Abstract

ABSTRACT Aim: The Advanced Biliary Cancer (ABC)-02 randomized trial demonstrated the superiority of cisplatin and gemcitabine (CisGem) chemotherapy over gemcitabine (Gem) alone in patients with advanced biliary tract cancer (ABTC). Neutrophil to lymphocyte ratio (NLR) has been shown to be a prognostic factor in advanced biliary cancer. Derived NLR (dNLR) has similar prognostic value to NLR. The aim of the current analysis was to evaluate dNLR as a predictor of the survival benefit conferred by CisGem compared with Gem alone in patients with ABTC. Methods: A post-hoc exploratory analysis of ABC-02 was performed on all patients with available white blood cell (WBC) and absolute neutrophil count (ANC) data. The dNLR was calculated using a formula that was previously shown. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. The Cox proportional hazards model was used to evaluate independent prognostic factors and to estimate their effects on PFS and OS. Results: WBC count and ANC were available in 322 patients: 162 patients received Gem and 160 patients received CisGem. The baseline characteristics remained balanced between the two treatment arms. dNLR was an independent prognostic factor for OS for the entire cohort (p = 0.001); A high dNLR was defined using a cutoff value of 3.0; it was selected by rounding the mean value of dNLR for the entire cohort, which was 2.94. The median OS was 6.9 months versus 10.6 months for patients with dNLR > 3.0, versus NLR Conclusions: These data suggest that dNLR has prognostic significance and may represent a clinical biomarker predicting benefit of cis/gem combination compared with gemcitabine alone in patients with ABTC. dNLR >3.0 may indicate lack of survival advantage of adding cisplatin to gemcitabine. Disclosure: All authors have declared no conflicts of interest.

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