604P - Overall and progression-free survival of patients with metastatic colorectal cancer: A real-world prospective, longitudinal cohort study on the continuum of care (PROMETCO)

Background

Advances in metastatic colorectal cancer (mCRC) treatment have improved overall survival (OS) in clinical trials, but real-world survival data, in particular in later lines of treatment, are scarce. PROMETCO (NCT03935763) is the first international, prospective, real-world study to investigate the continuum of care in all patients (pts) with mCRC after two disease progressions since diagnosis.

Methods

Adult mCRC pts who were willing to receive subsequent treatment were included. Endpoint data presented include OS, progression-free survival (PFS; defined as start of treatment until progressive disease, death or start of new treatment), patient characteristics and treatment patterns.

Results

As of April 2023, 738 pts from 18 countries were enrolled (Table). 49% of pts were RAS mutant; 32% RAS/BRAF wild type; 5% BRAF mutant. 40% of pts had unknown microsatellite instability (MSI) status; 2% were MSI high; 3% were MSI low; 55% were microsatellite stable. Median time from mCRC diagnosis to PROMETCO inclusion was 22.0 mo. During the course of their disease, most pts had received fluoropyrimidine (99%), oxaliplatin (88%), irinotecan (96%), an anti-VEGF (79%) or an anti-EGFR antibody (40%), FTD/TPI (75%) or regorafenib (25%). 64% and 23% of pts had colorectal or liver surgery, respectively. For 628 pts who completed the study, mOS from mCRC diagnosis was 35.4 mo; mOS from inclusion in PROMETCO (i.e., after second disease progression) was 6.8 mo; and mOS from start of third-line treatment was 6.4 mo. Median PFS was 9.5 mo in first-; 4.8 mo in second-; 2.6 mo in third- and 2.4 mo in fourth-line.

Conclusions

These data provide key insights on pts characteristics, survival (which reflects observations from clinical trials) and treatment patterns in the real-world, which are generally consistent with ESMO guidelines.

Table: 604P

Patient characteristics at enrollment

Clinical trial identification

NCT03935763.

Editorial acknowledgement

Editorial assistance was provided by Liz Meredith of Empowering Strategic Performance Ltd and supported by Servier.

Legal entity responsible for the study

Servier.

Funding

This study was sponsored by Servier Affaires Médicales, France.

Disclosure

M. Koopman: Financial Interests, Institutional, Advisory Board, advisory board and speaker: Pierre Fabre; Financial Interests, Institutional, Advisory Board: MSD, Bayer; Financial Interests, Institutional, Advisory Board, Advisory Board, speaker: Servier; Financial Interests, Institutional, Invited Speaker: Merck, Bristol Myers Squibb; Financial Interests, Institutional, Trial Chair: Servier; Financial Interests, Institutional, Research Grant: Servier, Roche, Bayer, Bristol Myers Squibb, Merck, Personal Genomics Diagnostics, sirtex, Pierre Fabre; Financial Interests, Institutional, Funding: Pierre Fabre, Amgen, Nordic Pharma, Novartis, merck, Servier, Bristol Myers Squibb; Non-Financial Interests, Leadership Role, vice-chair of DCCG: Dutch Colorectal Cancer Group; Non-Financial Interests, Advisory Role, Member of KWF scientific board: KWF; Non-Financial Interests, Other, ESMO faculty member for the Gastro-Intestinal Tumours – colorectal cancer: ESMO; Non-Financial Interests, , Advisory Role, expert member of committee “regie op registers dure geneesmiddelen” ZINNL: ZiNNL; Non-Financial Interests, Advisory Role, CRC expert on Kanker.nl platform for answering online CRC questions of CRC (non) patients: Patient Respresentative Organisation (Kanker.nl); Non-Financial Interests, , Leadership Role, chair of RWD & DH working group: ESMO; Other, PI of the Dutch Prospective Colorectal Cancer Cohort study: PLCRC project. R. Garcia-Carbonero: Financial Interests, Personal, Advisory Board: AAA, Advanz Pharma, Amgen, Bayer, Bristol Myers Squibb, HMP, Ipsen, Merck, Midatech, MSD, Novartis, PharmaMar, Pierre Fabre, Servier; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, MSD, Pfizer; Non-Financial Interests, Leadership Role, Global PI of investigator-initiated clinical trials (AXINET, NICENEC, PEMBROLA): Bristol Myers Squibb, MSD, Pfizer; Other, Honoraria received by spouse for advisory board or invited speaker roles: AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Genomica, Lilly, MSD, Merck, Novartis, Pfizer, PharmaMar, Roche, Sanofi, Servier, Takeda. C. Pinto: Financial Interests, Personal, Advisory Board: Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Lilly, Merck Serono, MSD, Novartis, Roche, Sanofi, Servier; Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Lilly, Merck Serono, MSD, Novartis, Roche, Sanofi, Servier. A. Mitroshkin: Financial Interests, Personal, Other: Servier, Bayer, Pierre Fabre, Merck; Financial Interests, Personal, Funding: Servier, Bayer, Pierre Fabre, Merck. G. Bodoky: Financial Interests, Personal, Advisory Board: Roche, Bayer, Janssen, Novartis, Pfizer, Bristol Myers Squibb , Merck; Financial Interests, Personal, Invited Speaker: Roche, Bayer, Janssen, Novartis, Pfizer, Bristol Myers Squibb, Merck. V. Bourgeois: Financial Interests, Personal, Research Funding: Servier; Financial Interests, Personal, Advisory Board: Servier, Pierre Fabre, AstraZeneca; Financial Interests, Personal, Advisory Role: Servier, AstraZeneca; Financial Interests, Personal, Invited Speaker: Pierre Fabre, MSD; Financial Interests, Personal, Speaker’s Bureau: Merck. A. Ruiz-Casado: Financial Interests, Personal, Invited Speaker: Servier, Abbott, Nestle, Medtronic; Financial Interests, Personal, Advisory Board: Pierre Fabre, Amgen. A. Fernandez Montes: Financial Interests, Personal, Invited Speaker: Lilly, Pierre Fabre, Amgen, Servier, Eisai, AstraZeneca, MSD. A. Sullivan, E. Choucair, M. Sicaire: Other, Personal, Full or part-time Employment, Employee of Servier: Servier. F.E. Marti: Financial Interests, Personal, Other, Has received honoraria from Servier: Servier. J. Bachet: Financial Interests, Personal, Other: Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, GSK, MSD, Merck Serono, Pierre Fabre, Roche, Sanofi, Servier; Non-Financial Interests, Personal, Other: Amgen, Merck Serono, Roche, Servier. All other authors have declared no conflicts of interest.