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Purpose: In Japan, Japan's Ministry of Health, Labor, and Welfare decided to suspend govermental recommendation for HPV vaccination in FY 2013. The HPV vaccination rate for those born in FY 2000 or thereafter declined dramatically. In 2021, the "suspension of recommendation" ended. The catch-up vaccinations for the unvaccinated have been offered nationwide from FY 2022 to FY 2024. We aimed to quantify the vaccination intentions and characteristics of those young women now eligible for catch-up vaccination. Methods: In February of 2022, we conducted an internet survey targeted women who were born in 1997–2004 but who had not yet been HPV vaccinated. Results: We received 1,648 valid responses. 41.6% of the respondents wanted to uptake the catch-up HPV vaccination, 29.7% were undecided, and 28.7% did not want to be vaccinated. The intention to uptake catch-up HPV vaccination was associated with a good history of gynecological visits, intention to receive cervical cancer screening, sexual activity, degree of anxiety about cervical cancer, familiarity with problems associated with cervical cancer, experience with vaccination recommendations, and knowledge about cervical cancer (p < 0.05, respectively). In the vaccinated generation, the proportion of the group that did not want to be vaccinated was significantly higher (p < 0.05). In the vaccine-suspended generation, the proportion of the group that wanted to be vaccinated was significantly higher (p < 0.05). Conclusion: Our survey revealed that catch-up vaccination intentions differed depending on the vaccination environment. It is necessary for all organizations involved with HPV vaccination, such as government, medical institutions, and educational institutions, to make recommendations based on an understanding of the characteristics of the "vaccinated generation" and the "vaccine-suspended generation". [ABSTRACT FROM AUTHOR]

Aim: To evaluate changes of treatment strength and its impact on prognosis in older patients with ovarian cancer. Methods: We compared relative dose intensity (RDI) as a representative of treatment strength, prognosis, and other features between older (≥65 years) and younger patients (<65 years) retrospectively. Seventy‐seven older patients of 301 who received dose‐dense‐paclitaxel‐carboplatin (dTC) and 93 older patients of 304 who received conventional‐paclitaxel‐carboplatin (cTC) from the Japanese Gynecologic Oncology Group (JGOG) 3016 clinical trial were analyzed. Results: The RDI of older patients was lower than that of younger patients in cTC (87.4% vs. 90.8%, p = 0.009) but not in dTC (79.0% vs. 81.2%, p = 0.205). In both regimens, older patients had worse overall survival than younger patients: hazard ratio [HR] = 1.80; 95% confidence interval [CI]: 1.25–2.59; p = 0.001 for dTC, and HR = 1.59; 95% CI: 1.15–2.19; p = 0.04 for cTC. However, the RDI was not determined as a prognostic factor statistically. The prognostic factors identified by multivariate analysis for both regimens were clinical stage and residual disease; for dTC were age, performance status, and serum albumin; and for cTC was white blood cell count. There was no difference in neutropenia observed between age groups in either regimen. Conclusions: The RDI of older patients varies according to the administered schedule and is not always lower than that of younger patients. Older patients with comparable treatment strength to younger patients in the dTC group did not accomplish the same level of prognosis as younger patients. Other biologic factors attributable to aging may affect prognosis. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to clarify the accuracy of pregnant women's knowledge and understanding regarding infectious disease screening in early pregnancy and clarify the roles that should be played by health care providers in promoting the health of pregnant women and their children. Methods: A cross-sectional questionnaire survey was conducted in 25 hospitals across Japan from May 2018 to September 2019. We compared the agreement rates regarding screening results for hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, human T-cell leukemia virus-1 (HTLV-1), and cervical cytology in the medical records and understanding of their results by pregnant women. We then investigated whether participants had knowledge regarding the risk of mother-to child transmission in these diseases and factors associated with their knowledge. Results: We enrolled 2,838 respondents in this study. The rates of agreement for HBV and cervical cancer screening related to human papillomavirus infection were "substantial," those for syphilis was "moderate," and those for HCV and HTLV-1 were "fair," according to the Kappa coefficient. The rate of knowledge regarding mother-to-child transmission of syphilis was highest (37.0%); this rate for the other items was approximately 30%. Increased knowledge was associated with higher educational level and higher annual income. Conclusions for Practice: Pregnant women in Japan had generally good levels of understanding regarding their results in early-pregnancy infectious disease screening. However, they had insufficient knowledge regarding mother-to-child transmission of these diseases. Health care providers should raise awareness in infectious disease prevention among pregnant women and the general public, providing appropriate measures and implementing effective perinatal checkups and follow-ups for infectious diseases. Significance: A previous study reported biases in knowledge about mother-to-child disease transmission among pregnant women. However, there are no reports on the accuracy of pregnant women's understanding and their backgrounds related to knowledge about infectious diseases. In this report, Japanese pregnant women had generally good understanding of their results in infectious disease screening. However, they had insufficient knowledge regarding mother-to-child transmission of infectious diseases. It is crucial for health care providers to raise awareness in infectious disease prevention and provide appropriate measures for pregnant women and the general public, such as implementing effective perinatal checkups and follow-ups. [ABSTRACT FROM AUTHOR]

Background: The phase 3 VELIA trial evaluated veliparib with carboplatin/paclitaxel and as maintenance in patients with high-grade serous ovarian carcinoma. Methods: Patients with previously untreated stage III–IV high-grade serous ovarian carcinoma were randomized 1:1:1 to control (placebo with carboplatin/paclitaxel and placebo maintenance), veliparib-combination-only (veliparib with carboplatin/paclitaxel and placebo maintenance), or veliparib-throughout (veliparib with carboplatin/paclitaxel and veliparib maintenance). Randomization stratification factors included geographic region (Japan versus North America or rest of the world). Primary end point was investigator-assessed median progression-free survival. Efficacy, safety, and pharmacokinetics were evaluated in a subgroup of Japanese patients. Results: Seventy-eight Japanese patients were randomized to control (n = 23), veliparib-combination-only (n = 30), and veliparib-throughout (n = 25) arms. In the Japanese subgroup, median progression-free survival for veliparib-throughout versus control was 27.4 and 19.1 months (hazard ratio, 0.46; 95% confidence interval, 0.18–1.16; p = 0.1 [not significant]). In the veliparib-throughout arm, grade 3/4 leukopenia, neutropenia, and thrombocytopenia rates were higher for Japanese (32%/88%/32%) versus non-Japanese (17%/56%/28%) patients. Grade 3/4 anemia rates were higher in non-Japanese (65%) versus Japanese (48%) patients. Early introduction of olanzapine during veliparib monotherapy maintenance phase may help prevent premature discontinuation of veliparib, via its potent antiemetic efficacy. Conclusions: Median progression-free survival was numerically longer in Japanese patients in the veliparib-throughout versus control arm, consistent with results in the overall study population. Pharmacokinetics were comparable between Japanese and non-Japanese patients. Data for the subgroup of Japanese patients were not powered to show statistical significance but to guide further investigation. [ABSTRACT FROM AUTHOR]

Background: In Japan, in June 2013, The Ministry of Health, Labor and Welfare (MHLW) decided to temporarily suspend its official recommendation for the participation of girls in the national immunization program. The HPV vaccination rate in Japan soon declined to below 1%. In October 2020, the MHLW notified that the municipalities could and should begin to individually notify girls and their parents targeted for routine vaccination. We have examined how that type of individual notification has affected the number of vaccinations. Methods: From 12 municipalities (with a combined total population of approximately 4.06 million), we collected vaccination data for all girls who attended grades 6 through 10 from April 2019 to March 2021. We analyzed the number of initial-round vaccinations that occurred by month and the timing and the subjects of the individual notifications. Results: The annual vaccination rate for tenth-grade students in 2020 in the six municipalities that had implemented individual notification was 9.46% (342/3618), which was significantly higher than the rate of 3.22% (54/1676) in the three municipalities that had not implemented individual notification (p < 0.001). On the other hand, the annual vaccination rate for the sixth to ninth-grade students in 2020 in the six municipalities that had implemented individual notification was not significantly (p = 0.56) higher than the rate in the three municipalities that did not: 1.43% (197/13,785) versus 1.33% (83/6260), respectively. Conclusion: This study clearly demonstrates the importance of providing information for routine vaccination directly to the targets and their parents. [ABSTRACT FROM AUTHOR]

In 2013, the Ministry of Health, Labor, and Welfare (MHLW) in Japan announced a suspension of the governmental recommendation for routine HPV vaccinations. In 2020, MHLW started individual notifications of HPV vaccine to the targeted girls. In April 2022, the governmental recommendation was restarted, and catch-up vaccinations started. We evaluated the benefits and limitations of the MHLW's new vaccination strategies by estimating the lifetime risk for cervical cancer for each birth FY under different scenarios to suggest a measure for the vaccine suspension generation. It was revealed that catch-up immunization coverage among the unvaccinated must reach as high as 90% in FY2022, when the program begins, in order to reduce the risk of the females already over the targeted ages to the same level or lower than that of women born in FY1994-1999 who had high HPV vaccination rates. For women whose vaccination coverage waned because of their birth FYs, strong recommendations for cervical cancer screening should be implemented. [ABSTRACT FROM AUTHOR]

