Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial

Background No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab, an anti-PD-1 antibody, in these patients. Methods This was a multicentre, placebo-controlled, double-blind, parallel group, randomised, phase 3 trial done in 24 hospitals in the UK. Adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression, were randomly assigned (2:1) to receive nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo until disease progression or a maximum of 12 months. The randomisation sequence was generated within an interactive web response system (Alea); patients were stratified according to epithelioid versus non-epithelioid histology and were assigned in random block sizes of 3 and 6. Participants and treating clinicians were masked to group allocation. The co-primary endpoints were investigator-assessed progression-free survival and overall survival, analysed according to the treatment policy estimand (an equivalent of the intention-to-treat principle). All patients who were randomly assigned were included in the safety population, reported according to group allocation. This trial is registered with Clinicaltrials.gov, NCT03063450. Findings Between May 10, 2017, and March 30, 2020, 332 patients were recruited, of whom 221 (67%) were randomly assigned to the nivolumab group and 111 (33%) were assigned to the placebo group). Median follow-up was 11·6 months (IQR 7·2–16·8). Median progression-free survival was 3·0 months (95% CI 2·8–4·1) in the nivolumab group versus 1·8 months (1·4–2·6) in the placebo group (adjusted hazard ratio [HR] 0·67 [95% CI 0·53–0·85; p=0·0012). Median overall survival was 10·2 months (95% CI 8·5–12·1) in the nivolumab group versus 6·9 months (5·0–8·0) in the placebo group (adjusted HR 0·69 [95% CI 0·52–0·91]; p=0·0090). The most frequently reported grade 3 or worse treatment-related adverse events were diarrhoea (six [3%] of 221 in the nivolumab group vs two [2%] of 111 in the placebo group) and infusion-related reaction (six [3%] vs none). Serious adverse events occurred in 90 (41%) patients in the nivolumab group and 49 (44%) patients in the placebo group. There were no treatment-related deaths in either group. Interpretation Nivolumab represents a treatment that might be beneficial to patients with malignant mesothelioma who have progressed on first-line therapy. Funding Stand up to Cancer–Cancer Research UK and Bristol Myers Squibb

You've got to use street talk - Australian medical practice and international medical graduates

http://www.anzame.unsw.edu.au/conf_past.ht

Vulva Keratoacanthoma: A case report

Background: Vulval Keratoacanthoma (KA) is very rare and its differential diagnosis from the commonly occurring Vulval Squamous Cell Carcinoma (SCC) is important to avoid overtreatment. Case: A case of Vulval KA in a 79-year-old lady is reported. She presented with a 9-mm firm raised lesion on the antero-lateral left side of the clitoris of a few months' duration with no associated symptoms. The lesion was resected with clear margins and the excision site was well healed at her appointment 4 weeks later. Conclusion: We share our experience reporting the fifth case of a vulval KA in the world literature. Consideration to the occurrence of vulval KA is important to avoid both an erroneous diagnosis of vulval SCC and the associated consequences of radical surgery

Fluidic bus system for chemical process engineering in the laboratory and for small-scale production

Within the framework of a BMBF-funded project, five research institutes are developing a standardized system for the combination of microstructured devices and laboratory equipment of various suppliers thus leading to the building of chemical plants. The concept is based upon the bus system and simultaneously handles a number of tasks such as mechanical stability, fluidic flow and signal transmission. A key feature of the backbone interface developed is its open architecture. It does not rely on standardized connections thus allowing the combination of devices from various suppliers. The interface shows robustness, withstands high pressures and temperatures while thermal cross-talk is minimized through the use of different materials. Its application in chemical synthesis has shown truly promising results