TY - JOUR
T1 - Every-Other-Day Versus Once-a-Week Urethra-Sparing Prostate Stereotactic Body Radiation Therapy
T2 - 5-Year Results of a Randomized Phase 2 Trial
AU - Zilli, Thomas
AU - Jorcano, Sandra
AU - Bral, Samuel
AU - Symon, Zvi
AU - Rubio, Carmen
AU - Bruynzeel, Anna M. E.
AU - Ibrahimov, Roman
AU - Minn, Heikki
AU - Oliveira, Angelo
AU - Bertaut, Aurélie
AU - Constantin, Guillaume
AU - Miralbell, Raymond
N1 - Funding Information:
Disclosures: T.Z. reports honoraria from Janssen, Amgen, Ferring, Debiopharm, Bayer, and Astellas and research grants from Varian Medical Systems outside the submitted work. R.M. reports research grants from Fundació Privada CELLEX and BrainLab. A.M.E.B. reports research grants and honoraria from ViewRay Inc outside the submitted work. No other disclosures were reported.
Funding Information:
This study was funded by a grant from Fundació Privada Cellex and BrainLab. The granting bodies are not involved in data collection or analysis.
Funding Information:
We acknowledge Laurence Zulianello, PhD, Isabelle Semac, PhD, Michel Rouzaud, MSc, Angele Marzin, MSc, and Maud Jaccard, MSc, of Geneva University Hospital, Geneva, Switzerland.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023
Y1 - 2023
N2 - Purpose: The objective of this study was to present the 5-year results from a prospective, multicenter, phase 2 randomized trial of every-other-day (EOD) versus once-a-week (QW) urethra-sparing stereotactic body radiation therapy for localized prostate cancer. Methods and Materials: Between 2012 and 2015, 170 patients with cT1c-3aN0M0 prostate cancer from 9 European institutions were randomized to 36.25 Gy in 5 fractions (6.5 Gy/fraction to the urethra) delivered either EOD (arm A, n = 84) or QW (arm B, n = 86). The median follow-up was 78 months (interquartile range, 66-89 months) and 77 months (interquartile range, 66-82 months) for arms A and B, respectively. Results: Among the 165 patients treated and retained for the final analysis (arm A, n = 82; arm B, n = 83), acute toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 scale) was mild or absent, with no differences between arms. The 5-year grade 2 or greater genitourinary toxicity-free survival was 75.9% and 76.1% for arms A and B, respectively (P =.945), whereas the 5-year grade 2 or greater gastrointestinal toxicity-free survival was 89% and 92% for arms A and B, respectively (P =.596). No changes in European Organisation for Research and Treatment of Cancer QLQ-PR25 scores were observed in both arms for genitourinary, gastrointestinal, and sexual domains at 5-year follow-up compared with baseline. At the last follow-up, biochemical failure was observed in 14 patients in the EOD arm and in 7 patients in the QW arm, with a 5-year biochemical relapse-free survival rate of 92.2% and 93% for arms A and B, respectively (P =.13). Conclusions: Stereotactic body radiation therapy for prostate cancer with a 10% dose reduction to urethra was associated with a minimal effect on urinary function and quality of life regardless of an EOD or QW fractionation schedule. Biochemical control so far has been encouraging and much alike in both study arms, although longer follow-up is probably needed to assess the true value of overall treatment time on disease outcome.
AB - Purpose: The objective of this study was to present the 5-year results from a prospective, multicenter, phase 2 randomized trial of every-other-day (EOD) versus once-a-week (QW) urethra-sparing stereotactic body radiation therapy for localized prostate cancer. Methods and Materials: Between 2012 and 2015, 170 patients with cT1c-3aN0M0 prostate cancer from 9 European institutions were randomized to 36.25 Gy in 5 fractions (6.5 Gy/fraction to the urethra) delivered either EOD (arm A, n = 84) or QW (arm B, n = 86). The median follow-up was 78 months (interquartile range, 66-89 months) and 77 months (interquartile range, 66-82 months) for arms A and B, respectively. Results: Among the 165 patients treated and retained for the final analysis (arm A, n = 82; arm B, n = 83), acute toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 scale) was mild or absent, with no differences between arms. The 5-year grade 2 or greater genitourinary toxicity-free survival was 75.9% and 76.1% for arms A and B, respectively (P =.945), whereas the 5-year grade 2 or greater gastrointestinal toxicity-free survival was 89% and 92% for arms A and B, respectively (P =.596). No changes in European Organisation for Research and Treatment of Cancer QLQ-PR25 scores were observed in both arms for genitourinary, gastrointestinal, and sexual domains at 5-year follow-up compared with baseline. At the last follow-up, biochemical failure was observed in 14 patients in the EOD arm and in 7 patients in the QW arm, with a 5-year biochemical relapse-free survival rate of 92.2% and 93% for arms A and B, respectively (P =.13). Conclusions: Stereotactic body radiation therapy for prostate cancer with a 10% dose reduction to urethra was associated with a minimal effect on urinary function and quality of life regardless of an EOD or QW fractionation schedule. Biochemical control so far has been encouraging and much alike in both study arms, although longer follow-up is probably needed to assess the true value of overall treatment time on disease outcome.
UR - http://www.scopus.com/inward/record.url?scp=85153080010&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2023.03.057
DO - 10.1016/j.ijrobp.2023.03.057
M3 - Article
C2 - 37001763
SN - 0360-3016
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
ER -