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Clinical Utility of Combidex in Various Cancers

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Presentation on theme: "Clinical Utility of Combidex in Various Cancers"— Presentation transcript:

1 Clinical Utility of Combidex in 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 significant clinical benefit Prostate Bladder Head and Neck Breast

3 Blinded Image Evaluation Pre-Contrast Post-Contrast
Published Studies Primary Tumor Patients Nodes Blinded Image Evaluation Pre-Contrast Post-Contrast Prostate Harisinghani-NEJM-2003 80 334 X Bladder Deserno-Radiology-2004 58 172 Head and Neck Mack-Radiology-2002 27 1029 Breast Michel-Radiology-2002 20 296

4 Post-Contrast Results – Published Studies

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)

6 Prostate Cancer Imaging Performance – Patient Level
True Positive Negative False Pre-contrast 15 37 10 18 Post-contrast 33 45 2 NEJM 2003 Harisinghani

7 Prostate Cancer Impact on Treatment Planning
5/80 patients (6%) Guided needle biopsy for solitary unenlarged (5–8 mm) positive LN on Combidex MRI All 5 confirmed positive 9/80 patients (11%) PLND extended outside usual field due to positive LN on Combidex images All 9 confirmed positive NEJM 2003 Harisinghani

8 Prostate Cancer 7 mm partly metastatic node outside surgical field
Biopsy positive → Androgen ablation

9 Prostate Cancer Possibly metastatic
1 mm metastasis in LN outside obturator fossa.

10 Bladder Cancer 24% LN positive despite negative preoperative imaging
Nodal metastases (N2-3, or >4) radically changes treatment 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)

11 Bladder Cancer Imaging Performance – Nodal Level
172 LN (58 patients) Pre Post p-Value Sensitivity 76% 96% <.001 Specificity 99% 95% Accuracy 92% PPV 97% 89% NPV 91% 98% <.01 10/12 normal size positive LNs seen on post-Combidex MRI only Radiology 2004 Deserno

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%

13 Head and Neck Cancer Imaging Performance – Nodal Level
1029 LN (27 Patients) % Post Sensitivity 86 59/69 Specificity 100 960/960 Accuracy 99 1019/1029 PPV 59/59 NPV 960/970 Combidex MRI on LN level accurate in 26/27 (96%) patients 26% had reduced extent of surgery Radiology 2002 Mack

14 Head and Neck Cancer 12 mm node Normal
Neck dissection could have been avoided

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

16 Breast Cancer Imaging Performance – Nodal Level
296 LNs (18 Patients) 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% Radiology 2002 Michel

17 Breast Cancer Normal Metastatic Sentinel node + Primary tumor

18 Summary: Clinical Relevance
Current techniques to detect positive LNs in prostate, bladder, head and neck, and breast cancer have significant limitations Combidex MRI shows high sensitivity and specificity in these tumors Combidex MRI may reduce the extent of surgery and 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.

20 COMBIDEX® (ferumoxtran-10)

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