ec916 eva gallardo, md medical manager, biocompatibles uk drug eluting bead: clinical updates and...
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Eva Gallardo, MDMedical Manager, Biocompatibles UK
Drug Eluting Bead: Clinical Updates and Histological Data
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Doxorubicin Bead Irinotecan Bead
Primary Liver Cancer Colorectal MetastasesVery Early/Early Stage Prior to resection Bridge to transplant RFA + PRECISION TACE
Intermediate Stage Precision I Precision II Precision V
Advanced Stage Sorafenib + PRECISION TACE
Secondary Liver Cancer Other Primary Cancers
Renal Breast Melanoma Gastric Neuroendocrine Cholangiocarcinoma Sarcoma
Early CT Lines
Late Stage
DC Bead: Clinical Programme
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Investigators: Camillo Aliberti, MD Giammaria Fiorentini, MD
Department of Diagnostic and Interventional Radiology,Delta Hospital AUSL Ferrara, Ferrara Italy
Department of Oncology, General Hospital San Giuseppe, Empoli, Florence, Italy
PRECISION TACE in treatment of Colorectal Metastases
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• 62 patients (M/F = 42/20), median aged 64.6 (range 42-85)
• Not operable and pretreated at least two lines of chemo (range 2-6)
• Maximum dose 4 ml (2ml of 100-300mm and 2ml of 300-500mm) with 200mg of Irinotecan
• 2-3 TACE 4 weeks
Irinotecan Bead in Advanced Colorectal Cancer: Patient
Selection
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Postembolization-syndrome
RUQP (G2-G3) 100%
Fever (G2) 90%
Nausea and Vomiting (G2-G3)
100%
Increased Transaminases (G2-G3)
80% 0
5
10
15
20
25
30
35
40
Procedures
Pain Vomiting Fever Asthenia
Irinotecan Bead in Advanced Colorectal Cancer: Toxicity
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• The median follow-up was 15.4 months
• 1 month CT scan showed reduction of metastatic CE 85%, range 75-100% in all patients
• RECIST at 3 months: 78%
• 55/62 pts (90%) declared a general improvement of QoL lasting 6.5 months, range 3-12
Irinotecan Bead in Advanced Colorectal Cancer: Response to
Treatment
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• Median survival not reached at 22 months
• Median Free Time from symptoms 5.3 (5-20 months)
• Median Time to further chemoteraphy 6.3 (5-22 months )
0
10
20
30
40
50
60
70
80
90
100
0 2 4 6 8 10 12 14 16 18 20 22time months
surv
ival
(%
)
Irinotecan Bead in Advanced Colorectal Cancer: Survival
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18 months after TACE
Irinotecan Bead in Advanced Colorectal Cancer: Cases
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02.2005 09.2005
6 months after TACE
Irinotecan Bead in Advanced Colorectal Cancer: Cases
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Principal Investigator: Thierry De Baere, MDChief of Interventional Radiology Department
Institut de Cancérologie Gustave Roussy - Villejuif - France
Neuroendocrine Metastasis
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Doxorubicin Bead in NET:Materials and Methods
• 20 patients with liver metastases from low-grade GEP tumour
• Progressive liver disease on two subsequent imaging studies according to RECIST criteria
• Disease predominant to the liver
• Up to 4ml DC Bead 500-700mm loaded with up to 100mg doxorubicin
• Concomitant treatment with long-acting ST analog
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Doxorubicin Bead in NET:Results
• 34 sessions (6 unilobar, 14 bilobar)
• RECIST 3M: – 16/20 (80%) partial response– 3/20 (10%) stable disease– 1/20 (15%) progressive disease
• After a median follow-up of 15 months (6-24), disease remained controlled without tumour progression in 45%
• 1 patient become resectable
Progression
161520
0%10%
20%30%
40%50%60%
