Table 2.
Characteristics of major adjuvant chemoradiotherapy studies.
| Author | Trial type | Year | Country | N | Treatment arms | Primary endpoint | Results | |
|---|---|---|---|---|---|---|---|---|
| Regimen/Drug | Survival (Months) | |||||||
| Nassour [37] | R | 2017 | USA | 4190 | 1. ACRT (568), Ob (568) 2. ACT (768), Ob (768) |
Median OS | ACRT vs Ob ACT vs Ob |
38.1 vs 31.0 (P = 0.02) 47.2 vs 35.5 (P < 0.01) |
| Bolm [43] | R | 2020 | Europe | 214 | 1. AT (75): ACT with Gem (35), ACT with Gem + Oxaliplatin (7), ACRT (7), Capecitabine (6), Folfox (5), Unknown (15) 2. Ob (139) |
Median OS | AT vs Ob PB/Mixed: AT vs Ob |
113 vs 168 (P = 0.608) 85 vs 65 (P = 0.005) |
| Zhou [54] | R | 2009 | USA | 111 | 1. ACRT (50): 5-FU (37), Capecitabine (10), Gem + 50.4 Gy (3) 2. Ob (61) |
Median OS | ACRT vs Ob node-positive: ACRT vs Ob |
33.4 vs 36.2 (P = 0.969) 21.6 vs 13.0 (P = 0.092) |
| Smeenk [55] | RCT | 2007 | Europe | 218 | 1. AT (110): ACRT with 5-FU + 40Gy 2. Ob (108) |
Median OS | ACRT vs Ob | 1.8 year vs 1.6 year (P. NS) |
| Turan [56] | R | 2015 | Turkey | 563 | 1. CRT-CT (231): Gem (151), 5-FU + Leucovorin (48), FU (30), Others (13) 2. CT (26) 3. CRT (215): Gem (71), Gem + Cisplatin (70), 5-FU + Leucovorin (41), Gem + Leucovorin + 5-FU (28), Cisplatin + 5-FU (5) |
Median OS | CRT-CT vs CT | NS (P = 0.003) |
| Kim [57] | R | 2008 | Korea | 118 | 1. ACRT (41): 5-FU (500 mg/m2/day.i.v.) + 40Gy 2. Ob (77) |
Median OS | node-positive: ACRT vs Ob | NS (P = 0.003) |
| Kim [58] | R | 2020 | South Korea | 651 | 1. AT (255): ACT with 5-FU/Gem, ACRT with 5-FU/Gem + 50.4Gy 2. Ob (396) |
5-year OS rate | T1/T2: ACRT vs Ob T3/T4: ACRT vs Ob node-positive: ACRT vs Ob |
57.6% vs 80.7% (P = 0.007) 62.4% vs 55.2% (P = 0.087) 46.9% vs 26.3% (P = 0.12) |
| Krishnan [59] | R | 2008 | USA | 96 | 1. ACRT (54): 5-FU (29)/Capecitabine (24)/Gem (1) + 45 Gy (25, preoperative) / 50.4 Gy (29, postoperative) 2. Ob (42) |
Median OS | T3/T4: ACRT vs Ob | 35.2 vs 16.5 (P = 0.06) |
Abbreviation: AT adjuvant therapy; ACRT adjuvant chemoradiotherapy; CRT chemoradiotherapy; CT chemotherapy; CRT-CT chemoradiotherapy with maintained chemotherapy; Ob observation; Gem gemcitabine; 5-FU 5-fluorouracil; OS overall survival; NS not state; PB pancreatobiliary.