management of biliary tract cancer: a case report giovanni brandi institute of hematology end...
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Management of biliary Management of biliary tract cancer: a case tract cancer: a case
reportreport
Giovanni BrandiGiovanni Brandi
Institute of Hematology end Medical Oncology “L e A Seràgnoli”
Bologna University
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JANUARY 2008
MAN, 74 YEARS OLD
20-01-08: abdominal pain, localized in the superior part of abdomen and involving the lumbar region
E.O, CHEST-X-RAY, ABDOMEN-X-RAY : normal
BLOOD TEST: Bil. Tot: 8,22; Bil. Dir: 6,27; AST: 63 UI/L; ALT: 100 UI/L; GGT: 253 UI/l; ALP: 525 UI/L; CA19.9: 928 U/ML
ABDOMINAL ULTRASOUND SCAN: gallstones and presence of a hypoecoic mass in the bottom of the gallbladder (4,5 x 3,0 cm)
ABDOMINAL CT WITH CONTRAST MEAN : lesion of gallbladder corpus with probably infiltration of hepatic parenchyma
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FEBRUARY 2008
06/02/2008 SURGERY: resection of IV-V haepatic segments, including gallbladder
HISTOLOGICAL DIAGNOSIS: adenocarcinoma not well differentiated of the gallbladder infiltrating the surrounding fat and the liver.
Margins of liver resection not involved by neoplasm. Limph node metastasis
pT3N1M0, STAGE IIB
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Biliary tract cancer treatment : results from the Biliary Tract Cancer Statistics Registry in Japan
Nagakawa et al. Journal of HBP Surgery, 2001
Gallbladder Cancer OS by staging and lymph node status
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Staging Lymph node statusOS
Hilar-upper
papilla
lower
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Killeen R P M et al, Abdom Imaging, 33(1):54-7,
2008
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Is adjuvant therapy necessary in the gallbladder cancer?
Choose an alternative:
Only with N+ No
Always It’s not well defined
15 $1 MILLION14 $500.00013 $250.00012 $100.00011 $50.00010 $25.0009 $16.0009 $16.0008 $8.0007 $4.0006 $2.0005 $1.0004 $5003 $3002 $2001 $100
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ADJUVANT THERAPY, TO DO OR NOT TO DO?
ADJUVANT THERAPY IS NOT EXECUTED
FOLLOW-UP
• In biliary tract cancer the percentage of curative resection is extremely low (37.7% GBC, 30.4% BDC)
• an effective adjuvant therapy could be useful in order to improve the overall survival
• standard adjuvant treatment is still not settled
• there are only few inadequate randomised trials
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Randomised clinical trials of adjuvant chemotherapy for pancreatic and biliary tract cancer. Takada, 2002
Mitomycin C and 5FU therapy has not been established as the standard postoperative therapy in BTC, but this trial suggests the efficacy and the need of adjuvant treatments
Takada T at al. Cancer 2002; 95:1685-95
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APRIL 2008
BLOOD TEST: CA19.9: 87 U/ML (N.V. <33)
PET: high FDG uptake (SUV max 10) at V-VI hepatic segments with involvement of hepatic capsule and adjacent peritoneum
CEUS: not homogeneous area at IV-V hepatic segments with fluid component (4.8 x 1.8 cm) near metallic clips
Follow-up was established at 2 months to clarify the clinical picture
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APRIL 2008
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SEPTEMBER 2008
BLOOD TEST: CA19.9: 220 U/ML (N.V. <33); AST: 34 U/L; ALT: 48 U/L; ALP: 281 U/L
PET: reduction of uptake at V-VI hepatic segments but find of a weak new area in the hilary region
CEUS: hypoechogenous hilary mass (2,9x2,1x2,0 cm), near main biliary duct
INTRAHEPATIC RECURRENCE OF CHOLANGIOCARCINOMA
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SEPTEMBER 2008
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OTTOBRE 2008CONCLUSIONS: unresectable patients.
Program: chemotherapy
Yonemoto et al. Jpn J Clin Oncol 2007Glimelius et al. Ann of Oncol 1996
Author, year Regimen Study N° pts
OS
Glimelius, 1996 Chemotherapy vs BSC
Randomised 90 6 mo vs 2,5 (P<0,01)
Yonemoto, 2007
Chemotherapy vs BSC
Retrospective
304 7.38 mo vs 3,12 (P<0,001)
CT
BSC
CT
BSC
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Which is the best chemotherapy?
