Chemotherapy in the treatment of advanced gallbladder cancer

Oncology. 2004;66(2):138-42. doi: 10.1159/000077440.


Objective: To clarify the role of chemotherapy for advanced gallbladder cancer (GBC).

Methods: We reviewed 89 GBC patients: 21 admitted before 1997 were treated with a combination of cisplatin, epirubicin, and 5-fluorouracil (CEF); 25, admitted subsequently, received a combination of 5-fluorouracil, doxorubicin and mitomycin (FAM), and the remaining 43, ineligible for these trials, received supportive care. We investigated the relation between pretreatment clinical variables and long-term survival in these 89 subjects, and analyzed whether chemotherapy could favor longer survival.

Results: There were no significant differences in survival time between the chemotherapy groups, whereas the response rate to the CEF regimen was 4-fold higher than to the FAM regimen (32 vs. 8%). Subgroup analysis suggested that chemotherapy favored longer survival in patients with a performance status (PS) of 0 or 1, but not in patients with a PS of 2. Cox regression analysis suggested a significant hazard reduction by chemotherapy in patients with a PS of 0 or 1, but not in patients with a PS of 2.

Conclusions: GBC patients with poor PS should not be treated with chemotherapy at present. It is essential to design good clinical trials and develop more effective chemotherapy regimens.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage
  • Clinical Trials as Topic
  • Doxorubicin / administration & dosage
  • Epirubicin / administration & dosage
  • Female
  • Fluorouracil / administration & dosage
  • Follow-Up Studies
  • Gallbladder Neoplasms / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage
  • Odds Ratio
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome


  • Epirubicin
  • Mitomycin
  • Doxorubicin
  • Cisplatin
  • Fluorouracil

Supplementary concepts

  • FAM protocol