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COT-12 The role of clinical research professional in the registration study of pediatric solid tumor in Japan Children’s Cancer Group

Abstract A larger scale prospective registration study for pediatric solid tumor has been conducted nationwide in Japan since 2011 in Japan Children’s Cancer Group (JCCG). In the study, the clinical data and surgical specimen are collected into the National Center for Child Health. Kyoto University Hospital has participated in the study since IRB approval in 2011. We reviewed our patients registered to the study and assessed the role of clinical research professional in the registration study. Fifty-one patients with pediatric brain tumors participated in this study from 2011 to 2020. There were 17 intracranial germ cell tumors, 9 medulloblastomas, 14 gliomas and ependymomas in 5 diffuse midline gliomas, 9 pilocytic astrocytoma, and 2 other types of tumor. Forty surgical specimens were collected for central review. The status of clinical data entry was complete in 33 patients. The registrations and sending of clinical data and specimens have remarkably increased without exceptions since a clinical research professional supported the study in 2018. The study collecting and analyzing pathological diagnosis, molecular diagnosis, treatment, and clinical information in patients with pediatric brain tumor are important to realize the current status. The clinical research professional plays an important role to register patients and to send the specimens and clinical data into the study.

INTRODUCTION: Malignant glioma is the most common and aggressive primary brain tumor and requires multimodality treatment. Regarding surgical treatment, it is desirable to achieve maximum resection while considering function preservation. There is consensus that the survival prognosis is prolonged in gross or subtotal resection. However, there are cases in which biopsy or partial resection is performed due to the spread of lesions at the time of onset, underlying diseases, and social background. The purpose of this study was to retrospectively analyze the cases of malignant glioma at our university and to find out the factors related to the prognosis of cases in which removal was insufficient.
TARGET: 55 cases of malignant glioma treated at our university since 2013 who underwent biopsy or partial resection.
METHOD: Overall/progression-free survival period is the end point, and parameters are age, bevacizumab use, pathological diagnosis, photodynamic diagnosis use at operation, immunotherapy, ventricular invasion, contralateral invasion, sex, preoperative Performance Status (PS), postoperative PS, left or right, navigation use, steroid use, anticonvulsant drug type, radiation, IDH mutation, 1p19q co-deletion, MGMT methylation, TERT mutation, p53 mutation, biopsy or partial resection. After narrowing down the evaluation items by univariate analysis(Logrank test), multivariate analysis(Cox proportional hazard model)was performed.
RESULT: The univariate analysis was significant in 5 items including bevacizumab use, radiation therapy, levetiracetam use, postoperative PS70 or higher, and partial resection instead of biopsy. Multivariate analysis detected two statistically significant differences, bevacizumab use and post-operative PS70 and above. There was no difference in the timing of bevacizumab use.
CONSIDERATION: In poorly resection cases, the weight of postoperative treatment is high, so continuity of treatment and selection of postoperative treatment are important, and maintenance of ADL and use of bevacizumab are significant among them.

ADMINISTRATION OF BEVACIZUMAB FOR PATIENTS WHO FAILED TO COMPLETE STUPP REGIMEN AFTER GLIOBLASTOMA SURGERY
Takashi Kon 1,2 , Yoichi Imaizumi 2 , Yusuke Kobayashi 1 , Yosuke Sato 1 , Katsuyoshi Shimizu 1 , Tohru Mizutani 1 ; 1 Department of Neurosurgery, Showa University Stupp regimen is widely used as the standard treatment after glioblastoma surgery, but in some cases treatment must be discontinued for various reasons. We experienced Bevacizumab in two patients who were unable to continue treatment in the Stupp regimen, and report our experience with literature review. First patient is a man in his 60s. Resection of glioblastoma of the left cerebral hemisphere was performed, and postoperatively right hemiparesis and aphasia remained. Irradiation and administration of Temozolomide were performed, but Temozolomide was unable to continue because of side effects. After systemic management, Bevacizumab was administered, and reduction of residual tumor and peripheral edema were observed, and the patient began to speak. After 12 cycles of administration, the tumor regrew, and he died. Second patient is a woman in her 80s. Craniotomy was performed for hemorrhagic infarction of the left cerebral hemisphere, postoperatively, aphasia, right hemiparesis remained, bedridden, and was unable to eat. Four months after initial surgery, a tumor was found in left parietal lobe and was resected. The pathological diagnosis was glioblastoma. For the treatment of recurrence, the patient was unable to be transferred for radiochemotherapy, so the patient was treated with Temozolomide and Bevacizumab. The patient's condition became better, eat by herself, and could play in rehabilitation facility on the wheelchair. After 12 cycles of bevacizumab, the tumor subsequently enlarged, and died. Although the effect is limited, there are some cases in which Bevacizumab administration could maintain patient's condition by controlling tumor growth for a certain period of time. From the experience of these patients, it seems that even in patients with postoperative poor Karnofsky Performance Status (KPS)and elderly people, Bevacizumab administration would be an option before transitioning to end-of-life care.

