Gemcitabine, Cisplatin, and Nab-Paclitaxel as a First-Line Therapy for Advanced Biliary Tract Cancers

J Gastrointest Cancer. 2024 Mar;55(1):263-269. doi: 10.1007/s12029-023-00946-z. Epub 2023 Jun 27.

Abstract

Introduction: Locally advanced, inoperable, or metastatic gallbladder cancers (GBC) are treated with either gemcitabine-platinum combinations or gemcitabine alone based on physician discretion. However, the combination of gemcitabine, cisplatin, and nab-paclitaxel (GCNP) has shown increased response rates and prolonged survival in a phase II trial of biliary tract patients.

Materials and methods: Consecutive series of patients diagnosed with locally advanced (liver infiltration > 5 cm, large nodes at porta, abutting duodenum), inoperable, and metastatic biliary tract patients between January 2018 and August 2022 were evaluated for first-line chemotherapy GCNP, in the multidisciplinary joint clinic (MDJC). The primary endpoint was ORR, and the major secondary endpoint was event-free survival (EFS).

Results: A total of 142 patients received GCNP during the specified time period. The median age of the cohort was 52 years (range: 21-79), the majority were females (61.3%), and the majority were GB (81.7%). Response rates were available in 137 patients. Complete response, partial response, and stable disease were seen in 9 (6.3%), 87 (61.3%), and 24 (16.9%), respectively, for an ORR of 67.6% and a clinical benefit rate of 84.5%. The median EFS was 9.92 (95% CI, 7.69-12.14) months. Of the 52 patients in whom GCNP was given with NACT intent for locally advanced GBC, 17 patients underwent surgery (34%).

Conclusion: Our study indicates that GCNP leads to improved response rates, increased chances of resectability, and possibly better survival in patients with GBC.

Keywords: Disease-free survival; Gallbladder carcinoma; Nab-paclitaxel; Progression-free survival.

MeSH terms

  • Adult
  • Aged
  • Albumins* / administration & dosage
  • Albumins* / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Biliary Tract Neoplasms* / drug therapy
  • Biliary Tract Neoplasms* / mortality
  • Biliary Tract Neoplasms* / pathology
  • Cisplatin* / administration & dosage
  • Cisplatin* / therapeutic use
  • Deoxycytidine* / administration & dosage
  • Deoxycytidine* / analogs & derivatives
  • Deoxycytidine* / therapeutic use
  • Female
  • Gallbladder Neoplasms / drug therapy
  • Gallbladder Neoplasms / mortality
  • Gallbladder Neoplasms / pathology
  • Gemcitabine*
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel* / administration & dosage
  • Paclitaxel* / therapeutic use
  • Retrospective Studies
  • Young Adult