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Background: To determine surgical, survival and quality of life outcomes across different tumour streams and lessons learned over 28 years., Methods: Consecutive patients undergoing pelvic exenteration at a single, high volume, referral hospital, between 1994 and 2022 were included. Patients were grouped according to their tumour type at presentation as follows, advanced primary rectal cancer, other advanced primary malignancy, locally recurrent rectal cancer, other locally recurrent malignancy and non-malignant indications. The main outcomes included, resection margins, postoperative morbidity, long-term overall survival, and quality of life outcomes. Non-parametric statistics and survival analyses were performed to compare outcomes between groups., Results: Of the 1023 pelvic exenterations performed, 981 (95.9%) unique patients were included. Most patients underwent pelvic exenteration due to locally recurrent rectal cancer (N = 321, 32.7%) or advanced primary rectal cancer (N = 286, 29.2%). The rates of clear surgical margins (89.2%; P < 0.001) and 30-days mortality were higher in the advanced primary rectal cancer group (3.2%; P = 0.025). The 5-year overall survival rates were 66.3% in advanced primary rectal cancer and 44.6% in locally recurrent rectal cancer. Quality of life outcomes differed across groups at baseline, but generally had good trajectories thereafter. International benchmarking revelled excellent comparative outcomes., Conclusions: The results of this study demonstrate excellent outcomes overall, but significant differences in surgical, survival and quality of life outcomes across patients undergoing pelvic exenteration due to different tumour streams. The data reported in this manuscript can be utilized by other centres as benchmarking as well as proving both subjective and objective outcome details to support informed decision-making for patients., (© 2023 Royal Australasian College of Surgeons.)

Introduction: Hepatitis C virus (HCV) is a global public health threat, and novel models of care are required to treat those currently or previously at highest risk of infection, particularly persons who inject drugs (PWID; ever injected), as conventional healthcare models do not have the reach to deliver cure of HCV to disadvantaged, disproportionately affected communities. In Western Europe and Australasia, it is estimated that HCV affects between 0.4% and 1.0% of the regions' populations, accordingly, it affects between 0.4% and 0.7% of the populations of countries in this study (Scotland, Wales and Australia). R eaching m E thadone users A ttending C ommunity p H armacies with HCV (REACH HCV) will evaluate community pharmacy-based diagnostic outreach and HCV treatment against conventional HCV testing and treatment pathways for clients receiving opioid substitution therapy (OST) in community pharmacies., Methods and Analysis: REACH HCV is an international multicentre cluster randomised controlled trial with sites in Scotland, Wales and Australia. The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway. Participants are recruited from OST clients in these pharmacies.In the pharmacy intervention pathway, participants receive a rapid point-of-care HCV PCR test in their pharmacy by a study outreach nurse. If positive, direct-acting antivirals (DAAs) are delivered to participants via their pharmacist in line with their OST schedule.In the education-only pathway, pharmacists counsel OST clients on HCV and refer them to the nearest nurse-led clinic or general practitioner offering HCV testing according to standard care protocols. If positive, DAAs are delivered as in the intervention pathway.The primary endpoint for both pathways is sustained viral response at 12 weeks post-treatment . Secondary outcomes are: cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions.A statistical analysis plan will be finalised prior to data lock. Analysis will be by intention to treat (ITT) to show superiority. Modified ITT analysis will also be undertaken to explore the steps in the pathways., Ethics and Dissemination: The trial received ethical favourable opinion from the East of Scotland Research Ethics Committee 2 (19/ES/0025) for UK sites and approval from the Alfred Hospital Ethics Committee (148/19) for Australian sites and complies with principles of Good Clinical Practice. Final results will be presented in peer-reviewed journals and at relevant conferences., Trial Registration Number: ClinicalTrials.gov Registry NCT03935906., Protocol Version: V.4.0-19 March 2020., Competing Interests: Competing interests: AR has received personal honoraria from AbbVie and Gilead and