TABLE 3.
Studies Evaluating Adjuvant Chemotherapy ± Radiation for Resected Hilar Cholangiocarcinoma
| Investigator/Year | Country | Type Study | Years Data | # EHBTC/Total # Study | % Total Hilar | % AT | 5 year % OS AT | OS AT (months) | AT Regimen | Improved Survival with AT? | Improved Survival AT-Node Positive Subset? |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Takada14 2002 |
JAPAN | Phase III RCT, multicenter | 1986-1992a | 139b/508 | – | 50 | 26.7c | – | MMC + 5FU | No | – |
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| Borghero22 2008 |
USA | Retro, single centerd | 1984-2005 | 65/65 | 55 | 65e | 36 | 31 | ChemoXRT (5FU based) | – | – |
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| Lim8 2009 |
KOREA | Retro, single center | 2000-2006 | 120/120 | 49 | 75 | (3yr) 62.6 | – | CCRT vs. CCRT+ 5FU based chemo | Yes | No |
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| Kim9 2011 |
KOREA | Retro, single center | 2001-2009 | 168/168 | 53.9 | 68 | 36.5 | – | 5FU/LCV + XRT | Yes | Yes |
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| Murakami10 2011 |
JAPAN | Retro, single center | 1990-2009 | 106/127 | 39 | 39 | 47 | – | GEM based | Yes | Yes |
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| Park20 2011 |
KOREA | Retro, single center | 1998-2007 | 101/101 | 35 | 84 | 34 | 24 | All XRT, 84% chemo (most CAP based) | – | – |
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| Glazer13 2012 |
USA | Retro, single center | 1978-2009 | 40/197 | – | 49.1 | – | 46/53f | CAP/GEM based, 15.3% ChemoXRT | No | – |
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| Horgan19 2012 |
N/A | Meta-analysis | 1960-2010 | −/6712 | – | – | – | – | Multiple regimens | No | Yes |
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| Ben- Josef21 2015 |
USA | Phase II Trial, multicenter | 2008-2012a | 35/79 | 48 | 86g | (2yr) 65 | 35 | GEM + CAP, 87% also XRT | – | – |
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| Kang7 2016 |
KOREA | Retro, single center | 1991-2010 | 260/260 | 100 | 48.8 | 21.2 | 24.8 | ChemoXRT (5FU based), some just XRT/chemo | No | Yes |
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| Edeline15 2017 |
EUROPE | Phase III RCT, multicenter | 2009-2014 | 69/193 | 8 | – | – | – | GEM + OX | No | No |
Abbreviations: EHBTC, extra hepatic biliary tract cancer; AT, adjuvant therapy; OS, overall survival; RCT, randomized controlled trial; MMC, mitomycin C; 5FU, 5-fluorouracil; retro, retrospective; chemoXRT, chemotherapy and radiation therapy; CCRT, concurrent chemoradiotherapy; LCV, leucovirin; XRT, radiation therapy; GEM, gemcitabine; CAP, capecitabine; OX, oxaliplatin.
a
Years patients enrolled
b
Intrahepatic cholangiocarcinoma included in group with no exact numbers given
c
For extrahepatic cholangiocarcinoma group
d
Most at a single center
e
Only R1 and/or N1 underwent chemoXRT
f
46/53 month med survival chemo/chemoXRT groups
g
% completed