International journal of radiation oncology, biology, physics · 2026
Acute Toxicity and Quality of Life With Stereotactic Body Radiation Therapy Versus Conventional Fractionated Intensity Modulated Radiation Therapy to the Prostate and Pelvis in High-Risk Prostate Cancer: A Randomized Phase 2 Trial.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Poon Darren M C, Wong Kenneth, Lam Daisy, Johnson David, Chan Landon, Chu Cheuk-Man, Ng Chi-Fai, Mo Frankie, Chan Anthony T C, Mok Tony
Аннотация
PURPOSE: Stereotactic body radiation therapy (SBRT) to the prostate and pelvis in high-risk prostate cancer (HR-PC) may shorten treatment, but acute toxicity and quality of life (QoL) outcomes compared with conventional fractionated intensity modulated radiation therapy (IMRT) remain uncertain. We report acute toxicity and early QoL outcomes from a randomized phase 2 trial.
METHODS AND MATERIALS: Between 2019 and 2024, 121 patients with node-negative HR-PC were randomized to SBRT (40 Gy in 5 weekly fractions to prostate, 36.25 Gy to seminal vesicles, and 25 Gy to pelvis) or IMRT (76 Gy in 38 daily fractions: 50 Gy to prostate and pelvis, followed by 26 Gy prostate boost), with androgen deprivation therapy (18-24 months). The primary endpoint was acute grade ≥2 gastrointestinal (GI) or genitourinary (GU) toxicity occurring during radiation therapy or within 120 days after treatment completion (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0). Secondary endpoints included patient-reported outcomes (Expanded Prostate Cancer Index Composite, International Prostate Symptom Score).
RESULTS: Baseline characteristics were balanced (median age, 72 years; 49.6% prostate-specific antigen ≥20 ng/mL; 69% Gleason ≥8). Acute grade ≥2 GI toxicity occurred in 8.3% with SBRT versus 39.0% with IMRT (P <.0001); grade ≥2 GU toxicity in 23.3% versus 36.1%, respectively (P =.126). Grade 3 diarrhea occurred in 1 patient with IMRT; no grade ≥3 GU events were observed. At 1 month, bowel QoL declined more with IMRT (-10.4) than SBRT (-1.9; P =.0008), as did urinary domain decline (-11.3 vs -7.5). At 1 week, the International Prostate Symptom Score and QoL worsened less with SBRT than with IMRT (+4.55 vs +7.49; P =.062; QoL P =.029).
CONCLUSIONS: Once-weekly SBRT to the prostate and pelvis significantly reduced acute GI toxicity and provided comparable GU safety relative to IMRT, with supportive early patient-reported outcomes. These findings extend SBRT evidence to the pelvis-inclusive setting in HR-PC and support phase 3 trials.
METHODS AND MATERIALS: Between 2019 and 2024, 121 patients with node-negative HR-PC were randomized to SBRT (40 Gy in 5 weekly fractions to prostate, 36.25 Gy to seminal vesicles, and 25 Gy to pelvis) or IMRT (76 Gy in 38 daily fractions: 50 Gy to prostate and pelvis, followed by 26 Gy prostate boost), with androgen deprivation therapy (18-24 months). The primary endpoint was acute grade ≥2 gastrointestinal (GI) or genitourinary (GU) toxicity occurring during radiation therapy or within 120 days after treatment completion (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0). Secondary endpoints included patient-reported outcomes (Expanded Prostate Cancer Index Composite, International Prostate Symptom Score).
RESULTS: Baseline characteristics were balanced (median age, 72 years; 49.6% prostate-specific antigen ≥20 ng/mL; 69% Gleason ≥8). Acute grade ≥2 GI toxicity occurred in 8.3% with SBRT versus 39.0% with IMRT (P <.0001); grade ≥2 GU toxicity in 23.3% versus 36.1%, respectively (P =.126). Grade 3 diarrhea occurred in 1 patient with IMRT; no grade ≥3 GU events were observed. At 1 month, bowel QoL declined more with IMRT (-10.4) than SBRT (-1.9; P =.0008), as did urinary domain decline (-11.3 vs -7.5). At 1 week, the International Prostate Symptom Score and QoL worsened less with SBRT than with IMRT (+4.55 vs +7.49; P =.062; QoL P =.029).
CONCLUSIONS: Once-weekly SBRT to the prostate and pelvis significantly reduced acute GI toxicity and provided comparable GU safety relative to IMRT, with supportive early patient-reported outcomes. These findings extend SBRT evidence to the pelvis-inclusive setting in HR-PC and support phase 3 trials.