Resectable Stage Early-Onset Biliary Tract Cancer: Survival and Prognostic Scoring (EOB-RS and EOB-OS) in Turkish Patients (TOG/GI-SAFRADJU-2502-EO)

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PURPOSE Early-onset gastrointestinal cancers are concerning entities globally, yet early-onset biliary tract cancers (EOBTCs) are understudied. Early-stage disease is crucial for young patients' survival. METHODS TOG/GI-SAFRADJU (ClinicalTrials.gov identifier: NCT06975917 ) is a multicenter, hospital-based, registry initiative of the Turkish Oncology Group, including patients with resected BTCs. Early-onset was defined as a diagnosis at age <50 years. Characteristics and survival of EOBTC and non-EOBTC were compared. Among patients with EOBTC, prognostic factors for recurrence-free survival (RFS) and overall survival (OS) were analyzed. Risk scores were assigned on the basis of hazard ratios. RESULTS Six hundred seventeen patients from 44 centers were included. 12.6% (n = 78) were EOBTC. R1 resection rate was significantly higher among EOBTC (37.1% v 25.7%, P = .038). Adjuvant treatments did not differ between EOBTC and non-EOBTC. Among patients who received adjuvant chemotherapy, RFS (13.9 months [95% CI, 11.4 to 22.1] v 15.9 months [95% CI, 13.6 to 18.9], P = .947) and OS (35.6 months [95% CI, 28.0 to 81.4] v 31.3 months [95% CI, 27.8 to 44.3], P = .670) were similar between EOBTC and non-EOBTC groups. Among patients with EOBTC, R1-resection and high CA19-9 levels were associated with shorter RFS, and gallbladder localization and high CA19-9 were associated with shorter OS in adjusted analyses. Using these factors, risk scores early-stage EOBTC RFS score (EOB-RS) for RFS and early-stage EOBTC OS score (EOB-OS) for OS were formed, each including three ranks. Both scores significantly ordered the prognosis of patients with EOBTC (EOB-RS, [0 points]: 22.7 months, [1 or 2]: 10.3 months, [3]: 5.7 months, P < .001, EOB-OS: [0]: 110.9 months, [1 or 2]: 29.6 months, [3]: 10.1 months, P < .001). CONCLUSION Resected EOBTC patients showed survival comparable to older counterparts receiving surgery/adjuvant therapy. This study suggests a potential risk scoring system for early-stage EOBTC, pending validation.

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