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FOLFIRI as third- or later-line treatment for advanced biliary tract cancer in Northern Thailand
Background
The combination of gemcitabine and cisplatin, and FOLFOX (fluorouracil and oxaliplatin) are recognized as the standard first- and second-line chemotherapy regimen in advanced biliary tract cancer (BTC). However, there are significant number of patients progressing after these treatments, and also there are no available data regarding the benefit of the later-line treatment in Thai patients. This study aims to evaluate the efficacy and safety of FOLFIRI (fluorouracil and irinotecan) after failure from two or more lines of chemotherapy.
Methods
A single institution, retrospective cohort study was conducted in Lampang Hospital. Patients who were diagnosed as locally advanced or advanced BTC from January 2017-December 2019, treated with FOLFIRI as third-line or beyond regimen were included. The primary endpoint was overall survival (OS). Secondary endpoints were response rate and toxicity. Exploratory analysis was performed to define possible prognostic factors related to OS.
Results
Thirteen patients were included, 10 (77%) of which were intrahepatic cholangiocarcinoma. Nine patients (69.2%) received prior gemcitabine plus cisplatin as first-line regimen, and 10 (77%) received FOLFOX/CapeOX as second-line treatment. Median OS was 4.2 months (95% CI; 2.10 - 9.18), with three patients achieved stable disease, providing disease control rate (DCR) of 23.1%. Nine grade 4 toxicities were documented, including four events of septic shock requiring hospitalization. Poor prognostic factors for OS were total bilirubin level > 1 mg/dl (HR 6.20, p = 0.03, 95% CI; 1.19 - 32.36) and neutrophil-lymphocyte ratio (NLR) > 5 (HR 7.89, p = 0.02, 95% CI; 1.40 - 44.62).
Conclusions
Though activity in late-line treatment of advanced BTC with FOLFIRI is modest and associated with significant toxicities, further studies with dose modification are warranted in patients with BTC refractory to standard chemotherapy and novel treatment inaccessible.
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosures
All authors have declared no conflicts of interest.
