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Poster display session

1821 - Quality-of-life in patients with metastatic colorectal cancer (mCRC) treated with aflibercept and FOLFIRI – Interim results of the non-interventional AIO study QoLiTrap

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Colon and Rectal Cancer

Presenters

Roger von Moos

Citation

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

Authors

R. von Moos1, G. Derigs2, F. Scholten3, J. Thaler4, C. Losem5, H. Kroening6, C. Windemuth-Kieselbach7, R.D. Hofheinz8

Author affiliations

  • 1 Medical Oncology, Hospital Graubuenden, 7000 - Chur/CH
  • 2 Oncology, Hospital Frankfurt, 65929 - Frankfurt/DE
  • 3 Oncoogy, Klinikum Frankfurt Hoechst, 65929 - Frankfurt am Main/DE
  • 4 Oncology, Klinikum Wels-Grieskirchen GmbH, 4600 - Wels/AT
  • 5 Oncology, Facharztzentrum Neuss, Neuss/DE
  • 6 Oncology, Medical Practice, 39104 - Magdeburg/DE
  • 7 Biostatistics, Alcedis, Gießen/DE
  • 8 Oncology, University Hospital, Mannheim/DE
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Resources

Abstract 1821

Background

The anti-angiogenic fusion protein Aflibercept targets VEGF-A, VEGF-B and PlGF. Aflibercept in combination with FOLFIRI is approved in patients with mCRC that is resistant or has progressed after oxaliplatin-containing therapy.

Methods

QoLiTrap (AIO-LQ-0113) is an international (Austria, Germany, Switzerland) non-interventional study with a recruitment target of 1500 patients. Primary goal is to evaluate Quality-of-life (QoL) in mCRC patients treated with aflibercept + FOLFIRI using the EORTC-QLQ C30 questionnaire at baseline and before every cycle.

Results

For this interim analysis (data cut-off: 02 March 2017) 576 patients (mean age: 64.7 ± 10 years; 65.1% male, 50.5% with documented RAS mutation, ECOG 0-1: 85.6% of patients) who completed the baseline and at least 2 post-baseline EORTC-QLQ C30 questionnaires were evaluated. Aflibercept was administered for a median number of 6 (and up to 55) cycles. Patients had a median global health score of 58.3 which decreased moderately (mean change -4.0, p 

Conclusions

The current interim analysis indicates that aflibercept + FOLFIRI in mCRC patients under routine conditions was accompanied by a moderate decline in global health status. Preliminary efficacy results are encouraging, also for patients pretreated with anti-EGFR antibody and/or bevacizumab, who showed a disease control rate of 73% in second line aflibercept therapy. This study is supported by Sanofi-Aventis Deutschland GmbH.

Clinical trial identification

AIO-LQ-0113

Legal entity responsible for the study

Sanofi Aventis GmbH

Funding

Sanofi Aventis Deutschland GmbH

Disclosure

R. von Moos: Advisory board: Sanofi, Roche, Merck. Research grant: Amgen, Merck. G. Derigs: Advisory activities: Janssen, Roche, Clegene. F. Scholten: Advisory activities: BMS, Celgene. Honorarium: Janssen, Sanofi. Poster creation: Sanofi. R.D. Hofheinz: Advisory Board: Sanofi. Honorarium: Sanofi. All other authors have declared no conflicts of interest.

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