2.East Asian Gynecologic Oncology Trial Group (EAGOT): founding history and future perspective
Takayuki ENOMOTO ; Aikou OKAMOTO ; Jae-Hoon KIM ; Chyong-Huey LAI ; Xiaohua WU ; Yong-Man KIM
Journal of Gynecologic Oncology 2023;34(5):e86-
Racial and regional differences exist in morbidity, histology, drug response, toxicity, and prognosis of gynecologic cancer. However, most large-scale phase III studies have been conducted in Western countries, and these data on Asians, who account for more than half of the world’s population, are limited. To build a global clinical trial network in Asia, four clinical trial groups with high expertise and international competitiveness in East Asia, namely the Japanese Gynecologic Oncology Group in Japan, the Korean Gynecologic Oncology Group in Korea, the Taiwanese Gynecologic Oncology Group in Taiwan, and the Chinese Gynecologic Cancer Society in the People’s Republic of China, established a new group called the East Asia Gynecologic Oncology Trial Group (EAGOT) on November 19, 2021. It includes four committees: the Cervical Cancer Committee, Uterine Corpus Cancer Committee, Ovarian Cancer Committee, and Translational Research Committee. The purpose of EAGOT is to conduct international clinical trials in an effort to provide the best treatments for Asian women affected by gynecologic cancer. Discussions on new collaborative clinical trials have already begun. The first Annual EAGOT Meeting was held on May 25-27, 2023 in Niigata, Japan. EAGOT, the largest healthcare/investigational innovation network in Asia in the area of gynecologic cancers, will become a platform for establishing standards of care and lead to guidelines for Asian women suffering from gynecologic cancer. The harmonization of regulatory/investigator-initiated clinical trials, simultaneous approval of unapproved drugs in the four countries under a common protocol, and expansion of indications will improve the prognosis of gynecologic cancers in Asia in the near future.
3.BRCA1/2 mutation status in patients with metachronous breast and ovarian malignancies: clues towards the implementation of genetic counseling
Angel CHAO ; Yi-Hao LIN ; Lan-Yan YANG ; Ren-Chin WU ; Wei-Yang CHANG ; Pi-Yueh CHANG ; Shih-Cheng CHANG ; Chiao-Yun LIN ; Huei-Jean HUANG ; Cheng-Tao LIN ; Hung-Hsueh CHOU ; Kuan-Gen HUANG ; Wen-Ling KUO ; Ting-Chang CHANG ; Chyong-Huey LAI
Journal of Gynecologic Oncology 2020;31(3):e24-
Objective:
The characteristics of patients with metachronous breast and ovarian malignancies and the pathogenic role of BRCA1/2 mutations remain poorly understood. We investigated these issues through a review of hospital records and nationwide Taiwanese registry data, followed by BRCA1/2 mutation analysis in hospital-based cases.
Methods:
We retrospectively retrieved consecutive clinical records of Taiwanese patients who presented with these malignancies to our hospital between 2001 and 2017. We also collected information from the Data Science Center of the Taiwan Cancer Registry (TCR) between 2007 and 2015. Next-generation sequencing and multiplex ligation-dependent probe amplification were used to identify BRCA1/2 mutations and large genomic rearrangements, respectively. When BRCA1/2 mutations were identified in index cases, pedigrees were reconstructed and genetic testing was offered to family members.
Results:
A total of 12,769 patients with breast cancer and 1,537 with ovarian cancer were retrieved from our hospital records. Of them, 28 had metachronous breast and ovarian malignancies. We also identified 113 cases from the TCR dataset. Eighteen hospital-based cases underwent BRCA1/2 sequencing and germline pathogenic mutations were detected in 7 patients (38.9%, 5 in BRCA1 and 2 in BRCA2). All BRCA1/2 mutation carriers had ovarian high-grade serous carcinomas. Of the 12 patients who were alive at the time of analysis, 5 were BRCA1/2 mutation carriers. All of them had family members with BRCA1/2-associated malignancies.
Conclusions
Our results provide pilot evidence that BRCA1/2 mutations are common in Taiwanese patients with metachronous breast and ovarian malignancies, supporting the clinical utility of genetic counseling.
4.Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
Chyong-Huey LAI ; Elizabeth VALLIKAD ; Hao LIN ; Lan-Yan YANG ; Shih-Ming JUNG ; Hsueh-Erh LIU ; Yu-Che OU ; Hung-Hsueh CHOU ; Cheng-Tao LIN ; Huei-Jean HUANG ; Kuan-Gen HUANG ; Jiantai QIU ; Yao-Ching HUNG ; Tzu-I WU ; Wei-Yang CHANG ; Kien-Thiam TAN ; Chiao-Yun LIN ; Angel CHAO ; Chee-Jen CHANG
Journal of Gynecologic Oncology 2020;31(1):e5-
Objectives:
An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer.
Methods:
Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis.
Results:
Enrollment was slow, accrual was closed when 7+ years had passed. With a medianfollow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19–0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCAon-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11–1.18; p=0.091).
Conclusions
Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.
5.Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
Chyong Huey LAI ; Elizabeth VALLIKAD ; Hao LIN ; Lan Yan YANG ; Shih Ming JUNG ; Hsueh Erh LIU ; Yu Che OU ; Hung Hsueh CHOU ; Cheng Tao LIN ; Huei Jean HUANG ; Kuan Gen HUANG ; Jiantai QIU ; Yao Ching HUNG ; Tzu I WU ; Wei Yang CHANG ; Kien Thiam TAN ; Chiao Yun LIN ; Angel CHAO ; Chee Jen CHANG
Journal of Gynecologic Oncology 2020;31(1):5-