The median follow-up time was 54 months
(range 2-204 months). The 10-year overall survival (OS), disease-free survival
(DFS), locoregional relapse-free survival (LRFS) and metastases-free survival
(MFS) were 39.4%, 39.5%, 40.3% and 40.4%, respectively. Patients with bulky
primary tumour (>4 cm) and positive lymph node (pelvic with or without
paraaortic) status treated with 50.4 Gy EBRT and 4x7 Gy BT showed better
outcomes compared with the group of patients received 3x7 Gy
BT: LRFS was 55.1% and 53.8% (p=0.0485),
DFS was 52.8% vs. 47.9% (p=0.0026) and OS was 62.3% vs. 46.1% (p=0.0199) in 4x7
Gy versus 3x7 Gy BT groups.
Cumulative grade 0 GI toxicity occurred in 65.1%,
grade 1 in 13.3%, grade 2 in 12.4%, grade 3 in 7.6% and grade 4 in 1.6% of the
patients. Small bowel resection was performed in 23 patients (5.8%) due to
grade 3-4 toxicity. 7.9% of the survivors (36 patients) still have late grade
1-2 GI toxicity.
Referring to late GU toxicity, 79.3% of the patients
reported grade 0 toxicity, 8.1% of the patients had grade 1, 11.0% had grade 2
and 1.6% had grade 3 events. Grade 4 GU toxicity was not registered. Persistent
grade 1-2 incontinence still occurs in 11% (32 patients) and one patient had
grade 3 incontinence.
Neither the dose of
the EBRT, BT nor the equivalent dose at
fractionation of 2 Gy took effect on the rate of the late GI and GU toxicity.