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.

We assessed the relationships between lumbar bone mineral density (BMD) in middle and old-aged women and dietary habits, especially in their youth (about 18-25 years) and physiologic factors (height, weight, menarche, menopause, etc.). The subjects were 90 women at age 45-87 [63.5±9.5 (mean±SD) years] who visited our outpatient clinic of osteoporosis. Of them, 83 women had already ceased menstruation. Quantitave computed tomography (QCT) was used for measurements of the BMD of the trabecular bone in the third lumber vertebra (L3 expressed in mg/cm³ of CaCO₃), where pronounced changes associated with osteoporosis occur early.
There were significant negative correlations between age or menarcheal age and BMD of L3. Significant positive correlations were found between height or weight at the present and L3, but there was no correlation between body mass index (BMI) and L3. Significant positive correlations were noted between the values subtracted height at the present from height in the youth and L3. There were no correlations between frequency of pregnancy and delivery or outdoor life hour and L3. High milk-consumers in their youth (milk-drinking≥5 days per week) had higher L3 than low milk-consumers (milk-drinking≤2 days per week), and women, who had ate small fish 3 days or more per week in their youth, showed significantly higher L3 than thoes who had 2 days or less per week. We concluded that there are negative correlations between age or menarcheal age and L3 and positive correlations between height or weight and L3, and that low intake of milk and small fish in the youth may influence BMD in later years, leading to osteoporosis.