Multivariate prognostic factors analysis for second-line chemotherapy in advanced biliary tract cancer.
BACKGROUND
The role of second-line chemotherapy (CT) is not established in advanced biliary tract cancer (aBTC). We investigated the outcome of aBTC patients treated with second-line CT and devised a prognostic model.


METHODS
Baseline clinical and laboratory data of 300 consecutive aBTC patients were collected and association with overall survival (OS) was investigated by multivariable Cox models.


RESULTS
The following parameters resulted independently associated with longer OS: Eastern Cooperative Oncology Group performance status of 0 (P<0.001; hazard ratio (HR), 0.348; 95% confidence interval (CI) 0.215-0.562), CA19.9 lower than median (P=0.013; HR, 0.574; 95% CI 0.370-0.891), progression-free survival after first-line CT ≥ 6 months (P=0.027; HR, 0.633; 95% CI 0.422-0.949) and previous surgery on primary tumour (P=0.027; HR, 0.609; 95% CI 0.392-0.945). We grouped the 249 patients with complete data available into three categories according to the number of fulfilled risk factors: median OS times for good-risk (zero to one factors), intermediate-risk (two factors) and poor-risk (three to four factors) groups were 13.1, 6.6 and 3.7 months, respectively (P<0.001).


CONCLUSIONS
Easily available clinical and laboratory factors predict prognosis of aBTC patients undergoing second-line CT. This model allows individual patient-risk stratification and may help in treatment decision and trial design.
Department of Oncology, Unit of Medical Oncology, Azienda USL2 Lucca Via dell'Ospedale 1, 55100 Lucca, Italy.
L
L
Fornaro
Department of Medical Oncology, San Raffaele Scientific Institute, 20133 Milano, Italy.
S
S
Cereda
Department of Oncology, University and General Hospital, 33100 Udine, Italy.
G
G
Aprile
Unit of Medical Oncology, Sant'Orsola Malpighi Hospital, University of Bologna, 40138 Bologna, Italy.
S
S
Di Girolamo
Medical Oncology, University Campus Bio-Medico, 00128 Roma, Italy.
D
D
Santini
Unit of Medical Oncology, National Cancer Institute Giovanni Paolo II, 70124 Bari, Italy.
N
N
Silvestris
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IRCCS, 35128 Padova, Italy.
S
S
Lonardi
Unit of Medical Oncology, Institute for Cancer Research and Treatment IRCCS Candiolo, University of Torino, 10060 Torino, Italy.
F
F
Leone
Medical Oncology A, Regina Elena National Cancer Institute, 00144 Roma, Italy.
M
M
Milella
Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56126 Pisa, Italy.
C
C
Vivaldi
Department of Medical Oncology, San Raffaele Scientific Institute, 20133 Milano, Italy.
C
C
Belli
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IRCCS, 35128 Padova, Italy.
F
F
Bergamo
Department of Oncology, University and General Hospital, 33100 Udine, Italy.
S E
SE
Lutrino
Unit of Medical Oncology, Institute for Cancer Research and Treatment IRCCS Candiolo, University of Torino, 10060 Torino, Italy.
R
R
Filippi
Medical Oncology, University Campus Bio-Medico, 00128 Roma, Italy.
M
M
Russano
Medical Oncology A, Regina Elena National Cancer Institute, 00144 Roma, Italy.
V
V
Vaccaro
Unit of Medical Oncology, National Cancer Institute Giovanni Paolo II, 70124 Bari, Italy.
A E
AE
Brunetti
Department of Oncology, Unit of Medical Oncology, Azienda USL2 Lucca Via dell'Ospedale 1, 55100 Lucca, Italy.
V
V
Rotella
Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56126 Pisa, Italy.
A
A
Falcone
Unit of Medical Oncology, Sant'Orsola Malpighi Hospital, University of Bologna, 40138 Bologna, Italy.
M A
MA
Barbera
Unit of Medical Oncology, Sant'Orsola Malpighi Hospital, University of Bologna, 40138 Bologna, Italy.
J
J
Corbelli
Department of Oncology, University and General Hospital, 33100 Udine, Italy.
G
G
Fasola
Unit of Medical Oncology, Institute for Cancer Research and Treatment IRCCS Candiolo, University of Torino, 10060 Torino, Italy.
M
M
Aglietta
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IRCCS, 35128 Padova, Italy.
V
V
Zagonel
Department of Medical Oncology, San Raffaele Scientific Institute, 20133 Milano, Italy.
M
M
Reni
Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56126 Pisa, Italy.
E
E
Vasile
Unit of Medical Oncology, Sant'Orsola Malpighi Hospital, University of Bologna, 40138 Bologna, Italy.
G
G
Brandi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011379:Prognosis; D012189:Retrospective Studies