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OBJECTIVES: To review the outcomes of immune checkpoint inhibitor (ICI) treatment of advanced cutaneous squamous cell carcinoma (CSCC) outside clinical trials. STUDY DESIGN: Retrospective observational study; review of patient records in fifteen Australian institutions. SETTING, PARTICIPANTS: All Australian adults with locally advanced or metastatic CSCC not amenable to curative surgery or radiotherapy treated with ICIs, 5 May 2017 - 23 May 2022, through a cemiplimab compassionate access scheme (Therapeutic Goods Administration Special Access Scheme) or who personally covered the cost of pembrolizumab prior to the start of the access scheme. MAIN OUTCOME MEASURES: Best overall response rate (ORR) according to standardised assessment criteria using the hierarchy: Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the modified World Health Organization clinical response criteria, and the Positron Emission Tomography Response Criteria (PERCIST 1.0); overall and progression-free survival. RESULTS: A total of 286 people with advanced CSCC received ICI therapy during May 2017 - May 2022 (cemiplimab, 270; pembrolizumab, 16). Their median age was 75.2 years (range, 39.3-97.5 years) and 232 were men (81%); median follow-up time was 12.2 months (interquartile range, 5.5-20.5 months). Eighty-eight people (31%) were immunocompromised, 27 had autoimmune disease, and 59 of 277 (21%) had ECOG performance scores of 2 or 3. The ORR was 60% (166 of 278 evaluable patients): complete responses were recorded for 74 (27%) and partial responses for 92 patients (33%). Twelve-month overall survival was 78% (95% confidence interval [CI], 72-83%); progression-free survival was 65% (95% CI, 58-70%). Poorer ECOG performance status was associated with poorer overall survival (per unit: adjusted hazard ratio [aHR], 3.0; 95% CI, 2.0-4.3) and progression-free survival (aHR, 2.4; 95% CI, 1.8-3.3), as was being immunocompromised (overall: aHR, 1.8; 95% CI, 1.1-3.0; progression-free: aHR, 1.8

Contains fulltext : 291573.pdf (Publisher’s version ) (Open Access), One of the promising opportunities of digital health is its potential to lead to more holistic understandings of diseases by interacting with the daily life of patients and through the collection of large amounts of real-world data. Validating and benchmarking indicators of disease severity in the home setting is difficult, however, given the large number of confounders present in the real world and the challenges in collecting ground truth data in the home. Here we leverage two datasets collected from patients with Parkinson's disease, which couples continuous wrist-worn accelerometer data with frequent symptom reports in the home setting, to develop digital biomarkers of symptom severity. Using these data, we performed a public benchmarking challenge in which participants were asked to build measures of severity across 3 symptoms (on/off medication, dyskinesia, and tremor). 42 teams participated and performance was improved over baseline models for each subchallenge. Additional ensemble modeling across submissions further improved performance, and the top models validated in a subset of patients whose symptoms were observed and rated by trained clinicians.

Background: Use of neoadjuvant (NA) chemotherapy is recommended when pancreatic ductal adenocarcinoma (PDAC) is borderline resectable. Method: A retrospective analysis of consecutive patients with localized PDAC between January 2016 and March 2019 within the Australasian Pancreatic Cancer Registry (PURPLE, Pancreatic cancer: Understanding Routine Practice and Lifting End results) was performed. Clinicopathological characteristics, treatment, and outcome were analyzed. Overall survival (OS) comparison was performed using log-rank model and Kaplan–Meier analysis. Results: The PURPLE database included 754 cases with localised PDAC, including 148 (20%) cases with borderline resectable pancreatic cancer (BRPC). Of the 148 BRPC patients, 44 (30%) underwent immediate surgery, 80 (54%) received NA chemotherapy, and 24 (16%) were inoperable. The median age of NA therapy patients was 63 years and FOLFIRINOX (53%) was more often used as NA therapy than gemcitabine/nab-paclitaxel (31%). Patients who received FOLFIRINOX were younger than those who received gemcitabine/nab-paclitaxel (60 years vs. 67 years, p =.01). Surgery was performed in 54% (43 of 80) of BRPC patients receiving NA chemotherapy, with 53% (16 of 30) achieving R0 resections. BRPC patients undergoing surgery had a median OS of 30 months, and 38% (9 of 24) achieved R0 resection. NA chemotherapy patients had a median OS of 20 months, improving to 24 months versus 10 months for patients receiving FOLFIRINOX compared to gemcitabine/nab-paclitaxel (Hazard Ratio (HR).3, p <.0001). Conclusions: NA chemotherapy use in BRPC is increasing in Australia. One half of patients receiving NA chemotherapy proceed to curative resection, with 53% achieving R0 resections. Patients receiving Infusional 5-flurouracil, Irinotecan and Oxaliplatin (FOLIRINOX) had increased survival than gemcitabine/nab-paclitaxel. Treatment strategies are being explored in the MASTERPLAN and DYNAMIC-Pancreas trials.

