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.

BACKGROUND: Recently, the prevalence of food allergies during childhood is increasing, with fruits being common allergens. However, data on allergens that cause fruit and vegetable allergies and pollen-food allergy syndrome (PFAS) in childhood are relatively few. This study aimed to examine the allergens in fruit and vegetable allergies in pediatric patients and to determine the association between fruit and vegetable allergies and PFAS.OBJECTIVE: This study aimed to examine the current status of fruit and vegetable allergies in Japanese children.METHODS: This was a multicenter case series observational study. The participants included children aged <15 years who developed allergic symptoms after eating fruits and vegetables and subsequently received treatment in the Pediatric Department of 6 hospitals in the Osaka Prefecture in Japan during the study period from August 2016 to July 2017. Participants' information was obtained using a questionnaire, and data were obtained by performing several types of allergy tests using blood samples.RESULTS: A total of 97 children (median age, 9 years; 56 males) were included in the study. Apple was the most common allergen, followed by peach, kiwi, cantaloupe, and watermelon. A total of 74 participants (76%) exhibited allergic symptoms due to PFAS; moreover, pathogenesis-related protein-10 (PR-10) was the most common allergen superfamily. On the contrary, in the group where neither PR-10 nor profilin was sensitized, kiwi and banana were the most common allergens, and the age of onset was lower than that in the PFAS group. Specific antibody titer was significantly associated with Birch for Bet v1 and latex for Bet v2 (r = 0.99 and r = 0.89).CONCLUSION: When we examine patients with fruit and vegetable allergies, we should first consider PFAS even in childhood specifically for children greater than 4 years old.
Age of Onset ; Allergens ; Asian Continental Ancestry Group ; Betula ; Child ; Citrullus ; Clinical Study ; Cucumis melo ; Eating ; Food Hypersensitivity ; Fruit ; Humans ; Hypersensitivity ; Japan ; Latex ; Musa ; Observational Study ; Prevalence ; Profilins ; Prunus persica ; Rhinitis ; Rhinitis, Allergic, Seasonal ; Vegetables

No abstract available.
Carcinosarcoma*

Objective: At Kitasato Institute Hospital, Kitasato University (henceforth, the hospital), the first edition of an antimicrobial use guidebook (henceforth, the guidebook) was produced in 2000.  This time, the Pharmaceutical Department’s members on the hospital’s Infection Control Committee (ICC) took the lead and revised the guidebook so that it better conforms to clinical conditions and assessed the guidebook they created.
Methods: A Working Group (WG) consisting of two ICC Pharmaceutical Department members and two members of the Medical Products Information Office staff examined the items to be listed in the guidebook.  These items were approved by the ICC and then assigned to physicians and pharmacists to be written up.  A questionnaire survey was conducted on the physicians and pharmacists in the hospital as to their assessment of the content and the conditions of use of the guidebook created.
Results: In the revised edition, “Antimicrobials PK/PD,” “TDM,” “Empiric Therapy for Infections in Each Department,” etc. have been added, the physicians wrote “Empiric Therapy for Infections in Each Department” and everything else was written by the WG.  The return rate of the questionnaire was 65.7% (N=99), and the guidebook utilization rate was 75.4%.  Frequently viewed items were “List of Antimicrobials Used In-Hospital,” “How to Administer Medication during Decreased Renal Function,” “Empiric Therapy for Infections in Each Department,” etc. by the internal medicine physicians, “List of Antimicrobials Used In-Hospital” and “How to Administer Medication during Decreased Renal Function,” etc. by the surgeons, and “Classification of Antimicrobials,” “List of Antimicrobials Used In-Hospital,” “When Renal Function is Decreased,” “TDM,” and “Empiric Therapy for Infections in Each Department,” etc. by the residents.  Furthermore, there were no items deemed “not necessary for inclusion” for a clear reason.  As to be expected in this guidebook, 72.3% of all respondents mentioned it was “a source of information on basic antimicrobial use” and next, “a source of information for treating infections outside one’s area of specialty.”
Conclusion: The items listed in the guidebook are thought to be appropriate, and its usage conditions are also good.  As they are specialists on antimicrobials, the pharmacists playing a central role while cooperating with the physicians on the ICC led to the creation of a highly useful guidebook.