clinical utility of combidex in various cancers jelle o. barentsz, md professor of radiology...
Post on 22-Dec-2015
213 Views
Preview:
TRANSCRIPT
Clinical Utility of Combidexin Various Cancers
Jelle O. Barentsz, MD
Professor of Radiology
University Medical Center Nijmegen, Netherlands
2
Clinical Utility in Cancer
Post-Phase III peer reviewed publications
NEJM, Radiology
Blinded post-contrast image evaluation with histopathology
Impact on treatment planning
Areas where Combidex MRI provides significantclinical benefit
Prostate Bladder Head and Neck Breast
3
Published Studies
Primary Tumor Patients NodesBlinded Image Evaluation
Pre-Contrast Post-Contrast
Prostate
Harisinghani-NEJM-2003
80 334 X X
Bladder
Deserno-Radiology-2004
58 172 X X
Head and Neck
Mack-Radiology-2002
27 1029 X X
Breast
Michel-Radiology-2002
20 296 X
Post-Contrast Results –Published Studies
0
20
40
60
80
100
Sensitivity Specificity Accuracy
Prostate
Bladder
Head and Neck
Breast
5
Prostate Cancer
Current imaging has insufficient sensitivity for LN staging
Surgical LN Sampling – Samples only a limited area – 11–31% +LN outside sampled area – Complications: 22% (open), 5% (lap)
– Lymphocele, lymphedema, DVT, PE, nerve damage, blood loss Extended LN dissection detects more + LN but increases morbidity
Zincke (Mayo), Walsh (JHH), Burkhard (Bern)
Prostate CancerImaging Performance – Patient Level
True
Positive
True
Negative
False
Positive
False
Negative
Pre-contrast
15 37 10 18
Post-contrast
33 45 2 0
NEJM 2003 Harisinghani
5/80 patients (6%)• Guided needle biopsy for solitary unenlarged (5–8 mm)
positive LN on Combidex MRI
9/80 patients (11%)• PLND extended outside usual field due to positive LN on Combidex images
All 5 confirmed positive
All 9 confirmed positive
Prostate CancerImpact on Treatment Planning
NEJM 2003 Harisinghani
8
7 mm partly metastatic node outside surgical field
Biopsy positive → Androgen ablationBiopsy positive → Androgen ablation
Prostate Cancer
10
24% LN positive despite negative preoperative imaging
Nodal metastases (N2-3, or >4) radically changestreatment options
Extended LN dissection
– Detects more LN
– Increases survival for minimal disease
– Does not sample all areas of LN
– Increases morbidity Studer (Switzerland) Skinner (USC) Ghoneim
(Egypt)
Bladder Cancer
Bladder CancerImaging Performance – Nodal Level
10/12 normal size positive LNs
seen on post-Combidex MRI only
Radiology 2004 Deserno
172 LN (58 patients)
Pre Post p-Value
Sensitivity
76% 96% <.001
Specificity
99% 95%
Accuracy 92% 95%
PPV 97% 89%
NPV 91% 98% <.01
12
Head and Neck Cancer
5 yr survival 91% (localized) and 63% (regional LN)
Status of cervical LN is vital for choice of therapy
25% LN positive despite negative preoperative imaging (contrast CT) as metastatic nodes are small (5–10 mm)
Radical neck dissection
– Commonly performed– Results in cosmetic deformity– Complication rate 36–54%
Head and Neck CancerImaging Performance – Nodal Level
Combidex MRI on LN level accurate in 26/27 (96%) patients 26% had reduced extent of surgery
Radiology 2002 Mack
1029 LN (27 Patients)
% Post
Sensitivity
86 59/69
Specificity
100 960/960
Accuracy 99 1019/1029
PPV 100 59/59
NPV 99 960/970
15
Breast Cancer
Sentinel Lymph Node Staging (SLN)
– 3–10% false negative
The Sentinel Node is the only positive node in 61% of patients with positive LNs
– These patients all undergo axillary dissection– High rate of clinically significant complications
Breast CancerImaging Performance – Nodal Level
Radiology 2002 Michel
Reader 1 Reader 2 Average
Sensitivity 83% (25/30) 73% (24/33) 78%
Specificity 97% (252/261) 96% (253/263) 96%
Accuracy 95% (277/291) 94% (277/296) 94%
PPV 74% (25/34) 71% (24/34) 72%
NPV 98% (252/257) 97% (253/262) 97%
296 LNs (18 Patients)
18
Summary: Clinical Relevance
Current techniques to detect positive LNs in prostate, bladder, head and neck, and breast cancer havesignificant limitations
Combidex MRI shows high sensitivity and specificityin these tumors
Combidex MRI may reduce the extent of surgeryand morbidity
Combidex MRI identifies additional positive LNs for biopsy or image-guided extended dissection (improve staging)
19
Indication
Combidex® (ferumoxtran-10) is for intravenous administration as a contrast agent for use with magnetic resonance imaging (MRI). Combidex can assist in the differentiation of metastatic and non-metastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases.
The information provided by Combidex should be considered in conjunction with other diagnostic information and lymph node findings from Combidex images should be pathologically confirmed unless medically contraindicated.
top related