Table 1.
Characteristics of major adjuvant chemotherapy studies.
| Author | Trial type | Year | Country | N | Treatment arms | Primary endpoint | Result | |
|---|---|---|---|---|---|---|---|---|
| Regimen/Drug | Survival (Months) | |||||||
| Kim [25] | R | 2020 | Korea | 646 | 1. Fluoropyrimidine-based (123) 2. Ob (123) |
Median OS Median RFS |
Fluoropyrimidine-based vs Ob Fluoropyrimidine-based vs Ob |
41 vs 36 (P = 0.134) 18 vs 16 (P = 0.205) |
| Al Abbas [32] | R | 2019 | America | 121 | 1. 5‐FU (14) 2. Gem (33) 3. Ob (74) |
Median OS | ACT vs Ob 5-FU vs Ob Gem vs Ob 5-FU vs Gem |
45.6 vs 32.1 (P = 0.032) 87.4 vs 32.1 (P = 0.046) 38.0 vs 32.1 (P = 0.167) 87.4 vs 38.0 (P = 0.203) |
| 1. PB (58): 5-FU (6) Gem (24) Ob (28) 2. IN (39): 5-FU (4) Gem (6) Ob (29) 3. AM (24):5-FU (4) Gem (3) Ob (17) |
Median OS | PB: 5-FU vs Gem vs Ob IN: 5-FU vs Gem vs Ob AM: 5-FU vs Gem vs Ob |
40.4 vs 30.4 vs 29.4 (P. NS) 52.7 vs NR vs 32.4 (P. NS) 87.4 vs 23.5 vs 33.5 (P. NS) |
|||||
| 1. Stage Ⅰ + Ⅱ A: ACT (10) Ob (29) 2. Stage Ⅱ B + Ⅲ: ACT (37) Ob (26) |
Median OS | stage Ⅰ + Ⅱ A: ACT vs Ob stage Ⅱ B + Ⅲ: ACT vs Ob |
NS (P = 0.121) 38.6 vs 21.4 (P < 0.01) |
|||||
| Schiergens [33] | R | 2015 | Germany | 95 | 1. Gem (34) 2. Ob (60) |
OS | Gem vs Ob | NS (P = 0.832) |
| 1. PB (46): Gem (22) Ob (24) 2. IN (47): Gem (12) Ob (35) 3. Undifferentiated (2) |
Median OS | PB: Gem vs Ob IN: Gem vs Ob |
32 vs 13 (P = 0.013) 35 vs 112 (P = 0.193) |
|||||
| Moekotte [34] | R | 2020 | Six countries | 976 | 1. Gem-based (194) 2. Ob (194) |
Median OS | Gem vs Ob | NR vs 60 (P = 0.051) |
| 1. PB/AM (194): Gem-based (97) Ob (97) 2. IN (90): Gem-based (45) Ob (45) |
Median OS | PB/AM: Gem-based vs Ob IN: Gem-based vs Ob |
NR vs 32 (P = 0.020) NR vs NR (P = 0.719) |
|||||
| Neoptolemos [35] | RCT | 2012 | Europe Australia Japan Canada | 428 | 1. CF + FU (143) 2. Gem (141) 3. Ob (144) |
Median OS | ACT vs Ob CF + FU vs Ob Gem vs Ob |
43.1 vs 35.2 (P = 0.03) 38.9 vs 35.2 (P = 0.74) 45.7 vs 35.2 (P = 0.10) |
| Ramaswamy [36] | R | 2019 | India | 214 | 1. PB (105): Gem-based (64) Ob (16) 2. IN (109): Gem-based (50) Ob (9) |
Median OS | PB: Gem vs Ob IN: Gem vs Ob |
PB: 58.09 vs 18.46 (P < 0.001) IT: NR vs 28.62 P < 0.001) |
| 1. Stage Ⅰ + Ⅱ + Ⅲ (214): Gem-based (135) Ob (79) 2. Stage Ⅱ + Ⅲ (139): Gem-based (114) Ob (25) |
Median OS | Stage Ⅰ + Ⅱ + Ⅲ: Gem-based vs Ob Stage Ⅱ +Ⅲ: Gem-based vs Ob |
NS (P = 0.603) NR vs 22.28 (P = 0.036) |
|||||
| Author | Trial type | Year | Country | N | Treatment arms | Primary endpoint | Result | |
|---|---|---|---|---|---|---|---|---|
| Regimen/Drug | Survival (Months) | |||||||
| Ecker [39] | R | 2019 | Multinational | 357 | 1. FU-based (29) 2. Gem-based (57) 3. Ob (70) |
OS | ACT vs Ob FU-Based vs Ob Gem-Based vs Ob |
NS (P = 0.69) NS (P = 0.68) NS (P = 0.74) |
| 1. PB (65): 5-FU (9) Gem (29) Ob (27) 2. IN (78): 5-FU (19) Gem (18) Ob (41) |
OS | PB: 5-FU vs Ob Gem vs Ob IN: 5-FU vs Ob Gem vs Ob |
NS (P = 0.94) NS (P = 0.77) NS (P = 0.72) NS (P = 0.63) |
|||||
| 1. Stage Ⅰ (30): ACT (14) Ob (16) 2. Stage Ⅱ (19): ACT (12) Ob (7) 3. Stage Ⅲ (99): ACT (52) Ob (47) |
OS | stage Ⅰ: ACT vs Ob stage Ⅱ: ACT vs Ob stage Ⅲ: ACT vs Ob |
NS (P = 0.05) NS (P = 0.55) NS (P = 0.36) |
|||||
| Kim [40] | R | 2013 | Korea | 21 | XELOX (21) | ORR Median TTP Median OS |
38%⁎ 7.6 19.7 |
|
| 1. PB (10) 2. IN (7) |
Median TTP | PB vs IN | 6.4 vs 13.1 (P = 0.038) | |||||
| Overman [41] | P | 2009 | America | 30 SBA 18 AAC 12 |
CAPOX (30) | ORR Median TTP Median OS |
50%⁎(SBA 61%,AAC 33%) 11.3 20.4 |
|
| Kim [42] | R | 2010 | Korea | 29 | Platinum-based (29) | ORR Median TTP Median OS |
27.5%⁎ 4.9 12.5 |
|
| 1. FP (11) 2. XP (9) 3. GP (9) |
TTP OS |
FP vs XP vs GP FP vs XP vs GP |
NS (P = 0.79) NS (P = 0.85) |
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Abbreviation: R retrospective; RCT randomized controlled trial; P prospective; Gem gemcitabine; 5-FU 5-fluorouracil; CF folinic acid; XELOX capecitabin + oxaliplatin; CAPOX capecitabin + oxaliplatin; Ob observation; FP 5-FU+cisplatin; XP capecitabine + cisplatin; GP gemcitabine + cisplatin; IN intestinal; PB pancreatobiliary; AM ambiguous; ACT adjuvant chemotherapy; OS overall survival; RFS recurrence-free survival; ORR objective response rate/overall response rate; TTP time to progression; PFS progression-free survival; AAC ampullary adenocarcinoma; SBA small bowel adenocarcinoma; NR not reached; NS not state. ⁎The value is a percentage