Donald B Fuller1, Aaron D Falchook2, Tami Crabtree3, Brent L Kane4, Clinton A Medbery5, Kelly Underhill6, James R Gray7, Anuj Peddada8, Ronald C Chen9. 1. CyberKnife Centers of San Diego, San Diego, CA, USA. Electronic address: dfuller@genhp.com. 2. Department of Radiation Oncology, Memorial Cancer Institute, Memorial Healthcare System, Hollywood, FL, USA. 3. Advance Research Associates, Santa Clara, CA, USA. 4. California Cancer Center, Fresno, CA, USA. 5. Southwest Radiation Oncology, Oklahoma City, OK, USA. 6. Benefis Sletten Cancer Institute, Great Falls, MT, USA. 7. Sarah Cannon Research Institute, Nashville, TN, USA. 8. Penrose-St. Francis Health Services, Colorado Springs, CO, USA. 9. University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Abstract
BACKGROUND: Stereotactic body radiation therapy is an emerging treatment for prostate cancer (PC), with potential biological and oncologic advantages. A well-established radiation dosing schedule (38Gy in 4 fractions) has shown excellent long-term efficacy in high-dose-rate (HDR) brachytherapy. OBJECTIVE: To report 5-yr efficacy, toxicity, and quality-of-life (QOL) outcomes of a novel 4-d SBRT regimen. DESIGN, SETTING, AND PARTICIPANTS: This was a single-arm prospective phase 2 trial involving 259 patients with low- or intermediate-risk PC treated at 18 US centers from December 2007 to February 2012. The median follow-up was 5yr (interquartile range 37-85mo). INTERVENTION: SBRT with 38Gy in four fractions; radiation plans mimicked HDR brachytherapy dosimetry. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We measured freedom from biochemical recurrence (BCR) and assessed toxicities using the Common Terminology Criteria for Adverse Events v3.0 and QOL using the Expanded Prostate Cancer Index Composite. RESULTS AND LIMITATIONS: The 5-yr BCR-free rates were 100% and 88.5% for patients with low- and intermediate-risk PC, respectively. The cumulative 5-yr grade 2, 3, and 4 toxicity rates were 12.4%, 1.9%, and 0.4% for urinary, and 3.4%, 0%, and 0% for gastrointestinal toxicities, respectively. The median baseline prostate-specific antigen (PSA) level of 5.12ng/ml decreased to 0.1ng/ml by ≥42mo. QOL scores decreased at 1mo but returned to baseline by 6mo, with a later decline (≥24mo) in the urinary continence domain (pad use was 2% at baseline and 10% at 5yr), and lower sexual potency over time. Comparative outcomes versus other types of radiotherapy are difficult because the trial was not randomized. CONCLUSIONS: This regimen yields a high rate of BCR-free survival, with a very low median PSA nadir suggesting prostate ablation. For properly selected patients with low- or intermediate-risk PC who choose SBRT, this treatment regimen is effective. PATIENT SUMMARY: This potent four-treatment stereotactic body radiotherapy regimen appears to be effective for patients with early prostate cancer.
BACKGROUND: Stereotactic body radiation therapy is an emerging treatment for prostate cancer (PC), with potential biological and oncologic advantages. A well-established radiation dosing schedule (38Gy in 4 fractions) has shown excellent long-term efficacy in high-dose-rate (HDR) brachytherapy. OBJECTIVE: To report 5-yr efficacy, toxicity, and quality-of-life (QOL) outcomes of a novel 4-d SBRT regimen. DESIGN, SETTING, AND PARTICIPANTS: This was a single-arm prospective phase 2 trial involving 259 patients with low- or intermediate-risk PC treated at 18 US centers from December 2007 to February 2012. The median follow-up was 5yr (interquartile range 37-85mo). INTERVENTION: SBRT with 38Gy in four fractions; radiation plans mimicked HDR brachytherapy dosimetry. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We measured freedom from biochemical recurrence (BCR) and assessed toxicities using the Common Terminology Criteria for Adverse Events v3.0 and QOL using the Expanded Prostate Cancer Index Composite. RESULTS AND LIMITATIONS: The 5-yr BCR-free rates were 100% and 88.5% for patients with low- and intermediate-risk PC, respectively. The cumulative 5-yr grade 2, 3, and 4 toxicity rates were 12.4%, 1.9%, and 0.4% for urinary, and 3.4%, 0%, and 0% for gastrointestinal toxicities, respectively. The median baseline prostate-specific antigen (PSA) level of 5.12ng/ml decreased to 0.1ng/ml by ≥42mo. QOL scores decreased at 1mo but returned to baseline by 6mo, with a later decline (≥24mo) in the urinary continence domain (pad use was 2% at baseline and 10% at 5yr), and lower sexual potency over time. Comparative outcomes versus other types of radiotherapy are difficult because the trial was not randomized. CONCLUSIONS: This regimen yields a high rate of BCR-free survival, with a very low median PSA nadir suggesting prostate ablation. For properly selected patients with low- or intermediate-risk PC who choose SBRT, this treatment regimen is effective. PATIENT SUMMARY: This potent four-treatment stereotactic body radiotherapy regimen appears to be effective for patients with early prostate cancer.
Authors: Rebecca G Levin-Epstein; Naomi Y Jiang; Xiaoyan Wang; Shrinivasa K Upadhyaya; Sean P Collins; Simeng Suy; Nima Aghdam; Constantine Mantz; Alan J Katz; Leszek Miszczyk; Aleksandra Napieralska; Agnieszka Namysl-Kaletka; Nicholas Prionas; Hilary Bagshaw; Mark K Buyyounouski; Minsong Cao; Nzhde Agazaryan; Audrey Dang; Ye Yuan; Patrick A Kupelian; Nicholas G Zaorsky; Daniel E Spratt; Osama Mohamad; Felix Y Feng; Brandon A Mahal; Paul C Boutros; Arun U Kishan; Jesus Juarez; David Shabsovich; Tommy Jiang; Sartajdeep Kahlon; Ankur Patel; Jay Patel; Nicholas G Nickols; Michael L Steinberg; Donald B Fuller; Amar U Kishan Journal: Radiother Oncol Date: 2020-10-07 Impact factor: 6.280
Authors: William C Jackson; Jessica Silva; Holly E Hartman; Robert T Dess; Amar U Kishan; Whitney H Beeler; Laila A Gharzai; Elizabeth M Jaworski; Rohit Mehra; Jason W D Hearn; Todd M Morgan; Simpa S Salami; Matthew R Cooperberg; Brandon A Mahal; Payal D Soni; Samuel Kaffenberger; Paul L Nguyen; Neil Desai; Felix Y Feng; Zachary S Zumsteg; Daniel E Spratt Journal: Int J Radiat Oncol Biol Phys Date: 2019-04-06 Impact factor: 7.038
Authors: Kyle Wang; Panayiotis Mavroidis; Trevor J Royce; Aaron D Falchook; Sean P Collins; Stephen Sapareto; Nathan C Sheets; Donald B Fuller; Issam El Naqa; Ellen Yorke; Jimm Grimm; Andrew Jackson; Ronald C Chen Journal: Int J Radiat Oncol Biol Phys Date: 2020-12-22 Impact factor: 7.038
Authors: S Kawakami; H Tsumura; T Satoh; K Tabata; A Sekiguchi; T Kainuma; M Nakano; M Iwamura; H Ishiyama Journal: Radiat Oncol Date: 2022-04-04 Impact factor: 3.481