4944 - POLAF study: Efficacy and safety of FOLFIRI/aflibercept in a phase II trial in patients with metastatic colorectal cancer: Results of plasmatic prognostic and predictive markers

Background

Biomarkers associated to antiangiogiogenic agents in metastatic colorectal cancer (mCRC) have not yet been validated Here we present the efficacy and safety results of FOLFIRI and aflibercept in second line therapy for mCRC and the analysis of biomarkers as predictive factors of efficacy.

Methods

POLAF is a multicenter, non comparative, phase II study conducted in patients with mCRC previously treated with oxaliplatin (NCT02970916) Plasma biomarkers were assayed using ELISA Vascular endothelial growth factor (VEGF A) and angiotensin-converting enzyme (ACE) biomarkers were statistically analyzed (Roc Curve) with respect to the primary endpoint (PE): progression free survival (PFS) (Kaplan Meier).

Results

Between November 2016 and December 2017, 101 patients for the PE were enrolled: male 59.4%, median age of 63.8 years and ECOG 0 in 46.5% of them The median of treatment duration was 5.7 months. Later antitumor therapies were received by 54.5% pts With a median follow up of 11.7 months, response rates were: PR 15.8%, SD 53.5% and PD 25.7%. The median OS, PFS, TTP and to TTF were 12.6, 7.4, 8.3 and 6.1 months, respectively Of note, both OS and PFS were significantly longer in pts with lower plasma VEGF A levels (<1.941 ng/ml) in comparison to those with higher levels (p < 0.001) No significant differences were detected in plasma ACE levels (Table) A total of 74.3% pts presented at least 1 grade ≥ 3 toxicity, being the most common asthenia (24.8%) hypertension (22.8%) and neutropenia (23.9%) and three pts presented grade 5 toxicity: one hepatic encephalopathy, one gastrointestinal toxicity and one unknown reason that treatment relationship could not be ruled out.Table:

585P

Optimal point that maximizes sensitivity and specifity (ng/ml).

Conclusions

This study confirms the efficacy outcomes of FOLFIRI/aflibercept regimen in second line mCRC Our data shows that VEGF-A could be related to the survival of this population and its role as a potential predictive biomarker for efficacy should be considered.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Sanofi.

Disclosure

M.E. Elez Fernandez: Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Sanofi; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (institution), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self): Servier; Honoraria (self), Honoraria (institution): Array; Honoraria (institution): Novartis; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): MSD; Honoraria (institution): Servier; Honoraria (institution): Bayer; Honoraria (institution): GSK; Honoraria (institution): Pharmamar. B. Graña Suarez: Research grant / Funding (self): Sanofi; Research grant / Funding (self): Gilead; Research grant / Funding (self): Amgen. M. Valladares-Ayerbes: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AMGEN; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Servier; Honoraria (self), Speaker Bureau / Expert testimony: Bayer; Honoraria (self): BRISTOL; Advisory / Consultancy: Sanofi. M. Salgado Fernandez: Travel / Accommodation / Expenses: Sanofi. E. Martínez de Castro: Speaker Bureau / Expert testimony: Sanofi. A. Ruiz-Casado: Honoraria (self), Research grant / Funding (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Merck; Honoraria (self): Lilly; Honoraria (self): Servier; Honoraria (self): Roche; Honoraria (self): Medtronic; Honoraria (self): BTG; Honoraria (self): Bayer. E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. All other authors have declared no conflicts of interest.