Regional therapy - Tyndall Technology Days

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Management of liver confined metastatic
colorectal cancer
Tyndall Technology Forum – Nov 18-20th 2014
Dr Derek Power - Consultant Medical Oncologist
Mr Criostoir O’Suilleabhain - Consultant Hepatobiliary and Pancreas Surgeon
Cancer Atlas
NCR 2012
Multi-disciplinary team
• Gastroenterologist
• Surgeon
• Pathologist
• Radiologist
• Medical Oncologist
• Radiation Oncologist
• Nurse specialists
• Dietician
Colorectal Liver Metastases
• 50% of all CRC patients will develop liver metastases (LM)
• Liver is the only site of metastases in 33% of patients
• Portal venous drainage of the colon explains this
Kemeny, Oncology (Williston Park) 2006
CRLM – facts!
CLM in 2014
80% of patients will have unresectable LM at diagnosis
Without liver resection: 5 yr OS <3%
Systemic chemo-biologic therapy
– Median OS ~20-24 months
Conversion strategies
Power, J Clin Oncol 2010
CLM in 2014
Curative strategies are now possible
Surgical advances
Chemotherapy
Biologic therapy
Regional therapy
Tomlinson, J Clin Oncol 2007
Rees, Ann Surg 2008
Fernandez, Ann Surg 2004
Abdalla, Ann Surg 2004
Choti, Ann Surg 2002
$$ Financial Toxicity $$
Schrag, New Engl J Med 2004
Schrag, New Engl J Med 2004
Therapy targeted to the liver
REGIONAL THERAPY
ANATOMICAL BASIS
• 33% of patients with advanced CRC will have liver metastases as the only
site of metastatic disease.
Liver
Lungs
other Organs
• Liver has a dual blood supply
• Hepatic arterial infusion
• Floxuridine
- High Liver Extraction
• Normal liver parenchyma is spared
Regional Infusion for Colorectal Hepatic Metastases:
A randomised trial comparing the hepatic artery with the portal vein.
Daly et al Arch Surg 1987;122:1273-77
PUMP PLACEMENT
Synchromed II
Synchromed II
Figure 2
Synchromed II
Synchromed II
Synchromed II Pump
Radiopaque
Identifier
Reservoir
Suture Loop
Pump Rollers
REGIONAL THERAPY
CATHETER PLACEMENT
• Pre-Operative Coeliac Axis Angiogram
• Laparotomy and ligation and division of all accessory vessels distal to site
of catheter placement
• Cholecystectomy
• Methylene Blue into side post to see if any extrahepatic perfusion
• Loop catheter is then connected to the pump in a subcutaneous pocket on
the abdominal wall
• Heparin & Saline instilled in Operating Room
• Pump refilled prior to discharge with heparin and saline again
NORMAL PUMP STUDY Tc99 MAA
Technetium-99m-macroaggregated serum albumin
radionucleide study
DEVICE RELATED COMPLICATIONS
•Clotting of the catheter or the hepatic artery
•50% bleeding
•Incomplete or Extrahepatic perfusion
•Thrombosis of the Gastroduodenal artery
DEVICE
FAILURE
MEDIAN HA
PATENCY
PORT
90%
9 MONTHS
PUMP
32%
28 MONTHS
COMPLICATIONS
% Elevation
% Bili
Sclerosis
# Pts
% Ulcer
SGOT
Bil.
Niederhuber
70
8
32
24
--
Balch
50
6
23
23
--
Kemeny, N
41
29
71
22
5
Shepard
53
20
49
24
--
Cohen
50
40
10
25
--
Johnson
40
8
50
13
5
Kemeny, M
31
6
47
--
19
Hohn
61
2
0
78
29
No diarrhea, neutropenia or alopecia
BILIARY SCLEROSIS
HAI FUDR +/- DECADRON
FUDR and
DECADRON
FUDR
ALONE
TOXICITY
BILIRUBIN > 3
9%
30%
RESPONSE
71%
40%
MEDIAN
SURVIVAL
MONTHS
23
13
Kemeny et al Cancer 1992
Complications
Seroma
– Fluid accumulation in pump pocket
• May require drainage prior to pump access
• Send fluid for C & S
Pump pocket infection
– Redness, warmth, skin breakdown at site
– Educate patient to report fevers immediately
– Cephalosporins prescribed
– Pump may need to be removed
Complications
The Flipped pump
– Unable to palpate
– Verified by X-ray
– Pump flipped back by
MD/fluoroscopy
septum
Why no HAI therapy in Ireland/EU
Lack of expertise
Pharma conflict
Lack of randomised trials
Pump infrastructure demands time and resources
Status of our trial
Cork Research Ethics Committee approval
Medtronic support
Human Products Authorisation and Registration (HPRA)
assessment ongoing
HAI nurse specialist – hiring process ongoing
Funding sources being identified
Dedicated clinic and theatre time being identified
Expected trial opening – Feb 2015
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