608P - Resectability of colorectal liver metastases (CLM) with aflibercept plus FOLFIRI: Results from a prospective French cohort

Background

Liver resection is the only treatment offering a chance of long-term overall survival (OS) to patients (pts) with CLM.This prospective cohort evaluates the R0/R1 resection rate in pts with predominant CLM who were treated with aflibercept (AFL)+FOLFIRI after failure of an oxaliplatin-based regimen.

Methods

All pts with predominant CLM initiating AFL (4 mg/kg q2w) + FOLFIRI per physician choice were eligible. Primary endpoint was R0/R1 resection rate. Secondary endpoints included overall response rate (ORR), progression-free survival (PFS), OS and safety. Assuming a resection rate of 10-20% and 10% of follow-up loss, 140 patients were needed to determine R0/R1 resection rate with good precision.

Results

From July 2017 to July 2020, 136 consecutive pts with CLM [median age 65 years; 64.7% males; 28.7% right-sided; 55.1/8.1% RAS/BRAFmt; 80.1% synchronous; 46.3% extrahepatic sites and median of 4 CLM] were enrolled at 21 French sites. All pts received a prior oxaliplatin-based regimen, 77.4% prior anti-VEGF and 19.0% prior anti-EGFR agents. A median of 7 cycles of AFL+FOLFIRI was given. Overall, 16.2% of pts had R0/R1 liver resections (19.2% for liver only disease): 4/11 (36.4%) after failure of adjuvant oxaliplatin, 17/99 (17.2%) in 2^nd line and 1/26 (3.8%) in 3^rd line mCRC. Of 22 pts resected, 4 were judged resectable upfront, 15 potentially resectable and 3 unresectable before treatment by the investigator. Median duration of follow-up was 10.7 months (Table). Four pts (18.2%) had post-operative complications (all Dindo-Clavien grade I-II); 34.3% had grade ≥3 adverse events with AFL+FOLFIRI, mainly general health deterioration (8.0%) and diarrhoea (3.6%). Table: 608P

Secondary efficacy endpoints

∗Complete + partial responses; mCRC: metastatic colorectal cancer; CI: confidence interval; mo: months; NR, not reported

Conclusions

This prospective cohort suggests that AFL+FOLFIRI allows a clinically relevant rate of conversion from potentially resectable/unresectable to resectable CLM.

Clinical trial identification

NCT00454220.

Editorial acknowledgement

Editorial assistance was provided by Nazmeen Saba at Sanofi at the direction of the authors.

Legal entity responsible for the study

Sanofi.

Funding

Sanofi.

Disclosure

R. Adam: Financial Interests, Personal, Invited Speaker, speaker at symposium: Merck Serono; Financial Interests, Personal, Invited Speaker, Speaker at symposium: Sanofi. B. Chibaudel: Financial Interests, Personal, Invited Speaker: Sanofi, Roche, Merck, Servier, Pierre Fabre, Bristol Myers Squibb, MSD, BeiGene, Lilly, Biocartis, SeqOne, Amgen, Bayer; Financial Interests, Institutional, Local PI: Sanofi. S. Kim: Financial Interests, Personal, Invited Speaker: Merck, Pfizer, Amgen, Bayer, Servier; Financial Interests, Personal, Advisory Board: MSD. J.M. Phelip: Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Advisory Board: Sanofi. M. Bouattour: Financial Interests, Personal, Advisory Board: MSD, Bristol Myers Squibb, Sirtex Medical, Ipsen, AbbVie, AstraZeneca, Servier, Taiho; Financial Interests, Personal, Invited Speaker: Roche; Non-Financial Interests, Principal Investigator: MSD, Bristol Myers Squibb, Sirtex Medical, AstraZeneca. T. Lecomte: Financial Interests, Personal, Invited Speaker: Ipsen, Pierre Fabre, AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Sanofi, Merck Serono, Servier, Amgen, Deciphera, Advanced , Accelerator, Applications, Pierre Fabre; Financial Interests, Institutional, Local PI: AstraZeneca, Mirati, ALX Oncology; Financial Interests, Institutional, Funding: Leo Pharma, Pierre Fabre. H. Perrier: Non-Financial Interests, Principal Investigator: Roche, Amgen, Merck, Pierre Fabre, Servier, Sanofi, Bayer, Seagen. F.X. Caroli Bosc: Financial Interests, Personal, Invited Speaker: Sanofi, Pierre Fabre; Financial Interests, Personal, Advisory Board: Sanofi, Pierre Fabre. J. Metges: Non-Financial Interests, Principal Investigator: Sanofi. M. Ferec: Non-Financial Interests, Principal Investigator, Trial ASPIK (FFCD): FFCD; Financial Interests, Institutional, Local PI, Local investigator trial APICAT (APHP) on apixaban (Bristol Myers Squibb): Bristol Myers Squibb; Other, 16/09/21 congress invitation: Ipsen Pharma; Other, 02/06/22 training evening: Sandoz; Other, 21/09/22 training evening: Merck Serono. V. Hautefeuille: Financial Interests, Personal, Invited Speaker: AAA, Ipsen; Financial Interests, Personal, Advisory Board: Amgen , Deciphera, Servier , Merck, Pierre Fabre. D. Tougeron: Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Amgen, MSD, Roche, Servier, Pierre Fabre. All other authors have declared no conflicts of interest.