The ESMO Asia Congress is the Asian annual conference of the European Society for Medical Oncology (ESMO), and is one of the most important oncology academic conferences in Asia-Pacific region. The 2023 ESMO Asia Congress is held in Singapore from December 1 to 3, 2023, to showcase and discuss the latest scientific and clinical advancements in the field of oncology. These advancements are not only globally relevant but also specifically targeted towards the Asia-Pacific region. In addition, the 2023 ESMO Asia congress will bring together the most experienced international experts, providing high-level multidisciplinary educational sessions and special sessions that cover all major types of tumors, and offer important opportunities for international peers to communicate.

Cancer of unknown primary (CUP) is a type of metastatic malignant tumor that remains difficult to identify the primary site even after comprehensive clinical examination. CUP is a challenging and important research field in clinical oncology, requiring multidisciplinary collaboration and extensive experience and expertise from doctors. Through research and exploration of CUP, we can gain a deeper understanding of the mechanism of tumorigenesis and development, providing new methods for diagnosis and treatment. However, there is still a lack of prospective, randomized controlled phase III clinical trials to confirm the clinical significance of gene expression profiling in guiding the specific treatment of CUP patients. In this background, the cancer of multiple primaries and unknown primary team of Fudan University Shanghai Cancer Center officially launched the prospective randomized controlled phase III clinical trial of CUP001 in September 2017. In this research, Canhelp Genomics’90-gene expression assay was used to determine the origin of tumor, followed by site-specific therapy based on the test results.

In the morning of December 1, Professor Liu Xin from Fudan University Shanghai Cancer Center, representing the Cancer of Multiple Primaries and Unknown Primary team, unveiled the detailed data from a five-year prospective randomized controlled phase III clinical trial based on 90-gene expression assay to determine the origin of tumor tissue in CUP patients and subsequently guide site-specific therapy. The CUP001 study, which enrolled 182 patients, and those patients were randomly assigned in a 1:1 ratio to receive either site-specific therapy or empirical chemotherapy. In the site-specific therapy group, the tumor origin was predicted using the 90-gene expression assay, and treatments were administered accordingly. The empirical chemotherapy group only received traditional empirical chemotherapy. The results showed that the progression free survival (PFS) of patients with site-specific therapy was significantly better than that of patients with empirical chemotherapy, reaching the main research endpoint. The PFS of the site-specific therapy group and the empirical chemotherapy group were 9.6 months and 6.6 months, respectively. The OS of the site-specific therapy group and the empirical chemotherapy group were 28.2 months and 19 months, respectively. The risk of disease progression was reduced by 32% (P = 0.017). The 2-year survival rate of the site-specific therapy group and the empirical chemotherapy group was 57.1% and 41.8%, respectively, and the risk of death was reduced by 15% (P = 0.036). The incidence of adverse events (grade 3 and above) in the site-specific therapy group was lower than that in the empirical chemotherapy group (56.1% vs. 61.2%).

CUP001, the world's first prospective randomized controlled phase III clinical trial of cancer of unknown primary initiated by Chinese investigators, has proved for the first time that site-specific treatment guided by 90-gene expression assay can significantly improve PFS and OS compared with empirical chemotherapy in CUP patients. This finding provides high-level evidence-based medical evidence for gene expression profile testing to guide organ-specific treatment for CUP patients, which is expected to change the current treatment status of CUP. At the same time, the success of this study also indicates the tremendous potential and application prospects of gene expression profile testing in tumor diagnosis and treatment. There is reason to believe that with continuous technological advancements and improvements, gene expression profile testing will play an increasingly important role in tumor diagnosis and treatment, bringing good news to more patients.

During the special discussion session, the conference invited internationally renowned clinical expert Professor Linda Mileshkin from Peter MacCallum Cancer Center in Australia, to make a special comment on the CUP001 study. Professor Mileshkin highly affirmed the significance of the CUP001 clinical trial, congratulated the research team, and provided constructive suggestions for the study.

After the meeting, Dr. Xu Qinghua, Founder and CEO of Canhelp Genomics, had a in-depth discussion with Professor Mileshkin on the performance of the 90-gene expression assay and the cooperation in conducting international clinical research.

Canhelp Genomics took advantage of the ESMO Asia Congress by setting up an exclusive booth, facilitating interactions with experts and scholars from various countries in the Asia-Pacific region. This strategic move aims to introduce the innovative technology and clinical value of the 90-gene expression assay, laying the groundwork for the product to expand its influence and market share in the Asia-Pacific region.

Overall, the CUP001 study and its presentation at the ESMO Asia Congress represent a milestone in advancing the understanding and treatment of cancer of unknown primary, offering promising implications for the future of gene expression profiling in tumor diagnosis and treatment.