Simple Summary: The available evidence does not sufficiently indicate the status of pregnancy-associated cervical cancer in Japan and the associated treatment options. This study aimed to assess the occurrence of pregnancy-associated cervical cancer, available treatments, and the impact on the mother and the unborn child. The results show that pregnancy-associated cervical cancer is occurring more frequently in Japan, and most of the patients with early-stage disease have successful deliveries, although some have preterm births. Our findings also show that pregnant women with stage IB1 cervical cancer have the option of continuing pregnancy in addition to chemotherapy, as well as removal of the cervix and surrounding tissues. Thus, the treatment approach for pregnancy-associated cervical cancer must consider the stage of the cancer and the benefits that will accrue for both the mother and the unborn child. Large-scale data on maternal and neonatal outcomes of pregnancy-associated cervical cancer in Japan are scarce, and treatment strategies have not been established. This multicenter retrospective observational study investigated clinical features and trends in pregnancy-associated cervical cancer treatments at 523 hospitals in Japan. We included cervical cancer cases that were histologically diagnosed (between 1 January 2012, and 31 December 2017), and their clinical information was retrospectively collected. Of 40 patients diagnosed with pregnancy-associated cervical cancer at ≥22 gestational weeks, 34 (85.0%) were carefully followed until delivery without intervention. Of 163 diagnosed at <22 gestational weeks, 111 continued and 52 terminated their pregnancy. Ninety patients with stage IB1 disease had various treatment options, including termination of pregnancy. The 59 stage IB1 patients who continued their pregnancy were categorized by the primary treatment into strict follow-up, conization, trachelectomy, and neoadjuvant chemotherapy groups, with no significant differences in progression-free or overall survival. The birth weight percentile at delivery was smaller in the neoadjuvant chemotherapy group than in the strict follow-up group (p = 0.029). Full-term delivery rate was relatively higher in the trachelectomy group (35%) than in the other groups. Treatment decisions for pregnancy-associated cervical cancer are needed after estimating the stage, considering both maternal and fetal benefits. [ABSTRACT FROM AUTHOR]

Aim: We aimed to grasp the actual working hours of Japanese obstetricians and gynecologists (OB/GYN doctors) as accurately as possible, using the same method of the Ministry of Health, Labour, and Welfare (MHLW). Methods: The time study targeted OB/GYN doctors working at 10 universities nationwide including Niigata University and 21 institutions which take a role of perinatal care in Niigata prefecture. Working hours per week were calculated based on the following categories: regular and overtime work inside the hospital, work outside the hospital, self‐improvement, education, research, and others. Data on weekly working hours were converted to yearly data for analyses. Results: A time study of 10 universities nationwide revealed that 30% of doctors work overtime for more than 1860 h even if they do not include on‐call shifts in their working hours. In 21 institutions in Niigata, physicians in Niigata University worked more overtime than other hospitals. It became clear that community health care was supported by dispatching physicians working at university. Furthermore, the results of simulations predicted the pessimistic situation of perinatal medical care in Niigata. Conclusions: Our study showed the possibility to exist much more OB/GYN doctors who work more than 1860 h of overtime work per year than the data presented by the MHLW based on nation‐wide survey in 2019. The fact that the working hours at the side jobs had a great influence on the increase in overtime work of physicians in University was the same result as the report of MHLW published in 2021. [ABSTRACT FROM AUTHOR]

Objective: Epithelial borderline ovarian tumor (BOT) frequently occurs in young women. Because progression‐free survival, overall survival, and reproductive function are important outcomes, BOT is often treated by fertility‐sparing surgery (FSS). We conducted a Japan‐wide study to understand post‐FSS prognosis in relation to clinical characteristics and types of FSS performed. Methods: We analyzed clinical and outcome data pertaining to 531 adolescent and young adult (AYA) patients (aged 15–39 years) who underwent FSS for BOT between 2009 and 2013. Results: Median (range) age was 30 (15–39) years, and median observation time was 70 (2–120) months. The disease was of FIGO stage I in 492 (93%) patients. Histopathologically, tumors were of the mucinous (n = 372, 70%), serous (n = 120, 23%), seromucinous (n = 23, 4%), and other (n = 16, 3%) types. Five‐year overall survival was 99.5% among patients with stage I and 100% among those with stage II–IV. Five‐year progression‐free survival was 96.7% and 69.3%, respectively. Multivariate analysis in cases of stage I showed a positive peritoneal cytology to be a significant risk factor for recurrence (HR, 5.199; p = 0.0188). The post‐FSS pregnancy rate was relatively low for patients aged ≥30 years (OR, 0.868; 95% CI, 1.16–3.00; p = 0.0090). Conclusion: Post‐FFS outcomes in terms of overall and progression‐free survival are favorable, especially for AYA patients with stage I BOT. However, the relapse rate is high for patients with FIGO stage II–IV and for those with stage I but a positive peritoneal cytology. A long‐term prospective observation is needed before reproductive outcomes can be fully established. [ABSTRACT FROM AUTHOR]

Studies on vulvar adenocarcinoma are lacking. Thus, we aimed to compare the characteristics and survival outcomes between vulvar adenocarcinoma and squamous cell carcinoma (SCC). This was a preplanned sub-analysis of a previously organized nationwide retrospective observational study in Japan conducted between 2001 and 2010 (JGOG-1075S). Surgically treated women with stage I-IV vulvar invasive adenocarcinoma were compared to those with SCC. Multivariable analysis was performed to identify patient and tumor characteristics related to adenocarcinoma. Inverse probability of treatment weighting was used to balance the background differences, and a Cox proportional hazards regression model was fitted to estimate the effect of the histological type on survival. Forty-eight women with adenocarcinoma were compared with 537 women with SCC. On multivariable analysis, women with adenocarcinoma were younger (median age, 64.5 vs. 70 years, adjusted odds ratio [OR] per age 0.975, 95% confidence interval [CI] 0.955–0.995, P = 0.016) and had higher positive surgical margin rates (31.2% vs. 18.4%, adjusted OR 2.376, 95% CI 1.188–4.754, P = 0.014) than those with SCC. However, according to the weighted model, the survival outcomes were comparable (hazard ratio for progression-free survival, 1.088, 95% CI 0.740–1.601, P = 0.667 and hazard ratio for overall survival, 1.008, 95% CI 0.646–1.573, P = 0.973). Similar associations were observed when the cohort was stratified by age (≤70 or >70 years), stage (I-II or III-IV), and surgical margin (negative or positive) (all, P > 0.05). Vulvar adenocarcinoma is characterized by a younger age at diagnosis and higher positive surgical margin rates than SCC, but the survival outcomes are comparable. [ABSTRACT FROM AUTHOR]

Objective: The purpose of our study was to conduct a detailed survey of radical hysterectomy in Japanese patients with early-stage cervical cancer, and to compare oncologic outcomes between open and minimally invasive radical hysterectomy. Methods: In Japan during 2015, the medical records of 929 patients with FIGO stage IB1 and IIA disease treated with radical hysterectomy were retrospectively reviewed. We assessed patients' characteristics, disease-free survival (DFS), overall survival (OS) and prognostic factors for survival. Results: The median patient age was 44 (20–80) years. Most patients (94.4%) had stage IB1 disease. Of the patients who underwent radical hysterectomy, 91.2% underwent open surgery and 8.8% underwent minimally invasive surgery (MIS). The median follow-up period was 40.8 months (range, 0.49–51.1 months). The rate of DFS and OS at 4 years in all patients was 88.3% and 96.4%, respectively. Multivariate analysis identified age (≥ 47), adenocarcinoma histology, tumor size (≥ 2 cm), parametrial invasion, positive lymph node metastasis and institutional accreditation as independent predictors of recurrence, and adenocarcinoma, other cell types, and positive lymph node metastasis as independent predictors of death. Oncologic outcomes in all patients were similar between open and MIS, including DFS and OS. Conclusion: The survival rate of the Japanese patients underwent radical hysterectomy for early-stage cervical cancer was favorable. No significant differences were observed for DFS and OS between open and MIS performed by a limited number of surgeons at a limited number of facilities in Japan. Further investigations are required to identify the appropriate patients might benefit from MIS. [ABSTRACT FROM AUTHOR]

Background: Despite being widely used, to date (June 2021), the regimen of bevacizumab 10 mg/kg every 2 weeks (Q2W) combined with chemotherapy is not approved in Japan for patients with platinum-resistant recurrent ovarian cancer. In this retrospective analysis, we evaluated the usage patterns of bevacizumab administered for platinum-resistant recurrent ovarian cancer. Methods: We obtained clinical data from 155 Japanese medical facilities between November 2013 and December 2018 via a survey. Items included the number of cases of platinum-resistant recurrent ovarian cancer treated with bevacizumab according to dosage. For regimens including bevacizumab 10 mg/kg Q2W, additional information was requested relating to concomitantly administered agents, and the efficacy and safety of the regimen. Results: Of 1739 bevacizumab-containing regimens reported in 1633 patients with recurrent ovarian cancer, 264 used 10 mg/kg Q2W. The overall response rate (ORR) with this regimen was 26.1%. Response rates varied according to regimen and were particularly favorable when bevacizumab 10 mg/kg Q2W was administered with paclitaxel (ORR, 53.0%) versus liposomal doxorubicin (15.0%; P < 0.0001) and irinotecan (7.7%; P < 0.028). The most frequent Grade ≥ 3 adverse events associated with bevacizumab 10 mg/kg Q2W were neutropenia (11.7%) and hypertension (11.7%). The most frequent bevacizumab-associated Grade ≥ 3 adverse events with bevacizumab plus paclitaxel versus bevacizumab plus liposomal doxorubicin were hypertension (9.0% versus 13.9%) and proteinuria (3.0% versus 8.4%). Conclusions: Bevacizumab 10 mg/kg Q2W appears efficacious for patients with recurrent ovarian cancer, with a manageable toxicity profile. Approval of this regimen is clinically desirable for Japanese patients with ovarian cancer. [ABSTRACT FROM AUTHOR]

