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BackgroundMucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).MethodsPatients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.Results1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients.ConclusionPembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.

Objective: There is much interest in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. This study aimed to describe the process and challenges involved in obtaining ethical approval and research governance authorisation for a research project that started on 7 December 2018 in Queensland and make recommendations for improving the process. Methods: There were three aspects: (a) ethics approval; (b) governance – site-specific assessment (SSA); and (c) governance – Public Health Act (PHA) Application Assessment. Results: The process to satisfy all requirements took more than 1 year (371 days); ethics took 16 days and PHA approval 16 days. The major hurdle was the SSA, which took 98–274 days across five sites. The main issues were opaqueness in processes and inconsistences in approach leading to considerable frustration. Discussion: It is recommendeded that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. Frustration of government officials and researchers led the National Health and Medical Research Council to streamline ethics approval processes, but the same cannot be said for the governance process. It is appreciated that LHN processes were developed for good and valid reasons, but the onerous and inconsistent application of these processes hinder timely and relevant research. It is time for action: follow the success of the ethics process to redesign governance. What is known about the topic?: Researchers are interested in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. There are challenges in obtaining ethical approval and research governance authorisation for research projects. What does this paper add?: We identified that the main hurdle was obtaining site-specific agreements across numerous hospital sites. What are the implications for practitioners?: We recommend that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. The ethics approval process has been streamlined in recent years so we need to follow this success to redesign governance. [ABSTRACT FROM AUTHOR]

Indigenous Australians diagnosed with cancer experience higher mortality and lower survival rates compared to non-Indigenous Australians. Reasons are multifaceted and complex. Knowledge about Indigenous cancer survivors' perspectives of positive cancer survivorship is a gap in research evidence. The study explored cancer survivorship perspectives of Indigenous cancer survivors, their support people and healthcare workers with a view to developing recommendations for cancer survivorship. Indigenous Australians who completed cancer treatment in the previous 6 months to 5 years, their support people and primary healthcare workers were recruited from primary healthcare centres and a large tertiary Queensland hospital. Semi-structured interviews and focus groups were conducted with written and informed consent obtained prior. Participants emphasised key action areas and recommendations to enhance cancer survivorship, namely: establishing a community cancer advocate and peer support program, availability and use of a cancer-specific Indigenous primary healthcare worker and hospital-based Indigenous patient navigator, as well as adoption of question prompt lists and cancer survivorship care plans. Existing research suggests significant benefits from implementing the key recommendations identified in this study. Greater support and commitment across health sectors and funding bodies is needed to promote institutional change and health system development. [ABSTRACT FROM AUTHOR]

Results of recent studies suggest that circulating levels of vitamin D may play an important role in cancer-specific outcomes. The present systematic review was undertaken to determine the prevalence of vitamin D deficiency ( <25 nmol/L) and insufficiency (25-50 nmol/L) in cancer patients and to evaluate the association between circulating calcidiol (the indicator of vitamin D status) and clinical outcomes. A systematic search of original, peer-reviewed studies on calcidiol at cancer diagnosis, and throughout treatment and survival, was conducted yielding 4,706 studies. A total of 37 studies met the inclusion criteria for this review. Reported mean blood calcidiol levels ranged from 24.7 to 87.4 nmol/L, with up to 31% of patients identified as deficient and 67% as insufficient. The efficacy of cholecalciferol supplementation for raising the concentration of circulating calcidiol is unclear; standard supplement regimens of <1,000 IU D3/day may not be sufficient to maintain adequate concentrations or prevent decreasing calcidiol. Dose-response studies linking vitamin D status to musculoskeletal and survival outcomes in cancer patients are lacking. [ABSTRACT FROM AUTHOR]

