A new clinically based staging system for perihilar cholangiocarcinoma.
OBJECTIVE
Current staging systems for perihilar cholangiocarcinoma (pCCA) are inadequate, as they are based on surgical pathology and therefore not relevant to unresectable patients. Clinical trials for potential targeted therapies for pCCA are hampered by the lack of an accurate, nonoperative staging system for predicting survival. We aimed at developing a clinical staging system for pCCA, which would be of prognostic relevance for all pCCA patients and help stratify patients for clinical trials.


METHODS
Clinical information at the time of pCCA diagnosis of 413 patients seen at Mayo Clinic, Rochester, MN between 2002 and 2010 was retrospectively analyzed. A survival predictive model was developed using Cox proportional hazards analysis. The performance of the staging system was compared with the current AJCC/UICC (the American Joint Committee on Cancer/the Union for International Cancer Control) 7th tumor-node-metastasis (TNM) staging system.


RESULTS
Eastern Cooperative Oncology Group (ECOG) status, tumor size and number, vascular encasement, lymph node and peritoneal metastasis and CA 19-9 level were grouped into a four-tier staging system. The median survivals of stages I, II, III, and IV patients were 48.6, 21.8, 8.6, and 2.8 months, with hazard ratios (95% confidence interval) of 1.0 (reference), 1.7 (1.1-2.6), 3.1 (2.0-4.7), and 8.7 (5.2-14.5), respectively (P<0.0001). This staging system had greater concordance statistics (standard error) than the TNM staging system (0.725 (0.018) vs. 0.614 (0.017)), indicating better performance in predicting survival.


CONCLUSIONS
This staging system, based on nonoperative information at the time of pCCA diagnosis, has excellent discriminatory power to classify patients into four prognostic stages. It could be useful to clinicians and for the design of clinical trials.
1] Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA [2] Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
Roongruedee
R
Chaiteerakij
Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
William S
WS
Harmsen
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Carlos Romero
CR
Marrero
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Mohammed M
MM
Aboelsoud
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Albert
A
Ndzengue
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Joseph
J
Kaiya
Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Terry M
TM
Therneau
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
William
W
Sanchez
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Gregory J
GJ
Gores
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Mayo Clinic Cancer Center, Rochester, Minnesota, USA.
Lewis R
LR
Roberts
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000097:blood / Q000473:pathology*; D001653:Bile Ducts, Intrahepatic / Q000473:pathology*; D018395:CA-19-9 Antigen / Q000097:blood; D018281:Cholangiocarcinoma / Q000097:blood / Q000473:pathology*; D015331:Cohort Studies; D003549:Cystic Duct / Q000473:pathology*; D005260:Female; D006500:Hepatic Duct, Common / Q000473:pathology*; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D047368:Tumor Burden; D055815:Young Adult
D018395:CA-19-9 Antigen