Présenté par le Dr S. KIM
S. Kim (Besançon, France) E. Francois (Nice, France) F. Bidard (Paris, France) E. Samalin (Montpellier, France) F. El Hajbi (Lille, France) N. Baba-Hamed (Paris, France) S. Dumont (Paris, France) S. Pernot (Paris, France) D. Peiffert (Nancy, France) F. Ghiringhelli (Dijon, France) O. Bouche (Reims, France) J. Desrame (Lyon, France) M. Zoubir (Paris, France) A. Parzy (Caen, France) D. Smith (Bordeaux, France) C. De la Fouchardiere (Lyon, France) B. Buecher (Paris, France) V. Vendrely (Bordeaux, France) F. Bonnetain (Besançon, France) C. Borg (Besançon, France)
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.
66 patients were enrolled from September 2014 to January 2017. Median age was 60.05 years (range, 38-78) 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 <2, and being eligible for DCF. Patients received either 6 cycles of standard DCF or 8 cycles of modified DCF depending on age (> vs. < = 75 years-old) and ECOG-PS (0 vs. 1). The trial was set up based on a Simon’s optimal two-stage design, allowing an early futility interim analysis amid the first 21 patients. The primary endpoint was the observed PFS rate at 12months from the first DCF cycle. A PFS rate above 25% was expected. With a unilateral alpha error of 5% and a statistical power of 90%, 66 evaluable patients had to be included.
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.