Metastatic melanoma is poorly responsive to treatment, and immunotherapeutic approaches are potentially beneficial. Predictors of clinical response are needed to identify suitable patients. We sought factors associated with melanoma-specific clinical response following intradermal vaccination with autologous melanoma peptide and particulate hepatitis B antigen (HBsAg)-exposed immature monocyte-derived dendritic cells (MDDC). Nineteen patients with metastatic melanoma received a maximum of 8, 2-weekly vaccinations of DC, exposed to HBsAg in addition to autologous melanoma peptides. A further 3 patients received an otherwise identical vaccine that did not include HBsAg. Patients were assessed 1–2 monthly for safety, disease volume, and cellular responses to HBsAg and melanoma peptide. There was no significant toxicity. Of 19 patients receiving HBsAg-exposed DC, 9 primed or boosted a cellular response to HBsAg, and 10 showed no HBsAg response. HBsAg-specific responses were associated with in vitro T cell responses to melanoma peptides and to phytohemagglutinin (PHA). Zero out of 10 non-HBsAg-responding and 4/9 HBsAg-responding patients achieved objective melanoma-specific clinical responses or disease stabilization – 1 complete and 2 partial responses and 1 case of stable disease (P=0.018). Development of melanoma-specific cellular immunity and T cell responsiveness to mitogen were greater in the group of patients responding to HBsAg. Therefore stimulation of an immune response to nominal particulate antigen was necessary when presented by melanoma peptide-exposed immature DC, to achieve clinical responses in metastatic melanoma. Since general immune competence may be a determinant of treatment response, it should be assessed in future trials on DC immunotherapy. [ABSTRACT FROM AUTHOR]

The author discusses a research related to resource tensions and realworld constraints in multidisciplinary oncology team meetings by K. Lamprell and others. Topics discussed include constraints associated with putting these principles into practice; potential barriers experienced in the Australian health environment for multidisciplinary cancer care meetings; and issues of leadership and team dynamics.

The article focuses on the shortage in workforce in the medical oncology field in Australia. Results of a survey by the Medical Oncology Group of Australia (MOGA) indicate that the MO workforce in the country faces a shortage and uneven distribution. It stresses the need for a solution that covers not only the shortages in medical oncology but all medical disciplines. The MOGA survey suggests a national cancer workforce plan that can determine projections and recommendations for cancer care.

Background and Objectives: Vitamin D plays an important role in bone and muscle function, and cell prolifera-tion. The impact of chemotherapy and associated behavioural changes such as fatigue and sun avoidance on vit-amin D (25(OH) D) is unknown. This study aims to evaluate variations in serum vitamin D during chemotherapy and the predictive value of latitude, season and pre-existing vitamin D deficiency.Methods and Study Design: A 12-week prospective cohort study was conducted in chemotherapy-naïve patients in two Australian locations with different sun exposure. Vitamin D deficiency was defined as ≤25 nmol/L and insufficiency 26-50 nmol/L 25(OH) D. Demographics, chemotherapy regimen, nutritional status, sun exposure, geographic location, and sea-son were collected at baseline, 6 and 12 weeks after commencing chemotherapy.Results: Eighty-five patients (μ55.3±13.4 years of age; 49% female) were recruited, 96% Caucasian. Fifty-four patients were treated with cura-tive intent (mostly for breast [n=29] or colorectal [n=12] cancers). At baseline, 10 patients were vitamin D defi-cient and 33 were insufficient. Mean serum 25(OH) D (nmol/L) was higher at latitude -27.5o (Brisbane) than lati-tude -34.9o (Adelaide) (μ61.9±22.1 vs μ42.2±19.2, p<0.001) and varied according to season (spring: μ46.9±20.3, summer: μ50.8±18.2, autumn: μ76.4±25.2, winter: μ36.5±15.7, p<0.001). Serum 25(OH) D decreased with chemotherapy (baseline: μ49.2±22.3, 6-weeks: μ40.9±19.0, 12-weeks: μ45.9±19.7, p=0.05), with a significant and more rapid decline in winter and autumn (p=0.03).Conclusions: Chemotherapy is associated with a decrease in serum vitamin D, particularly during winter and autumn. Investigations into the underlying mechanism and as-sociated potential outcomes with this decrease requires further investigation. [ABSTRACT FROM AUTHOR]