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Poster display session

2191 - AMALTHEA: A prospective, single-arm study of the Hellenic Cooperative Oncology Group evaluating the efficacy and safety of 1st line FOLFIRI+Aflibercept in patients with metastatic colorectal cancer.


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Colon and Rectal Cancer


George Pentheroudakis


Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393


G. Pentheroudakis1, V. Kotoula1, G. Koliou1, I. Tikas1, V. Karavasilis1, E. Samantas1, G. Aravantinos1, E. Daskalaki1, I. Souglakos2, G. Koumakis1, I. Efstratiou1, C. Petraki1, C. Poulios1, D. Bafaloukos1, D. Pectasides1, E. Vrettou1, G. Fountzilas1

Author affiliations

  • 1 Data Office, Hellenic Cooperative Oncology Group (HeCOG), 11524 - Athens/GR
  • 2 Division Of Internal Medicine, University of Crete, Heraklion/GR


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Abstract 2191


The efficacy and safety of the FOLFIRI regimen combined with aflibercept has not been studied in the first-line management of patients with metastatic colorectal cancer (mCRC).


In the context of a prospective single-arm trial, patients with mCRC received standard doses of Leucovorin, 5-Fluorouracil and Irinotecan (FOLFIRI) combined with aflibercept (4 mg/KBW iv) every 2 weeks until disease progression, unacceptable toxicity or completion of 12 cycles, followed by aflibercept maintenance. Endpoints were the 12-month Progression-Free Rate (PFR12), efficacy and toxicity.


73 fit patients were enrolled in the study between 2014 and 2016. Fifty-five patients had tumors in the left colon, forty-four presented with synchronous metastases. Median relative dose intensities administered were 0.85 (95% CI 0.74-0.84) for 5-FU CI, 0.80 (95% CI 0.73-0.89) for Irinotecan and 1.0 (95% CI 0.92-0.98) for Aflibercept. In total, adverse events occurred in 70 patients (95.9%), with no toxic deaths. The most common grade 3 or 4 adverse events were neutropenia (13 patients, 18%), febrile neutropenia (3 patients, 4%), diarrhoea (11 patients, 15%), hypertension (19 pts, 26%), proteinuria (8 pts, 11%), infections (8 pts, 11%), mucositis (6 pts, 8%). Among 85 adverse events of special interest (AESI) observed, 57 events ended with complete recovery. Among eight patients with severe proteinuria, improvement to grade 0/2 occurred in six at a median time of 4.8 months. The Objective Response Rate (ORR) was 46.6% in the ITT population (n = 73) and 51.5% in the evaluable population (n = 66). Among potential prognostic clinicopathological parameters (including RAS, BRAF status, primary site), the presence of synchronous metastases and a relapse-free interval


The FOLFIRI + Aflibercept regimen is active and safe, however it failed to improve historical benchmarks of efficacy in chemonaive patients with mCRC.

Clinical trial identification

EudraCT No.: 2013-002567-26

Legal entity responsible for the study

Hellenic Cooperative Oncology Group (HeCOG)




V. Karavasilis: Advisory Board: Novartis, Roche, Astellas, Merck, Sanofi, Pfizer, Astra-Zeneca, Janssen. Honoraria: Novartis, Roche, Astellas, Merck, Sanofi, Pfizer, Astra-Zeneca, Janssen. G. Aravantinos: Honoraria: Genesis pharma SA Scientific Advisory Board: Amgen, Astra-Zeneca, BMS, GSK, Roche, Sanofi. I. Souglakos: Honoraria: Sanofi. Research grant: Sanofi. G. Fountzilas: Honoraria: Astra-Zeneca. Consulting or Advisory Role: Pfizer, Sanofi, Roche. Stock and other ownership interests (an Immediate family member): Ariad. All other authors have declared no conflicts of interest.

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