KANAL 2 and ACCORD 03 were phase 2 and phase 3 trials with same inclusion criteria. The patients recruited had cancer of the anal canal of ≥ 4 cm or N+ treated with concomitant radiochemotherapy (45 Gy/25 fractions) with 5FU and cisplatin. A univariate and multivariate analysis of different potential explanatory factors (patients, tumors, and treatments) were carried out through Cox regression modeling.
Three hundred and ninety two patients were included. In multivariate analyses, the circumferential tumor spread (less than 1/3; between 1/3 and 2/3; more than 2/3) (HR = 2.06 and HR = 2.94, p = 0.003); the inguinal node involvement (HR = 1.64, p = 0.04) and the total radiotherapy dose below 60 Gy or above 65 Gy (HR = 1.97 and HR = 2.2, p = 0.006) were associated with a lower rate of colostomy-free survival. Age of over 55 years (HR = 0.64, p = 0.03) was associated with a higher rate of colostomy-free survival.
This prospective prognosis study demonstrates that, in patients with locally advanced anal cancer, the degree of circumferential tumor spread, the inguinal node involvement, and an overly low or high total radiotherapy dose are poor prognostic factors for colostomy-free survival. On the other hand, age of over 55 years is a positive prognostic factor.