ObjectivesTo examine whether the overall results of the CASTLE study pertain to both genders, we analysed the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir in 277 female and 606 male patients in the open-label, multinational trial over 96 weeks. The trial is registered with ClinicalTrials.gov, number NCT00272779.
TPS8577 Background: At initial diagnosis, 20% of patients (pts) with NSCLC present with early-stage disease. The 5-year overall survival (OS) rate after surgery for stage IB–IIIA NSCLC is 25%–60%. Addition of adjuvant chemotherapy to surgery only provides a 5% absolute OS benefit at 5 years. Neoadjuvant treatment with immune checkpoint inhibitors may extend OS in early-stage NSCLC by enhancing systemic immunity and eradicating micrometastatic disease. In contrast to the adjuvant setting, the neoadjuvant setting is associated with a higher tumor burden, the presence of abundant tumor antigens, and the consequent potential for tumor-associated neoantigen presentation to the immune system. In an ongoing feasibility trial in pts with stage IB–IIIA NSCLC, nivolumab (nivo; a fully human PD-1 immune checkpoint inhibitor antibody) given alone as neoadjuvant treatment induced a major pathological response (MPR; < 10% residual viable tumor cells) rate of 39% (7/18), did not delay or interfere with surgery, and was not associated with new safety signals. In a phase 1 study in pts with stage IIIB/IV NSCLC, first-line nivo + ipilimumab (ipi; a CTLA-4 immune checkpoint inhibitor antibody) showed a greater radiologic objective response rate than nivo alone (39% vs 23%). These data provided the rationale for Checkmate 816 (NCT02998528), a phase 3 study evaluating nivo + ipi vs platinum-doublet chemotherapy as neoadjuvant treatment for early-stage NSCLC. Methods: Approximately 326 pts aged ≥18 years with resectable stage IB/II/IIIA NSCLC, ECOG performance status 0–1, pulmonary function capable of tolerating lung resection, and available lung tumor tissue will be enrolled in North America, South America, Europe, and Asia. Pts are ineligible if they have autoimmune disease or had received prior treatment with immune checkpoint inhibitors. Pts will be randomized to receive nivo + ipi or platinum-doublet chemotherapy. The primary endpoint is MPR rate. Secondary endpoints include event-free survival, OS, and complete pathological response. Start date is January 2017. The estimated primary completion date is July 2019. Clinical trial information: NCT02998528.
Methods Randomized, open-label prospective study comparing once-daily ATV/r with twice-daily LPV/r, both in combination with once-daily fixed dose combination tenofovir/ emtricitabine in antiretroviral-naive HIV-1 infected subjects. Proportion of subjects with HIV RNA <50 c/mL (confirmed virologic response/CVR), changes in CD4 cell count and lipids from baseline, and adverse events (AEs) through 48 weeks are presented among chronic HBVand/or HCV-infected (Hep+) subjects.
We herein report a case of slowly progressive cutaneous, rhinofacial, and pulmonary mucormycosis caused by Mucor irregularis in an immunocompetent woman who was successfully managed by combined surgical debridement and antifungal therapy. Slow progression, pulmonary involvement, occurrence in an immunocompetent patient, and good prognosis are unusual features of our case.
Summary A 20‐year‐old female patient presented with erythematous plaques on the nose which were progressively spreading to the trunk and the extremities, sometimes with erosions and scars. The patient was misdiagnosed as having seborrhoeic dermatitis and subacute cutaneous lupus erythematosus. The histopathological biopsy revealed mycotic infectious granuloma. Samples taken from skin lesions and other locations grew Trichosporon asahii in cultures. The identification was confirmed by molecular biological methods. The patient was treated successfully with liposomal amphotericin B in combination with fluconazole orally.
