Table 2.
Summary of first-line treatments in advanced settings.
| Fist Line | ||||
|---|---|---|---|---|
| Study | Number and Type of Patients | Study Arms | PFS | OS |
| Valle et al. [12] Phase III ABC-02 trial | 410 locally advanced or metastatic CCA, gallbladder cancer, or ampullary cancer | GemCis: cisplatin 25 mg/m2 followed by Gem 1000 mg/m2 (on days 1 and 8, every 3 weeks for 8 cycles) vs. Gem alone 1000 mg/m2 (on days 1, 8, and 15, every 4 weeks for six cycles) for up to 24 weeks. | 8.0 vs. 5.0 months | 11.7 vs. 8.1 months HR (0.64; 95% confidence interval, 0.52 to 0.80; p < 0.001) |
| Shroff et al. [25] open-label, single-arm, Phase II trial | 60 advance BTC | GAP: Gem 1000 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 125 mg/m2, on days 1 and 8 of 21-day cycles | 11.8 months (95% CI, 6.0 to 15.6) | 19.2 months (95% CI, 13.2 months to not estimable) |
| Phelip et al. [29] Phase II/III trial PRODIGE38-AMEBICA trial | intra or extra hepatic or hilar or gallbladder carcinoma | FOLFIRINOXm Oxali 85 mg/m2, IRI 180 mg/m2 (IV 90 min), folinic acid 400 mg/m2 (IV 2 h), 5 FU 2400 mg/m2 (46 h) every 2 weeks vs. GemCIs: cisplatin 25 mg/m2 followed by Gem 1000 mg/m2 (on days 1 and 8) every 3 weeks | n.a | n.a |
| Berger et al. [30] Phase II NIFE trial | locally advanced, non-resectable or metastatic BTC | Nal-IRI: nal-IRI mg/m2 (46 h infusion), 5-FU 2400 mg/m2 (46 h infusion), leucovorin 400 mg/m2 (0.5 h infusion) on day 1 every 2 weeks Vs. GemCis: cisplatin 25 mg/m2 followed by Gem 1000 mg/m2 (on days 1 and 8) every 3 weeks |
n.a | n.a |
CCA = cholangiocarcinoma; BTC = biliary tract cancer; Gem = gemcitabine; Cap = capecitabine; Cis = cisplatin; Oxali = oxaliplatin; IRI = irinotecan; 5-FU = 5-fluorouracil; nal = nanoliposomial; GemOx = gemcitabine, oxaliplatin; OS = overall survival; n.a = not available; PFS = progression free survival; CI = confidence.