Aim: We aimed to conduct a fixed‐point observation questionnaire survey of changes in young women's human papillomavirus (HPV) vaccination status over the course of 10 years. We also investigated the influence of suspension of governmental recommendation for HPV vaccination since June 2013. Methods: During 2011–2020, we conducted a self‐completed questionnaire survey among newly enrolled female medical school students in Yokohama, Japan. The questionnaire featured items regarding HPV vaccination status, age, previous sex education, and knowledge about cervical cancer and HPV vaccination. Results: HPV vaccine uptake rates in 2011 (5.4%) and 2012 (13.5%), when vaccination was self‐funded, increased after 2013 (48.7%), when vaccination fees were subsidized. The rate dropped drastically in 2019 (14.3%) and 2020 (5.1%), after suspension of recommendation by the government. Comparisons between new students in 2015/2016, who had high vaccination rates (65.2%), and new students in 2019/2020, who had low vaccination rates (9.8%), showed decreased levels of HPV vaccination awareness, with fewer students having covered cervical cancer prevention in sex education and with respondents having less knowledge about the details of HPV vaccination. Conclusions: After the suspension of proactive HPV vaccine recommendation, markedly fewer students have been vaccinated against HPV, even those at the vaccination target age. This situation has substantially influenced the lower awareness about cervical cancer prevention, even among medical school students. To protect young women from cervical cancer in Japan, it is crucial for the government to resume proactive recommendation of HPV vaccines as soon as possible. [ABSTRACT FROM AUTHOR]

Aim: We aimed to evaluate regional disparities in the proportion of the three main laparoscopic surgeries for benign gynecological diseases among 47 prefectures in Japan and their correlation with the number of laparoscopy‐qualified gynecologists per population. Methods: In this retrospective ecological study, we collected the data of patients from 47 prefectures in 2017 using "The National Database of Health Insurance Claims and Specific Health Checkups of Japan" Open Data from the Ministry of Health, Labor and Welfare in Japan. The primary outcome of the study was the proportion of laparoscopic surgeries conducted for benign gynecologic diseases (hysterectomy, myomectomy and surgery for the benign ovarian diseases). The main exposure was the number of laparoscopy‐qualified gynecologists per 100 000 females. Results: The average proportion of laparoscopic hysterectomies, myomectomies and surgeries for the benign ovarian disease were 38% (standard deviation (SD) 16, range 12–74), 48% (SD 18, range 9–81) and 60% (SD 11, range 36–79), respectively. Multiple regression analysis showed a significant correlation between the number of laparoscopy‐qualified gynecologists per 100 000 females and the proportion of the three main laparoscopic surgeries. Conclusion: There are obvious regional disparities in the proportion of the three main laparoscopic procedures for benign gynecological diseases among 47 prefectures. The number of laparoscopy‐qualified gynecologists correlated significantly with these regional disparities. The academic society should monitor these regional disparities and make an effort to reduce these regional disparities by increasing laparoscopy‐qualified gynecologists in areas where the widespread use of laparoscopic techniques is lagging. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to investigate the trends in overall hysterectomy and other alternative therapies for benign uterine diseases per population aged 40–54 years in Japan. Methods: We conducted a national representative cohort study in Japan. We obtained data from 'The National Database of Health Insurance Claims and Specific Health Checkups of Japan' Open Data. The primary outcome was the number of overall hysterectomies for benign gynecologic diseases per population aged 40–54 years, from 2014 to 2017 in Japan. The secondary outcome was the number of alternative surgical and drug therapies to hysterectomy per population. We also analyzed the correlation between the number of laparoscopy‐qualified gynecologists and the number of overall hysterectomies per population among 47 prefectures in 2017. Results: The number of overall hysterectomies for benign gynecological diseases per 100 000 females aged 40–54 years gradually increased from 320 in 2014 to 344 in 2017 (7.5% increase overall). Moreover, there was a significant increase in the use of levonorgestrel intrauterine systems. We could not explain the reason for this increase in the rate of overall hysterectomies by summarizing the increase or decrease of alternative therapies to hysterectomy. Multiple regression analysis showed a significant correlation between the number of laparoscopy‐qualified gynecologists and the number of overall hysterectomies among 47 prefectures. Conclusion: Despite the spread of alternative therapies to hysterectomy, there was an increasing trend for overall hysterectomies in Japan. The reason was not clear but may be related to the spread of laparoscopic hysterectomy. [ABSTRACT FROM AUTHOR]

Aim: Endometriosis mostly affects the ovary but can also be present outside of the ovary including the pelvic peritoneum, intestine, urinary tract and lung. In case of ovarian endometriotic cyst, an increased risk of ovarian cancer, especially of clear cell and endometrioid histology, has been reported. However, because of the rarity, cancer occurrence from endometriosis at less common sites/rare sites is poorly understood. Methods: We conducted a nationwide survey on the less common/rare site endometriosis in 3539 authorized facilities in Japan. We requested to complete a case report form for each case, including information on the history of endometriosis, treatment for endometriosis, type of surgery, involved site(s) of cancer and endometriosis, histology of cancer, chemotherapy and outcome. Results: Out of 1397 confirmed cases of less common/rare site endometriosis, 11 cases of rare site endometriosis‐associated cancer (RSEAC) were reported: seven of them were associated with intestinal endometriosis, three were associated with urinary tract endometriosis and one was associated with umbilical endometriosis. Interestingly, the histology was endometrioid in seven (64%) cases, and serous, seromucinous borderline, clear cell and mucinous in one case each (10%), differing from the case of ovarian endometriosis‐associated cancer, in which clear cell carcinoma are more common. Conclusion: Our nationwide survey on RSEAC has revealed that: (i) the incidence of malignant transformation may be lower than ovarian endometriosis, (ii) malignant transformation from endometriosis outside the abdominal cavity may be extremely rare and (iii) the histology of RSEAC is predominantly endometrioid type, suggesting an association of a hormonal effect. [ABSTRACT FROM AUTHOR]

Aim: In the recent years, the number of cervical conization procedures performed for diagnostic or therapeutic purposes is increasing, accompanied by increased cervical neoplasia among young women. This study aimed to analyze the clinical data of patients who underwent conization in Japan. Methods: Among the 14 832 cases of conization registered in 205 facilities over 2 years (2009–2011), the data of 2409 and 12 417 patients who underwent conization for diagnostic and therapeutic purposes, respectively, were retrospectively analyzed. Results: The median age of the patients in diagnostic and therapeutic conization groups was 44 and 37 years, respectively. When comparing the diagnostic and therapeutic groups, 25.5% of the patients in the former were suspected with invasive cancer preoperatively, which is higher than that in the latter (2.7%). About 25.7% in the diagnostic and 14.1% in the therapeutic group had positive margin in the conization specimens. Additional treatment was required for 36.0% and 5.5% of the patients in the diagnostic and therapeutic groups, respectively, which are high figures for both. The risk factors of pathological upgrade in the conization specimens were diagnostic purpose, postmenopausal status and glandular lesion. Additional hysterectomy was performed in 1304 patients after conization, and pathological diagnosis was upgraded in 550 cases. Multivariate analysis revealed that postmenstrual status was an independent risk factor. Conclusion: This study revealed that cervical lesions of glandular lineage and patients with postmenopausal status benefit from diagnostic conization. However, in postmenopausal patients, the underlying disease cannot be excluded in the preserved uterus even by diagnostic conization. [ABSTRACT FROM AUTHOR]

Background: This study aimed to identify the clinical background and treatment outcomes of risk-reducing salpingo-oophorectomy (RRSO) in Japan for women with hereditary breast and ovarian cancer (HBOC). Methods: In the present retrospective observational study, we examined the Japanese HBOC Consortium's (JHC) database. This database contains 11,711 probands who received BRCA genetic testing, or their relatives, with any cancer in 2433 pedigrees. This study was supported by the registration committee of the JHC. Results: We analyzed 488 individuals diagnosed with HBOC, of which 153 (31.4%) underwent RRSO. Of the latter patients, 88 carried BRCA1 mutation (B1); 62 carried BRCA2 mutation (B2); and 3 carried both mutations. During a mean follow-up period of 2.6 years (range 0–12.6), one patient developed a primary peritoneal cancer (PPC). Clinical background comparison for individuals who underwent RRSO vs. those > 45 years of age who did not undergo RRSO revealed that significant factors were represented by B1 (p < 0.0001); child bearing (p < 0.00001); and breast cancer history (p < 0.01). However, family history of ovarian cancer and menopause status were not significantly different. Conclusion: Over 30% HBOC's in Japan underwent RRSO. In Japan, individuals with breast cancer history and B1 generally underwent RRSO, whereas those who did not bear a child mostly avoided RRSO. [ABSTRACT FROM AUTHOR]

