Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study

Abstract

Purpose

Biliary tract cancers (BTCs) have a poor overall prognosis, as patients who underwent curative surgery frequently experience disease recurrence. At present, there is a paucity of well-documented adjuvant chemotherapy regimen. This study aimed to assess whether gemcitabine plus platinum or S-1 adjuvant chemotherapy have different impact on relapse-free survival (RFS).

Patients and Methods

We selected patients undergoing radical biliary tract cancer surgery, pathologically confirmed adenocarcinoma and received gemcitabine plus platinum (cisplatin or oxaliplatin) or S-1 adjuvant chemotherapy from September 2013 to May 2020. The primary study endpoint was RFS. The secondary endpoint was safety.

Results

Overall 136 patients were enrolled. The median follow-up was 32.3 months and the median RFS was 17.0 months (95% CI 8.9–25.1). The median RFS was 14.1 months (95% CI 6.7–21.5) in gemcitabine plus platinum group and 33.0 months (95% CI 9.3–56.7) in gemcitabine plus S-1 (GS) group, a non-significant difference both in univariate (P=0.092) and in multivariate analysis (P=0.058). Lymph node status (N- vs N+: HR=0.477, 95% CI 0.285–0.799; P=0.005) and chemotherapy cycles (<6 vs 6–8: HR=1.828, 95% CI 1.117–2.993; P=0.016) were independent impact factors for RFS. GS group had lower incidence of adverse reactions.

Conclusion

Compared with gemcitabine plus platinum, GS regimen has a tendency to obtain longer RFS (although there is no statistically significant difference) and less toxic. GS regimen has the potential to be investigated as a standard regimen for adjuvant chemotherapy.

Keywords:

• biliary tract cancer
• adjuvant chemotherapy
• gemcitabine
• platinum
• S-1

Acknowledgment

The authors thank the dedicated staff of the Department of Medical Oncology and the Department of Hepatobiliary Surgery of the First Affiliated Hospital of Xi’an Jiaotong University, the Department of Oncology of the Second Affiliated Hospital of Xi’an Jiaotong University, and the Department of Medical Oncology of Tumor Hospital of Shaanxi for their valuable work.

Ethics Approval and Consent to Participate

This study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the First Affiliated Hospital of Xi’an Jiaotong University (NO: XJTU1AF2019LSK-067). Due to the retrospective non-interventional research design, informed consent was obtained. In addition, we confirm that the access to patients’ data complied with data protection privacy laws.

Disclosure

The authors report no conflicts of interest in this work.