Patients treated with curative intent and followed prospectively were included. The SB loops closed to CTV were delineated, but no specific dose constraint was applied. The dosimetric data, converted in 2-Gy equivalent, were confronted with the occurrence of late morbidity assessed using the CTC-AE 3.0. Dose–effect relationships were assessed using mean-dose comparisons, log-rank tests on event-free periods, and probit analyses.
A total of 115 patients with a median followup of 35.5 months were included. Highest grade per patient was: Grades 0 for 17, 1 for 75, 2 for 20, and 3 for 3. The mean D2cm3 and D0.1cm3 were, respectively, 68.7 ± 13.6 Gy and 85.8 ± 33.1 Gy and did not differ according to event severity (p = 0.47 and p = 0.52), even when comparing Grades 0–1 vs. 2–4 events (68.0 ± 12.4 vs. 71.4 ± 17.7 Gy; p = 0.38 and 83.7 ± 26.4 vs. 94.5 ± 51.9 Gy; p = 0.33). Log-rank tests were performed after splitting the cohort according to four D2cm3 levels: >80 Gy, 70–79 Gy, 60–70 Gy, and <60 Gy. No difference was observed for Grades 1–4, Grades 2–4, or Grades 3–4 (p = 0.21–0.52). Probit analyses showed no correlation between the dosimetric parameters and probability of Grades 1–4, 2–4, or 3–4 events (p = 0.19–0.48).
No significant dose–volume effect relationships were demonstrated between the D2cm3 and D0.1cm3 and the probability of late SB morbidity. These parameters should not limit the pulsed-dose rate brachytherapy optimization process.