Abstract 308P
Background
The prognosis for patients with advanced biliary tract cancer (BTC) who have not responded to gemcitabine and cisplatin (GP)-based therapy is dismal. Fluorouracil (5-FU)-based chemotherapy could be considered for those patients. Our study aimed to assess the real-world effectiveness and safety of second-line 5-FU-based treatments in patients with advanced BTC who are refractory to GP-based treatments.
Methods
This study analyzed patients from Seoul St. Mary's Hospital and St. Vincent's Hospital with advanced BTC who had previously failed to GP-based chemotherapy. From June 2020 to January 2024, these patients received 5-FU-based chemotherapy as a second-line treatment. The 5-FU-based treatments encompassed 5-FU, leucovorin and oxaliplatin (FOLFOX); 5-FU, leucovorin and liposomal irinotecan (nal-IRI/FL); and 5-FU, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Results
In total of 105 patients, the tumor sites were distributed with 42 (40.0%) having intrahepatic cholangiocarcinoma, 31 (29.5%) with extrahepatic cholangiocarcinoma, and 32 (30.5%) with gallbladder cancer. The median progression-free survival (mPFS) and overall survival (mOS) for the entire cohort were 2.1 and 4.9 months, respectively. The mPFS was 2.1 months in the FOLFOX group, 2.1 months in the nal-IRI/FL group, and 2.0 months in the FOLFIRINOX group. When compared to the FOLFOX group, there was no significant difference observed in the nal-IRI/FL group (p = 0.206) and the FOLFIRINOX group (p = 0.212). The mOS was 5.1 months in the FOLFOX group, 5.7 months in the nal-IRI/FL group, and 4.5 months in the FOLFIRINOX group. Likewise, when comparing the FOLFOX group with the nal-IRI/FL (p = 0.767) and FOLFIRINOX (p = 0.610) groups, no significant differences were found. Grade 3 or 4 neutropenia occurred in 25.0% of the FOLFOX group, 39.3% of the nal-IRI/FL group, and 51.5% of the FOLFIRINOX group.
Conclusions
In patients with advanced BTC who failed to gemcitabine and cisplatin treatment, the FOLFOX regimen demonstrated similar efficacy compared to other 5-FU based treatments. Given its favorable toxicity profile in a real-world setting, it should be considered as a standard second-line treatment option.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.