HANGZHOU, China, July 31,
2024 /PRNewswire/ -- A team of clinicians and
scientists from Fudan University Shanghai Cancer Center and Canhelp
Genomics, a cancer diagnostic company in Hangzhou, China have discovered that
site-specific treatment guided by a 90-gene expression assay
(Canhelp-Origin test) for tumor origin classification significantly
improves therapeutic outcomes in patients with cancer of unknown
primary. On July 25th, the
results of the study, FUDAN-CUP001, were published in The Lancet
Oncology. Article link:
www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00313-9/abstract 
Cancer of unknown primary (CUP) is defined as pathologically
diagnosed metastatic cancer without identification of the primary
tumour after a comprehensive diagnostic approach. CUP accounts for
2–5% of all malignancies and has a high mortality rate. CUP poses
significant diagnostic and therapeutic challenges due to its
biological heterogeneity and poor response to standard
chemotherapy.
The FUDAN-CUP001 prospective study aimed to evaluate the
efficacy of site-specific therapy guided by Canhelp Genomics'
China and EU approved 90-gene
expression assay, Canhelp Origin test, compared to empirical
chemotherapy in CUP patients. Prior to this study, the clinical
benefit of predicted primary site of CUP patients has not been
clearly defined. Published in The Lancet Oncology, the FUDAN-CUP001
trial is the first randomized study in the world showing that
site-specific treatment guided by the 90-gene expression assay
significantly improves progression-free survival time (PFS) and
reduces the risk of disease progression by 32% compared to
empirical chemotherapy.
The clinical trial enrolled 182 patients, who were randomly
assigned in a 1:1 ratio to receive either site-specific therapy or
empirical chemotherapy. The results showed that PFS for patients
receiving site-specific therapy (9.6 months) was significantly
better than for those receiving empirical chemotherapy (6.6
months), reaching the primary study endpoint.
"This clinical study provides high-level clinical evidence for
using gene expression profiling to guide site-specific therapy in
CUP patients." said Dr. Xichun Hu,
the principal investigator from Fudan University Shanghai Cancer
Center. "We anticipate that FUDAN-CUP001 will pave the way for a
new approach to CUP diagnosis and treatment, offering renewed hope
for patients."
"As mentioned by the end of the publication, the findings of
FUDAN-CUP001 study suggest that identifying the tissue of origin as
a guide for sites specific therapy has the potential to be the new
standard of care in patients with CUP in the era of precision
medicine." said Dr. Qinghua Xu, CEO
of Canhelp Genomics, "based on this study as high-level evidence of
clinical benefit, Canhelp Genomics' core product, Canhelp-Origin
Test, stands out as a distinctive and clinically validated tool,
empowering pathologists and oncologists to diagnose and treat CUP
patients with enhanced precision."
In The Lancet Oncology journal, oncology experts from the
Sarah Cannon Research Institute and Cancer Center, Harvard Medical School and Dana-Farber Cancer
Institute in the U.S., and the Gustave Roussy Institute in
France also addressed the clinical
significance of FUDAN-CUP001 study in a commentary titled
"Molecular Diagnosis and Site-Specific Therapy in Cancer of Unknown
Primary: An Important Milestone."
Article link:
www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00344-9/abstract
Media Contact:
Yan
Wu
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SOURCE Canhelp Genomics