Abstract 146P
Background
Biliary tract cancers (BTC) is characterized by insidious onset, aggressiveness and poor prognosis. Surgery is the first recommended treatment for patients with early-stage BTC, and postoperative adjuvant chemotherapy with capecitabine is the current standard of treatment. However, the 2-year recurrence rate after capecitabine adjuvant chemotherapy is still as high as approximately 50% (median relapse free survival(mRFS): 24.4 months).
Methods
This is a retrospective study that collected clinical data from patients who were diagnosed with BTC and underwent radical resection with pathologic type of adenocarcinoma and who used adjuvant chemotherapeutic regimen of gemcitabine plus capecitabine (GEMCAP) or capecitabine (CAP) postoperatively in our hospital from May 2017 to May 2023. The main study index was RFS.
Results
302 patients with BTC received postoperative adjuvant chemotherapy, 123 cases with GEMCAP regimen and 179 cases with CAP regimen. (ICC=153 cases, pCCA=65 cases, dCCA=33 cases and GBC =51 cases). The median follow-up time was 30.2 months. The mRFS in the GEMCAP group was significantly better than that in the CAP group (25.2 months vs. 16.6 months, HR=0.700, 95% CI: 0.513-0.957, P=0.024). In further RFS subgroup analyses, the GEMCAP group showed consistent benefit or trend toward benefit compared to the CAP group in almost all clinicopathologic characteristic subgroups. Survival analysis after PSM showed that mRFS in the GEMCAP group remained significantly better than that in the CAP group (25.2 months vs. 14.0 months, HR=0.615, 95% CI: 0.433 to 0.873, P=0.006). In terms of overall survival, the data for both groups are not yet mature enough to obtain a median survival time.
Conclusions
This retrospective study showed that adjuvant chemotherapy with the GEMCAP regimen significantly prolong the RFS of postoperative patients with BTC compared to the CAP regimen, which is currently the standard postoperative adjuvant regimen. Therefore, the GEMCAP regimen may be a superior adjuvant chemotherapy regimen for postoperative BTC patients and deserves further investigation in a stage III stage clinical trial.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.