We attempted to comprehensively assess the possible association between p53 Arg72Pro polymorphism and the risk of basal cell carcinoma (BCC).We performed a literature search of case-control association studies on p53 Arg72Pro polymorphism and BCC susceptibility in PubMed and EMBASE. 7 eligible studies were finally identified and their data were extracted for this meta-analysis. BCC risk was determined with the fixed effects model using a pooled odds ratio (OR).Using distinct genetic models, we found that p53 Arg72Pro polymorphism was not associated with the overall risk of BCC. We observed a similar trend towards the association when performing subgroup analysis for Caucasians and Asians.Our results suggest that presence of the common p53 Arg72Pro polymorphism may not play a role in the development of BCC. Larger studies are needed to better confirm the association.
Along with fast development of economy, public health demand and research budget, the medical research in China increased rapidly recent years, and the number of articles focusing on medicine from China, which were published by Journals indexed by Science Citation Index Expanded (SCI-E) or embodied in MEDLINE, increased obviously.1-3Chinese Medical Journal (CMJ) is a leading platform in China for following the progress of medical research in various disciplines from China and any part of the world. As an international, peer-reviewed general medical journal from the Chinese Medical Association, impact factor (IF) of CMJ increased to 1.016 in 2013 (Thomson Reuters, USA). A bibliometric analysis of the CMJ from 1999 to 2013 in the PubMed database (7 991 articles) was performed for analyzing the publication trends in this journal. There has been a dramatic rise in the annual publications and a steady increase in IF of CMJ during the past 15 years (Figure 1). The published articles of CMJ increased obviously from 276 in 1999 to 1 033 in 2013, while IF increased from 0.111 to 1.016 respectively. Geographic authorship patterns found contributions from 45 countries, but authors from the mainland of China published most of the articles (91.0%), followed by Hong Kong, China (1.2%) and United States (0.7%) (Table 1). Analysis on cities showed that Beijing (33.0%), Shanghai (12.1%) and Guangzhou (6.8%) were the top 3 leading contributors to CMJ. Based on the analysis for the type of top 20 cited articles (Table 2), seventeen were original articles, two were review articles and one was editorial, in which Beijing (30%), Nanjing (20%) and Guangzhou (15%) were the leading contributors, while 65% and 35% of articles of the top 20 cited articles were clinical research and basic research respectively. Biochemistry and molecular biology (48.9%), pharmacology/pharmaceutics (27.5%), geriatrics/gerontology (27.4%), cardiovascular system/cardiology (24.3%) and genetics/heredity (23.9%) were top 5 research areas.Figure 1.: Publication trends of the Chinese Medical Journal from 1999 to 2013 by quantity of articles and impact factor.Table 1: Articles of the Chinese Medical Journal from 1999 to 2013 by geographic regions, research areas and citationsTable 2: Top 20 most-cited articles in Chinese Medical Journal from 1999 to 2013Along with the 3.7-fold increase in the number of articles from 1999 to 2013, IF increased steadily, which means that both the quality and citation rate of the articles published in CMJ have been improved as well. With increased number of published articles and IF of CMJ, more countries’ articles were published in CMJ, but the proportion of articles excluding China in the last fifteen years was still low. With regard to China, articles were submitted from almost every region of the country, but as the main centers of medical research in China with a large number of universities and research institutions, Beijing, Shanghai and Guangzhou were still at the top position in medical research, which was also reported by another bibliometric analysis of biomedical articles from China during 1999 to 2013 in MEDLINE database (458 593 articles).2 Clinical and basic original articles made up the majority in top 20 cited articles from 1999 to 2013, according to the previous analysis of 50 top-cited articles published in CMJ in 2010.4 The major research interests of the articles published in CMJ are related to basic and clinical research of common diseases such as diseases of cardiovascular, respiratory and digestive systems, and geriatrics or gerontology ranks the third research field with the rapidly expanding aged population in China. Based on the publication trends of CMJ, the performance of CMJ over the last fifteen years is promising, and the journal is on the way to increase the quality of papers. At the backdrop of increasing competitions with other biomedical journals from China and worldwide, further efforts need to be made to achieve further internationalization of CMJ in the future.5