Background: In recent years, the incidence of malignant disease in pregnancy has been increasing, but there are few large-scale surveys of malignant disease in pregnancy in Japan. The aim of this study was to survey malignant disease occurring during pregnancy in Japan.Methods: Malignant disease in pregnancy was defined as diagnosis or treatment for malignant disease, except in situ carcinoma during pregnancy, or within 1-year postpartum. First, a primary survey questionnaire of the incidence of malignant disease in pregnancy and the number of deliveries over the course of 2014 was sent to 510 medical centers in Japan. Second, the survey questionnaires on the incidence of malignant diseases in pregnancy were collected and analyzed in detail.Results: Of the 510 medical centers, 411 (81%) responded to the survey. There were 215,372 deliveries and 189 incidents (0.09%) of malignant disease in pregnancy. Of the 189 patients with malignancy, 157 detailed responses about the patients were received. The most frequently encountered cancer types were cervical cancer (36%), breast cancer (24%), and ovarian cancer (15%). During the 2 years after delivery, 15 patients (1 with breast cancer, 2 with ovarian cancer, 3 with hematologic malignancy, 4 with intestinal cancer, and 5 with others) died of the disease; most of them had advanced disease. In particular, 88% of the patients with intestinal cancers at diagnosis had advanced disease, and half of them died of disease.Conclusions: In Japan, the most common malignancies in pregnancy in order of frequency are cervical cancer, breast cancer, and ovarian cancer. Early diagnosis and appropriate management of cancer during pregnancy are important for improving maternal and neonatal outcomes, because advanced diseases have a poor prognosis. [ABSTRACT FROM AUTHOR]

Aim: To provide information including the trend of gynecological malignancies in Japan, we hereby present the Annual Patient Report for 2015 and the Annual Treatment Report for 2010 on the outcomes of patients who started treatment in 2010. Methods: The Japan Society of Obstetrics and Gynecology maintains an annual tumor registry where information on gynecological malignancies from various participating institutions is gathered. The data of patients whose treatment was initiated in 2015 were analyzed retrospectively. Survival of the patients who started treatment in 2010 was analyzed by using the Kaplan–Meier, log‐rank and Wilcoxson tests. Results: Treatment was initiated in 2015 for 7527 patients with cervical cancer, 10 119 with endometrial cancer, 6424 with ovarian cancer and 2181 with ovarian borderline tumors. This clinicopathological information was summarized as the Patient Annual Report. Prognoses were analyzed across 4309 patients with cervical cancer, 5054 with endometrial cancer and 3423 with ovarian cancer, whose treatment was initiated in 2010. The 5‐year survival rates of the patients with cervical cancer were 92.1%, 74.2%, 52.0%, and 29.8% for stages I, II, III, and IV, respectively. The 5‐year survival rates for the patients with endometrial cancer were 94.3%, 88.8%, 74.0% and 26.6% for stages I, II, III and IV, respectively. The 5‐year survival rates for the patients with ovarian cancer (surface epithelial‐stromal tumors) were 88.5%, 80.1%, 46.3% and 36.2% for stages I, II, III and IV, respectively. Conclusion: The annual tumor report is an important survey that provides knowledge on gynecological malignancy trends in Japan. [ABSTRACT FROM AUTHOR]

Background: Proactive recommendations for human papillomavirus (HPV) vaccines in Japan have been suspended for 5 years because of safety concerns. While no scientific evidence exists to substantiate these concerns, one reason given for not reinstating recommendations is the lack of reliable vaccine effectiveness (VE) data in a Japanese population. This study reports the VE of the bivalent HPV vaccine in Japanese women aged 20-22 years.Methods: During cervical screening between 2014 and 2016, women had Papanicolaou smears and HPV tests performed and provided data about their sexual history. Estimates of VE for vaccine-targeted HPV type 16 (HPV16) and 18 and cross-protection against other types were calculated.Results: Overall, 2197 women were tested, and 1814 were included in the analysis. Of these, 1355 (74.6%) were vaccinated, and 1295 (95.5%) completed the 3-dose schedule. In women sexually naive at vaccination, the pooled VEs against HPV16 and 18 and for HPV31, 45, and 52 were 95.5% (P < .01) and 71.9% (P < .01), respectively. When adjusted for number of sex partners and birth year, pooled VEs were 93.9% (P = .01) and 67.7% (P = .01) for HPV16 and 18 and HPV31, 45, and 52, respectively.Conclusions: The bivalent HPV vaccine is highly effective against HPV16 and 18. Furthermore, significant cross-protection against HPV31, 45, and 52 was demonstrated and sustained up to 6 years after vaccination. These findings should reassure politicians about the VE of bivalent HPV vaccine in a Japanese population. [ABSTRACT FROM AUTHOR]

The Japan Society of Gynecologic Oncology (JSGO) Guidelines 2017 for the Treatment of Uterine Cervical Cancer are for the purpose of providing standard treatment strategies for cervical cancer, indicating treatment methods currently considered appropriate for cervical cancer, minimizing variances in treatment methods among institutions, improving the safety of treatment and prognosis of diseases, reducing the economic and psychosomatic burden of patients by promoting performance of appropriate treatment, and enhancing mutual understanding between patients and healthcare professionals. The guidelines were prepared through consensus of the JSGO Guideline Committee, based on careful review of evidence gathered through the literature searches and in view of the medical health insurance system and actual clinical practice situations in Japan. The guidelines comprise eight chapters and five algorithms. The main features of the 2017 revision are as follows: (1) evidence was collected using a search formula and with cooperation of the Japan Library Association. The bibliographical search formula was placed at the end of the book; (2) regarding clinical questions (CQs) where evidence or clinical inspection in Japan was lacking, opinions of the Guidelines Committee were described as "proposals for future directions"; (3) cervical intraepithelial neoplasia (CIN) 3 and adenocarcinoma in situ (AIS) were treated as a cervical precancerous lesion; (4) the CQs of endoscopic surgery, radical trachelectomy, and sentinel node biopsy were newly added in Chapter 3, "primary treatment for stage IB-II cervical cancer"; and (5) the CQ about hormone replacement therapy after cancer treatment was newly established. Each recommendation is accompanied by a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here, we present the English version of the JSGO Guidelines 2017 for the Treatment of Uterine Cervical Cancer. [ABSTRACT FROM AUTHOR]

Background: In(Lu) is characterized by a reduced expression of antigens in the Lutheran blood group system as well as other blood group antigens. Mutations of the erythroid transcription factor, KLF1, have been reported to cause the In(Lu) phenotype, and we investigated Japanese In(Lu) to estimate the prevalence of the phenotype and KLF1 polymorphism.Study Design and Methods: Blood samples were screened by monoclonal anti-CD44 and the In(Lu) phenotype was confirmed by tube tests including adsorption and elution tests using anti-Lua and anti-Lub . KLF1, LU, and A4GALT genes were analyzed by polymerase chain reaction and sequencing.Results: We identified 100 of 481,322 blood donors (0.02%), and the previously characterized 20 donors, who had the In(Lu) phenotype with the LUB/LUB genotype. A total of 100 of the 120 In(Lu) individuals had mutant KLF1 alleles, and we identified 13 known and 21 novel alleles. The mutant KLF1 alleles with c.947G>A (p.Cys316Tyr), c.862A>G (p.Lys288Glu), or c.968C>G (p.Ser323Trp) were major in the In(Lu) individuals. The P1 antigen of 29 In(Lu) (two P1 /P1 , 27 P1 /P2 ) showed significantly weakened expression by hemagglutination.Conclusions: The prevalence of the In(Lu) phenotype in the Japanese population was 0.02%, and we identified 13 known and 21 novel KLF1 alleles. The KLF1 mutations cause the reduced expression of the P1 antigen. [ABSTRACT FROM AUTHOR]

Background: Most adolescents in Japan have recently been refraining from receiving the human papillomavirus (HPV) vaccine, following media reports of adverse medical events surrounding the vaccination and suspension of the Japanese governmental recommendation. We have previously reported that HPV vaccination of young girls is heavily influenced by guidance from their physicians concerning the vaccine and by the knowledge and attitude of the girls' mothers towards cervical cancer. However, it has been unclear as to how the obstetricians and gynecologists were themselves affected by the negative media reports. Methods: A questionnaire, including questions about their working status, attitudes toward HPV vaccination and about cervical cancer, and the HPV vaccination status of their daughters, was posted to obstetricians and gynecologists. Results: None of the daughters of the responding obstetrician and gynecologists received the HPV vaccination after the announced suspension of the governmental recommendation for the vaccine. The number who received the HPV vaccine in the 6th to 9th grade in 2014 was significantly lower than those in 2012 ( p = 0.012). However, 64.7 % of the responders whose daughters were eligible and in the 6th to 12th grade still intended to vaccinate their daughters in the future. Of the responders, 65 % also intended to recommend vaccination to their teenage patients. Conclusions: Our study revealed that obstetricians and gynecologists, like the general population, were negatively influenced by media reports of the adverse effect of the HPV vaccine and the suspension of the governmental recommendation. However, their intention to vaccinate their daughters was much higher than that of the general population. Restart of the governmental recommendation for HPV vaccines and better education about the HPV vaccine, including its adverse effects, and about cervical cancer and cervical cancer screening, are strongly recommended, for both the general public and for doctors, for improved prevention of cervical cancer. [ABSTRACT FROM AUTHOR]

