Table 1.
Summary of adjuvant treatments.
| Study | Number and Type of Patients | Study Arms | RFS | OS |
|---|---|---|---|---|
| Primrose et al. [15] randomised, controlled, multicentre, phase III BILICAP trial | 447 CCA or muscle-invasive gallbladder cancer | Cap: 1250 mg/m2 twice a day on days 1 to 14 of a 3-week cycle for 24 weeks (8cycles) vs. Obs |
Cap: 24.6 months (95% CI, 18.9 to 36.7 months) Obs: 17.6 months (95% CI, 12.8 to 27.6 months) HR 0.76 (95% CI, 0.58 to 0.99; p = 0.039) |
Cap: 51.1 months (95% CI, 34.6 to 59.1 months) Obs: 36.4 months (95% CI, 29.7 to 44.5 months) HR: 0.81 (95% CI, 0.63 to 1.04; p = 0.097) |
| Edeline et al. [14] multicentre, open-label, randomised phase III PRODIGE 12-ACCORD 18 trial | 196 resected BTC | Gem 1000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 on day 2 for 12 cycles vs. Surveillance |
GemOx: 30.4 months (95% CI, 15.4 to 43.0 months) Surveillance: 18.5 months (95% CI, 12.6 to 38.2 months) HR 0.71 (95% CI, 0.62 to 1.25; p = 0.48) |
GemOx: 24-months OS 69% 48-months OS 51% 72-months OS 51% Surveillance: 24-months OS 76% 48-months OS 52% 72-months OS 48% |
| Ebata et al. [13] randomised phase III BCAT trial | 225 resected BTC | Gem 1000 mg/m2 on days 1,8, and 15 every 4 weeks (6 cycles) vs. Obs |
Gem: 36.0 months Obs: 39.9 months HR 0.93 (95% CI, 0.66 to 1.32; p = 0.693) |
Gem: 62.3 months Obs: 63.8 months HR 1.01 (95% CI, 0.70 to 1.45; p = 0.964) |
| Kobayashi et al. [16] multicentre, randomised phase II KHBO 1208 trial | 70 BTC after major hepatectomy | Gem 1000 mg/m2 on days 1 and 8 every 2 weeks vs. S1 80 mg/m2/day for 28 days every 6 weeks |
1-year 51.4% vs. 62.9% 2-year 31.4% vs. 51.4% |
1-year 80% vs. 97.1% HR 0.48 (CI 90%, 0.24-0.93) 2-year 60% vs. 80% |
| Nakachi et al. [17] open-label, multicentre, randomised phase III ASCOT trial | 350 resected BTC | S1: 40–60 mg/day related to BSA (body surface area) vs. Obs | n.a | 3-year OS n.a vs. 47% |
| Stein et al. [18] randomised, multidisciplinary, multinational phase III ACTICCA-01 trial | CCA and gallbladder cancer | Cis/Gem on days 1 and 8 every 3 weeks, Cisplatin (25 mg/m2) and Gemcitabine (1000 mg/m2) vs. Cap from days 1 to 14 every 3 weeks (1250 mg/m2, twice daily) |
n.a | n.a |
CCA = cholangiocarcinoma; BTC = biliary tract cancer; Gem = gemcitabine; Cap = capecitabine; Obs = observation; S1 = tegafur/gimeracil/oteracil; Cis = cisplatin; OS = overall survival; RFS = relapse-free survival; n.a = not available; DFS = disease free survival; CI = confidence interval.