Adjuvant systemic therapy after resection of node positive gallbladder cancer: Time for a well-designed trial? (Results of a US-national retrospective cohort study)

Int J Surg. 2018 Apr:52:171-179. doi: 10.1016/j.ijsu.2018.02.052. Epub 2018 Feb 26.

Abstract

Background: Ideal oncologic management of gallbladder carcinoma (GBCA) after complete surgical resection is unclear. We sought to define benefit of post-resection adjuvant systemic chemotherapy alone in T2 or greater gallbladder carcinoma utilising a large national dataset.

Study design: The National Cancer Data Base (NCDB) 2004-2012 cohort was retrospectively reviewed for patients with GBCA (T2+) undergoing curative-intent resection and surviving at least 6 weeks. Univariate group comparisons, unadjusted Kaplan-Meier and adjusted Cox proportional hazards analyzed overall survival.

Results: 4373 patients were included (N = 2479 T2, N = 1894 T3/4). Overall, 22.1% of patients received adjuvant chemotherapy. Use of multi-agent chemotherapy increased during the study period. Patients receiving adjuvant therapy were younger, had fewer comorbidities, more often node-positive and more likely R1-margins than those receiving surgery alone. Unadjusted overall survival was improved in all patients with node-positive disease as well as for those with inadequate nodal staging. The benefit of chemotherapy persisted after adjustment for patient and tumor factors.

Conclusion: Adjuvant systemic chemotherapy is associated with survival benefit in patients with T2 or greater GBCA with node positive disease. We recommend a multidisciplinary approach in these patients as less than 1-in-4 of them currently receive adjuvant chemotherapy. Future clinical trials should address adjuvant chemotherapy in node positive GBCA.

Keywords: Adjuvant chemotherapy; Gallbladder cancer.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Chemotherapy, Adjuvant / methods*
  • Cholecystectomy / methods*
  • Cohort Studies
  • Combined Modality Therapy
  • Databases, Factual
  • Female
  • Gallbladder / pathology
  • Gallbladder / surgery
  • Gallbladder Neoplasms / mortality
  • Gallbladder Neoplasms / pathology
  • Gallbladder Neoplasms / therapy*
  • Humans
  • Lymph Nodes / pathology
  • Lymphatic Metastasis
  • Male
  • Margins of Excision
  • Middle Aged
  • Neoplasm Staging
  • Proportional Hazards Models
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome
  • United States