70%80%
90%100%
0 6 12 18 24Months since treatment
Pro
gre
ssio
n r
ate
Patients at risk
At 12 months : 47% (95%CI = 23% - 72%)
Median Time to Progression: 15 months
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• Post-embolisation syndrome:– < 7 days in 67% sessions– > 7 days in 22% sessions– No symptoms in 11% sessions
• Hypodense subsegmental peripheral areas (TACE-induced necrotic liver tissue?) in 5 patients at 1 month CTscan
• 1 death: resected patient due to postoperative septic complications
Doxorubicin Bead in NET:Toxicity
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Doxorubicin Bead in NET:Cases
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Doxorubicin Bead in NET:Cases
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Principal Investigator: Riccardo Lencioni, MDAssociate Professor of Diagnostic and Interventional
RadiologyDepartment of Oncology, Transplants, and Advanced
Technologies in Medicine – Pisa University, Italy
Combined PRECISION TACE/RFA: Results and Outcome
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Vessel
Sub-lethal heating(45-50 °C)
50 °C
RFA: Inherent Limitations
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DEB-Enhanced RFA of HCC: A Pilot StudyDesign / Enrollment Criteria
20 pts (mean age, 70 ± 6 ) with residual viable tumour at CT / MRI 1-2 hrs after RFA
- Tumour diameter 3.3-7.0 cm (mean, 5.0 cm ± 1.4)- Child-Pugh class A, ECOG 0- PT ratio > 50%, platelets > 50,000/mm3
Excl: - Eligibility for liver resection or transplantation- Vascular invasion / extrahepatic disease
- Any previous treatment for HCC
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DEB-Enhanced RFA of HCC: A Pilot StudyMaterials and Methods
Follow-up period 6-20 months (mean, 12 months ± 5)
DC Bead (Biocompatibles) injection < 24 hrs of RFA
- 50 mg doxorubicin in 2 ml of 100-300 μm beads - Additional loads (100-300 / 300-500 µm) if needed
Tumour response: RECIST criteria - EASL amendment
- CR: absence of enhancement at 1-month CT / MRI- Confirmed CR: CR lasting no less than 6 months- OR: confirmed CR target lesion, no new lesions
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61% +
Abl
atio
n V
olum
e (m
m3)
0,000
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
Standard RFA DEB-Enhanced RFA
DEB-Enhanced RFA of HCC: A Pilot StudyResults – Change in Ablation Volume
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DEB-Enhanced RFA of HCC: A Pilot StudyResults – Clinical Case # 2
Pre-treatment CT
6 cm
Post-RFA Post-TACE
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Target lesions
Table. Overall Response at the End of Follow-Up
New lesions
CR
PR
CR / PR
PD
Note: Numbers are numbers of patients. Overall number of patients: 20.
No
No
Yes
Yes / No
Overall response
CR
PR
PD
No. (%)
10 (50%)
5 (25%)
3 (15%)
2 (10%)
DEB-Enhanced RFA of HCC: A Pilot StudyResults – Overall Response
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0 6 12 18 240
20
40
60
80
100
DEB-enhanced RFA (n = 20)
months
30
100%
DEB-Enhanced RFA of HCC: A Pilot StudyResults – Overall Survival
92%
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Doxorubicin Bead prior to liver transplant
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TACE Prior to Transplant
• Major issue = Dropout rate (30-40%)Major issue = Dropout rate (30-40%)
• Role of TACE:Role of TACE:• Patients within Milan criteria (maintain in waiting list)Patients within Milan criteria (maintain in waiting list)• Patients outside Milan criteria (for downstaging to fullfil Patients outside Milan criteria (for downstaging to fullfil
Milan criteria)Milan criteria)
• Induce high hystological tumour response rateInduce high hystological tumour response rate
• Decrease recurrence rates?Decrease recurrence rates?
