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Background The open-label, randomized, active-controlled KEYNOTE-045 study (NCT02256436) showed that second-line pembrolizumab significantly improved overall survival (OS) of patients with advanced/metastatic urothelial cancer (UC) that progressed after first-line platinum-containing chemotherapy, compared with standard chemotherapy (paclitaxel, docetaxel, or vinflunine). Pembrolizumab is approved for patients with bladder cancer in Japan. Patients and methods Analysis was performed in the subgroup of Japanese patients enrolled in the KEYNOTE-045 study. Coprimary end points were OS and progression-free survival (PFS). Objective response rate (ORR) and safety were secondary end points. Results Fifty-two Japanese patients (pembrolizumab, n = 30; chemotherapy, n = 22) were followed up for a median of 26.1 months. Patients who received pembrolizumab compared with chemotherapy had a 19% lower risk for death (hazard ratio [HR] 0.81, 95% CI 0.44–1.50); after adjusting for baseline covariates, the HR for OS was 0.61 (95% CI 0.32–1.15). The 24-month OS rate was higher with pembrolizumab (26.9% vs 14.3%). PFS was 2.0 and 4.9 months for pembrolizumab and chemotherapy, respectively (HR 1.71, 95% CI 0.95–3.08). ORR was similar for pembrolizumab and chemotherapy (20.0% vs 18.2%); durability of response was higher with pembrolizumab: 67% and 33% of patients, respectively, maintained a response for > 12 months. Treatment-related adverse events, including grade 3–5 events, occurred less frequently with pembrolizumab. Conclusions Pembrolizumab provided durable antitumor activity in patients with locally advanced/metastatic UC that progressed after platinum-containing chemotherapy in the overall population and in the Japanese subgroup; safety profile was consistent with that previously observed for pembrolizumab.

* Revised：A Panel Study of ‘Zombie’ SMEs in Japan: Identification, Borrowing and Investment Behavior [13-16, 2013], We estimated the extent to which ‘zombie’ SMEs existed in Japan by using panel data set of firms and investigated borrowing and investment functions of ‘zombie’ SMEs. We found that 5%~13% of SMEs are ‘zombie’ firms. As for borrowing behavior, ‘zombie’ firms did not succeed in reducing their loans. A fall in land value of SMEs induced an increase in borrowing of ‘zombie’firms or ever-greening. We also find that the profitability of investment, measured by marginal q and the increment of output, did not increase investment for the ‘zombie’firm, but rather ever-greening of loans increased investment in less productive and profitable projects.

[CRUISE REPORT] This document is a preliminary report of YK16-02 Leg1 on S/V YOKOSUKA from 2016-05-01 to 2016-05-11 and YK16-02 Leg2 on S/V YOKOSUKA from 2016-05-12 to 2016-05-23.

[CRUISE REPORT] This document is a preliminary report of YK16-18 on S/V YOKOSUKA from 2016-12-19 to 2016-12-24.

More than half of persons living with HIV infection in the United States (U.S.) will be ≥50 years of age by 2020, including postmenopausal women. We conducted a systematic literature review about the effects of (1) HIV infection on age at menopause and (2) menopause on antiretroviral therapy (ART) response, in order to inform optimal treatment strategies for menopausal women living with HIV infection. We used the Ovid Medline database from 1980 to 2012. We included studies that focused on HIV-infected persons, included postmenopausal women, and reported outcome data for either age at menopause or response to ART across menopause. We identified six original research articles for age at menopause and five for response to ART across menopause. Our review revealed that current data were conflicting and inconclusive; more rigorous studies are needed. Disentangling the effects of menopause requires well-designed studies with adequate numbers of HIV-infected and HIV-uninfected women, especially disproportionately affected women of color. Future studies should follow women from premenopause through menopause, use both surveys and laboratory measurements for menopause diagnoses, and control for confounders related to normal aging processes, in order to inform optimal clinical management for menopausal women living with HIV.