Abstract 74P
Background
PROMETCO (NCT03935763) is the first international, prospective, real-world study to investigate the continuum of care in patients (pts) with metastatic colorectal cancer (mCRC) after two disease progressions since diagnosis. This study provides an opportunity to assess real-world effectiveness data according to treatment line.
Methods
Adult mCRC pts willing to receive subsequent treatment were included. Median progression-free survival (mPFS) and overall survival (mOS) are presented by first (1L) - and second-line (2L) of treatment. Treatment groups were: Group A (1L & 2L) - doublet/ triplet + anti-vascular endothelial growth factor (VEGF) twice; B (1L & 2L) - doublet/triplet + anti-epidermal growth factor receptor (EGFR) and doublet/triplet + anti-VEGF (any order); C (1L & 2L) - doublet/triplet alone twice; D (1L & 2L) - doublet/triplet alone and doublet/triplet + anti-VEGF (any order); E (1L & 2L) - doublet/triplet alone and doublet/triplet + anti-EGFR (any order); F - any other treatment. Descriptive statistics were used.
Results
655 pts were included here (161, 117, 55, 85, 45 and 192 in Groups A-F, respectively). Groups A and C had a shorter time since diagnosis and a higher number of metastases at baseline, and Groups B and E had the largest proportion of RAS wild-type pts (97.4% and 80.0%, respectively). Group E had the lowest proportion of patients with ECOG PS 0 (20.0%) and Group B had the highest (50.0%). mPFS and mOS by treatment group is presented (Table). Table: 74P
mPFS and mOS by treatment (Tx) group
| A (n=161) | B (n=117) | C (n=55) | D (n=85) | E (n=45) | F (n=192) | |
| months 95% CI | ||||||
| mOS from mCRC diagnosis | 31.2 27.3-33.5 | 35.0 32.0-41.7 | 26.7 22.7-66.5 | 38.3 32.4-48.6 | 41.9 34.4-47.9 | 41.6 39.1-46.4 |
| mOS from 3L Tx | 6.1 5.3-7.3 | 6.3 5.3-7.4 | 4.7 3.9-6.1 | 6.7 6.0-8.1 | 8.1 5.4-10.5 | 8.7 7.3-10.6 |
| mPFS from 1L Tx | 8.3 1.4-87.4 | 12.5 0.6-87.8 | 6.1 0.1-22.7 | 10.3 0.0-81.6 | 10.9 0.8-34.6 | 9.7 0.2-43.3 |
| mPFS from 2L Tx | 4.4 0.0-29.5 | 6.0 0.3-51.5 | 4.9 0.5-28.2 | 6.9 0.5-53.2 | 5.7 0.6-24.2 | 3.9 0.1-68.7 |
| mPFS from 3L Tx | 2.7 0.1-11.5 | 2.5 0.1-17.4 | 2.5 0.2-44.7 | 2.8 0.2-10.4 | 2.6 0.3-11.1 | 2.8 0.0-13.4 |
| mPFS from 4L Tx | 2.3 0.5-12.1 | 2.1 0.4-14.8 | 2.5 1.6-6.2 | 3.2 0.1-14.9 | 2.6 0.2-12.3 | 2.7 0.3-28.4 |
% based on n
Conclusions
Real-world data show support for, and adherence to, ESMO guidelines: pts with RAS wild-type mostly treated with anti-EGFR had longer mOS; pts who received chemotherapy alone had a shorter mOS than those treated with a biologic. Third (3L) - and fourth (4L) -line mPFS was similar regardless of 1L and 2L treatment regimen.
Clinical trial identification
NCT03935763.
Editorial acknowledgement
Editorial assistance was provided by Emily Eagles of Empowering Strategic Performance Ltd and supported by Servier.
Legal entity responsible for the study
Servier.
Funding
Servier.