INTRODUCTION: The detrimental impact of smoking tobacco can be mitigated when cancer patients quit smoking. Smoking cessation clinical pathways are inconsistently implemented within Australian cancer services. The aim of this study was to pilot test and evaluate the reach, adoption, and implementation of a smoking cessation checklist within oncology services. METHODS: The checklist was implemented over a 6-month period in medical and radiation oncology services at two metropolitan and one rural hospital. The RE-AIM framework guided the evaluation process. Implementation strategies included training, process mapping, and identifying champions. Evaluation measures included a clinical data audit, surveys, and semi-structured interviews with healthcare professionals (HCPs). RESULTS: Healthcare professionals (HCPs; N = 63; 41% oncologists, 32% nurses, 27% others) completed 1276 checklists with cancer patients between November 2019 and December 2020. Of the 126 (10%) identified current smokers, 34 (27%) accepted a referral to either Quitline, Nicotine Replacement Therapy, to a general practitioner or dedicated HCP for follow-up telephone support. There was variation in screening adoption by HCPs across the three hospitals, with 16%, 92% and 89.5% of patients screened respectively. Contextual factors, such as perceived commitment, role identity, and communication processes appeared to influence the outcomes. CONCLUSION: A checklist is a simple, effective, and versatile intervention used to standardise smoking cessation practices in medical and radiation oncology services. The checklist supports standardisation of referral practices to smoking cessation services for cancer patients by either oncologist and/or nurses.

Background: The COVID-19 pandemic has had a vast impact on cancer service delivery around the world. Previously reported results from our international survey of oncology clinicians, conducted through March-April 2020, found that clinicians reported altering management in both the curative and palliative settings and not in proportion to the COVID-19 case burden in their region of practice. This follow-up survey, conducted from 27th September to 7th November 2020, aimed to explore how attitudes and practices evolved over the 2020 pandemic period. Participants and methods: Participants were medical, radiation and surgical oncologist and trainees. Surveys were distributed electronically via ESMO and other collaborating professional societies. Participants were asked to compare their practice prior to the pandemic to both the period of March-April 2020, referred to as the ‘early’ period, and the current survey period, referred to as the ‘later’ period. Results: One hundred and seventy-two oncology clinicians completed the survey. The majority of respondents were medical oncologists (n = 136, 79%) and many were from Europe (n = 82, 48%). In the ‘early’ period, 88% (n = 133) of clinicians reported altering their practice compared to 63% (n = 96) in the ‘later’ period. Compared to prior to the pandemic, clinicians reported fewer new patient presentations in the ‘early’ period and a trend towards more patients presenting with advanced disease in the ‘later’ period. Conclusions: Results indicate a swing back towards pre-COVID-19 practices despite an increase in the rate of cumulative COVID-19 cases across 2020. The impact of these changes on cancer associated morbidity and mortality remains to be measured over the months and years to come.

