Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial.
Details
Serval ID
serval:BIB_917F606AA3AD
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial.
Journal
European urology
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK)
Contributor(s)
Gut P., Thum P., Collon J., Putora P.M., Plasswilm L., Sassowsky M., Thalmann G.N., Aebersold D.M., Sumila M., Kranzbühler H., Zaugg K., Papachristofilou A., Zimmermann F., Najafi Y., Brown M., Guckenberger M., Wuttke S., Reuter C., Oehler C., Zwahlen D.R., Azinwi N.C., Bosetti D.G., Pesce G., Tacacs I., Bodis S., Gomez S., Khanfir K., Behrensmeier F., Beer K., Messer P., Hölscher T., Baumann M., Polat B., Flentje M., Lewitzki V., Hildebrandt G., Müller A.C., Zips D., Ghadjar P., Wust P., Budach V., Ganswindt U., Belka C., Pinkawa M., Eble M.J., Berkovic K., Stuschke M., Ost P., Vandaele F.
ISSN
1873-7560 (Electronic)
ISSN-L
0302-2838
Publication state
Published
Issued date
09/2021
Peer-reviewed
Oui
Volume
80
Number
3
Pages
306-315
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
Salvage radiotherapy (SRT) is utilized for biochemical progression of prostate cancer after radical prostatectomy (RP).
To report the outcomes of the SAKK 09/10 trial comparing conventional and dose-intensified SRT.
SAKK 09/10 was a randomized, multicenter, phase 3 trial that recruited men with biochemical progression after RP.
Patients were randomly assigned to conventional-dose (64 Gy) or dose-intensified SRT (70 Gy) to the prostate bed without hormonal therapy.
The primary endpoint was freedom from biochemical progression (FFBP). Secondary endpoints included clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), acute and late toxicity (Common Terminology Criteria for Adverse Events v4.0), and quality of life (QoL).
Between February 2011 and April 2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175). Median prostate-specific antigen at randomization was 0.3 ng/ml. After median follow-up of 6.2 yr, the median FFBP was 8.2 yr in the 64 Gy arm and 7.6 in the 70 Gy arm (log-rank p = 0.4), with a hazard ratio of 1.14 (95% confidence interval 0.82-1.60). The 6-year FFBP rates were 62% and 61%, respectively. No significant differences in clinical PFS, time to hormonal treatment, or OS were observed. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21%) and 13 (7.9%) patients in the 64 Gy arm, and 46 (26%) and seven (4%) in the 70 Gy arm, respectively (p = 0.8). Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009). There were no significant differences in QoL.
Conventional-dose SRT to the prostate bed is sufficient in patients with early biochemical progression of prostate cancer after RP.
The optimal radiation therapy dose for patients who have increased tumor markers after surgery for prostate cancer is unclear. We found that administering a higher dose only increased the gastrointestinal side effects without providing any benefits to the patient. This clinical trial is registered on ClinicalTrials.gov as NCT01272050.
To report the outcomes of the SAKK 09/10 trial comparing conventional and dose-intensified SRT.
SAKK 09/10 was a randomized, multicenter, phase 3 trial that recruited men with biochemical progression after RP.
Patients were randomly assigned to conventional-dose (64 Gy) or dose-intensified SRT (70 Gy) to the prostate bed without hormonal therapy.
The primary endpoint was freedom from biochemical progression (FFBP). Secondary endpoints included clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), acute and late toxicity (Common Terminology Criteria for Adverse Events v4.0), and quality of life (QoL).
Between February 2011 and April 2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175). Median prostate-specific antigen at randomization was 0.3 ng/ml. After median follow-up of 6.2 yr, the median FFBP was 8.2 yr in the 64 Gy arm and 7.6 in the 70 Gy arm (log-rank p = 0.4), with a hazard ratio of 1.14 (95% confidence interval 0.82-1.60). The 6-year FFBP rates were 62% and 61%, respectively. No significant differences in clinical PFS, time to hormonal treatment, or OS were observed. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21%) and 13 (7.9%) patients in the 64 Gy arm, and 46 (26%) and seven (4%) in the 70 Gy arm, respectively (p = 0.8). Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009). There were no significant differences in QoL.
Conventional-dose SRT to the prostate bed is sufficient in patients with early biochemical progression of prostate cancer after RP.
The optimal radiation therapy dose for patients who have increased tumor markers after surgery for prostate cancer is unclear. We found that administering a higher dose only increased the gastrointestinal side effects without providing any benefits to the patient. This clinical trial is registered on ClinicalTrials.gov as NCT01272050.
Keywords
Aged, Disease Progression, Humans, Male, Middle Aged, Neoplasm Recurrence, Local/blood, Neoplasm Recurrence, Local/radiotherapy, Prostate-Specific Antigen/blood, Prostatectomy/adverse effects, Prostatic Neoplasms/blood, Prostatic Neoplasms/radiotherapy, Prostatic Neoplasms/surgery, Quality of Life, Radiotherapy Dosage, Salvage Therapy/methods, Biochemical progression, Prostate cancer, Salvage radiotherapy
Pubmed
Web of science
Create date
16/11/2022 17:02
Last modification date
10/07/2023 16:04
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