FOLFOX VERSUS FOLFIRI IN THE SECOND-LINE SETTING OF METASTATIC BILIARY TRACT CARCINOMA (MBTC): A RETROSPECTIVE ANALYSIS

Background: Metastatic biliary tract carcinoma (mBTC) patients are treated in first-line with gemcitabine plus plantinum combination therapy, but survival is poor. Recently, FOLFOX has been shown to be active in second line as compared to active symptom control. However, resistance to a platinum component may impair secondline outcomes and impact therapy choice in real-life practice. Methods: This was a retrospective study of patients treated at a large cancer center. All patients had mBTC and underwent second-line FOLFOX or FOLFIRI. Our objective was to compare overall survival (OS) and time to treatment failure (TTF) between regimens. Kaplan-Meir and log-rank were used to estimate survival and possible differences. Qui-square and Fisher tests were used to compare categorical variables. Results Between June/2011 and June/2017, thirty-eight patients were identified. Eighteen and twenty pts underwent FOLFOX and FOLFIRI, respectively. Median follow-up was 17.2m (95% IC 13.7 20.8). Cisplatin plus gemcitabine was used as first-line in 97.4%. Median age was 57.5y for FOLFOX and 60.5y for FOLFIRI. ECOG was 0/1 in 72.2% and 75% (p = 1.0) for FOLFOX and FOLFIRI, respectively. Intrahepatic cholangiocarcinoma was the most prevalent site (FOLFOX 70%, FOLFIRI 50%); four patients had primary gallbladder in the FOLFOX cohort versus none in FOLFIRI (p = 0.092). Liver metastases were present in 77.8% and 55% in each cohort (p = 0.18), respectively. More patients in the FOLFOX regimen had more than two sites of disease (83.3% versus 35%, p = 0.004). Overall survival was numerically higher in the FOLFIRI cohort (6.76 versus 4.0m, p = 0.29). TTF was 2.79m and 2.33m for FOLFOX and FOLFIRI respectively (p = 0.93). Conclusion: In our retrospective analysis FOLFOX and FOLFIRI had similar efficacy. FOLFIRI had a slightly better OS, but FOLFOX patients had more unfavorable prognostic characteristics. Second-line FOLFOX offers similar OS as compared to the ABC-06 trial. TTF were low for both regimens, which demonstrates urgent need of better treatment options for these patients. FOLFIRI should be better evaluated in prospective trials as an alternative to platinum intolerant or resistant patients.