Prognostic value of baseline ECOG performance status, frailty phenotype, and geriatric screening tools (G8 and VES-13) in vulnerable older patients with metastatic colorectal cancer: The randomized NORDIC9-study

Background: Appropriate patient selection based on functional status is crucial when considering older adults for palliative chemotherapy. This pre‐planned analysis of the randomized NORDIC9‐study explores the prognostic value of four functional status measures regarding progression‐free survival (PFS) and overall survival (OS) in vulnerable older patients with metastatic colorectal cancer (mCRC) receiving palliative chemotherapy. Methods: Patients ≥70 years of age with mCRC not candidates for standard full‐dose combination chemotherapy were randomized to receive either full‐dose S1 or reduced‐dose S1 plus oxaliplatin. At baseline, functional status was assessed using ECOG performance status (ECOG PS), frailty phenotype, Geriatric 8 (G8), and Vulnerable Elderly Survey‐13 (VES‐13). Multivariable regression models were applied and C‐statistics were estimated. Results: In total, 160 patients with a median age of 78 years (IQR: 76‐81) were included. While in univariate analyses, ECOG PS, frailty phenotype, and VES‐13 were associated with significant differences in OS between subgroups, G8 was not. However, a trend toward statistical significance was observed (HR: 1.55 95%CI: 0.99‐2.41, p=0.050). In multivariable analyses adjusted for age, sex, BMI, and treatment allocation, we found significant differences between subgroups for all applied tools (Table); best prediction was seen for ECOG PS and VES‐13 with C‐statistics in the moderate range. Concerning PFS, significant differences were observed between subgroups of ECOG PS, G8, and VES‐13 both in uni‐ and multivariable analyses, but not for frailty phenotype. [Formula presented] Conclusions: All applied tools showed prognostic value; moderate predictive power of ECOG PS and VES‐13 was demonstrated in vulnerable older patients with mCRC receiving palliative chemotherapy. Clinical trial identification: EudraCT 2014‐000394‐39. Legal entity responsible for the study: Department of Oncology, Odense University Hospital. Funding: This investigator‐initiated study was partly funded by Taiho Pharmaceuticals, Nordic Group, The Danish Cancer Society, the Academy of Geriatric Cancer Research (AgeCare), The Swedish Cancer Society, and the Region of Southern Denmark. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Disclosure: All authors have declared no conflicts of interest.