1.Ovarian conservation for young women with clinical stage IB–IIB cervical cancer in Japan.
Koji MATSUO ; Muneaki SHIMADA ; Mikio MIKAMI
Journal of Gynecologic Oncology 2017;28(4):e60-
No abstract available.
Female
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Humans
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Japan*
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Uterine Cervical Neoplasms*
2.Prevalence of β₂-agonist inhalation for outpatients in a pediatric emergency center during enterovirus D68 epidemic
Masafumi ZAITSU ; Tatsuhiro MIZOGUCHI ; Muneaki MATSUO ; Toshimitsu TAKAYANAGI ; Okito SHIMADA ; Tsuneyoshi BABA
Asia Pacific Allergy 2018;8(2):e16-
BACKGROUND: Enterovirus D68 (EV-D68) has been reported to have caused severe bronchial asthma attacks and hospitalization epidemics in Japan in September 2015. OBJECTIVE: To investigate the prevalence of β2-agonist inhalation in a pediatric emergency center during a period of increased hospitalization for bronchial asthma, which was suggested to be associated with EV-D68. METHODS: We investigated the prevalence of β2-agonist inhalation in a pediatric emergency center in Saga city, Japan, from April 2013 to October 2015, and also clarified the trends in bronchial asthma hospitalization in the same area during that time. RESULTS: The prevalence of β2-agonist inhalation in the pediatric emergency center, September 2015 was highest when EV-D68 became widespread. The monthly average for β2-agonist inhalation during the study period was 91 cases, but the count in September 2015 was 255 cases. Hospitalized cases of bronchial asthma in September 2015 were increased for age ≥3 years and not increased for age <3 years, but the prevalence of β2-agonist inhalation at the pediatric emergency center was increased even under the age of 3 years. CONCLUSION: During the epidemic period for EV-D68, cases requiring β2-agonist inhalation were increased. The EV-D68 epidemic may be related to not only severe cases requiring hospitalization, but also exacerbation of relatively mild symptoms of bronchial asthma.
Asthma
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Emergencies
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Enterovirus
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Hospitalization
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Humans
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Inhalation
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Japan
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Outpatients
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Prevalence
3.Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)
Hiroshi ASANO ; Katsutoshi ODA ; Kosuke YOSHIHARA ; Yoichi M ITO ; Noriomi MATSUMURA ; Muneaki SHIMADA ; Hidemichi WATARI ; Takayuki ENOMOTO
Journal of Gynecologic Oncology 2022;33(4):e55-
Background:
Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%–10% of BRCA1/2 alterations and 4%–6% of carcinomas of the uterine corpus, and 2.5%–4% of the uterine cervix have alterations of BRCA1/2. 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 BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 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.
4.Risk stratification models for para-aortic lymph node metastasis and recurrence in stage IB–IIB cervical cancer
Koji MATSUO ; Muneaki SHIMADA ; Tsuyoshi SAITO ; Kazuhiro TAKEHARA ; Hideki TOKUNAGA ; Yoh WATANABE ; Yukiharu TODO ; Ken ichirou MORISHIGE ; Mikio MIKAMI ; Toru SUGIYAMA
Journal of Gynecologic Oncology 2018;29(1):e11-
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.
Cohort Studies
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Female
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Humans
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Hysterectomy
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Incidence
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Lymph Nodes
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Neoplasm Metastasis
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Odds Ratio
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Recurrence
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Retrospective Studies
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Risk Factors
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Uterine Cervical Neoplasms
5.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.
6.Update on rare epithelial ovarian cancers: based on the Rare Ovarian Tumors Young Investigator Conference.
