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Muneaki Shimada,Kosuke Yoshihara,Terumi Tanigawa,Hiroyuki Nomura,Junzo Hamanishi,Satoe Fujiwara,Hiroshi Tanabe,Hiroaki Kajiyama,Masaki Mandai,Daisuke Aoki,Takayuki Enomoto,Aikou Okamoto 대한부인종양학회 2023 Journal of Gynecologic Oncology Vol.34 No.3
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.
Koji Matsuo,Muneaki Shimada,Tsuyoshi Saito,Kazuhiro Takehara,Hideki Tokunaga,Yoh Watanabe,Yukiharu Todo,Kenichirou Morishige,Mikio Mikami,Toru Sugiyama 대한부인종양학회 2018 Journal of Gynecologic Oncology Vol.29 No.1
Objective: To examine the surgical-pathological predictors of para-aortic lymph node (PAN) metastasis at radical hysterectomy, and for PAN recurrence among women who did not undergo PAN dissection at radical hysterectomy. Methods: This is a retrospective analysis of a nation-wide cohort study of surgically-treated stage IB–IIB cervical cancer (n=5,620). Multivariate models were used to identify independent surgical-pathological predictors for PAN metastasis/recurrence. Results: There were 120 (2.1%) cases of PAN metastasis at surgery with parametrial involvement (adjusted odds ratio [aOR]=1.65), deep stromal invasion (aOR=2.61), ovarian metastasis (aOR=3.10), and pelvic nodal metastasis (single-node aOR=5.39 and multiple-node aOR=33.5, respectively) being independent risk factors (all, p<0.05). Without any risk factors, the incidence of PAN metastasis was 0.9%, while women exhibiting certain risk factor patterns (>20% of the study population) had PAN metastasis incidences of ≥4%. Among 4,663 clinically PAN-negative cases at surgery, PAN recurrence was seen in 195 (4.2%) cases that was significantly higher than histologically PAN-negative cases (2.5%, p=0.046). In clinically PAN-negative cases, parametrial involvement (adjusted hazard ratio [aHR]=1.67), lympho-vascular space invasion (aHR=1.95), ovarian metastasis (aHR=2.60), and pelvic lymph node metastasis (single-node aHR=2.49 and multiple-node aHR=8.11, respectively) were independently associated with increased risk of PAN recurrence (all, p<0.05). Without any risk factors, 5-year PAN recurrence risk was 0.8%; however, women demonstrating certain risk factor patterns (>15% of the clinically PAN-negative population) had 5-year PAN recurrence risks being ≥8%. Conclusion: Surgical-pathological risk factors proposed in this study will be useful to identify women with increased risk of PAN metastasis/recurrence.
Hiroshi Asano,Katsutoshi Oda,Kosuke Yoshihara,Yoichi M Ito,Noriomi Matsumura,Muneaki Shimada,Hidemichi Watari,Takayuki Enomoto 대한부인종양학회 2022 Journal of Gynecologic Oncology Vol.33 No.4
Background: Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutationsin , have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%–10% of alterations and 4%–6% of carcinomas of the uterine corpus, and 2.5%–4% of the uterine cervix have alterations of. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052. Methods: JGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with mutations (cohort A, C) and HRD positive uLMS without mutations (cohort B). Participants must have 1–3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16–20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate.
Futagami, Masayuki,Yokoyama, Yoshihito,Sato, Tetsumi,Hirota, Kazuyoshi,Shimada, Muneaki,Miyagi, Etsuko,Suzuki, Nao,Fujimura, Masaki Asian Pacific Journal of Cancer Prevention 2016 Asian Pacific journal of cancer prevention Vol.17 No.10
Purpose: To evaluate palliative care for patients with gynecologic cancer in Japan. Materials and Method: A questionnaire asking facility characteristics, systems to coordinate palliative care, current status of end-of-life care, provision of symptom relief, palliative radiation therapy and chemotherapy, and cases of death from gynecological cancer, was mailed to facilities treating gynecologic cancer. Results: A total of 115 facilities (29.3% of the total) responded to the questionnaire. Of these, 33.0 (29.0%) had a palliative care ward. End-of-life care was managed by obstetricians and gynecologists in 72.0% of the facilities. The site where end-of-life care was provided was most often a ward in the department where the respondent worked. The waiting period for transfer to a hospice was 2 weeks or more in 52% of facilities. Before the start of primary treatment, pain control was managed by obstetrians and gynecologists in 98.0% of facilities. Palliative radiation therapy or chemotherapy was administered at 93.9% and 92.0% of facilities, respectively. Of the 115 facilities, 34.0 (29.6%) reported cases of death from gynecological cancer. There were 1,134 cases of death. The median time between the last cycle of chemotherapy and death was 85 days for all gynecological cancers. The proportion of patients receiving chemotherapy in the last 30 and 14 days of life were 17.4% and 7.1%, respectively. Conclusions: This large-scale survey showed characteristics of palliative care given to patients with gynecologic cancer in Japan. Assessment of death cases showed that the median time between the last cycle of chemotherapy and death was relatively short.
Ji Yon Agnes Jang,Nozomu Yanaihara,Eric Pujade-Lauraine,Yoshiki Mikami,Katsutoshi Oda,Michael Bookman,Jonathan Ledermann,Muneaki Shimada,Takako Kiyokawa,김병기,Noriomi Matsumura,Tsunehisa Kaku,Takafumi K 대한부인종양학회 2017 Journal of Gynecologic Oncology Vol.28 No.4
There has been significant progress in the understanding of the pathology and molecular biologyof rare ovarian cancers, which has helped both diagnosis and treatment. This paper provides anupdate on recent advances in the knowledge and treatment of rare ovarian cancers and identifiesgaps that need to be addressed by further clinical research. The topics covered include: low-gradeserous, mucinous, and clear cell carcinomas of the ovary. Given the molecular heterogeneity andthe histopathological rarity of these ovarian cancers, the importance of designing adequatelypowered trials or finding statistically innovative ways to approach the treatment of these raretumors has been emphasized. This paper is based on the Rare Ovarian Tumors Conferencefor Young Investigators which was presented in Tokyo 2015 prior to the 5th Ovarian CancerConsensus Conference of the Gynecologic Cancer InterGroup (GCIG).