Xin Qi1, Hong-Zhen Li1, Xian-Shu Gao2, Shang-Bin Qin1, Min Zhang1, Xiao-Mei Li1, Xiao-Ying Li1, Ming-Wei Ma1, Yun Bai1, Xue-Ying Li3, Dian Wang4. 1. Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China. 2. Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China. Electronic address: doctorgaoxs@126.com. 3. Department of Medical Statistics, Peking University First Hospital, Peking University, Beijing, People's Republic of China. 4. Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois. Electronic address: dian_wang@rush.edu.
Abstract
PURPOSE: Our purpose was to compare toxicity and biochemical control in postprostatectomy patients treated withconventional (66 Gy) or dose-intensified (72 Gy) radiation therapy. METHODS AND MATERIALS: Patients who had stage pT3-4, positive surgical margins, or rising prostate-specific antigen ≥ 0.2 ng/mLafter radical prostatectomy were randomly assigned to receive either 66 Gy in 33 fractions or 72 Gy in 36 fractions. A primary endpoint was to assess the difference in biochemical progression-free survival (bPFS) between these 2 cohorts, and secondary endpoints were to assess differences in genitourinary (GU), gastrointestinal (GI), and hematologic toxicities between these 2 cohorts. bPFS was estimated by the Kaplan-Meier method and toxicities were compared using the χ2 test. RESULTS:Between September 2011 and November 2016, 144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort. The median follow-up time was 48.5 months (range, 14-79 months). There was no difference in 4-year bPFS between the 66 Gy and 72 Gy cohorts (75.9% vs 82.6%; P = .299). However, in patients with a higher Gleason score (8-10), the 72 Gy cohort had statistically significant improvement in bPFS compared with the 66 Gy cohort (79.7% vs 55.7%; P = .049). Toxicity analysis showed no difference in ≥2 acute or late GI or GU toxicities between these 2 cohorts. A total of 48 patients were scored as urinary incontinence before radiation therapy, of which 39 (81.3%) reported incontinence recovery or stable at 1-year follow-up, and only 9 (18.8%) patients reported worsening. There was no difference between the 2 cohorts in urinary incontinence either at baseline or at 1-year follow-up. CONCLUSIONS: Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen. However, the dose escalation was not associated with greater acute or late GU or GI toxicities and did not increase urinary incontinence.
RCT Entities:
PURPOSE: Our purpose was to compare toxicity and biochemical control in postprostatectomy patients treated with conventional (66 Gy) or dose-intensified (72 Gy) radiation therapy. METHODS AND MATERIALS: Patients who had stage pT3-4, positive surgical margins, or rising prostate-specific antigen ≥ 0.2 ng/mL after radical prostatectomy were randomly assigned to receive either 66 Gy in 33 fractions or 72 Gy in 36 fractions. A primary endpoint was to assess the difference in biochemical progression-free survival (bPFS) between these 2 cohorts, and secondary endpoints were to assess differences in genitourinary (GU), gastrointestinal (GI), and hematologic toxicities between these 2 cohorts. bPFS was estimated by the Kaplan-Meier method and toxicities were compared using the χ2 test. RESULTS: Between September 2011 and November 2016, 144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort. The median follow-up time was 48.5 months (range, 14-79 months). There was no difference in 4-year bPFS between the 66 Gy and 72 Gy cohorts (75.9% vs 82.6%; P = .299). However, in patients with a higher Gleason score (8-10), the 72 Gy cohort had statistically significant improvement in bPFS compared with the 66 Gy cohort (79.7% vs 55.7%; P = .049). Toxicity analysis showed no difference in ≥2 acute or late GI or GU toxicities between these 2 cohorts. A total of 48 patients were scored as urinary incontinence before radiation therapy, of which 39 (81.3%) reported incontinence recovery or stable at 1-year follow-up, and only 9 (18.8%) patients reported worsening. There was no difference between the 2 cohorts in urinary incontinence either at baseline or at 1-year follow-up. CONCLUSIONS: Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen. However, the dose escalation was not associated with greater acute or late GU or GI toxicities and did not increase urinary incontinence.
Authors: Asunción Hervás-Morón; Jose Domínguez-Rullán; Victor Duque Santana; Mireia Valero; Carmen Vallejo; Sonsoles Sancho; Juan David García Fuentes; Fernando López-Campos; Miguel Cámara Gallego Journal: World J Clin Oncol Date: 2022-07-24