PrevistageTM GCC colorectal cancer
test featured at the 2013 ASCO Annual Meeting
QUEBEC CITY, June 3,
2013 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR) (OTCQX:
DGCRF) today reported that results of a new study were presented on
Sunday, June 2, during the 2013
American Society of Clinical Oncology (ASCO) Annual Meeting held in
Chicago, Illinois. The abstract of
the presentation entitled "Guanylyl cyclase C (GCC) expression in
lymph nodes (LNs) as a determinant of recurrence in stage II colon
cancer (CC) patients (pts)" (Abstract #3639), by Dr. Daniel J. Sargent, Professor of Biostatistics
and Oncology at Mayo Clinic, and colleagues, is now available on
the American Society of Clinical Oncology's website,
www.asco.org.
"We believe this new study provides very strong
evidence that measuring the expression level of GCC in lymph nodes
is central to improved staging for patients diagnosed with
node-negative colon cancer." said Dr Yves
Fradet, President and Chief Medical Officer of DiagnoCure.
"Prognostic risk stratification in stage II colon cancer remains a
very clinically important issue and the ability of our
PrevistageTM GCC test to predict recurrence
independently of traditional histopathology risk factors should
have significant clinical impact for physicians treating colon
cancer and their patients."
The VITAR retrospective study (Validating
Indicators To Associate Recurrence) had been designed to assess the
relationship between GCC gene expression in formalin fixed (FFPE)
LNs and time to recurrence (TTR) in stage II Colon Cancer patients
not treated with adjuvant chemotherapy. The second phase (called
VITAR II), the results of which were presented at the 2013 ASCO
meeting, focused on the positive lymph node ratio (LNR), defined as
the number of nodes in which cancer cells were identified with the
GCC assay, divided by the total number of nodes examined to provide
recurrence risk stratification. On a validation set including 463
untreated stage II (T3N0) colon cancer patients from North American
and European sites, the study showed that molecular staging based
on GCC LNR status was able to predict higher recurrence risk for
195 patients (42%) treated by surgery alone. All patients had not
been treated with adjuvant chemotherapy mainly because their lymph
nodes appeared cancer-free by examination under the microscope, yet
10% of them had a disease recurrence or died from cancer
afterwards.
Outcome associations were also strengthened when
considering a 3-level GCC categorization. In the final study cohort
(n=366), the PrevistageTM GCC test classified 21.8% of
patients as having a high risk of recurrence following surgery,
17.5% at intermediate risk and 60.7% of patients at low risk of
recurrence. In this subset analysis, the 5-year recurrence risk was
estimated at 8% and 22% for the low and high risk groups
respectively, with a hazard ratio of 2.7 (p=0.006) supporting the
prognostic capabilities of the GCC nodal status as an independent
risk factor.
These findings complement those obtained during
the first phase of the prospectively specified multi-center VITAR
study performed on 241 stage II CC patients which were published in
2011 (Sargent, Annals Surg Onc 2011).
About Colorectal Cancer and
PrevistageTM GCC
Every year in the
United States and Canada,
165,000 people are diagnosed with colorectal cancer. Of that
number, 69,000 are considered at low risk after surgery.
Nonetheless, up to 20% of them suffer recurrence of a more advanced
cancer. To date, results of published studies totaling over 1,000
patients have shown that, compared with traditionally-used factors,
the GCC biomarker is a better predictor of disease recurrence in
early‐stage colorectal cancer patients. PrevistageTM GCC
is currently the only colorectal cancer staging test that provides
prognostic information based on the tumor burden measured at the
molecular level in the lymph nodes. Tumor burden in the lymph nodes
has become more widely recognized by treating physicians as a key
prognostic factor to determine the risk of recurrence of cancer
patients, and hence, to determine which patients might benefit most
from adjuvant chemotherapy and which could be safely managed
without chemotherapy.
About DiagnoCure
DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life
sciences corporation that develops and commercializes high-value
cancer diagnostic tests that increase clinician and patient
confidence in making critical treatment decisions. In 2008, the
Corporation launched a colorectal cancer staging test through its
U.S. CLIA laboratory. PrevistageTM GCC is currently available for
licensing. The Corporation has granted a worldwide exclusive
license to Gen-Probe, now a wholly-owned subsidiary of Hologic Inc.
operating as Hologic Gen-Probe, for the development and
commercialization of a prostate cancer test using PCA3,
DiagnoCure's proprietary molecular biomarker. Hologic Gen-Probe's
PROGENSA® PCA3 test is commercialized in Europe under CE mark and is approved for
commercialization in Canada and
the United States. For more
information, please visit www.diagnocure.com.
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SOURCE DiagnoCure inc.