Abstract 47P
Background
Regorafenib was validated in clinical trials and has become a standard of care for patients(pts) with metastatic colorectal cancer (mCRC) in an advanced setting.However the benefit in Overall Survival(OS),Progression free survival(PFS) are quite modest.
Methods
We aimed to assess the prognostic value of different metastatic sites in pts with mCRC treated with Regorafenib in SOREGATT - PRODIGE 68 - UCGI 38 study. The primary objective:evaluate the impact of metastatic location on OS and PFS. The secondary objective: evaluate the impact of ECOG; RAS/BRAF status; primary tumor location; number of metastatic sites.
Results
A total of 117 patients treated with Regorafenib in the 3rd or 4th line were selected and included in our study. The main characteristics: 67 males (57.3%), median age of 67 years (IQR: 58-72); ECOG performance status (PS) 1 (n=73, 64.6%). The median duration from initial diagnosis was 33 months (m) (IQR 20.2-52), and the median number of Regorafenib cycles was 2 (IQR: 2-3). The patients were divided according to their metastatic site into 4 groups: group 1 - lung with peritoneal or lymph nodes metastasis (n=19, 16.2%); group 2 - liver metastasis only (n=65, 55.6%); group 3 - liver with peritoneal or ovarian metastasis (n=17, 14.5%); group 4 - peritoneal, ovarian, or lymph nodes (no liver or lung metastasis) (n=16, 13.7%). After a median follow-up of 23 m, the median OS (mOS) was as follows: group 1 - 6.16m [95% CI 2.86-14.23]; group 2 - 6.37m [95% CI 4.76-8.02]; group 3 - 3.64m [95% CI 2.49-8.64]; group 4 - 7.61m [95% CI 4.01-11.37]. Despite a numerical advantage in group 4, no statistical difference was seen between groups (p=0.14). The median progression-free survival (PFS): 1.84m [95% CI 1.44-2.73]; 1.87m [95% CI 1.81-2.27]; 1.77m [95% CI 1.38-1.94]; 1.94m [95% CI 1.81-3.57],no statistical difference between groups (p=0.12). In multivariate analysis, only ECOG was associated with better OS (p<0.05), no predictive factors were found for PFS.
Conclusions
In pts with mCRC treated with Regorafenib, the metastatic location do not seem to have a prognostic value, however the groups were not equally represented. For a better pts selection further studies are needed.
Clinical trial identification
- NCT04450836 / EudraCT 2019-004196-39.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Smolenschi: Financial Interests, Institutional, Invited Speaker: Roche, Servier; Financial Interests, Personal, Sponsor/Funding: Merck; Non-Financial Interests, Institutional, Principal Investigator: BMS. M. Ben Abdelghani: Financial Interests, Personal, Invited Speaker: Incyte, Servier, Pierre Fabre; Financial Interests, Personal, Advisory Board: Merck, BMS, Bayer; Financial Interests, Institutional, Advisory Board: Deciphera. D. Tougeron: Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Amgen, MSD, Roche, Servier, Pierre Fabre, BMS, Bayer; Non-Financial Interests, Member of Board of Directors: Federation Francophone de Cancerologie Digestive. O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, Apmonia Therapeutics, Deciphera, Astellas, Takeda; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. J. Bachet: Financial Interests, Personal, Invited Speaker: Amgen, Merck Serono, Roche, Servier; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: AstraZeneca, Pierre Fabre, Viatris. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Merck, Servier, Pierre Fabre, Amgen, BMS, Novartis, Pfizer, Sanofi, Rottapharm, Takeda; Financial Interests, Personal, Expert Testimony: Astellas, Takeda; Financial Interests, Personal, Invited Speaker: Amgen, BMS, Merck, MSD, Novartis; Financial Interests, Personal, Invited Speaker, symposia: Astellas; Financial Interests, Personal, Other, steering committee of clinical trial: Novartis; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the prodige intergroup: Federation Francophone de Cancerologie Digestive (FFCD); Non-Financial Interests, Other, steering committee of clinical trials: Pfizer, Servier. F. Khemissa Akouz: Financial Interests, Personal, Invited Speaker: Servier, AstraZeneca; Other, fees for congress (jfhod): MSD; Other, fees for congress: Servier. N. Fares: Financial Interests, Personal, Invited Speaker: Pierre Fabre, Servier, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche. N. Etchepare: Financial Interests, Personal, Invited Speaker: MSD; Non-Financial Interests, Principal Investigator: Roche. C. Coutzac: Financial Interests, Personal, Advisory Board: BMS, Servier, Pierre Fabre, Merck Serono; Financial Interests, Institutional, Advisory Board: BMS, Amgen; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, MSD, ImCore Roche Genentech. M.P. Ducreux: Financial Interests, Personal, Invited Speaker: Roche, Amgen, Pierre Fabre, Merck KGaA, Pfizer, Bayer, Lilly, Servier, MSD, BeiGene; Financial Interests, Personal, Advisory Board: Roche, Basilea, Pierre Fabre, Boehringer Ingelheim, Rafael, Servier, Zymeworks, Ipsen, Bayer, HalioDX, Lilly, GSK, Daiichi Sankyo, MSD, Servier, BeiGene; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of bevacizumab in NET: Roche; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of steptozotocin in NET: Keocyt; Financial Interests, Institutional, Invited Speaker: Rafael, Amgen; Financial Interests, Institutional, Funding: Bayer; Other, My wife is head of the oncology business unit in the French Affiliate of Sandoz: Sandoz France. All other authors have declared no conflicts of interest.