Real-World Data on Pembrolizumab for Pretreated Non-Small-Cell Lung Cancer: Clinical Outcome and Relevance of the Lung Immune Prognostic Index.

BACKGROUND: Pembrolizumab is licensed for the treatment of pre-treated and PD-L1 positive non-small cell lung cancer (NSCLC), but response is heterogeneous. In this context, the Lung Immune Prognostic Index (LIPI) has been proposed as tool to prognosticate outcome. OBJECTIVE: To investigate the real-world efficacy and safety of pembrolizumab in pre-treated NSCLC patients and the clinical utility of LIPI for patients' selection. PATIENTS AND METHODS: Patients with pre-treated NSCLC and PD-L1 ≥ 1% treated with pembrolizumab were included in this retrospective series. The LIPI was used to classify patients in 3 prognostics subgroups according to the pre-treatment dNLR (derived neutrophil to lymphocyte ratio) and LDH in blood. The prognostic impact of the LIPI on progression free survival (PFS) and overall survival (OS) was evaluated with Cox regression. The combined effect of LIPI and other relevant prognostic factors was explored with multivariate regression. RESULTS: In total, 113 consecutive patients were included. Median (mPFS) and mOS was 4.3 (2.6-6.7) and 13.5 (10.3-17.7) months, respectively. Good-, intermediate-, and poor-LIPI was found in 54 (47.8%), 45 (39.8%), and 8 (7.1%) patients, respectively. Median PFS was 5.1 (2.8-9.1), 3.0 (2.5-6.8), and 1.4 (0.5-18.7) months, and mOS was 17.2 (12.0-26.4), 11.8 (8.4-17.1), and 3.7 (0.5-not calculable) months for good-, intermediate-, and poor-LIPI group, respectively. Patients with intermediate-LIPI and poor-LIPI had worse PFS versus good-LIPI, and statistically significant worse OS (p = 0.030 and p = 0.013, respectively). In the multivariate analysis, intermediate- versus good-LIPI (p = 0.190) was not independently associated to PFS or OS. Patients with both good-LIPI and high (≥ 50%) PD-L1 had better OS than all other subgroups defined by LIPI and PD-L1. Immune-related adverse events (irAEs) occurred in 47 (41.6%) patients (12.4% grade ≥ 3). In a time-varying analysis, irAEs were statistically associated with longer OS (HR 0.51, 0.31-0.84; p = 0.008). CONCLUSION: In our series, the outcome of pembrolizumab in pre-treated NSCLC is consistent with the registration trial. Lung Immune Prognostic Index is a readily available tool able to prognosticate outcome, also in PD-L1-high patients. The positive association between irAEs and OS might aid decision making.

Consent for septoplasty: Are we meeting patients' expectations?

The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic 'doctor knows best' model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the 'reasonable patient' and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The 'reasonable patient' regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the 'reasonable patient' would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient's reasonable expectations is an important factor.

In Vivo Randomized Controlled Study of the Bone Response of All-Suture Anchors and Biocomposite Anchors.

BACKGROUND: Suture anchors are widely used for labral reconstruction surgery. However, there has been some concern over the development of osteolysis around the anchor. This has been reported for both biocomposite and all-suture anchors, but they have not been compared directly in vivo. PURPOSE: To compare the bone response to 2 common suture anchors: a traditional biocomposite push-fit anchor and an all-suture anchor. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: Included in this study were 17 patients with a total of 37 unique suture anchors. Magnetic resonance imaging scans were performed at 3 weeks and 6 months postoperatively. A total of 38 senior radiologists and shoulder surgeons evaluated the images using a previously validated system for grading the bone response around suture anchors. The mean difference in grading at 3 weeks and 6 months was calculated using unpaired t tests, and the interrater reliability was evaluated with an intraclass correlation coefficient (ICC). RESULTS: At 3 weeks, there was no statistically significant difference in the degree of osteolysis surrounding each suture anchor type (P = .258), with little bone response. However, on the 6-month scans, there was a significantly lower level of osteolysis seen in the all-suture anchors compared with the biocomposite anchors (P = .040). Interrater reliability was excellent, with an ICC value of 0.975 (95% CI, 0.962-0.985). CONCLUSION: All-suture anchors cause significantly less osteolysis in glenoid bone at 6 months compared with biocomposite anchors.

How to optimise anticoagulation for patients who are obese.

Management of anticoagulation has become a hot topic in the last decade. Health-care professionals are encountering increasing number of patients diagnosed with a thromboembolic episode, probably as a result of heightened awareness. In addition, the recognition that hospital-acquired thrombosis causes substantial mortality has led to an emphasis on appropriate thromboprophylaxis in all patients deemed at risk of thrombosis. However, the use of anticoagulants for both treatment and prophylaxis of thrombosis can pose a challenge in individuals who are obese. There are no detailed studies in this area and as such the dosing and monitoring of anticoagulants in these individuals can be problematic.