Predictive factors of rectal toxicity after permanent iodine-125 seed implantation: Prospective cohort study in 2339 patients

Purpose To evaluate the incidence and the associated factors of rectal toxicity in patients with prostate cancer undergoing permanent seed implantation (PI) with or without external beam radiation therapy (EBRT) in a nationwide prospective cohort study in Japan (J-POPS) during the first 2 years. Methods and Materials A total of 2,339 subjects were available for the analyses. Rectal toxicity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results The 3-year cumulative incidence for grade ≥2 rectal toxicity was 2.88%, 1.76%, and 6.53% in all subjects, PI group and EBRT combination therapy group, respectively. On multivariate analysis, among all subjects, grade ≥2 rectal toxicity was associated with rectal volumes receiving 100% of the prescribed dose (R₁₀₀; p < 0.0001) and EBRT combination therapy (p = 0.0066). R₁₀₀ in the PI group (p = 0.0254), and R₁₀₀ (p = 0.0011) and interactive planning (p = 0.0267) in the EBRT combination therapy group were also associated with grade ≥2 toxicity. The 3-year cumulative incidence of grade ≥2 rectal toxicity was 3.80% and 1.37% for R₁₀₀ ≥ 1 mL and R₁₀₀ < 1 mL, respectively, in the PI group (p = 0.0068), and 14.09% and 5.52% for R₁₀₀ ≥ 1 mL and R₁₀₀ < 1 mL, respectively, in the EBRT combination therapy group (p = 0.0070). Conclusions Rectal toxicity was relatively rare in this study compared with previous reports. For Japanese prostate cancer patients, R₁₀₀ < 1 mL in both PI and EBRT combination therapy groups and interactive planning in EBRT combination therapy group may be effective in decreasing the incidence of rectal toxicity.