Aim: Followingmedia reports of adverse medical events surrounding human papillomavirus (HPV) vaccination and the suspension of Japanese governmental recommendation, most adolescents have refrained from receiving the vaccine. This represents a national critical event, because the incidence of cervical cancer in Japan continues to increase. Methods: We conducted an Internet survey to investigate why Japanese adolescent girls decline, continue or discontinue their HPV vaccination, howtheirmothers influence their decision, and the mothers' feelings about future HPV vaccination for their daughters. One thousandmothers with daughters 10-18 years of age were recruited for our questionnaire. Results: Our results suggest that acceptance of the HPV vaccine was determined predominantly by the mother's perceptions of risk versus benefits, rather than the daughter's wishes. The mothers' knowledge of the benefits of the prophylactic HPV vaccine and their attitude toward cervical cancer screening influenced their decision whether to allow their daughter to receive future vaccinations. The tenor of survey responses of those mothers who were anti-vaccine changed significantly to the positive in response to a proposed scenario where the governmental recommendation for the HPV vaccine was reinstated, whereas a hypothetical educational intervention sheet did not significantly change their attitude. Conclusions: Promotion of the HPV vaccine through comprehensive education for both mothers and daughters, not only on the vaccine itself, but also about cervical cancer and screening, is required for any successful program to prevent cervical cancer. [ABSTRACT FROM AUTHOR]

Background/Aims: An intraoperative diagnosis in cases with primary and metastatic ovarian carcinomas is important for adequate treatment. The aim of the present study was to find a reliable method to discriminate primary from metastatic mucinous adenocarcinomas (MACs) of the ovary intraoperatively. Methods: Clinical features of all primary and metastatic mucinous ovarian carcinomas diagnosed from 1994 to 2008 at the Osaka University and Osaka Rosai Hospitals, Osaka, Japan, were reviewed retrospectively. Results: Among the 73 MACs, 51 (70%) and 22 cases (30%) were diagnosed as primary and metastatic ovarian carcinomas, respectively. The distributions of tumor size, patient age, and serum CA125 level were significantly different between primary and metastatic cases. Our algorithm that categorizes patients ≥50 years whose tumor size was <10 cm into metastatic cases, and patients <50 years, or the ones whose tumor size was ≥10 cm, into primary tumors, provided an 84% accuracy in our population. Conclusions: A more reliable method to discriminate primary from metastatic MACs of the ovary by patient age and serum tumor markers was derived from our study population. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: The number of young patients with cervical cancer has been increasing recently in Japan. Radical trachelectomy is a potential option for patients who wish to preserve their fertility, but its status is not clear. The present survey was conducted to clarify the status of radical trachelectomy in Japan. Methods: Questionnaires were mailed to 164 selected institutions based on tumor registration with the Japanese Obstetrics Gynecology Society. The subjects were patients undergoing radical trachelectomy between 2000 and 2008. Results: The response rate to the questionnaire was 88.4% (145/164). Radical trachelectomy was performed on 269 patients in 26 institutions (17.9%) . Most cases (74.7%, 201/269) underwent an abdominal approach. Three institutions had performed more than 21 cases (max. 61 cases), whereas 8 institutions had performed only one case. Twenty pregnancies and 13 deliveries were achieved and the frequency of delivery later than the 29th gestational week was 62% (8/13). 'Tumor size ≤2 cm (81%)' and 'stage ≤Ib1 (96%)' were commonly regarded as indications for radical trachelectomy. On the other hand, 46% of the centers did not consider the histological type as an indication. Conclusion: This survey is the first report on the current status of radical trachelectomy in Japan. It reveals a difference in the criteria for surgery applied in each institution. [ABSTRACT FROM AUTHOR]

Objective: To clarify the frequency of pregnancy complicated by ovarian endometriosis and to investigate the size change and outcome of ovarian endometriosis during pregnancy. Design: Retrospective study. Setting: Departments of obstetrics and gynecology of the Osaka University and Izumiotsu Municipal Hospitals of Osaka, Japan. Patient(s): Women who delivered between 1996 and 2007. Intervention(s): None. Main Outcome Measure(s): The frequency of pregnancies complicated by ovarian endometriosis and the size change of the lesions during pregnancy. Result(s): The frequency of ovarian endometriosis-complicated pregnancy has almost quadrupled over the last 12 years, to become the most common adnexal mass detected during pregnancy; it was 0.14% (five cases among 3558 deliveries) during the 6-year period from 1996 to 2001, but has increased to 0.52% (19 cases among 3599 deliveries) during the 6-year period from 2002 to 2007, a statistically significant increase of 3.8-fold. Among 25 ovarian endometriotic lesions observed during pregnancy in 24 women (one case had two lesions), the size of the cyst decreased in 13 lesions (52%), went unchanged in 7 (28%), and increased in 5 (20%), that demonstrated decidualization, abscess and rupture. Conclusion(s): Ovarian endometriosis during pregnancy can be safely observed conservatively; however, further investigation is required to predict the occurrence of abscess formation or rupture of ovarian endometriosis, and to distinguish the enlargements due to malignant transformation from those related to decidualization. [Copyright &y& Elsevier]

Cervical intraepithelial neoplasia (CIN) has its highest incidence during women's reproductive years. During 2 sequential 7-year periods, 1994 to 2000 and 2001 to 2007, 3695 and 3894 deliveries were performed, respectively, at Osaka University Hospital. CIN was detected in 21 cases (0.57%) during 1994-2000 and in 43 cases (1.1%) during 2001-2007. By comparison, cervical intraepithelial neoplasia-complicated pregnancies increased significantly in the latter period (P = .015 by Fisher exact test, Odds ratio = 1.95; 95%CI: 1.16-3.30). We observed CIN regression in 34 (76%) of 45 cases of vaginal delivery and in 6 (50%) of 12 cases of cesarean delivery, indicating that the outcome of an initially diagnosed CIN and the delivery routes appeared not to be significantly related. However, a different result was obtained when only those patients whose CIN lesions persisted until the delivery were analyzed. Among the 35 such cases in the vaginal delivery group, 24 cases (69%) regressed after the delivery; in 8 such cases from the cesarean delivery group, only 2 cases (25%) regressed afterward. Our study clearly shows that pregnancy complicated with CIN is increasing rapidly in Japan. We also find that there is a significantly more frequent postpartum regression of biopsy-proven CIN lesions following a vaginal delivery compared to cesarean section (P = .042 by Fisher exact test, Odds ratio = 6.55; 95% CI: 1.13-37.8). [ABSTRACT FROM AUTHOR]

In Japan, government subsidies for human papillomavirus (HPV) vaccination of girls aged 13–16 commenced in 2010. By early 2013, vaccination had become a widely accepted national immunization program. However, in June of 2013, the Ministry of Health, Labor, and Welfare (MHLW), the government's lead agency, suspended its recommendation for vaccination in response to reports of adverse vaccine events. The rate of HPV vaccination quickly dropped from 70% to almost zero, where it has lingered for eight years. In 2020, a new 9-valent HPV vaccine was licensed in Japan. The momentum seemed to be building for the resumption of HPV vaccinations, yet Japanese mothers remain widely hesitant about vaccinating their daughters, despite the well-proven safety and efficacy of the HPV vaccines. The Japanese government and our educational and medical institutions must work harder as a team to inform our parents and their children about the life-saving benefits of the HPV vaccine, and at the same time, we must respond to all their concerns and questions. The vaccine hesitancy of unvaccinated women born in 2000 and thereafter is a natural consequence of the suspension of the government's recommendation. We must also take every possible measure to reduce the significant risk for cervical cancer these women have. [ABSTRACT FROM AUTHOR]

Background: The human papillomavirus (HPV) vaccination rate in Japan has fallen to nearly zero since the suspension of governmental proactive recommendations in 2013, owing to the development of purported adverse events.Objective: This study aimed to evaluate the effects of a brief web-based educational intervention using the theory of behavioral insights on the willingness of adults to consider the HPV vaccine for their daughters and sons.Methods: We recruited 1660 participants aged 20 years or older in March 2018 via a webpage and provided them with a 10-item questionnaire related to the following aspects: awareness regarding HPV infection and vaccination, willingness for immunization, and actions for prevention. We randomly stratified participants based on sex and age with or without a brief educational intervention involving scientific information presented in an easy-to-read format.Results: Only 484 (29.2%) of the respondents were aware of the benefits of HPV vaccination. Although only 352 (21.2%) of the respondents displayed a willingness for immunization of their daughters, there were 40 (4.8%) more respondents in the intervention group with this willingness (adjusted odds ratio [aOR] 1.32, 95% CI 1.04-1.69). In a subanalysis, the willingness toward vaccination for daughters in men was significantly higher in the intervention group (aOR 1.46, 95% CI 1.05-2.02). However, such a difference was not observed among women (aOR 1.20, 95% CI 0.83-1.73).Conclusions: This study suggests that a brief web-based educational intervention increases the willingness of adults to consider the HPV vaccine for their children, especially among men. Thus, providing adequate information to men may be a useful strategy to improve the currently low rates of HPV vaccination.Trial Registration: UMIN Clinical Trials Registry UMIN000049745 (UMIN-CTR); https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049745. [ABSTRACT FROM AUTHOR]

Recommendations for HPV vaccines were suspended in 2013 due to unfounded safety fears in Japan. We aimed to clarify the differences between vaccinated and unvaccinated females in their awareness, knowledge, and behaviors toward cervical cancer, HPV vaccination and sex. Questionnaires were administered online to women aged 16 to 20. We conducted investigations for the following: awareness, knowledge, and actions for cervical cancer, HPV vaccination, and sexual activity, as well as items related to participants' social background. The survey in 828 girls revealed three points. The first is that more than half of the surveyed Japanese girls had poor knowledge about cervical cancer screening, HPV, or HPV vaccines. The second is that those in the unvaccinated group had a particularly poor knowledge of the subject and tended to have higher sexual activity. The final is that only 0.5% of the girls experienced changes in awareness about sexual activity after vaccination. In conclusion, this is the first large-scale survey analyzing the association between HPV vaccination and sexual activity in Japanese girls. Not only do unvaccinated girls not benefit from vaccines, but they also tend to engage in high-risk sexual behavior, and thus it is even more important to provide information on the effectiveness of vaccines and the usefulness of cancer screening. [ABSTRACT FROM AUTHOR]