institutional research grants from MSD, AbbVie, Gilead and Roche. BH has received unrestricted educational grants, payments for advisory boards and payments for presentations from Jannen, Gilead, BMS, Abbvie and Merck in relation to HCV products. He has also received funding from Gilead, Merck, Abbvie and BMS for running meetings in relation to HCV in Wales. He has secured unrestricted funding from Abbvie, Merck and Gilead for project work related to management of HCV. JSD has received investigator initiated research support from AbbVie, Gilead Sciences, Merck and Bristol Myers Squibb; and has received honoraria from AbbVie, Gilead Sciences, and Merck. JFD has received personal honoraria for lectures and institutional research grants from MSD, AbbVie, Gilead, Roche and Janssen. PD has received grants from Gilead, Shire pharmaceuticals. PD is a member of the New Drugs Committee of the Scottish Medicines Consortium. AbbVie were involved in a collaborative, iterative process to develop the study protocol alongside the study Investigators as part of the AbbVie Investigator Initiated Scheme. AbbVie provided input to the protocol with regards to safety measures and reporting; the participant journey; and HCV medication guidance., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Novel efficacious treatments with long-term tolerability are needed for transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. This phase 2 study evaluated the safety and efficacy of all-oral ixazomib-cyclophosphamide-dexamethasone (ICd) followed by single-agent ixazomib maintenance., Patients and Methods: Patients were randomised (1:1) to receive 4.0 mg of ixazomib, 300 (Arm A) or 400 (Arm B) mg/m 2 of cyclophosphamide (days 1, 8, and 15), and 40 mg of dexamethasone (days 1, 8, 15, and 22) as induction (up to 13 × 28-day cycles), followed by single-agent ixazomib maintenance (28-day cycles) until progressive disease, death, or unacceptable toxicity. Primary end-point was complete response (CR) + very good partial response (VGPR) rate for ICd induction., Results: Seventy patients were enrolled (n = 36 Arm A; n = 34 Arm B); median age was 73 years (range, 61-87). At data cut-off, 66% of patients had completed 13 induction cycles followed by ixazomib maintenance. Median overall treatment duration was 19 cycles (range, 1-29); 21% of patients discontinued treatment during induction and 3% during maintenance due to adverse events (AEs). During induction, among 67 response-evaluable patients, CR+VGPR rate was 25%, and overall response rate (ORR) was 73%. Including the maintenance phase, CR+VGPR rate was 33%, and ORR was 76%. Median progression-free survival was 23.5 months (median follow-up: 26.1 months). The most common all-grade AE was neutropenia (31%). Grade ≥3 AEs were reported by 73% of patients. Five on-study deaths occurred (not treatment-related)., Conclusions: ICd treatment followed by ixazomib maintenance is tolerable and active in elderly, transplant-ineligible NDMM patients., Trial Registration Number: NCT02046070., (Copyright © 2018. Published by Elsevier Ltd.)

Objective: To evaluate a two-tiered trauma activation protocol in a major trauma referral hospital in Australia., Methods: A prospective study performed over a 12-month period of all consecutive trauma activations in a major trauma referral hospital. The triage tool assigned patients into two tiers of trauma activation. The full trauma activation was initiated where physiological or anatomical criteria were present. These patients were assessed by a multispecialty trauma team. A consult trauma activation was initiated where only mechanism of injury criteria was present. These patients were assessed by the Emergency Department Registrar and Surgical Registrar. The primary endpoint was major trauma outcome defined as either injury severity score (ISS) greater than 15, requirement for High Dependency Unit or Intensive Care Unit (HDU/ICU) admission, need for urgent operative intervention, or in hospital mortality., Results: Of 1144 trauma activations, 468 (41%) were full trauma and 676 (59%) were consult trauma activations. The full trauma activation group had a significantly higher proportion of the major trauma outcome (34% vs. 5%, p<0.01) and all 18 patients (2%) who died were in the full trauma activation group. Sensitivity of the triage tool for the major trauma outcome was 83%, specificity was 68%, undertriage was 3% and overtriage was 27%., Conclusions: The two-tiered trauma activation protocol is effective in identifying patients with major trauma from those with minor trauma. There were no deaths in undertriaged patients., ((c) 2010. Published by Elsevier Ltd. All rights reserved.)