1.1.Millennial Medical Record Project: Secondary Use of Medical Data for Research and Development Based on the Next Generation Medical Infrastructure Law
Japanese Journal of Pharmacoepidemiology 2022;27(1):3-10
The beginning of EHR (Electronic Health Record) can be traced back to the development of the Medical Markup Language (MML) from 1995 to 2000. In 2001, EHR with MML as a database structure was developed and expanded to Kumamoto, Miyazaki, Tokyo, and Kyoto (Dolphin Project). After that, the need for medical information management at the national level was recognized, and the need for secondary use of medical information was also recognized, and in 2015, the national level version of the EHR, the “Millennial Medical Record Project” began. The number of connected medical institutions reached 106 in the four years up to FY2018. In December 2019, the Life Data Initiative, a general incorporated association, became the first certified company under the Next Generation Medical Infrastructure Law, and is operating with the aim of achieving independent profitability, including the EHR department, which does not depend on subsidies.
2.An attempt to establish real-world databases of poly(ADP-ribose) polymerase inhibitors for advanced or recurrent epithelial ovarian cancer: the Japanese Gynecologic Oncology Group
Muneaki SHIMADA ; Kosuke YOSHIHARA ; Terumi TANIGAWA ; Hiroyuki NOMURA ; Junzo HAMANISHI ; Satoe FUJIWARA ; Hiroshi TANABE ; Hiroaki KAJIYAMA ; Masaki MANDAI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2023;34(3):e62-
The development of new treatments for gynecological malignancies has been conducted mainly through collaborative international phase III trials led by the United States and Europe. The survival outcomes of many gynecological malignancies have greatly improved as a result. Recent large-scale genome-wide association studies have revealed that drug efficacy and adverse event profiles are not always uniform. Thus, it is important to validate new treatment options in each country to safely and efficiently provide newly developed treatment options to patients with gynecological malignancies. The Japanese Gynecologic Oncology Group (JGOG) is conducting 5 cohort studies (JGOG 3026, 3027, 3028, 3030, and 3031) to establish real-world data (RWD) of poly(ADP-ribose) polymerase (PARP) inhibitor use in patients with advanced or recurrent epithelial ovarian cancer. The RWD constructed will be used to provide newly developed PARP inhibitors for women with advanced or recurrent ovarian cancer in a safer and more efficient manner as well as to develop further treatment options. In 2022, The JGOG, Korean Gynecologic Oncology Group, Chinese Gynecologic Cancer Society, and Taiwanese Gynecologic Oncology Group established the East Asian Gynecologic Oncology Trial Group to collaborate with East Asian countries in clinical research on gynecologic malignancies and disseminate new knowledge on gynecologic malignancies from Asia. The JGOG will conduct a collaborative integrated analysis of the RWD generated from Asian countries and disseminate real-world clinical knowledge regarding new treatment options that have been clinically implemented.
3.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.
4.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.
5.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.