The trend for cervical cancer in younger women has been increasing recently in Japan. However, as a result of the suspension of governmental recommendation, Japan's HPV (human papillomavirus) vaccination rate for girls born since 2000 has dropped sharply. We conducted an internet survey in December of 2019, 76 months after the suspension of recommendation, to verify the intention of mothers to inoculate their daughter under current circumstances and compared with our previous surveys and leaflet intervention effect. The rates of mothers who replied that they would "inoculate" were significantly higher at 9 and 23 months, but by 32 months after the suspension the rate was significantly lower (p < 0.05, p < 0.05, p < 0.05, respectively). The rates of the mothers who replied they would not inoculate were significantly lower at 9 months and 23 months, but at 76 months was significantly higher (p < 0.05, p < 0.05, p < 0.05, respectively). We found that intervention with a leaflet that could be used under the current suspension of the governmental recommendation did not increase the mothers' intention to inoculate their daughters. A leaflet that actively encourages vaccination may increase the intent of vaccination. It is strongly recommended that the MHLW promptly resume its recommendations for HPV vaccination. [ABSTRACT FROM AUTHOR]

Organized human papillomavirus vaccination (OHPV) in Japan was introduced in 2010 for girls aged 12–16 years who were born in 1994 or later. The rate of OHPV coverage was 70–80%. However, after suspension of the government vaccination recommendation, the coverage dramatically decreased. We aim to investigate the change in prevalence of HPV infection after the initiation of HPV vaccination. We recruited females aged 20–21 years attending public cervical cancer screening from 2014 to 2017 fiscal years (April 2014 to March 2018). Residual Pap test specimens were collected for HPV testing. We compared the prevalence of HPV type-specific infection between women registered in 2014 (born in 1993–1994, including the pre-OHPV generation) and registered in 2015–2017 (born in 1994–1997, the OHPV generation). We collected 2379 specimens. The vaccination coverage figures were 30.7%, 86.6%, 88.4% and 93.7% (p < 0.01) from 2014 to 2017, respectively. The prevalence of HPV16/18 infection significantly decreased from 1.3% in 2014 to 0% in 2017 (p = 0.02). The three most prevalent types were HPV52, 16 and 56 in 2014, and HPV52, 58 and 56 in 2015–2017, respectively. HPV16 and 33 infection rates decreased. On the other hand, the HPV58 infection rate was obviously increased after OHPV from 0.3% to 2.1%. Our study demonstrates that the prevalence of HPV16/18 infection dramatically decreased and the profile of type-specific HPV infection was changed after OHPV. [ABSTRACT FROM AUTHOR]

The Japanese government suspended proactive recommendations for the HPV vaccine in June 2013. The suspension is now in its seventh year, despite all the data pointing to the safety of the HPV vaccine. We reported a high vaccine effectiveness in the group of women vaccinated before their first intercourse (93.9%). The prevalence of cross-protected types of HPV 31/45/52 was also lower in the vaccinated group, and the vaccine effectiveness was 67.7%. Furthermore, prevalence of HPV16, 31 and 52 infection rates in the vaccinated group were obviously lower than that in the unvaccinated group, and no one had HPV18 or 45 infection in the vaccinated group. The addition of a cross-protective effect toward HPV types 31/45/52 to HPV types 16/18, which is the direct target of the bivalent HPV vaccine, may possibly prevent around 82% of invasive cervical cancer cases in Japan. With regard to the preventive effect of histological abnormalities, we also reported significant reduction in incidence of cervical intraepithelial neoplasia (CIN)3 or worse. Thus, the efficacy of the vaccine has been demonstrated for precancerous disease, and the diverse symptoms after HPV vaccination are likely functional somatic. For the future of Japanese girls, there is a need to resume the proactive recommendation of HPV vaccination and for immediate action to be taken by the Japanese government. [ABSTRACT FROM AUTHOR]

Background: To examine trends in the clinicopathological characteristics of vulvar cancer in Japan. Methods: This is a nationwide retrospective study examining consecutive women with vulvar cancer between 2001 and 2010 in Japan (n = 1061). Temporal trends in demographics, tumor characteristics, and survival were assessed by cohort-level analysis. The National Cancer Institute's Surveillance, Epidemiology, and End Result Program was used for external validation (n = 10,154). Results: The number of oldest-old women aged ≥80 years significantly increased (from 18.0% in 2001 to 30.6% in 2010; 70.5% relative increase) in the study period. A stage shift was observed, with stage I disease decreasing from 43.0% to 34.0% (21.0% relative decrease), and tumors with distant metastases increasing from 23.2% to 35.6% (53.3% relative increase, p < 0.05). The number of women who underwent surgical treatment decreased from 84.0% to 69.7% (17.0% relative decrease), whereas utilization of radiotherapy increased from 34.4% to 43.2% (25.7% relative increase) over time (p < 0.05). In the cohort-level analysis, the five-year survival rates significantly decreased from 2001 to 2010 (p < 0.05), specifically, 66.9% to 51.0% for progression-free survival (23.7% relative decrease), 79.5% to 67.9% for cause-specific survival (14.6% relative decrease), and 74.9% to 62.3% for overall survival (16.9% relative decrease). In the patient-level analysis, oldest-old women were less likely to undergo surgical treatment and were independently associated with decreased survival (p < 0.05). In the US cohort, the number of oldest-old women (25.2% to 27.8%) and the five-year cause-specific survival rate (81.8% to 79.9%) remained unchanged during the study period (p > 0.05). Conclusion: Demographics and outcomes of vulvar cancer in Japan significantly changed during the study period. An increasing oldest-old population and a stage shift to more metastatic disease resulted in a cohort-level decrease in survival rates. [ABSTRACT FROM AUTHOR]

Background: Malignancy during pregnancy has become a significant cause of maternal death in developed countries, likely due to both an older pregnant population, and increases of cervical cancer in younger women. Our aim is to investigate the clinical aspects of malignancy during pregnancy in Japan and to use this information to identify opportunities for earlier detection and treatment.Methods: We provided a questionnaire to 1508 secondary or tertiary care hospitals in Japan. We reviewed the clinical characteristics of cases with malignancy during pregnancy for the period of January to December, 2008. From the 760 institutions which responded, we obtained clinical information for 227 unique cases. The questionnaire provided clinical information, including disease site, pregnancy outcome and how the disease was detected.Results: The most common type of malignancy was cervical cancer (n = 162, 71.4%) followed by ovarian (n = 16, 7.0%) and breast cancer (n = 15, 6.6%). Leukemia (n = 7, 3.1%), colon cancer (n = 5, 2.2%), gastric cancer (n = 5, 2.2%), malignant lymphoma (n = 4, 1.8%), thyroid cancer (n = 3, 1.3%), brain cancer (n = 3, 1.3%), endometrial cancer (n = 2, 0.9%), and head and neck cancer (n = 2, 0.9%) accounted for the remaining cases. Overall, gynecological malignancies accounted for 79.3% (95% confidence interval 74.0-84.6) of pregnancy associated malignancies diagnosed in the present study. The majority of cervical cancers, 149 (92.0%) of 162, were diagnosed by a Pap (Papanicolaou) smear during early gestation. Ten (62.5%) of the ovarian cancer cases were diagnosed by ultrasonography during a prenatal checkup or at the time of initial pregnancy diagnosis. Out of 14 breast cancers, only one (7.1%) was diagnosed by screening breast exam.Conclusions: From this study, we reaffirm the clear and significant benefits of prenatal checkups starting at an early gestational age for the detection of gynecological cancers during pregnancy. Conversely, breast cancer detection during pregnancy was poor, suggesting new strategies for early identification of this disease are required. [ABSTRACT FROM AUTHOR]

• This is the first case of endometrial cancer after pancreas transplantation in Japan. • Carcinogenesis after pancreas transplantation may be a lethal late complication. • It is important to carry out regular screening examinations with carcinogenesis in mind. As the number of long-term survivors after organ transplantation increases, malignancy has become a problem as a late complication. We herein report a case of endometrial cancer during the follow-up of pancreas transplantation after kidney transplantation. A 49-year-old woman was diagnosed with endometrial cancer. The patient had developed type 1 diabetes at 8 years old and started insulin treatment, and at 29 years old, she started hemodialysis for diabetic nephropathy. At 31 years old, she received living donor kidney transplantation and withdrew from dialysis. Hypoglycemia unawareness began to occur frequently from around 36 years old, and at 48 years old, the patient underwent deceased donor pancreas transplantation after kidney transplantation and achieved insulin independence. At 49 years old, she was diagnosed with endometrial cancer. Surgical treatment (total abdominal hysterectomy with left salpingo-oophorectomy) was performed. The pathologic diagnosis was confirmed as stage 1A uterine endometrioid carcinoma grade 1. The postoperative course was uneventful. She was discharged from our hospital on postoperative day 8. There has been no evidence of recurrence and/or metastasis of endometrial cancer for 16 months since the surgery. Carcinogenesis after pancreas transplantation may be a lethal late complication. It is important to carry out regular screening examinations with carcinogenesis in mind. [ABSTRACT FROM AUTHOR]

