602P - REBECCA: A large cohort study of regorafenib (REG) in the real-life setting in patients (pts) previously treated for metastatic colorectal cancer (...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter David Tougeron
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors D. Tougeron1, F. Desseigne2, P.L. Etienne3, L.M. Dourthe4, L. Mineur5, B. Paule6, A. Hollebecque7, E. Tresch8, D. Spaeth9, P. Michel10, J. Dauba11, P. Laplaige12, C. Borg13, D. Bechade14, S. Clisant15, J. Phelip16, C. De La Fouchardiere2, T. André17, A. Adenis18
  • 1Hepato-gastro-enterologie, Centre Hospitalier Universitaire, 86021 - Poitiers/FR
  • 2Medical Oncology, Centre Leon Berard, FR-69008 - Lyon CEDEX/FR
  • 3Oncologie Medicale, Clinique Armoricaine de Radiologie, St Brieuc/FR
  • 4Oncologie, Clinique de l'Orangerie, Strasbourg/FR
  • 5Gastrointestinal And Liver Oncology–radiotherapy Unit, Institut Sainte-Catherine, Avignon/FR
  • 6Centre Hépato-biliaire, AP-HP Hôpital Paul Brousse, F-94800 - Villejuif/FR
  • 7Dept. Of Medicine, Institut Gustave Roussy, FR-94805 - Villejuif CEDEX/FR
  • 8Biostatistics Unit, Centre Oscar Lambret, 59000 - Lille/FR
  • 9Chimiothérapie Ambulatoire, Centre d'Oncologie de Gentilly, Strasbourg/FR
  • 10Gastroenterology And Digestive Oncology, CHU de Rouen, 76000 - Rouen/FR
  • 11Pneumologie, CH, Mont-de-Marsan/FR
  • 12Medecine Oncologie, Polyclinique de Blois, La Chaussee Saint Victor/FR
  • 13Medical Oncology, University Hospital Besançon, Besançon/FR
  • 14Gastro Entérologie, Institut Bergonié, Bordeaux/FR
  • 15Clinical Research, Centre Oscar Lambret, 59000 - Lille/FR
  • 16Gastro-entérologie Et Hépatologie, CHU de Saint Etienne, Saint Etienne/FR
  • 17Medical Oncology, Hopital Saint-Antoine and Université Pierre et Marie Curie, FR-75012 - Paris/FR
  • 18Gastrointestinal Oncology Department, Centre Oscar Lambret, 59020 - Lille/FR

Abstract

Aim

REG is a multi-kinase inhibitor with survival benefits in pts with pretreated mCRC, as demonstrated in the phase III CORRECT study. As a result, REG has been made available for medical practice use in the US, and in the EU. However, prescribing conditions in the real-life setting are known to be less stringent than selection criteria in clinical trials. The REgorafeniB in mEtastatic Colorectal cancer: a French Compassionate progrAm (REBECCA) is an ambispective cohort study designed to elucidate safety and effectiveness outcomes associated with REG as used in clinical practice for mCRC refractory to all available therapies.

Methods

Pts were identified from the database of the French ATU (Temporary Authorization for Use), approved by the French Health Authorities to provide early access to innovative, not yet approved medicinal products such as REG. Baseline patient and tumor characteristics, REG dosing and dose-intensity, REG-related adverse events, pre- and post REG treatments, predictors of events, and effectiveness data (PFS, OS) were collected from pts who agreed, and whom physicians accepted to collaborate to the REBECCA study which had OS estimate as a primary objective.

Results

1178 pts met the ATU criteria, of whom 1119 started on REG. 681/1178 (58%) were male. Median age was 64 years (range 25-92). ECOG PS was 0 (31%), 1 (59%), and ≥ 2 (10%). Median time since diagnosis of the metastatic disease was 2.7 years. KRAS mutation was documented in 604/1178 (51%) of pts. Metastases were predominantly located in the liver (76%) and lungs (62%). The starting dose of REG was 160 mg/day in 89.7% of pts. Of the 1178 pts who met the ATU criteria, 787 pts treated by 283 physicians were included in the REBECCA study. Analyses in these patients are in progress.

Conclusions

Apart from a baseline PS > 1 in 10% of the pts, the patterns of pts included in the ATU seem to be comparable to those of pts included in the phase III CORRECT study. REBECCA, which is the largest cohort study of REG in mCRC pts ever reported, will provide valuable insights in the therapeutic benefit of this new compound in the real-life setting. Full results of this study will be presented at the meeting.

Disclosure

A. Adenis: Bayer (advisory board, research funding). All other authors have declared no conflicts of interest.