Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers

Background Gastrointestinal (GI) cancers in older adults are often accompanied by frailty, malnutrition, and functional decline, which increase the risk of chemotherapy-related toxicity. While chemotherapy in the adjuvant setting is standard of care, toxicities may impair quality of life and adherence in this vulnerable population. Validated frailty screening tools may improve risk stratification and supportive care strategies. Study Design Type: Prospective, observational, single-center, non-randomized study Site: Ankara Etlik City Hospital, Department of Medical Oncology Target enrollment: 72 patients Population: Patients ≥65 years with non-metastatic or locally advanced GI cancers (esophageal, gastric, colorectal, pancreatic, or biliary tract) scheduled for adjuvant chemotherapy only Exclusion: ECOG PS ≥3, severe frailty at baseline, patients planned for chemoradiotherapy, or those receiving neoadjuvant chemotherapy Timeline: First patient in: January 15, 2024 Accrual closure: January 1, 2025 Final data collection (PFS/OS): January 1, 2026 Assessments Patients will be assessed at baseline, mid-treatment (\~3 months), and at the end of chemotherapy (\~6 months). All instruments have been validated in Turkish populations: G8 Screening Tool Range: 0-17 Cut-off ≤14 = frailty risk VES-13 (Vulnerable Elders Survey-13) Range: 0-13 Cut-off ≥3 = frailty SARC-F (Sarcopenia screening tool) Range: 0-10 Cut-off ≥4 = probable sarcopenia Mini Nutritional Assessment - Short Form (MNA-SF) 12-14 = normal nutrition 8-11 = at risk 0-7 = malnutrition Katz Index of Activities of Daily Living (ADL) Range: 0-6 (higher = more independence) Lawton-Brody Instrumental Activities of Daily Living (IADL) Range: 0-8 (higher = more independence) ECOG Performance Status Range: 0-5 (higher = worse functional state) Outcomes Primary outcome: Predictive value of G8 and VES-13 for grade ≥2 chemotherapy-related toxicity (CTCAE v5.0) Secondary outcomes: Associations between frailty and sarcopenia, nutrition, functional independence, and ECOG One-year Progression-Free Survival (PFS) One-year Overall Survival (OS) Statistical Analysis Categorical variables will be analyzed using Chi-square or Fisher's exact test. Continuous variables will be compared using t-test or Mann-Whitney U test, depending on distribution. Survival analyses (PFS, OS) will be estimated with Kaplan-Meier method. A p-value \<0.05 will be considered statistically significant.