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        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 대한부인종양학회 2020 Journal of Gynecologic Oncology Vol.31 No.1

        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 median follow-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 BRCA/non-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.

      • KCI등재후보

        Comparison of immediate germline sequencing and multi-step screening for Lynch syndrome detection in high-risk endometrial and colorectal cancer patients

        An-Shine Chao,Angel Chao,Chyong-Huey Lai,Chiao-Yun Lin,Lan-Yan Yang,Shih-Cheng Chang,Ren-Chin Wu 대한부인종양학회 2024 Journal of Gynecologic Oncology Vol.35 No.1

        Objective: Lynch syndrome (LS) is a hereditar y cancer predisposition syndrome witha significantly increased risk of colorectal and endometrial cancers. Current standardpractice involves universal screening for LS in patients with newly diagnosed colorectal orendometrial cancer using a multi-step screening protocol (MSP). However, MSP may notalways accurately identif y LS cases. To address this limitation, we compared the diagnosticperformance of immediate germline sequencing (IGS) with MSP in a high-risk group. Methods: A total of 31 Taiwanese women with synchronous or metachronous endometrialand colorectal malignancies under went MSP which included immunohistochemical stainingof DNA mismatch repair (MMR) proteins, MLH1 promoter hypermethylation analysis, andgermline sequencing to identif y pathogenic variants. All patients who were excluded duringMSP received germline sequencing for MMR genes to simulate IGS for the detection of LS. Results: Our findings indicate that IGS surpassed MSP in terms of diagnostic yield (29.0% vs. 19.4%, respectively) and sensitivity (90% vs. 60%, respectively). Specifically, IGS successfullyidentified nine LS cases, which is 50% more than the number detected through MSP. Additionally, germline methylation analysis revealed one more LS case with constitutionalMLH1 promoter hypermethylation, bringing the total LS cases to ten (32.3%). Intriguingly,we obser ved no significant differences in clinical characteristics or overall sur vival betweenpatients with and without LS in our cohort. Conclusion: Our study suggests that IGS may potentially offer a more effective approachcompared to MSP in identif ying LS among high-risk patients. This advantage is evident whenpatients have been pre-selected utilizing specific clinical criteria.

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        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 대한부인종양학회 2023 Journal of Gynecologic Oncology Vol.34 No.5

        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.

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