Abstract 4944
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
Cut offa | PFS | OS | |
---|---|---|---|
VEFG-A | <1.941 | 9.2 (8.4-10) | 18.9 (14.8-23) |
≥1.941 | 4.2 (2.7-5.6) | 7.6 (4.5-10.7) | |
p < 0.001 | |||
ACE | <135 | 8.8 (7.4-10.3) | 15.2 (9.4-21.1) |
≥135 | 6.8 (3.7-10) | 11.7 (9.0-14.5) | |
p = 0.103 | p = 0.889 |
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.
Resources from the same session
1025 - Liver metastases (LM) from intrahepatic cholangiocarcinoma (iCCA): Outcomes from the European Network for the Study of Cholangiocarcinoma (ENS-CCA) registry and implications on current American Joint Committee on Cancer (AJCC) staging.
Presenter: Angela Lamarca
Session: Poster Display session 2
Resources:
Abstract
5813 - Is MGMT methylation a new therapeutic target for Biliary Tract Cancer?
Presenter: Monica Niger
Session: Poster Display session 2
Resources:
Abstract
5839 - Biliary Tract Cancers in Portuguese families with BRCA gene mutation: a retrospective study.
Presenter: Patricia Pereira
Session: Poster Display session 2
Resources:
Abstract
4338 - Selection of patients with hepatocellular carcinoma for selective internal radiation therapy based on tumour burden and liver function: a post-hoc analysis of the SARAH trial
Presenter: Daniel Palmer
Session: Poster Display session 2
Resources:
Abstract
1700 - Second-line chemotherapy (SLC) in Patients with Advanced Biliary tract and Gallbladder Cancers (ABGC) Prolongs Survival: A Retrospective Population-based Cohort Study
Presenter: Adnan Zaidi
Session: Poster Display session 2
Resources:
Abstract
5562 - Overall survival of patients with hepatocellular carcinoma receiving sorafenib versus selective internal radiation therapy with predicted dosimetry in the SARAH trial
Presenter: Neil Hawkins
Session: Poster Display session 2
Resources:
Abstract
1838 - Multicenter phase II trial of axitinib monotherapy for advanced biliary tract cancer refractory to gemcitabine-based chemotherapy
Presenter: Naohiro Okano
Session: Poster Display session 2
Resources:
Abstract
3641 - Soluble Programmed Death-ligand 1 indicate poor prognosis in hepatocellular carcinoma patients undergoing transcatheter arterial chemoembolization
Presenter: Xiaolu Ma
Session: Poster Display session 2
Resources:
Abstract
2733 - The Prognostic Nutritional Index (PNI) is an independent predictor of survival in advanced biliary cancers (ABC) receiving first-line chemotherapy (1L).
Presenter: Francesco Caputo
Session: Poster Display session 2
Resources:
Abstract
3773 - Impact of centralisation of national cancer services on patient outcomes for hepatobiliary cancers in Ireland 2000 – 2016
Presenter: David O Reilly
Session: Poster Display session 2
Resources:
Abstract