Objective: DUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E. Methods: Patients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigatorassessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset. Results: In the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32–1.12) and durvalumab + olaparib (0.44, 95% CI=0.22–0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents. Conclusion Efficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/ paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.

The Japan Society of Gynecologic Oncology (JSGO) guideline for the treatment of uterine body neoplasm are revised from the 2018 guideline. This guideline aimed to provide standardized care for uterine body neoplasm, indicate appropriate current treatment methods for uterine body neoplasm, minimize variances in treatment methods among institutions, improve disease prognosis and treatment safety, reduce the economic and psychosomatic burden on patients by promoting the performance of appropriate treatment, and enhance mutual understanding between patients and healthcare professionals. The guidelines were prepared through the consensus of the JSGO guideline committee, based on a careful review of evidence from the literature searches and the medical health insurance system and actual clinical practice situations in Japan. The main features of the 2023 revision are as follows: 1) The Guidelines Formulation Committee members were asked to understand Minds' medical guideline development method in advance. 2) The clinical question (CQ) was changed to Patient, Intervention, Comparison, Outcome format as much as possible. 3) Introduced the "body of evidence," which summarizes the results of research reports collected for the CQs by outcome and study design, and the strength of evidence for each body of evidence was rated from levels A to D. 4) Introduction of systematic reviews in some CQs. 5) The strength of evidence, the balance of benefits and harms, value and hope for patients, and clinical applicability were considered while drafting recommendations. Herein, we present the English version of the JSGO guidelines 2023 for the treatment of uterine body neoplasm.

Coronavirus disease 2019 (COVID-19) has spread rapidly in Japan. The purpose of this study was to report the clinical experience of our COVID-19 patients early in the pandemic and lessons from our experience. An outpatient fever clinic was established on April 7. Admission of COVID-19 patients was started on July 23. Between April 7 and September 30, there were 364 walk-in outpatients and emergency patients with fever. Polymerase chain reaction test for SARS-CoV-2 RNA or COVID-19 antigen test were performed in all patients, and all results were negative. Twenty patients with COVID-19 were admitted to a newly established dedicated COVID-19 ward. They were discharged well. There were no cases of nosocomial infection at our hospital. Length of hospitalization was correlated with serum ferritin level at admission, serum CRP level at admission, and age. More than half the patients experienced psychological stress, and COVID-19 specialized nurses experienced some stress. It is essential to set up the medical system for COVID-19 according to the trends of the disease. Creation of our original database and our “problem notebook” were useful for treatment and care of COVID-19 patients as well as for mental care of nurses.

OBJECTIVE: To develop and validate a 3-year recurrence prediction score (RPS) system for predicting the baseline risk of recurrence of stage I–II endometrial carcinoma. METHODS: We reviewed 427 patients with International Federation of Gynecology and Obstetrics staging I–II endometrial carcinoma underwent surgery without any adjuvant therapy from 2005 to 2013. The patients were divided into 2 groups: the test cohort (n=251) comprising those who underwent surgery in odd-numbered years, and the validation cohort (n=176) comprising those who underwent surgery in even-numbered years. Multivariate analysis was performed using 7 candidate predictors to identify the risk factors for 3-year recurrence-free interval (RFI) in the test cohort. Each risk factor was scored based on logistic regression analyses of the test data set, and the sum of the risk factor scores was defined as the RPS system. We then applied the system in the validation cohort. RESULTS: Multivariate analysis revealed that the significant risk factors were age ≥60 years, pathological type II, positive cervical stromal invasion, and positive peritoneal cytology. In the test cohort, the 3-year RFI rates were 100%, 95.8%, 79.9%, and 33.3% for RPSs of 0, 1, 2, and 3, respectively. In the validation cohort, the 3-year RFI was significantly higher in the low-RPS group (RPS 0 or 1) than in the high-RPS group (RPS 2 or 3) (95.2% vs. 79.9%, p < 0.01). CONCLUSIONS: The RPS system shows significant reproducibility for predicting the baseline risk of recurrence. The system could potentially impact the choice of adjuvant therapy for stage I–II endometrial carcinoma.
Cohort Studies ; Dataset ; Endometrial Neoplasms* ; Female ; Gynecology ; Humans ; Logistic Models ; Multivariate Analysis ; Obstetrics ; Recurrence* ; Risk Factors

OBJECTIVE: Though there are no evidences that postoperative therapy improves overall survival (OS) in stage I–II endometrial carcinoma, many women receive postoperative radiation or chemotherapy. This study aimed to investigate the baseline risk of recurrence after complete resection without any adjuvant therapies and to suppose the validity of postoperative therapy for stage I–II endometrial carcinoma. METHODS: Charts for patients with stage I–II endometrial carcinoma who underwent operation without postoperative therapy between January 2005 and December 2011 were retrospectively reviewed and the baseline risk of recurrence and prognosis were assessed. Risk classifications were performed according to European Society for Medical Oncology (ESMO) clinical practice guidelines and Japanese guideline written by Japan Society of Gynecologic Oncology Group. RESULTS: Among 374 patients who underwent complete resection, 311 were evaluable. Five-year recurrence rates by ESMO and Japanese were 2.6% and 3.1% in low-risk, 9.2% and 6.6% in intermediate-risk and 13.5% and 13.8% in high-risk group (p=0.003 and 0.015, respectively). High-risk group had worse OS compared with low- and intermediate-risk groups (5-year OS, low: 97.9% and 97.6%, intermediate: 97.9% and 98.8%, and high: 89.5% and 87.5%; p=0.003 and 0.008, respectively). Independent predictive factors of recurrence were age over 60 years, type 2 (estrogen-independent) and peritoneal cytology. CONCLUSION: ESMO and Japanese risk classification similarly stratify the baseline risk of recurrence. Patients with stage I–II endometrial carcinoma, especially low- and intermediate-risk diseases, have low recurrence rate and favorable OS, and the benefit of postoperative therapy might be small.
Asian Continental Ancestry Group ; Classification ; Drug Therapy ; Endometrial Neoplasms ; Female ; Humans ; Japan ; Medical Oncology ; Postoperative Care ; Prognosis ; Recurrence ; Retrospective Studies