To examine the association between surgical margin status and recurrence pattern in invasive vulvar Paget's disease. This is a preplanned secondary analysis of a previously organized nationwide retrospective study in Japan (JGOG-1075S). Women with stage I-IV invasive vulvar Paget's disease who received surgical treatment from 2001-2010 were examined (n =139). Multivariable analysis was performed to assess local-recurrence, distant-recurrence, and all-cause mortality based on surgical margin status. The median age was 70 years. The majority had stage I disease (61.2%), and the median tumor size was 5.0cm. Nodal metastasis was observed in 15.1%. Simple vulvectomy (46.0%) was the most common surgery type followed by radical vulvectomy (28.1%). More than half received vulvar reconstructive surgery (59.0%). Positive surgical margin was observed in 35.3%, and close margin <1cm was observed in 29.5%. Vulvectomy type was not associated with surgical margin status (P =0.424). The median follow-up was 5.8 years. Positive surgical margin was associated with increased local-recurrence (5-year cumulative rates for positive versus negative margin: 35.8% versus 15.0%, P =0.010) but not distant-recurrence (18.3% versus 16.0%, P =0.567). Positive surgical margin was also associated with increased all-cause mortality (5-year overall survival rates for positive versus negative margin: 72.6% versus 88.2%, P =0.032). In multivariable analysis, positive surgical margin remained an independent factor associated with increased risk of local-recurrence (hazard ratio 2.80, 95% confidence interval 1.18-6.63) and all-cause mortality (hazard ratio 2.87, 95% confidence interval 1.20-6.83). Positive surgical margin appears to be common in invasive vulvar Paget's disease that is associated with increased local-recurrence and all-cause mortality risks. Role of alternative surgical technique or adjuvant therapy merits further investigation to improve local disease control. • Positive surgical margin was common after vulvectomy for invasive vulvar Paget's disease (35.3%). • Vulvectomy type was not associated with surgical margin status • Positive surgical margin was associated with increased risk of local-recurrence but not distant-recurrence • Positive surgical margin was associated with decreased overall survival in invasive vulvar Paget's disease [ABSTRACT FROM AUTHOR]

Vulvar cancer is a rare malignancy in the aging population, and optimizing treatment strategies requires large-scale investigation of the clinicopathological features of this disease. In Japan, no such surveys have been conducted in the past 30 years. This large-scale retrospective multi-center study aimed to examine the clinicopathological features of vulvar cancer in Japan. Upon obtaining ethical approval by the participating institutions' review boards, the medical records of patients with vulvar cancer, who were treated between 2001 and 2010 were reviewed. The impact of clinicopathological factors on overall survival (OS) was investigated using a multivariate Cox regression model. After applying the inclusion and exclusion criteria, 1068 patients treated in 108 centers were included. The median age was 72 years. The disease was in stage I in 402 patients (37.6%), stage II in 249 patients (23.3%), stage III in 252 patients (23.6%), and stage IV in 165 patients (15.4%). Squamous cell carcinoma, Paget's disease, adenocarcinoma, and other diseases were diagnosed in 773 (72.4%), 154 (14.4%), 59 (5.5%), and 82 (7.7%) patients, respectively. Positive inguino-femoral lymph nodes were found in 265 (24.8%) patients. The 5-year OS rate for stage I, II, III, and IV vulvar cancer were 85.6%, 75.1%, 48.8%, and 40.0%, respectively. Our study shows that advanced age, disease stage, histological diagnosis, tumor diameter, and lymph node metastases significantly affect the OS of patients with vulvar cancer in Japan. • Clinicopathological features of vulvar cancer and the survival of treatment methods in 1068 patients treated in Japan. • No large-scale clinicopathological studies reported in Japan for the past 30 years. • This study provides up-to-date data on vulvar cancer using a large patient population from the JGOG institutions. [ABSTRACT FROM AUTHOR]

To propose an ideal patient candidate with early-stage cervical cancer for undergoing fertility-sparing trachelectomy. This nationwide, multicenter, retrospective study was conducted by the Japan Society of Obstetrics and Gynecology involving women aged <45 years with clinical stage I-II cervical cancer who had planned fertility-sparing trachelectomy and pelvic lymphadenectomy between 2009 and 2013 (n = 393). Ideal candidates were defined to have a tumor size of ≤2 cm, no lymph node metastasis, no deep stromal invasion, and no high-risk histology (n = 284, 69.6%). Less-ideal candidates were defined to have any one of these four characteristics (n = 109, 30.4%). Propensity score inverse probability of treatment weighting was used to assess survival outcomes. Less-ideal candidates were more likely to undergo hysterectomy conversion (22.9% versus 3.2%), receive postoperative radiotherapy (11.9% versus 0.4%), or chemotherapy (32.1% versus 3.2%) compared with ideal candidates (all, P < 0.05). The weighted model revealed that among those who underwent trachelectomy (ideal candidates, n = 275 and less-ideal candidates, n = 84), less-ideal candidates had significantly decreased disease-free survival (5-year rates: 85.5% versus 95.5%; HR 3.93, 95% CI 1.99–7.74; P < 0.001) and cause-specific survival (92.5% versus 98.6%; HR 5.47, 95% CI 1.68–17.8, P = 0.001) compared with ideal candidates. Similarly, less-ideal candidates were significantly associated with decreased disease-free survival compared with ideal candidates among those who were young age, had small tumors or squamous histology, and underwent surgery alone (all, P < 0.05). Less-ideal candidates had approximately four-fold higher recurrence risk and cancer mortality compared with ideal candidates. Ideal candidates for fertility-sparing trachelectomy for early-stage cervical cancer proposed in our study may be useful as the future framework for developing guidelines for fertility-sparing trachelectomy in Japan. • A retrospective study was performed for 393 women underwent fertility-sparing trachelectomy for stage I-II cervical cancer. • Women without tumor size>2cm, deep stromal invasion, nodal metastasis, or high-risk histology may be ideal candidates. • Less-ideal candidates had approximately four-fold higher recurrence risk and mortality compared with ideal candidates. • Adjuvant chemotherapy for women with large tumors may have benefit for the purpose of fertility preservation. [ABSTRACT FROM AUTHOR]

To examine the trends of epithelial ovarian cancer histologic subtypes in Japan. A nationwide retrospective registry study was performed between 2002 and 2015 (Japan cohort, n = 48,640). Trends were also examined in The Surveillance, Epidemiology, and End Results Program (US cohort, n = 49,936). Time-specific proportional changes of four major histological subtypes (serous, clear cell, endometrioid, and mucinous) were examined. The Japan cohort had more stage I disease (44.1% versus 24.9%) and less stage IV disease (10.0% versus 23.1%) than the US cohort (P < 0.001). The Japan cohort had more non-serous histology, particularly clear cell carcinoma (26.9% versus 8.4%), than the US cohort (P < 0.001). In the Japan cohort, proportion of clear cell carcinoma increased significantly from 23.4% to 29.1% between 2002 and 2010 (P < 0.001). Among stage I disease, clear cell carcinoma increased significantly in the Japan cohort from 32.9% to 40.3% between 2002 and 2015 (P < 0.001), whereas mucinous carcinoma increased significantly in the US cohort from 15.0% to 24.8% (P = 0.01). In 2015, clear cell carcinoma was most common among women aged <50 years from the Japan cohort (30.2%) versus serous carcinoma in the US cohort (50.8%). In the Japan cohort, the peak age was 75 years for serous, 57 for clear cell, and 45 for endometrioid carcinoma (P < 0.001). Mucinous carcinoma decreased until 43 years and increased again after age 73 years (P < 0.001). Characteristics of epithelial ovarian cancer in Japan are largely different compared to the US. In Japan, clear cell carcinoma has increased significantly in recent years to account for nearly 30% of epithelial ovarian cancer. • The trends in four major histological subtypes of epithelial ovarian cancer (EOC) in Japan and the US were examined. • The characteristics of the histological subtypes of EOC in Japan are distinct from those in the US. • The frequency of clear cell carcinoma has increased in Japan, accounting for almost 30% of EOC in recent years. • The frequency of mucinous carcinoma has increased significantly among elderly in both countries. [ABSTRACT FROM AUTHOR]

The incidence of cervical cancer has been increasing, especially in younger generation, in Japan. The females born between 1994 and 1999, who achieved rates of HPV vaccination approaching 70%, have become the target of cervical cancer screening programs. Here, we have analyzed the cervical cancer screening rates among the vaccinated and unvaccinated women. The survey data for cervical cancer screening at age 20 in FY 2015 was derived from two cities, Toyonaka and Iwaki. Among 2,727 females, in Toyonaka and Iwaki, who were born in FY 1995 and targeted in FY 2015 at age 20 for cervical cancer screening, their HPV vaccination rate was 64.2% (1,753/2,727). The screening rate was 6.4% (112/1,753) in the vaccinated and 3.9% (38/974) in the unvaccinated. This difference was statistically significant (p < 0.01). We have demonstrated that HPV-vaccinated females tended to be effectively protected from future cervical cancer than the unvaccinated. [ABSTRACT FROM AUTHOR]

