Response Rates and Tolerance to Modified FOLFIRINOX Regimen in Metastatic or Unresectable Gallbladder Cancer: A Prospective Single-arm Interventional Pilot Study

IntroductIonThe most prevalent cancer of the biliary tract is gallbladder cancer (GBC).India has a high incidence rate, accounting for around 10% of the global GBC burden. 1 The majority of the patients present at an advanced stage, either locally advanced or metastatic, and the prognosis remains dismal.In advanced stages, with best supportive care, the reported median overall survival (OS) is very poor (3-4.5 months). [2][3]3][4] Gemcitabine and cisplatin doublet chemotherapy became the first-line regimen following the landmark ABC-02 trial, which demonstrated significant improvement in tumor control, disease-free survival (DFS), and OS over gemcitabine monotherapy. 5A review by Azizi et al. confirmed the significant survival advantage of gemcitabine-based combination therapies over best supportive care and chemotherapy monotherapy. 6he doublet regimen, which comprises either gemcitabine and oxaliplatin (GEMOX) or cisplatin and gemcitabine (Cis-Gem), is currently the first-line chemotherapy for patients with advanced pancreatic cancer. 7Extrapolating these results to GBC, owing to the biological and therapeutic similarities of pancreatic cancer and GBC, the current pilot study sought to assess the efficacy, safety, and tolerance for mFOLFIRINOX in patients with metastatic GBC. MaterIals a n d Methods Study DesignThis single-arm interventional pilot study was performed at a tertiary care center between July