Anal Squamous Cell Carcinoma (ASCC) is a rare disease, but its incidence is markedly increasing. To date, in advanced ASCC, no standard regimen exists. We have previously published the potential role of DCF regimen. Among 8 advanced ASCC consecutive patients who relapsed after CRT, the DCF regimen induced a complete response in 4 patients, including 3 pathological complete responses. Thus, this study was designed to confirm the interest of DCF regimen in advanced ASCC patients.
A multicentre phase II trial was conducted among 25 hospitals in France. Main eligibility criteria were histologically proved unresectable locally advanced recurrent or metastatic ASCC, ECOG-PS vs.
66 patients were enrolled from September 2014 to January 2017. Median age was 60.05 years (range, 38-78) with female predominance (81.8%). 40 (60.6%) patients had locoregional involvement at enrolment, and the most frequent metastatic sites were liver (60.6%), distal lymph node (48.5%), and lung (36.4%). At interim analysis, 10 (47.6%) patients were progression-free at 12 months from the first DCF cycle. To date, 65 patients are assessable for response rate by investigators. The objective response rate is 87.7%, including 36.9% of complete responses. Among the first 32 patients with ≥12 months of follow-up, 15 (46.9%) patients were progression-free at 12 months.
This first ever conducted prospective trial in front-line advanced ASCC demonstrated a high long-lasting response rate of the DCF regimen. DCF regimen should then be considered as a standard of care in this situation.
Clinical trial identification
Legal entity responsible for the study
University Hospital of Besancon
Research grant from the University Hospital of Besançon
All authors have declared no conflicts of interest.