Abstract 622P
Background
The modified mCCS intends to predict overall survival (OS) of mCRC patients (pts) at start of 1L therapy. Five clinical routine parameters assign pts into three prognostic risk groups from low to intermediate and high risk: tumor stage, tumor grading, lymph node ratio, primary tumor resection status and number of metastatic sites at start of 1L treatment (Marschner N, et al. Colorectal Dis. 2019). VALIDATE (NCT03043950) prospectively validates the mCCS in a large patient cohort with RAS WT mCRC.
Methods
VALIDATE is a multicenter, non-interventional study evaluating real-world effectiveness, safety and quality of life in pts with RAS WT mCRC receiving 1L PAN plus FOLFIRI/FOLFOX. Pts were allocated to three mCCS risk groups. This second interim analysis (IA2) was performed 24 months after last patient in. Data were analyzed descriptively for effectiveness, response rates and secondary resection rates.
Results
At data-base cut (Nov 17, 2022), 611 pts from 108 German and 5 Austrian sites were evaluable. Median age was 66.1 years, 68.9% of pts were male and 83.3% had an ECOG performance status 0/1. 59.4% of pts were diagnosed with a colon tumor. 84.3% of these pts had a left-sided tumor.
Table: 622P
Total N=611 | mCCS | |||
Low risk N=202 | Intermediate risk N=198 | High risk N=211 | ||
Overall response rate n (%) | 381 (62.4%) | 121 (59.9%) | 128 (64.6%) | 132 (62.6%) |
Secondary resections n (%) | 115 (18.8%) | 43 (21.3%) | 47 (23.7%) | 25 (11.8%) |
24-month OS rate [95%-CI] | 54.2% [50.0, 58.3] | 60.0% [52.4, 66.8] | 61.3% [53.8, 67.9] | 42.3% [35.3, 49.0] |
Most common grade 3/4 (MedDRA v20.0) treatment-emergent adverse drug reactions (TEADR) were dermatitis acneiform (5.8%), rash (2.9%) and diarrhea (3.2%). One investigator assessed fatal TEADR (arterial embolism) occurred.
Conclusions
The IA2 showed favorable effectiveness for PAN plus FOLFIRI/FOLFOX in the total population and in all mCCS risk groups in clinical routine in Germany and Austria. Interestingly, rates of secondary resections were >20% for low and intermediate risk pts. mCCS predicting OS will be validated in the final analysis. No new safety signals emerged.
Clinical trial identification
NCT03043950.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO AG.
Funding
Amgen.
Disclosure
M. Reiser: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. J. Uhlig: Financial Interests, Personal and Institutional, Advisory Board: Roche, Amgen, Servier, MSD, Bristol Myers Squibb, Sanofi, Merck, Celgene, Novartis, Janssen-Cilag, Boehringer Ingelheim, Bayer, BeiGene; Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. L. Jacobasch, L. Mueller: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. A. Schuch, L. Serrer, R. de Buhr: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. H.U. Siebenbach: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. T. Göhler: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. J.K. Schröder: Financial Interests, Personal and Institutional, Advisory Board: Celgene, Roche, Bristol Myers Squibb, Clovis Oncology, GSK, Boehringer Ingelheim, Amgen, Novartis, MSD, AOP, Searchlight, Pharma Partner, Medicline, Eisai, HE Research, Octapharma, AbbVie, NIO, I+E Pharma, ISPEN, BeiGene, Milteny; Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. D. Semsek: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. A. Koehler: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE; Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Amge, Daiichi Sankyo MSD. P. Stübs: Non-Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. K.M. Potthoff: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. N.W. Marschner: Non-Financial Interests, Personal and Institutional, Invited Speaker: Amgen, BeiGene, Roche, GSK, Euspharm, stemline, Seagen, Servier; Non-Financial Interests, Personal and Institutional, Advisory Board: Amgen, AstraZeneca, BeiGene, , Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier Stemline; Financial Interests, Personal and Institutional, Member of Board of Directors: iOMEDICO; Financial Interests, Personal and Institutional, Full or part-time Employment: iOMEDICO; Financial Interests, Institutional, Ownership Interest: iOMEDICO; Non-Financial Interests, Institutional, Research Grant: Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier, Stemline; Non-Financial Interests, Institutional, Funding: Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier, Stemline; Financial Interests, Personal, Project Lead: iOMEDICO/VALIDATE.
Resources from the same session
518P - Artificial intelligence real-world applications in pediatric neuro-oncology: The AICCELERATE project
Presenter: Federica D'Antonio
Session: Poster session 10
519P - The landscape of PDGFRA mutation in Chinese patients with glioma
Presenter: Qiang Lv
Session: Poster session 10
520P - Copy number variation spectrum analysis of primary glioblastoma
Presenter: Chuandong Cheng
Session: Poster session 10
521P - Deciphering a three-miRNA signature as a prognostic biomarker in glioma patients: Correlation with DFS and OS
Presenter: Ana Belen Diaz Mendez
Session: Poster session 10
522P - Galectin 3 binding protein as potential biomarker in glioma diagnosis
Presenter: Rashmi Rana
Session: Poster session 10
523P - Analysis of DNA damage response (DDR) gene expression as a prognostic factor for glioblastoma patient mortality
Presenter: Alessia-Tara Droesse
Session: Poster session 10
524P - Cell line study of nucleosome-based biomarkers in the diagnosis and detection of relapses in glioblastoma
Presenter: Jonathan Decarpentrie
Session: Poster session 10
525P - Immuno markers in newly glioblastoma patients underwent Stupp protocol after neurosurgery
Presenter: Lorena Gurrieri
Session: Poster session 10
526P - In silico evaluation of the mutational profile of glioblastomas with high expression of PD1, CTLA4 and LAG3 identifies the ERBB-PI3K pathway as a druggable vulnerability target
Presenter: Cristina Saiz-Ladera
Session: Poster session 10
527P - Targetable gene fusions and other alterations in central nervous system tumors assessed by RNA and DNA-based next-generation sequencing
Presenter: LEIMING WANG
Session: Poster session 10