COT-12 THE ROLE OF CLINICAL RESEARCH PROFESSIONAL IN THE REGISTRATION STUDY OF PEDIATRIC SOLID TUMOR IN JAPAN CHILDREN'S CANCER GROUP
Keiko Furukawa 1 , Yasuhide Makino 2 , Yohei Mineharu 2 , Katsutsugu Umeda 3 , Junko Takita 3 , Yoshiki Arakawa 2 ; 1 Kyoto University Hospital Cancer Center, Kyoto, Japan A larger scale prospective registration study for pediatric solid tumor has been conducted nationwide in Japan since 2011 in Japan Children's Cancer Group (JCCG). In the study, the clinical data and surgical specimen are collected into the National Center for Child Health. Kyoto University Hospital has participated in the study since IRB approval in 2011. We reviewed our patients registered to the study and assessed the role of clinical research professional in the registration study. Fifty-one patients with pediatric brain tumors participated in this study from 2011 to 2020. There were 17 intracranial germ cell tumors, 9 medulloblastomas, 14 gliomas and ependymomas in 5 diffuse midline gliomas, 9 pilocytic astrocytoma, and 2 other types of tumor. Forty surgical specimens were collected for central review. The status of clinical data entry was complete in 33 patients. The registrations and sending of clinical data and specimens have remarkably increased without exceptions since a clinical research professional supported the study in 2018. The study collecting and analyzing pathological diagnosis, molecular diagnosis, treatment, and clinical information in patients with pediatric brain tumor are important to realize the current status. The clinical research professional plays an important role to register patients and to send the specimens and clinical data into the study.

COT-13 CURRENT SITUATION AND PROBLEMS OF CANCER GENOMIC PROFILING TEST IN KYOTO UNIVERSITY HOSPITAL
Yoshiki Arakawa 1 , Junko Suga 2 , Yukinori Terada 1 , Kohei Nakajima 1 , Masahiro Tanji 1 , Yohei Mineharu 1 , Manabu Muto 2 , Susumu Miyamoto 1 ; 1 Department of Neurosurgery, Kyoto University of Graduate School of Medicine OBJECTIVE: Kyoto University Hospital has introduced the cancer genomic profiling tests, Oncoprime in 2015, Guardant360 in 2018, which are not under insurance coverage, FoundationOne CDx(F1CDx) and OncoGuide NCC Oncopanel system(NCC OP) in 2019, which received approval for insurance coverage for the first time in Japan. We investigated the results of cancer genomic profiling test under insurance coverage in our hospital. METHODS: A special facility for the cancer genomic profiling tests was produced. To perform the cancer genomic profiling test, an outpatient must visit the facility three times (learning, ordering of the test, and getting the results). The expert panels decide the final test results and treatment options with the all information of the patients. RESULTS: From November 2019 to March 2020, 51 and 9 patients were tested with F1CDx and NCC OP, respectively. 16 patients (31%) of F1CDX and 2 patients (22%) of NCC OP got treatment recommendations from the expert panels. However, only 5 patients (9.8%) of F1CDX and 1 patient (11%) of NCC OP received the treatments. The secondary finding suspecting germline mutations was found in 8 patients of F1CDX. CONCLUSION: After the approval the cancer genomic profiling tests with insurance coverage in Japan, it becomes easy for the patients to perform the test and get the genetic information of the tumor. However, it remains not easy to receive the recommended drugs because of several limitations of their usages.