Annual Report 2021
Preface
Under the vision of providing the best possible cancer treatment and care through a committed partnership with the community, the National Cancer Center Hospital (NCCH) Japan has functioned as a hub hospital for cancer therapy in Japan, provided the optimal medical treatment for each cancer patient, and undertaken high-quality clinical research to discover more effective, safer, brand-new medicines ever since its establishment in 1962.
In April 2020, the Tokyo metropolitan government requested special-function hospitals to hospitalize COVID-19 patients. Although our specialty is with cancer, we prepared an isolated ward with 32 beds, 2 of which were for severe cases, and hospitalized and cared for 556 patients requested by health centers and 72 in-house cancer patients with positive PCR test results in FY2021. Responding to the limitations on inter-prefectural travel from February 2021 onward, we launched an online second opinion service for rare and intractable cancers. According to the results of a questionnaire survey of 91 online patients, this system was confirmed to be equal to the conventional face-to-face consultations.
Our clinical research support and governance has been reinforced, allowing high-volume and safe clinical research covering early to late phase development, responding to unmet medical needs. ISO9001 certification for quality management of clinical research was approved in June 2021, and a Research Quality Management Office set up under the Clinical Research Promotion and Support Department was also launched in December 2021.
Building on our cancer care expertise and clinical research platform, we spearhead clinical trials and provide advanced therapeutics, as a clinical research core hospital. Interventional and invasive investigator-initiated clinical trials numbered 290 in March 2021. The new trials we started during FY2021 are 88 industry-sponsored, 7 investigator-initiated, 63 multinational, and 17 first-in-human trials, in addition to 3 advanced medical care trials. Our clinical research activity has never been restricted despite the COVID-19 pandemic.
We started initiatives with advanced medical care. A prospective study to assess the feasibility and clinical utility of gene panel test profiling upon initiating treatment of patients with solid tumors, Upfront NCC Oncopanel, was approved as advanced medical care B in April 2020, registered 201 patients, and was completed at the end of FY2021. Utilizing the scheme of patient-proposed healthcare services, a trial with multiple targeted agents with multigene panel test profiling registered a total of 212 cases within FY2021. Twelve cancer genomic medicine core hospitals participated, with 19 drugs from 6 sponsors, some of which were also provided to children; 4 drugs were provided at 6 participating hospitals.
In medical development, we continued the MASTER KEY project, an academia-industry collaborative registry study of rare cancer patients combined with multiple investigator-initiated trials. By the end of FY2021, 2264 patients with solid cancers and 218 patients with hematological cancers were enrolled, which is more than initially expected. Registered patients gained access to 9 industry-sponsored trials and 13 investigator-initiated trials, whilst 3 more trials were prepared. The Asian expansion part, MASTER KEY Asia, launched this year and 79 solid cancer patients from 6 Asian hospitals were enrolled.
The MIRAI (Minimally Invasive Revolutionary treatments with Advanced Intelligence) project was launched in 2020 to promote the development of innovative medical devices much called for by society, and nurture young talent driving the development of minimally invasive treatments. We are committed to integrating our innovative world-class gastrointestinal/respiratory endoscopy and pancreatic/biliary interventions with interventional radiology, and delivered breakthrough minimally invasive treatments in FY2021.
We have steadily carried on the ATLAS (Asian clinical TriaLs network for cAncerS) project with a grant from the Japan Agency for Medical Research and Development (AMED) received in April 2020. We shall support building infrastructures for clinical trials in the fast-growing ASEAN countries, establishing an early phase drug development network in Asia, provide equipment and capacity training programs, employ specialists, and conduct multiple international collaborative clinical trials. Initially, we had planned to organize on-site training such as on-the-job training for CRC. However, due to the COVID-19 pandemic, we instead launched an e-learning website for clinical research named ICRweb. The NCC has opened an Asian Partnerships Office in Bangkok to facilitate the progress of the ATLAS project via smooth communication with collaborators in person, local management, support for clinical research for participating sites, and further expansion of a trial network with stakeholders and key opinion leaders in cancer care.
During the year, all extra measures were carried out whilst minimizing the effects of the current pandemic on normal cancer care, and the NCCH has launched several projects to realize our vision. We appreciate your understanding and support as we report on fiscal year 2021.
National Cancer Center Hospital
The Director, Kazuaki Shimada