Table 3.
Summary of treatments in advanced settings.
| After First-Line | ||||
|---|---|---|---|---|
| Study | Number and Type of Patients | Study Arms | PFS | OS |
| Lamarca et al. [21] randomised phase III, multi-centre, open-label ABC-06 trial | 162 locally advanced/metastatic BTC patients previously-treated with CisGem chemotherapy | ASC+ mFOLFOX6: Oxali 85 mg/m2, folinic acid 350 mg/m2, 5-FU 400 mg/m2 (bolus) and 2400 mg/m2 (infusion) every 2 weeks for 12 cycles vs. ASC |
mOS: 6.2 vs. 5.3 months HR: 0.69 (95% CI 0.50–0.97; p = 0.031) 6-months OS: 50.6% vs. 35.5% 12-months OS: 25.9% vs. 11.4% |
|
| Zheng et al. [33] randomised, Phase II study | 64 advanced BTC patients progressed after CisGem | XELIRI: IRI 180 mg/m2 on day 1, cap 1000 mg/m2 twice daily on days 1–10 every 2 weeks vs. Irinotecan: IRI 180 mg/m2 every 2 weeks |
3.7 vs. 2.4 months | 9-month OS: 60.9% vs. 32.0%, mOS 10.1 vs. 7.3 months DCR: 63.3% vs. 50.0% |
| Guion-Dusserre et al. [34] | 13 metastatic intrahepatic CCA patients who were refractory to GemOx | FOLFIRI + bevacizumab: IRI 180 mg/m2 (IV 90 min), folinic acid 400 mg/m2 (IV 2h), 5-FU 2400 mg/m2 (46h), bevacizumab (5 mg/kg) every 2 weeks | 8 months (95% CI: 7–16 months) | 20 months (95% CI: 8–48 months) DCR: 84.5% (95% CI: 42%–100%) ORR: 38.4% (95% CI: 12.5%–89%) |
| Sebbagh et al. [35] retrospective trial | 52 recurrent/advanced BTC patients after progression to GemOx | FOLFIRI (after GemOx in fist line): IRI 180 mg/m2 (IV 90 min), folinic acid 400 mg/m2 (IV 2h), 5-FU 2400 mg/m2 (46h) | Fist-line GemOx: 4.8 months Second-line FOLFIRI: 3.2 months |
21.9 months |
| Chakrabarti et al. [36] Phase II trial | 27 advanced BTC previously treated | FTD/TPI 35 mg/m2/day | 3.8 months (95% CI, 2.0 to 5.8 months) | 6.1 months (95% CI, 4.4 to 11.4 months) |
CCA = cholangiocarcinoma; BTC = biliary tract cancer; Gem = gemcitabine; CisGem = cisplatin, gemcitabine; Cap = capecitabine; obs = observation; Cis = cisplatin; Oxali = oxaliplatin; IRI = irinotecan; 5-FU = 5-fluorouracil; GemOx = gemcitabine, oxaliplatin; FTD/TPI = trifluridine/tipiracil; ASC = active symptom control; OS = overall survival; TTP = time to progression; PFS = progression free survival; DCR = disease control rate; ORR = objective response rate; CI = confidence interval.