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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2645 - Aflibercept in combination with Irinotecan, fluorouracil and leucovorin (FOLFIRI) as first-line chemotherapy in metastatic colorectal cancer (mCRC) patients : a phase II multicentric study.

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Colon and Rectal Cancer

Presenters

Alexandra Lapeyre-Prost

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

A. Lapeyre-Prost1, S. Pernot2, J. Sigrand3, F. Mary4, K. Le Malicot5, T. Aparicio6, L. Dahan7, F. Caroli-Bosc8, T. Lecomte9, S. Racine Doat10, L. Marthey11, J. Desrame12, C. Lepage13, J. Taieb14

Author affiliations

  • 1 Gastroenterology Department, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Department Of Gastroenterology And Digestive Oncology, Hopital European George Pompidou, 75015 - Paris/FR
  • 3 Digestive Oncology, CHU La Timone, Marseille/FR
  • 4 Gastroenterology Department, Hôpital Avicenne, 93009 - Bobigny/FR
  • 5 Epicad Inserm Lnc-umr 1231, FFCD - Burgandy university, Dijon/FR
  • 6 Gastroenterology Department, Saint Louis Hospital AP-HP, 75010 - Paris/FR
  • 7 Department Of Gastroenterology And Oncology, CHU La Timone Adults, 13385 - Marseille/FR
  • 8 Gastroenterology Department, CHU Angers, Angers/FR
  • 9 Hepato-gastroenterology Department, CHU de Tours, Hôpital Trousseau, 37170 - Chambray-lès-Tours/FR
  • 10 Hepato-gastroenterology Department, Groupe Hospitalier Pitié Salpetriere, 75651 - Paris/FR
  • 11 Hepato-gastroenterology Department, Antoine Béclère Hospital, Clamart/FR
  • 12 Gastroenterology Department, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 13 Hepatogastroenterology And Digestive Oncology Department, University hospital Dijon, University of Burgundy and Franche Comté, FFCD, EPICAD INSERM LNC-UMR 1231, 21079 - Dijon/FR
  • 14 Department Of Gastroenterology And Digestive Oncology, Hospital European Georges Pompidou - Sorbonne Paris Cité, Paris Descartes University, 75015 - Paris/FR

Resources

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Abstract 2645

Background

FOLFIRI (5FU/leucovorin/irinotecan) + aflibercept significantly improves median overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) in patients (pts) with previously treated metastatic colorectal cancer (mCRC). The aim of this study was to investigate efficacy and tolerability of adding aflibercept to FOLFIRI in the first line setting.

Methods

Pts with untreated documented mCRC received aflibercept plus FOLFIRI every 14 days until progression or unacceptable toxicity in an open, phase II single arm, multicenter trial. The primary endpoint was the 6-months PFS rate. Secondary endpoints were overall PFS, OS and tolerability. A two- steps Simon design was used with H0: 55% and H1= 75%, respectively (one-sided α = 5%, 1-β=90%). Data were analyzed in intention to treat population. The study was stopped at the first stage.

Results

41 patients were included and 40 analyzed (1 consent withdrawal) in 9 French centers between 10/2014 and 02/2017. Median age was 65 y (46-81), 42% were men, 53% had two or more metastatic sites. Eighteen patients (54.5%, IC [38.940; 69.509]) were alive and non-progressive at 6 months. Treatment with FOLFIRI plus aflibercept was therefore considered ineffective, inclusions were stopped. Median follow-up was 20.5 months (95% CI (15,11 ; 27,86)). ORR was 54% and disease control rate was 80%. Median duration of treatment was 5.2 months, median PFS and OS were 8,3 and 21.9 months respectively. Grade 3-4 adverse events were mainly gastrointestinal (18 pts, 45% : mucositis (15%), diarrhea (12,5%), abdominal pain (10%)) and vascular (13 pts, 32,5% : hypertension (17,5%) and venous thromboembolism (15%)). Severe hematological toxicities occurred in 7,5% of pts. 87.5% of patients had at least one dose modification during treatment. 37 pts received a second line therapy.

Conclusions

First line FOLFIRI+ aflibercept for mCRC pts is feasible but with significant toxicities leading to dose reduction in the majority of patients. Median PFS and OS were close to those reported with classical doublet and targeted agents in this setting.

Clinical trial identification

EudraCT: 2013-004081-33.

Legal entity responsible for the study

Fédération Francophone de Cancérologie Digestive.

Funding

Sanofi.

Editorial Acknowledgement

Disclosure

S. Pernot: Honoraria: Amgen, Sanofi; Travel, accomodations, expenses: Amgen, Merck, Servier, Bayer T. Aparicio: Conference: Pfizer, Roche, Sanofi, Léo Pharma, Amgen, BMS, Servier, Shire, Ipsen; Board: Pierre Fabre Ipsen, HalioDX, BMS; Travels: Ipsen, Novartis, Roche, Hospira; Research: Novartis. L. Dahan: Honoraria: Sanofi, Amgen. T. Lecomte: Consultant, expert: Sanofi; Courses, trainings: Lilly, Merck, Amgen; Invitations to national or international congresses: Amgen C. Lepage: Clinical research: Ipsen, Novartis Oncology; Courses: Advanced Accelerator Applications; Invitations to national or international congresses: Amgen, Ipsen, Novartis Oncology, Bayer. J. Taieb: Consultancy: Roche, Merck KGaA, Amgen, Celgene, Lilly, Baxalta, Servier, Sirtex Medical; Speaker's bureau: Servier, Amgen, Baxalta, Roche/Genentech, Sanofi, Merck, Lilly. All other authors have declared no conflicts of interest.

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