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Table. 3.

Adjuvant Therapy for Resected Ampulla Adenocarcinoma

Author Year Number of patients Study design Treatment Survival p-value
Neoptolemos et al.93 (ESPAC-3 trial) 2012 PAC 428 (AA 297) RCT Gemcitabine or 5-FU/LV OS: 43.1 months (AC) vs. 35.2 months (no AC) 0.250
Takada et al.94 2002 PAC 508 (AA 48) RCT Mitomycin+5-FU 5YSR of AA: 28.1% (AC) vs. 34.3% (no AC) NS
Nassour et al.95 2018 AA 4,190 R - OS: 47.2 months (AC) vs. 35.5 months (no AC) <0.01
Moekotte et al.96 2020 AA 1,163 R Gemcitabine-based AC OS: Not reached (AC) vs. 60 months (no AC) 0.051
Kamarajah et al.97 2021 AA 7,358 R - OS: 47.5 months (AC) vs. 39.6 months (no AC) 0.003
Jin et al.98 2018 AA 121 R AC (gemcitabine, 5-FU/LV, FOLFOX) or ART OS: 45.5 months (AC or ART) vs. 34.3 months (no AC) 0.030
Acharya et al.99 (Meta-analysis) 2017 PAC 1,671 R AC or ART 5YSR of AA: 40% (AC or ART) vs. 37.5% (no AC) 0.067
Smeenk et al.104 2007 PAC 218 (AA 72) RCT ART (40 Gy) with 5-FU OS: 20 months (ART) vs. 18 months (no ART) NS
Klinkenbijl et al.105 (EORTC trial) 1999 PAC 93 RCT ART (40 Gy) with 5-FU 5YSR of AA: 38% (ART) vs.36% (no ART) 0.737
Bhatia et al.101 2006 AA 125 R ART (50.4 Gy) with 5-FU OS: 3.4 years (ART) vs. 1.6 years (no ART) (in positive lymph node) 0.01
Palta et al.103 2012 AA 137 R ART (50 Gy) with 5-FU or capecitabine 3YSR: 62% (ART) vs. 46% (no ART) 0.074
Krishnan et al.106 2008 AA 96 R ART (50.4 Gy) with 5-FU or capecitabine OS: 35.2 months (ART) vs. 16.5 months (no ART) 0.06
Kwon et al.109 (Meta-analysis) 2015 AA 3,361 R ART+chemotherapy (5-FU, mostly) Pooled OS: HR 0.75 0.01
Manne et al.100 2020 AA 63 R AC (capecitabine only) or ART (either capecitabine and 5-FU) OS: 51.7 months (AC or ART) vs. 40.5 months (no AC or ART) 0.93

ESPAC-3, European Study Group for Pancreatic Cancer-3; EORTC, European Organization for Research and Treatment of Cancer; PAC, periampullary carcinoma; AA, ampullary adenocarcinoma; RCT, randomized controlled trial; R, retrospective; 5-FU/LV, 5-fluorouracil/leucovorin; AC, adjuvant chemotherapy; ART, adjuvant radiotherapy; OS, overall survival; YSR, year survival rate; NS, not significant.

Korean J Gastroenterol 2023;82:159~170 https://doi.org/10.4166/kjg.2023.110
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