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.

Objective: This study analyzed the efficacy of add-on atezolizumab to standard first-line bevacizumab-containing therapy in 56 Japanese patients with metastatic and recurrent cervical cancer treated across 8 sites under the Japanese Gynecologic Oncology Group between October 2018 and August 2021 in the BEATcc trial. Methods: Patients were randomized to standard arm (standard therapy: cisplatin 50 mg/m 2or carboplatin area under the curve of 5, paclitaxel 175 mg/m 2 , and bevacizumab 15 mg/kg) or experimental arm (standard therapy with atezolizumab 1,200 mg). Results: Of 56 patients, 30 were in experimental arm vs. 26, standard arm (age: 53.2±12.9 vs.54.7±12.2 years). Median progression-free survival was 15.8 months (95% confidence interval [CI]=10.4–26.1) in experimental arm vs. 11.1 months (8.4–16.5) in standard arm (hazard ratio [HR]=0.51; 95% CI=0.26–1.01). Median overall survival was 34.1 months (23.2–38.6) in the experimental arm vs. 31.6 months (16.4–36.5), standard arm (HR=0.53; 95% CI=0.23–1.21). Objective: response rate was 86.7% in experimental arm vs. 84.6%, standard arm. Complete response and partial response, respectively, were 23.3% and 63.3% in experimental arm and 26.9% and 57.7% in standard arm. Grade ≥3 adverse events occurred in 80.0%, experimental arm and 88.5%, standard arm. Gastrointestinal/genitourinary fistula incidence was lower in Japanese patients (1 patient receiving atezolizumab), likely due to stricter inclusion criteria. Conclusion Overall, add-on atezolizumab enhances the efficacy of bevacizumab and chemotherapy in Japanese patients as those in overall BEATcc population and could be considered a new first-line treatment option for metastatic, persistent, or recurrent cervical cancer in Japan.

Objective: In this study, thermoelastic stress analysis was conducted to clarify the surface stress distribution of a femur in which a BiCONTACT E stem was inserted. The contact sites between the stem and femur were examined to investigate the association with the range of stress distribution.Materials and Methods: BiCONTACT E was set up using two synthetic femurs that mimic the morphology and mechanical properties of living bone. Preoperative planning was performed using three-dimensional imaging software. The synthetic bone was placed in a sample holder. After the stem was implanted into the synthetic bone, computed tomography imaging was performed. The contact sites between the stem and the cortical part of the synthetic bone were examined using the imaging software. Subsequently, thermoelastic stress measurements were performed on the sample.Results: The results of thermoelastic stress analysis indicated a minimum change in the sum of principal stresses [Δ (σ1+σ2)] on the medial side and a maximum change in the sum of principal stresses on the lateral side. Thus, no minimum change was observed in the sum of the principal stresses at the maximum proximal part. It is reasonable to assume that the use of a cementless stem can inevitably lead to bone atrophy in the proximal part of the femur. The contact sites between the stem and femur were also investigated, and the results of the study clearly and quantitatively demonstrated the correlation of the contact sites with a range of stress distributions.Conclusion: The surface stress distribution of a femur, in which a BiCONTACT E stem was inserted, was clarified. The contact sites between the stem and femur were also investigated. Furthermore, the correlation between these results and clinical bone response was investigated in this study.

No abstract available.
Asian Continental Ancestry Group ; Humans