Background: We previously reported that treatment with enzalutamide (ENZA) rather than an older non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), resulted in longer overall survival when added to standard first-line treatment, with or without concurrent early docetaxel, in mHSPC (hazard ratio 0.67, 95% CI 0.52 to 0.86, p = 0.002, NEJM 2019). Here we report effects on HRQL. Method(s): HRQL was measured with the EORTC QLQ-C30 and PR25 at weeks 0, 4, 12, and then 12-weekly until clinical progression. We used mixed models for repeated measures to calculate the least squares mean difference (LSMD), 95% CI, and p-value for comparisons of the randomly assigned groups for all assessments from week 4 to 156. For each analysis of deterioration-free survival, the endpoint was defined a-priori as the earliest of death, clinical progression, cessation of study treatment, or a 10-point worsening from baseline (minimum clinically important difference on scales scored from 0 to 100) in the pertinent HRQL sub-scale: physical functioning (PF), global health and quality of life (GHQL), cognitive functioning (CF), and fatigue; p-values were based on the log-rank test. Result(s): Completion of HRQL forms in 1016 men with a baseline assessment of HRQL (1125 randomised) ranged from 94% at week 12 to 78% at week 156. Random assignment to ENZA v NSAA was associated with modest impairments (LSMD, 95% CI) from week 4 to 156 in fatigue (5.0, 3.3 to 6.7, p < 0.0001), CF (3.9, 2.4 to 5.4, p < 0.0001), and PF (2.5, 1.2 to 3.8, p = 0.0002), but not GHQL (1.1, -0.4 to 2.6, p = 0.16). Deterioration-free survival rates at 3 years favoured ENZA over NSAA for GHQL (32% v 18%, p < 0.0001), CF (33% v 21%, p = 0.0003), and PF (31% v 22%, p = 0.001), but not fatigue (26% v 18%, p = 0.1). The effects of ENZA on HRQL were relatively stable over time and unaffected by treatment with concurrent early docetaxel. Conclusion(s): The addition of ENZA maintained GHQL and improved deteriora

Background: We previously reported that treatment with enzalutamide (ENZA) rather than an older non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), resulted in longer overall survival when added to standard first-line treatment, with or without concurrent early docetaxel, in mHSPC (hazard ratio 0.67, 95% CI 0.52 to 0.86, p=0.002, NEJM 2019). Here we report effects on HRQL. Method(s): HRQL was measured with the EORTC QLQ-C30 and PR25 at weeks 0, 4, 12, and then 12-weekly until clinical progression. We used mixed models for repeated measures to calculate the least squares mean difference (LSMD), 95% CI, and p-value for comparisons of the randomly assigned groups for all assessments from week 4 to 156. For each analysis of deterioration-free survival, the endpoint was defined a-priori as the earliest of death, clinical progression, cessation of study treatment, or a 10-point worsening from baseline (minimum clinically important difference on scales scored from 0 to 100) in the pertinent HRQL sub-scale: physical functioning (PF), global health and quality of life (GHQL), cognitive functioning (CF), and fatigue; p-values were based on the log-rank test. Result(s): Completion of HRQL forms in 1016 men with a baseline assessment of HRQL (1125 randomised) ranged from 94% at week 12 to 78% at week 156. Random assignment to ENZA v NSAA was associated with modest impairments (LSMD, 95% CI) from week 4 to 156 in fatigue (5.0, 3.3 to 6.7, p<0.0001), CF (3.9, 2.4 to 5.4, p<0.0001), and PF (2.5, 1.2 to 3.8, p=0.0002), but not GHQL (1.1,-0.4 to 2.6, p=0.16). Deterioration-free survival rates at 3 years favoured ENZA over NSAA for GHQL (32% v 18%, p<0.0001), CF (33% v 21%, p=0.0003), and PF (31% v 22%, p=0.001), but not fatigue (26% v 18%, p=0.1). The effects of ENZA on HRQL were relatively stable over time and unaffected by treatment with concurrent early docetaxel. Conclusion(s): The addition of ENZA maintained GHQL and improved deteriorationfree survival b