Ji Yon Agnes JANG ; Nozomu YANAIHARA ; Eric PUJADE-LAURAINE ; Yoshiki MIKAMI ; Katsutoshi ODA ; Michael BOOKMAN ; Jonathan LEDERMANN ; Muneaki SHIMADA ; Takako KIYOKAWA ; Byoung Gie KIM ; Noriomi MATSUMURA ; Tsunehisa KAKU ; Takafumi KURODA ; Yoko NAGAYOSHI ; Ayako KAWABATA ; Yasushi IIDA ; Jae Weon KIM ; Michael QUINN ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2017;28(4):e54-
There has been significant progress in the understanding of the pathology and molecular biology of rare ovarian cancers, which has helped both diagnosis and treatment. This paper provides an update on recent advances in the knowledge and treatment of rare ovarian cancers and identifies gaps that need to be addressed by further clinical research. The topics covered include: low-grade serous, mucinous, and clear cell carcinomas of the ovary. Given the molecular heterogeneity and the histopathological rarity of these ovarian cancers, the importance of designing adequately powered trials or finding statistically innovative ways to approach the treatment of these rare tumors has been emphasized. This paper is based on the Rare Ovarian Tumors Conference for Young Investigators which was presented in Tokyo 2015 prior to the 5th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG).
Consensus
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Diagnosis
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Female
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Humans
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Molecular Biology
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Mucins
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Ovarian Neoplasms*
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Ovary
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Pathology
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Population Characteristics
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Rare Diseases
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Research Personnel*
7.Clinicopathologic features, treatment, prognosis and prognostic factors of neuroendocrine carcinoma of the endometrium: a retrospective analysis of 42 cases from the Kansai Clinical Oncology Group/Intergroup study in Japan
Harunobu MATSUMOTO ; Mototsugu SHIMOKAWA ; Kaei NASU ; Ayumi SHIKAMA ; Takaya SHIOZAKI ; Masayuki FUTAGAMI ; Kentaro KAI ; Hiroaki NAGANO ; Taisuke MORI ; Mitsutake YANO ; Norihiro SUGINO ; Etsuko FUJIMOTO ; Norihito YOSHIOKA ; Satoshi NAKAGAWA ; Muneaki SHIMADA ; Hideki TOKUNAGA ; Yuki YAMADA ; Tomohiko TSURUTA ; Kazuto TASAKI ; Ryutaro NISHIKAWA ; Shiho KUJI ; Takashi MOTOHASHI ; Kimihiko ITO ; Takashi YAMADA ; Norihiro TERAMOTO
Journal of Gynecologic Oncology 2019;30(6):e103-
OBJECTIVE: We conducted a retrospective, multi-institutional, collaborative study to accumulate cases of neuroendocrine carcinoma of the endometrium, to clarify its clinicopathologic features, treatment, prognosis and prognostic factors to collate findings to establish future individualized treatment regimens. To our knowledge, this is the largest case study and the first study to statistically analyze the prognosis of this disease. METHODS: At medical institutions participating in the Kansai Clinical Oncology Group/Intergroup, cases diagnosed at a central pathologic review as neuroendocrine carcinoma of the endometrium between 1995 and 2014 were enrolled. We retrospectively analyzed the clinicopathologic features, treatment, prognosis and prognostic factors of this disease. RESULTS: A total of 65 cases were registered from 18 medical institutions in Japan. Of these, 42 (64.6%) cases were diagnosed as neuroendocrine carcinoma of the endometrium based on the central pathological review and thus included in the study. Advanced International Federation of Gynecology and Obstetrics stages (stage III and IV) and pure type small cell neuroendocrine carcinoma cases had a significantly worse prognosis. Upon multivariate analysis, only histologic subtypes and surgery were significant prognostic factors. Pure type cases had a significantly worse prognosis compared to mixed type cases and complete surgery cases had a significantly better prognosis compared to cases with no or incomplete surgery. CONCLUSION: Our findings suggest that complete surgery improves the prognosis of neuroendocrine carcinoma of the endometrium. Even among cases with advanced disease stages, if complete surgery is expected to be achieved, clinicians should consider curative surgery to improve the prognosis of neuroendocrine carcinoma of the endometrium.
Carcinoma, Large Cell
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Carcinoma, Neuroendocrine
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Carcinoma, Small Cell
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Endometrial Neoplasms
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Endometrium
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Female
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Gynecology
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Japan
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Medical Oncology
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Multivariate Analysis
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Obstetrics
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Prognosis
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Retrospective Studies