they persistently had a PSA level above 0.4 ng/mL, had received hormone therapy, had macroscopic local recurrence on contrast-enhanced imaging, or had evidence of lymph node metastasis. 

The primary endpoint was freedom from biochemical progression (FFBP), where progression was defined as a PSA of 0.4 ng/mL and rising or higher, while secondary endpoints included clinical PFS, time to hormone therapy, overall survival, toxicity and quality of life. 

After a median 6.2 years of follow-up, median FFBP in the intention-to-treat analysis was 7.6 years for the 174 patients who were randomly assigned to receive the dose-intensified regimen and 8.2 years for the 170 patients instead given the conventional radiotherapy, giving a hazard ratio of 1.14 that did not indicate a significant difference between the groups. 

Nor were there any differences detected for FFBP across patient subgroups, although the presenter did note that some subgroups in the analysis were small, for example there were just 19 patients with pT3b disease versus 155 patients with earlier-stage disease. 

The two treatment regimens were also comparable for the secondary endpoints of clinical PFS and time to initiation of androgen deprivation therapy, Pirus Ghadjar said. 

Genitourinary late toxicity was similar for the dose-intensified versus conventional radiotherapy with regard to rates of grade 2 (26 vs 21%) and grade 3 (4 vs 8%) adverse events. However, grade 2 gastrointestinal late toxicity was significantly more common with the dose-intensified regimen (20 vs 7%), although grade 3 events were comparable for the two groups (2 vs 4%). 

Finally, EORTC quality of life assessments showed no significant difference between the dose-intensified and conventional radiotherapy arms for changes in urinary or bowel symptoms over follow-up. 

“In conclusion, dose-intensified salvage radiotherapy was not superior to conventional dose”, Pirus Ghadjar concluded. 

“And higher dose was associated with increased late rectal toxicity.” 


Ghadjar P, Hayoz S, Bernhard J et al. Dose-intensified versus conventional dose-salvage radiotherapy for biochemically recurrent prostate cancer after prostatectomy: Six-year outcomes of the SAKK 09/10 randomized phase III trialJ Clin Oncol; 39: 2021 (suppl 6; abstr 194). DOI: 10.1200/JCO.2021.39.6_suppl.194

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2021 Springer Healthcare part of the Springer Nature group

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