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Dr Citron –Atlanta, US
• Retrospective study• 9 listed patients (>Child A-B, single nodules, mean
tumour size 2cm (0.3-5.1)• 1-3 treatments prior to transplant• 100-300 and/or 300-500mm DC Bead with up
150mg doxorubicin• Liver transplant (1-281 days post-treatment)
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Results
• CTscan:– Complete necrosis 88% patients
• Histology:– Complete necrosis 77% patients– 2 non-complete necrosis:
• Patient transplanted 8 hours after TACE with no necrosis• Patient with residual 0.5cm viable tumour within 7.5cm
necrotic tumour
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Dr Nicolini - Italy• Retrospective study Doxorubicin Bead vs TAE• 16 patients (15 waiting list/ 1 outside Milan)
DC Bead TAE
HCV
HDV + HBV
Others
3
3
2
4
0
4
Child-Pugh A
Child-Pugh B
5
3
6
2
Mean tumour size (cm) 3.0 3.4
Single
2 nodules
7
1
5
3
•1-4 treatments until complete RX response•DC Bead arm: 100-300mm DC Bead with 50mg epirubicin•TAE:100-300mm Embosphere
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Tumour ResponseDC Bead TAE
CTscan Response*
Complete Necrosis
Partial Necrosis (>70%)
88
12
45
55
Histological Response*
Complete Necrosis
Necrosis >70%
Necrosis <50%
78
22
0
P=0.04
27
54
19
* % Tumour response by tumours
• 62.5% DC Bead achieved complete RX response after one treatment vs 12.5% in TAE
• 15 patients alive with no recurrence
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Prof Goffette - Belgium• 16 patients:
– 9 within the Milan criteria for LT– 7 outside the Milan criteria for LT
• Diameter > 5 cm 4• More than 3 tumours 3
• Mean tumour size 5.4 cm (2.3-7.8) , 2 portal vein thrombosis• Standardized DC Beads doses and sizes:
– 4ml (2 vials) of 300-500 µm particles loaded with 25mg/ml doxorubicin:100 mg Doxo/session
• Additional unloaded particles (300-500,500-700µ) if persitent flow• Sequential treatment every 3 months (Max 4)• Alternate treatment if bi-lobar lesions
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Procedural Results• Mean number of sessions 2.7
4pts:1, 6pts:2, 7pts:3, 1pt:4
• Serious adverse event
Cholecystitis 1
• 30-day mortality 0
• Post-embol syndrome 15
• Transient impaired liver function 12
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• Transplanted patients 10
• Delay: 6.5 months (2-15)
• Biliary complications: 3• Follow-up: 7.5 months
– 1 recurrence at 5 m (40% necrosis)
• Patients on waiting list 4
• Deaths 2
• Pneumonia
• Terminal liver failure
• Significant downstaging in 6/7 patients
Clinical Results
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• Complete 4(25%)
• Partial 11(69%)– Residual peripheral enhancement 9– Persistent enhanced nodules 4
• Stable Disease 1
• Progressive Disease 0
• Objective Response 15(94%)
Results Imaging (EASL)
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Histological Response
PATHOLOGIC ASSESSMENT
All
patients
(n=12)
Vascular permeation
Portal thrombosis
Recurrence
After OLT
(n=10)
RESPONSE
Complete
tumor necrosis5 (42%) 0 0/5 (0%)
Partial
tumor necrosis ≥75%
and <99%
6 (50%) 2 0/4 (0%)
NO RESPONSEIncomplete
tumor necrosis < 50%
1 (8%) 1 1/1 (100%)
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Surgical Complications
• Complicated arterial anastomosis 7 – Co/proper Hep. Art. occlusion
4– Pedicular inflammation
3– Early arterial occlusion…redo-OLT in 1
• Difficult biliary anastomosis 3
• Severe chronic cholecystitis 4
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46 yr old male: Bilobar HCC ( >7cm seg IV)Downstaging before LT
First TACE session left lobeFirst TACE session left lobe
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Repeated controls CT after first sessionRepeated controls CT after first session
Second TACE (right lobe) and control CT……waiting listSecond TACE (right lobe) and control CT……waiting list
46 yr old male: Bilobar HCC ( >7cm seg IV)
Downstaging before LT