What
evidence scientifically, medically and economically justifies CEA-Scan?
CEA-Scan is too new to have compiled direct statistics demonstrating the
economic impact on the cost of care of colorectal cancer patients. Nevertheless, many
statistics, references and clinical experiences support such preop evaluation with
CEA-Scan:
- The incidence of metastatic disease is high.
"Fifteen to 20% of patients
with colorectal cancer present with distant metastases."1
- Histology and clinical judgment do not always predict cure.
"In spite of
having disease (believed to be) localized at operation, 30%-40% of patients initially
classified as Dukes B will develop metastases."2
- Recurrence rate is high.
"50% of patients who undergo curative resection
develop local, regional, or widespread recurrence. These statistics have remained
relatively constant over several decades despite improved methods of early diagnosis &
surgical treatment."3
- The incidence and risk of complications during and after curative surgery is high
even at cancer centers.
In a study at a major NCI comprehensive cancer center
(Roswell Park), 25 of 51 patients (49%) undergoing pelvic exenteration for primary
colorectal cancer developed severe complications4, with an operative mortality
rate of 6%. After exenteration for recurrent disease, 12 of 24 patients (50%) developed
severe complications, with an operative mortality rate of 4%.5
- The cost of those frequent complications is high.
Whether a patient with
colorectal cancer is curable or not, "indirect costs (of complications following
surgery for colorectal cancer) accounted for 38% [of cost of managing patients]" vs.
12% for the original operation. Nursing accounted for 25%; medical staff, 13%;
consumables, 16%. Tests accounted for just 8% of costs.6
- CEA-Scan has proven to help surgeons determine and adjust procedures to
patients potential for curative resection.
In a prospective study of CEA-Scan in
patients with primary & recurrent colorectal cancer, "...[CEA-Scan] had a
decisive influence on treatment planning in every third primary colorectal cancer
patient..."7
- CEA-Scan makes that contribution because it detects metastatic disease.
In
the pivotal trials of CEA-Scan, 11 of 23 primary-disease patients had metastatic disease
identified at surgery. CEA-ScanŽ correctly identified at least one metastatic lesion in
each of the 11 patients, including 10 patients who had liver metastases.8
- CEA-Scan makes a contribution unduplicated by CT, MRI, ultrasound, or any other
competitive modality.
Unlike standard diagnostic modalities, CEA-Scan detects
metastases by physiology, not anatomy specifically, by demonstrating the presence
of tissue that expresses carcinoembryonic antigen (CEA). It detects tumors in patients
with normal blood CEA levels, because virtually all primary and metastatic colorectal
tumors express CEA, even those that dont express enough to be detected on blood
assay. It can demonstrate tumors as small as a few millimeters because the angiogenesis of
those tumors provides them with a rich blood supply assures perfusion with the
radiolabeled CEA-Scan antibody. Thus, it can detect disease in lymph nodes and other
organs often missed by other modalities and intraoperative inspection.
- Surgeons from top institutions participating in the pivotal trials believe
CEA-Scan can stage patients and thus, help them to better stage-adjust their
procedures.
In those pivotal trials, the investigators concluded that, "In a
proportion of patients with locoregionally advanced primary disease, [CEA-Scan] disclosure
of previously unrecognized additional tumor deposits could materially affect surgical
decisionmaking and decisions regarding postoperative adjuvant therapy."9
This data, published in peer-reviewed journals, clearly demonstrate that
- Metastatic disease is common, despite judgment by current tests and surgery that
patients have received curative surgery.
- Attempts to thoroughly resect colorectal cancer presents risks of complications
that are extremely expensive, as well as life-threatening.
- CEA-Scan can help clinicians find that disease, and help them better determine
how to most appropriately use the range of surgical, chemotherapeutic and radiotherapy
tools at their disposal.
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