Korean Cancer Study Group
BIG Voting Representative: Prof Seock-Ah Im
The Korean Cancer Study Group (KCSG) is a multicentre oncology clinical trials group representing Korea. It was established on 12 June 1998 and constantly attempts to advance oncology through collaborative cancer studies, presenting rational policy to improve anti-cancer therapies and clinical trial practices, with the ultimate goal of fostering and enhancing public health. We have 720 members from 110 institutes or hospitals in Korea, and most of our members are well-trained and highly motivated medical oncologists. KCSG consists of a protocol review committee, an IRB (Institutional Review Board), a planning committee, an education committee, an international relationship committee, a public relations committee, and 10 disease committees including the Breast Cancer Committee. KCSG has its own data centre. CRAs (Clinical Research Associates), data managers and biostatisticians from the data centre work on study coordination, regulatory affairs, monitoring and data management. We also hold meetings for education, such as the Clinical Research Methodology Workshop, the Clinical Trial Education Workshop, the Institutional Review Board Workshop, and Collaborative R & D (Research & Development) Symposiums. Recently, an independent QC (Quality Control) committee was incorporated into the data centre to facilitate quality issues, which is outsourced. Our global partners for cooperative activities include ECOG (Eastern Cooperative Oncology Group), the EORTC (European Organisation for Research and Treatment of Cancer), AGITG (Australasian Gastro-Intestinal Trials Group), SWOG (South West Oncology Group) and TRIO (Translational Research in Oncology).
Picture: KCSG team
You may visit their website here.
Interview with Prof. Seock-Ah Im
Why did your group join the BIG network? What do you expect from this affiliation?
BIG is an international organisation of academic breast cancer research groups from around the world. KCSG’s mission is similar to that of BIG ̶ conducting clinical research and contributing to better patient outcomes ̶ and we also know that international collaboration can make it happen so much more quickly and efficiently. This is why we joined the BIG network. With the BIG affiliation, many more Asian breast cancer patients can now be involved in global clinical trials, so they can have a chance of better outcomes with new drugs. At the same time, BIG research can get results that are more globally representative of various races or countries, especially for Asian breast cancer patients. Study groups, pharmaceutical companies and governments need a more globally representative set of trial results to share. As a growing clinical trials group, we think we can learn from BIG about the harmonisation of collaborative work through international collaboration, including translational research.
What are the biggest challenges for your group? Do you think that these are likely to be shared with other BIG member groups?
Although Korea has participated very actively in pharmaceutical sponsor-initiated clinical trials, there are many challenges in the real world, especially for investigator-initiated clinical trials. First, as time goes on, it is becoming very difficult to receive investigational agents from global pharmaceutical companies for investigator-initiated trial platforms. Second, we faced major challenges for appropriate government funding for clinical trials. Besides the overburdened role as an investigator, other challenges are limited human resources, including data management, operation and international relationships. A particular challenge in Korea is the fact that there still is not enough understanding for breast cancer research in terms of translational and clinical trials, particularly in communications with the Korean government. The Korean healthcare system has a very unique structure, in which the Korean government has a responsibility as payer. Therefore, there is no reimbursement coverage for patients participating in clinical trials, which is a big issue in our society, although certain regimens may be reimbursed in the practical setting, though not for clinical trials. As a result, the burden for funding is increasing, which is exhausting for investigators. There are still several other challenging issues, including regulations for clinical trials, I & D procedure (Innovation and Development), etc. We expect that these can be shared and resolved through the collaboration with other study groups.
How are clinical trials run at the KCSG? In which clinical trials or research programmes is your group currently involved?
Since 1998, our group has completed, or is on the way to completing over 130 oncologic clinical trials, with recently increasing research activities.
Published articles of our KCSG Breast Cancer Committee
Ongoing IITs in KCSG Breast Cancer Committee
We have established collaborations with several international clinical trial groups, including TRIO (Translational Research in Oncology), ECOG (Eastern Cooperative Oncology Group), JBCRG (Japan Breast Cancer Research Group), among others. There are several completed or ongoing global collaborations of our Breast Cancer Committee with other study groups. The KRISTINE trial (TRIO021) is a randomised, multicentre, phase III neoadjuvant study evaluating trastuzumab emtansine plus pertuzumab compared with chemotherapy plus trastuzumab and pertuzumab for HER2-positive breast cancer. Korea is the 4th TOP recruiting country. Our group also participated in the large adjuvant trial, ALTTO (The Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation study) and recruited patients successfully. CREAT-X was nother successful multicentre study between Japan and Korea. This trial showed the benefit of adding adjuvant capecitabine for HER2-negative patients who could not achieve pCR followed by neoadjuvant chemotherapy, and the results were presented at SABCS 2015 (San Antonio Breast Cancer Symposium). We also joined the HERA, NeoALTTO, APHINITY and OlympiA trials through the participation of individual sites.
Collaboration is ongoing between our Breast Cancer Committee and the U.S. NCI (National Cancer Institute) for the RXPONDER trial [S1007], a phase III randomised clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2-negative breast cancer with recurrence score (RS) of 25 or less. Also, recently, we launched the ECOG-ECRIN (E2112) trial which compares the additional entinostat to exemestane in treating patients with recurrent hormone receptor-positive cancer that is locally advanced or metastatic.
Finally, what do you consider to be your group’s main achievements so far?
For the past 10 years, KCSG focused on nation-wide collaborative clinical research throughout Korea, while also setting the stage for broad-scale, multicentre clinical research in order to become a truly representative study group of Korean medical oncologists. Therefore, we have established infrastructures for multicentre clinical trials, including fast regulatory controls and data management systems. Based on these achievements, we have not only contributed high-volume patient recruitment but also high-quality data in global collaborative studies, and we are now regularly invited to serve as advisory board member in various clinical trials. Recently we have increased our reach outside the nation and contribute to global collaborative clinical trials as part of a core group of Asian breast cancer research societies.