In 2013, following the Ministry of Health, Labor and Welfare (MHLW)'s announced suspension of its vaccine recommendation due to media reports of "adverse events", HPV vaccination dropped to almost 0%. Here, we analyzed, by birth year, the cumulative vaccinations for girls up to age 16 (maximum age for public subsidies) and the results of cervical cancer screening in Matsuyama City. The incidence of CIN3 or worse was 0.09% (7/7872) for these unvaccinated generation born between 1991 and 1993, and 0.00% (0/7389) for the vaccination generation born between 1994 and 1996. This study is the first to show the significant reduction in incidence of CIN3+depending on birth year in Japan. We must keep in mind that the unacceptable high risk for cervical cancer has already begun for an entire new generation of unvaccinated girls born in or after 2000. This data encourages a resumption of MHLW's recommendation for HPV vaccination. [ABSTRACT FROM AUTHOR]

Homologous recombination deficiency (HRD) is a well-known biomarker of PARP inhibitor sensitivity. The Cancer Genome Atlas (TCGA) has clarified that about 50% of high-grade serous ovarian cancer shows HRD. However, the frequency of HRD in Japanese patients with ovarian cancer remains unclear. The aim of JGOG3025 study (NCT03159572) is to identify the frequency of HR-associated gene mutations in ovarian cancer, especially non-serous histologic types. The JGOG3025 study is a collaborative prospective observational study involving 65 study sites throughout Japan. We recruited 996 patients who were clinically diagnosed with ovarian cancer before surgery from March 2017 to March 2019, and 711 patients were eligible for JGOG3025 criteria. After central pathological review, we used frozen tumor tissues to extract DNA and performed targeted sequencing for 51 HR-associated genes in 711 ovarian cancers (298 high-grade serous, 189 clear cell, 142 endometrioid, 15 mucinous, 4 low-grade serous, and 63 others). To focus on pathogenic mutations of HR-associated genes which led to HRD, we used only loss-of-function (LOF) mutations (nonsense, readthrough, and frameshift) to perform subsequent analysis. At least one HR-associated gene was mutated in 105 high-grade serous (35.2%), 21 clear cell (11.1%), 36 endometrioid (25.4%), 1 low-grade serous (25.0%) carcinomas. Although 81.8% of ovarian cancers with BRCA1 LOF mutation were diagnosed as high-grade serous type, one case of mucinous carcinoma harbored BRCA1 c.1961delA. On the other hand, 71.4% of ovarian cancers harboring BRCA2 LOF mutation were high-grade serous type. Mutant allele frequencies of BRCA1 and RAD51D were apparently higher than that of other HR-associated genes, suggesting allelic imbalance. Our findings demonstrated that mutations in HR-associated genes were detected in not only high-grade serous but also non-serous histologic type ovarian cancers. To clarify the frequency of HRD in Japanese patients with ovarian cancer, we need to assess the pathogenicity of missense mutations and investigate the correlation between HR associated gene mutations and HRD score based on copy number assay. [ABSTRACT FROM AUTHOR]

To examine the association between surgical margin status and recurrence pattern in invasive vulvar Paget's disease. This is a preplanned secondary analysis of previously organized nationwide retrospective observational study in Japan (JGOG-1075S). Women with stage I-IV invasive vulvar Paget's disease who received surgical treatment from 2001-2010 were examined (n=139). Multivariable analysis was used to assess local-recurrence, distant-recurrence, and all-cause mortality based on surgical margin status. The median age was 70 years. The majority had stage I disease (61.2%), and the median tumor size was 5.0cm. Nodal metastasis was observed in 15.1%. Simple vulvectomy (46.0%) was the most common surgery type followed by radical vulvectomy (28.1%). More than half received vulvar reconstructive surgery (59.0%). Positive surgical margin was observed in 35.3%, and close margin <1cm was observed in 29.5%. Vulvectomy type was not associated with surgical margin status (P =0.424). The median follow-up was 5.8 years, and positive surgical margin was significantly associated with local-recurrent (5-year cumulative rates for positive versus negative margin: 38.0% versus 15.0%, P =0.005) but not distant-recurrence (20.5% versus 16.0%, P =0.388). Positive surgical margin was also associated with all-cause mortality (5-year overall survival rates for positive versus negative margin: 72.6% versus 88.2%, P =0.032). In multivariable analysis, positive surgical margin remained an independent factor associated with increased risk of local-recurrence (hazard ratio 3.32, 95% confidence interval 1.29-8.53) and all-cause mortality (hazard ratio 2.87, 95% confidence interval 1.20-6.83). [Display omitted] Positive surgical margin appears to be common in invasive vulvar Paget's disease that is associated with increased local-recurrence and all-cause mortality risks. Role of alternative surgical technique (e.g., Mohs micrographic surgery) or adjuvant therapy (e.g., imiquimod) merits further investigation to improve local disease control. [ABSTRACT FROM AUTHOR]

To examine the effect of hospital treatment volume on overall survival outcomes with gynecologic malignancies in Japan. This society-based retrospective study in Japan included women with gynecologic malignancies who diagnosed from 2004-2015. The association between the annual hospital treatment volume (aHTV) and overall survival (OS) was examined per tumor type using a multivariable Cox proportional hazards model with restricted cubic splines. Institutions were categorized into 3 groups based on fractional proportions: High- (1-10 percentile), moderate- (11-50 percentile), and low- (51-100 percentile) volume centers. A total of 206,845 women (Endometrial cancer n=80,741, cervical cancer n=73,647, and ovarian cancer n=52,457) at 431 hospitals were identified. There were 43 high-volume centers (34.6%, 40.5%, 31.5% of cases for endometrial, cervical, and ovarian cancer, respectively), 186 moderate-volume centers (50.3%, 49.8%, and 50.7% of cases), and 202 low-volume centers (15.1%, 9.8%, and 17.8% of cases) in the study sample. Among high-volume centers, the median annual hospital treatment volume were 52 (interquartile range (IQR), 44-71), 59 (IQR 50-80), and 34 (IQR 29-41) cases for endometrial, cervical, and ovarian cancer. Women treated at high-volume centers were younger, more likely to have rare tumor histology and to have undergone surgical management (P <0.001). During the study period, the proportion of high-volume centers decreased, whereas that of low-volume centers increased significantly (P <0.001) for all gynecologic tumors. Compared with low-volume centers, treatment at high-volume centers was associated with a reduction in overall mortality: adjusted-hazard ratio (aHR) 0.81, 95% confidence interval (CI) 0.76-0.87, aHR 0.77, 95% CI 0.73-0.83, and aHR 0.93, 95% CI 0.88-0.97 in endometrial, cervical, and ovarian cancer, respectively. Among initial surgical cases, the magnitude of statistical significance for overall survival was larger than that for the entire cohort across the three malignancies (aHR: 0.82; 0.86; and 0.89 for endometrial, cervical, and ovarian cancer). [Display omitted] High-volume centers were associated with a higher likelihood of improved overall survival outcome in women with gynecologic malignancies in Japan. Centralization of cancer treatment may improve survival outcomes. [ABSTRACT FROM AUTHOR]

This is a secondary exploratory analysis of a previously organized nationwide retrospective observational study in Japan (JGOG-1075S). This nationwide study examined consecutive 1,061 women with stage I-IV vulvar cancer, who received primary treatment care at 109 JGOG-affiliated centers from 2001-2010. The primary objective of analysis was to examine the association between hospital treatment volume of vulvar cancer and survival outcome. For the exposure allocation, hospital treatment volume over the 10-year study period was collected for any treatment modality that involved primary therapy after the vulvar cancer diagnosis. For the outcome measures of survival endpoint, progression-free survival and overall survival were assessed. Cox proportional-hazard regression models with restricted cubic spline transformation were fitted for analysis. [ABSTRACT FROM AUTHOR]

Objective: Hospital treatment volume affects survival in patients with endometrial cancer; notably, initial treatment at high-volume centers improves survival outcomes. Our study assessed the effect of hospital treatment volume on cost-effectiveness and survival outcomes in patients with endometrial cancer in Japan., Methods: A decision-analytic model was evaluated using the following variables and their impact on cost-effectiveness: 1) hospital treatment volume (low-, intermediate-, and high-volume centers) and 2) postoperative recurrent risk factors based on pathological findings (high- and intermediate-risk or low-risk). Data were obtained from the Japan Society of Obstetrics and Gynecology database, systematic literature searches, and the Japanese Diagnosis Procedure Combination database. Quality-adjusted life years (QALY) was used as a measure of effectiveness. The model was built from a public healthcare perspective and the impact of uncertainty was assessed using sensitivity analyses., Results: A base-case analysis showed that the incremental cost-effectiveness ratio at high-volume centers was below a willingness-to-pay (WTP) threshold of ¥5,000,000 with a maximum of ¥3,777,830/4.28 QALY for the high- and intermediate-risk group, and ¥2,316,695/4.57 QALY for the low-risk group. Treatment at the high-volume centers showed better efficiency and cost-effectiveness in both strategies compared to intermediate- or low-volume centers. Sensitivity analyses showed that the model outcome was robust to changes in input values. With the WTP threshold, treatment at high-volume centers remained cost-effective in at least 73.6% and 78.2% of iterations for high- and intermediate-risk, and low-risk groups, respectively., Conclusion: Treatment at high-volume centers is the most cost-effective strategy for guiding treatment centralization in patients with endometrial cancer., Competing Interests: Honorarium, Bristol Myers Squibb (H.M) and none for others., (© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

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., Competing Interests: No potential conflict of interest relevant to this article was reported., (© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)