BACKGROUND: The COVID-19 pandemic has had a vast impact on cancer service delivery around the world. Previously reported results from our international survey of oncology clinicians, conducted through March-April 2020, found that clinicians reported altering management in both the curative and palliative settings and not in proportion to the COVID-19 case burden in their region of practice. This follow-up survey, conducted from 27th September to 7th November 2020, aimed to explore how attitudes and practices evolved over the 2020 pandemic period. PARTICIPANTS AND METHODS: Participants were medical, radiation and surgical oncologist and trainees. Surveys were distributed electronically via ESMO and other collaborating professional societies. Participants were asked to compare their practice prior to the pandemic to both the period of March-April 2020, referred to as the 'early' period, and the current survey period, referred to as the 'later' period. RESULTS: One hundred and seventy-two oncology clinicians completed the survey. The majority of respondents were medical oncologists (n = 136, 79%) and many were from Europe (n = 82, 48%). In the 'early' period, 88% (n = 133) of clinicians reported altering their practice compared to 63% (n = 96) in the 'later' period. Compared to prior to the pandemic, clinicians reported fewer new patient presentations in the 'early' period and a trend towards more patients presenting with advanced disease in the 'later' period. CONCLUSIONS: Results indicate a swing back towards pre-COVID-19 practices despite an increase in the rate of cumulative COVID-19 cases across 2020. The impact of these changes on cancer associated morbidity and mortality remains to be measured over the months and years to come.

OBJECTIVES: To report clinician-perceived changes to cancer service delivery in response to COVID-19. DESIGN: Multidisciplinary Australasian cancer clinician survey in collaboration with the European Society of Medical Oncology. SETTING: Between May and June 2020 clinicians from 70 countries were surveyed; majority from Europe (n=196; 39%) with 1846 COVID-19 cases per million people, Australia (AUS)/New Zealand (NZ) (n=188; 38%) with 267/236 per million and Asia (n=75; 15%) with 121 per million at time of survey distribution. PARTICIPANTS: Medical oncologists (n=372; 74%), radiation oncologists (n=91; 18%) and surgical oncologists (n=38; 8%). RESULTS: Eighty-nine per cent of clinicians reported altering clinical practices; more commonly among those with versus without patients diagnosed with COVID-19 (n=142; 93% vs n=225; 86%, p=0.03) but regardless of community transmission levels (p=0.26). More European clinicians (n=111; 66.1%) had treated patients diagnosed with COVID-19 compared with Asia (n=20; 27.8%) and AUS/NZ (n=8; 4.8%), p<0.001. Many clinicians (n=307; 71.4%) reported concerns that reduced access to standard treatments during the pandemic would negatively impact patient survival. The reported proportion of consultations using telehealth increased by 7.7-fold, with 25.1% (n=108) of clinicians concerned that patient survival would be worse due to this increase. Clinicians reviewed a median of 10 fewer outpatients/week (including non-face to face) compared with prior to the pandemic, translating to 5010 fewer specialist oncology visits per week among the surveyed group. Mental health was negatively impacted for 52.6% (n=190) of clinicians. CONCLUSION: Clinicians reported widespread changes to oncology services, in regions of both high and low COVID-19 case numbers. Clinician concerns of potential negative impacts on patient outcomes warrant objective assessment, with system and policy implications for healthcare delivery at large.

Background and objective: While multidisciplinary team (MDT) care in lung cancer is widely practiced, there are few guidelines for MDT on best data collection strategies. MDT meetings need ready access to information for the provision of optimal treatment recommendations (the primary purpose of the meeting), audit of team performance and benchmarking. This study aimed to develop a practical data set designed for these goals through a recognized consensus process with health professionals who participate in formal MDT settings. Method(s): A modified Delphi process with three iterations (two surveys and one consensus conference) was carried out involving over 100 Australian lung cancer MDT health professionals. Result(s): In total, 122 lung cancer MDT health professionals responded to the Round 1 survey from over 350 invitees. Of the 122, 98 were available for invitation to Round 2. Of 98, 52 (53%) invitees responded to the Round 2 survey. After two rounds, 51 data elements across 8 domains (patient demographics, risk factors, biopsy data, staging, timeliness, treatment, follow-up and patient selection) achieved consensus, defined as 80% agreement. For Round 3, 33 MDT lead clinicians were invited to participate in a consensus conference. Of 33, 14 (42%) invitees distilled the 47 data elements into 23 elements across 8 domains to address the study objectives. Conclusion(s): A practical data set for lung cancer MDT to use for optimal treatment recommendations and to evaluate team performance was developed through recognized consensus methodology. Access to streamlined, relevant and feasible data collection strategies may improve MDT decision-making, audit of team performance and facilitate benchmarking.Copyright © 2018 Asian Pacific Society of Respirology