Disclosure
M. Koopman: Non-Financial Interests, Advisory Role: Eisai, Nordic Farma, Merck Serono, Pierre Fabre, Servier; Financial Interests, Institutional, Research Grant: Bayer, Bristol Myers Squibb, Merck, Personal Genome Diagnostics (PGDx), Pierre Fabre, Roche, Sirtex, Servier. R. Garcia-Carbonero: Financial Interests, Personal, Advisory Board: AAA, Advanz Pharma, Amgen, Astellas, Bayer, BMS, Boehringer Ingelheim, Esteve, Hutchmed, Ipsen, Midatech Pharma, MSD, Novartis, PharmaMar, Servier, Takeda; Financial Interests, Institutional, Research Grant: BMS, MSD, Pfizer; Non-Financial Interests, Leadership Role, Global PI of investigator-initiated clinical trials (AXINET, NICENEC, PEMBROLA): BMS, MSD, Pfizer; Non-Financial Interests, Leadership Role, Chair elect: European Neuroendocrine Tumor Society (ENETS); Non-Financial Interests, Leadership Role, Past president, Member of the Executive Committee: Grupo Español de Tumores Neuroendocrinos (GETNE); Other, Honoraria received by spouse for advisory board or invited speaker roles: Abbie, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Genomica, Lilly, MSD, Merck, Novartis, Pfizer, PharmaMar, Roche, Sanofi, Servier, Takeda. C. Pinto: Financial Interests, Other, Advisory board member or speaker: Amgen, Astellas, AstraZeneca, Bayer, BMS, Daiichi Sankyo, Janssen, Lilly, Merck Serono, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Servier. A. Mitroshkin: Financial Interests, Other, honoraria or grants: Bayer, Servier, Pierre Fabre, Merck. G. Bodoky: Financial Interests, Other, Received honoraria as an advisory board member or speaker: Amgen, AstraZeneca, Roche, Bayer, Pfizer, Janssen, Novartis, Lilly, Servier, Nordic Pharma, Taiho. F.E. Marti Marti: Financial Interests, Other, Honoraria: Servier. J.M.R. O'Connor: Financial Interests, Other, Received honoraria as an advisory board speaker and research grant: Amgen, Bayer, MSD, BMS, Servier, Merck Serono, Pfizer. S. John: Financial Interests, Other, Received honoraria as a speaker and travel grants: Amgen, Bayer, BMS, Merck, MSD, Pierre Fabre, Servier. J.I. Sgouros: Financial Interests, Institutional, Other, Received research grants/funding: Amgen; Financial Interests, Advisory Board: Servier; Financial Interests, Invited Speaker, Speaker's fees: Merck. H.F. Mansinho: Financial Interests, Other, Received honoraria as an advisory board member or speaker: Amgen, Servier, Daiichi Sankyo, Takeda, BMS, MSD, GSK, Incyte, Novartis, Merck, Pierre Fabre. R. Greil: Financial Interests, Personal, Advisory Board: Celgene, Novartis, Roche, BMS, Takeda, AbbVie, AstraZeneca, Janssen, MSD, Merck, Gilead, Daiichi Sankyo, Sanofi; Financial Interests, Institutional, Stocks/Shares: Novo Nordisk, Lilly; Financial Interests, Personal and Institutional, Funding: Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, BMS,MSD, Sandoz, AbbVie, Gilead, Daiichi Sankyo; Non-Financial Interests, Other, Travel, Accommodation, Expenses, Consulting, Adv Role: Roche, Amgen, Janssen, AstraZeneca, Novartis, MSD, Celgene, Gilead, BMS, AbbVie, Daiichi Sankyo, Sanofi; Other, Travel, Accommodation, Expenses, Consulting, Adv Role, Honoraria: Roche, Amgen, Janssen, AstraZeneca. Novartis, MSD, Celgene, Gilead, BMS, AbbVie, Daiichi Sankyo, Sanofi. P. Cuyle: Financial Interests, Advisory Role: MSD, Lilly, Amgen, Roche, Novartis, Pierre Fabre, Servier; Financial Interests, Other, Speaker honoraria: Ipsen, Novartis, Merck Serono, Roche. S. Plestina: Financial Interests, Other, Received honoraria as an advisory board member or speaker: Amgen, Astellas, AstraZeneca, Bayer, BMS, Janssen, Eli Lilly, Merck Serono, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Servier. J. Ocvirk: Financial Interests, Other, Received honoraria as an advisory board member or speaker: Amgen, Astellas, AstraZeneca, BMS, Merck Serono, MSD, Novartis, Servier. A. Sullivan: Financial Interests, Full or part-time Employment: Servier. E. Choucair: Financial Interests, Personal, Full or part-time Employment: Servier. B. Chevallier: Financial Interests, Full or part-time Employment: Serv. J. Bachet: Financial Interests, Other, Personal fees: AbbVie, Amgen, Bayer, Bristol Myers Squibb, GSK, Merck Serono, Merck Sharp & Dohme, Pierre Fabre, Sanofi, Servier, Takeda.