536P - Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell car...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Anal Cancer
Gastrointestinal Cancers
Presenter Stefano Kim
Citation Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393
Authors S. Kim1, E. Francois2, F. Bidard3, E. Samalin4, F. El Hajbi5, N. Baba-Hamed6, S. Dumont7, S. Pernot8, D. Peiffert9, F. Ghiringhelli10, O. Bouche11, J. Desrame12, M. Zoubir13, A. Parzy14, D. Smith15, C. de la Fouchardiere16, B. Buecher3, V. Vendrely17, F. Bonnetain18, C. Borg1
  • 1Medical Oncology, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 2Medical Oncology, Centre Antoine Lacassagne, Nice/FR
  • 3Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 4Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 5Oncology, Centre Oscar Lambret, Lille/FR
  • 6Oncology, Groupe Hospitalier Paris Saint-Joseph, Paris/FR
  • 7Oncology, Hopital St. Antoine, 75571 - Paris/FR
  • 8Oncology, Hôpital européen Georges-Pompidou, Paris/FR
  • 9Oncology, Institut de Cancérologie de Lorraine, Nancy/FR
  • 10Medical Oncology, Georges-Francois Leclerc Cancer Center, 21000 - Dijon/FR
  • 11Department Of Medicine-oncology, CHU Robert Debré, Reims/FR
  • 12Hepato-gastroenterology, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 13Oncology, Hôpital Privé des Peupliers, Paris/FR
  • 14Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 15Oncology, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 16Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 17Radiotherapy, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 18Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR

Abstract

Background

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.

Methods

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. 

Results

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.

Conclusions

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

NCT02402842

Legal entity responsible for the study

University Hospital of Besancon

Funding

Research grant from the University Hospital of Besançon

Disclosure

All authors have declared no conflicts of interest.