Objective. To analyse the factors related to the appearance, incidence and severity of toxicity associated with post-operative radiochemotherapy in rectal cancer.
Material and methods. Between January 1994 and September 1997, we prospectively collected the data on 122 patients treated for rectal adenocarcinoma in the B2-C stage. Surgery was followed by radiotherapy and chemotherapy (5-FU plus leucovorin) administered as an alternating, or as a concomitant, scheme. Pelvic volume was treated with a four-portal, or a two-portal, irradiation technique using megavoltage photon beams (60Co or 23 MV photons). Total administered dose was 50 Gy in 1.8-2 Gy fractions. Statistical analysis was performed to identify factors related to the incidence of toxicity, and its severity.
Results. Acute side effects were noted in 98 (80.3%) patients; the most frequent being diarrhea (55%) followed by skin reactions (40.1%). Toxicity occurred following the administration of a mean radiation dose of 26 Gy (range: 8-50 Gy). Grade 3 toxic events were observed in 20.5% of patients. It was necessary to interrupt treatment in 32.8% of patients for a mean period of 8.8 days. There were no grade 4 toxicities or therapy-related deaths. The concomitant scheme of radiochemotherapy (compared to alternating) was the main predictive factor for higher incidence (91.1% versus 74%; p=0.04), higher severity grade 3 (33.3% versus 13%; p=0.014) and early (following 22.7 Gy versus 28.4 Gy, p=0.012) acute toxicity.
With a median follow-up of 68.9 months, late grade 3 toxicity appeared in 13 patients (10.8%), and 10 patients (8.3%) required surgical treatment to resolve an intestinal obstruction. None of the parameters analysed influenced the late-onset toxicity, or the development of small-bowel obstruction.
Conclusions. In our study, the concomitant radiochemotherapy combination scheme was the main predictive factor for acute toxicity, but with no influence on late-onset toxicity. Our overall results were similar to others reported in the literature.
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