Choose an alternative:
Gem-based regimen
5-FU-based regimen
Not defined Taxanes
15 $1 MILLION14 $500.00013 $250.00012 $100.00012 $100.00011 $50.00010 $25.0009 $16.0008 $8.0007 $4.0006 $2.0005 $1.0004 $5003 $3002 $2001 $100
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70
20
0
10
50
40
30
60
5-FUPOLI
GEM GEM+5-FU
GEMOX
GEM POLI
CAPE TAXAN
other HAI
Chemotherapy in advanced BTC
653 321 155 437331 55 121161234N°
PTS
Resp
onse
%
RangeRO
CPT11
81
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Guidelines EBM 2008SINGLE AGENT
AGENT N° STUDY STUDY DESIGN RR(RANGE)
EVIDENCE LEVEL
5-fu/ analogues
12 1 Randomised11 Cohort study
05-34%
Level IILevel III
Gem 7 7 Cohort study 0-36% Level III
Taxanes 3 3 Cohort study 0-20% Level III
Others 4 4 Cohort study 8-10% Level III
COMBINATION THERAPY
AGENT N° STUDY STUDY DESIGN RR(RANGE)
EVIDENCE LEVEL
5-fu-BASED 4 4 Cohort study 0-29% Level III
Gem-BASED 11 11 Cohort study 9-38% Level III
Platinum-BASED
10 10 Cohort study 19-40% Level III
J Furuse. J Hepatobiliary Pancreat Surg 2008
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HOSPITALIZATION: obstructive jaundice. Bil. Tot.: 16,56 mg/dl
NOVEMBER 2008
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MANAGEMENT OF UNRESECTABLE BILIARY TUMOR
UNRESECTABLE TUMOR
JAUNDICE NO JAUNDICE
DECOMPRESSION OF BILIARY TRACT (stent/drainage)
CHEMOTHERAPY ± RADIOTHERAPY
ILBT ± EBRT
JAUNDICE RESOLUTION (bil ~ 3-4)
CHEMOTHERAPY
BSC
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NOVEMBER 2008
PTC: double internal-external trans-stenotic biliary drainage
COMMON BILE DUCT STENT HILAR STENT
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BRACHITHERAPY: two 7 Gy fractions (total dose 14 Gy)
DICEMBRE 2008
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Approachable lesion well defined small size
BRACHYTHERAPY
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JANUARY 2009
PET: patological uptake at VI hepatic segment (SUV max: 8.8). Another metastasis next to anterior margin of left hepativ lobe.
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SEPTEMBER 2008
JANUARY 2009
PET COMPARISON
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TERAPIA IN CORSOEXTERNAL BEAM RADIOTHERAPY + METRONOMIC CAPECITABINE + LMWH
RT+ CT
Author, year Treatment N° pts OS
Brunner et al, 2004
EBRT (50 Gy) + 5-FU or GEM-based chemotherapy 98 OS: 11.8 mo (all pts)OSstent: 9.3 mo
OSCT+RT: 16.5
Deodato et alIJROBP, 2005
EBRT + 5-FU i.c ± boost of ILBR (12 pts) 22 22 mo without ILBT13 mo with ILBT
Golfieri et al In Vivo 2006
A: drainage + ILBT +EBRT + CTA1: drainage + ILBT
B: surgical palliationC: percutaneous decompression alone
A: 9A1: 7
B: 5C: 5
A: 10 m.oA1: 6 m.o
B: 10 m.oC: 2.75 m.o
Brunner et al, Strahlenther Onkol 2004
This studies confirmed the role of concurrent chemoradiation in advanced BTC; the role of ILBT boost remains to be further analysed
CHEMORADIATION
STENT ALONE
A BA: OS from diagnosis
B: OS from start of chemoradiation
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TRIAL YEAR N° PTS DRUGS MEDIAN OS(months)
p
FAMOUS 2004 374 Dalteparin Placebo
10.8 9.14
p=0,19
CLOT 2005 602 DalteparinOral anticoagulants
62%61%
p=0,62
SCLC 2004 79 Dalteparin Placebo
13.08.0
p=0.01
MALT 2005 302 NadroparinPlacebo
8.06.6
p=0.021
LMWH AND CANCER TREATMENT
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November2005 March2009
A CASE OF STABLE DISEASE AFTER LMWH TREATMENT
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TTP : 7,2 m
OS: 13,2 m
GEM-CAPE Multicentre Phase II trial
Koeberle et al , JCO August 2008
N° pts 44 (36 BTC, 8 gallbladder)
Treatment
Gem 1000 (1,8/21)+ Cape 650 bid (1-14)
Pr( Recist)
25%
SD(≥8w) 55%
TTP 7,2 m
OS 13,2 m
QoL↔ ORR
Positive