ABSTRACT
Blood pressure is controlled through a complex network of interacting peptide systems, principally involving the angiotensin, natriuretic peptide, endothelin and apelin families. The most complex and thoroughly investigated is the renin-angiotensin system (RAS) in which selective and potent inhibitors of the key biosynthetic proteolytic enzymes, renin and angiotensin-converting enzyme (ACE), have proved to be valuable drugs for the effective treatment of hypertension and heart failure, as well as other cardiovascular and renal disorders. Some of the other proteases in these pathways, e.g.neprilysin and ACE2, are also being explored as potential drug targets. © 2023 Elsevier Inc. All rights reserved.
ABSTRACT
Global South non-government organizations rely on international funding and aid for continued service delivery. Service evaluation plays a significant role in ensuring compliance and ongoing service funding. Traditional service evaluation approaches could not take place during 2021 due to COVID-19, alternate mechanisms needed to be embraced. This article reports on the benefits and challenges of undertaking service evaluations online during the pandemic and the learnings and possibilities for a post-pandemic world. It emphasizes the importance of translating a relational approach to service evaluation to the online environment. Key learnings include that while some of the benefits of context and in-person connection are lost, taking a relational approach involving careful planning and reflexivity means the online evaluation process can be successful. Undertaking service evaluations online offers possibilities in a post-pandemic world as cost-effective alternatives to the expensive and time-consuming reality of in-person service evaluation across international borders and within development contexts. © The Author(s) 2022.
ABSTRACT
Background: AAP or ENZ added to ADT improves outcomes for mHSPC. Any benefit of combining ENZ & AAP in this disease setting is uncertain. Methods: STAMPEDE is a multi-arm, multi-stage (MAMS), platform protocol conducted at 117 sites in the UK & Switzerland. 2 trials with no overlapping controls randomised mHSPC patients (pts) 1:1 to ADT +/- AAP (1000mg od AA + 5mg od P) or AAP + ENZ (160mg od). Treatment was continued to progression. From Jan 2016 docetaxel 75mg/m2 3-weekly with P 10mg od was permitted + ADT. Using meta-analysis methods, we tested for evidence of a difference in OS and secondary outcomes (as described previously: failure-free, metastatic progression-free, progression-free & prostate cancer specific survival) across the 2 trials using data frozen 3 Jul 2022. All confidence intervals (CI) 95%. Restricted mean survival times (RMST) restricted to 84 months (m). Results: Between Nov 2011 & Jan 2014, 1003 pts were randomised ADT +/- AAP & between Jul 2014 & Mar 2016, 916 pts were randomised ADT +/- AAP + ENZ. Randomised groups were well balanced across both trials. Pt cohort: age, median 68 years (yr), IQR 63, 72;PSA prior to ADT, median 95.7 ng/ml, IQR 26.5, 346;de novo 94%, relapsed after radical treatment, 6%. In AAP + ENZ trial, 9% had docetaxel + ADT. OS benefit in AAP + ENZ trial, HR 0.65 (CI 0.55‒0.77) p = 1.4×10-6;in AAP trial, HR 0.62 (0.53, 0.73) p = 1.6×10-9. No evidence of a difference in treatment effect (interaction HR 1.05 CI 0.83‒1.32, p = 0.71) or between-trial heterogeneity (I2 p = 0.70). Same for secondary end-points. % (CI) of pts reporting grade 3-5 toxicity in 1st 5 yr: AAP trial, ADT: 38.5 (34.2-42.8), + AAP: 54.4 (50.0-58.8);AAP + ENZ trial, ADT: 45.2 (40.6 – 49.8), + AAP + ENZ: 67.9 (63.5 – 72.2);most frequently increased with AAP or AAP + ENZ = liver derangement, hypertension. At 7 yr in AAP trial (median follow-up: 95.8m), % (CI) pts alive with ADT: 30 (26, 34) versus with ADT + AAP: 48 (43, 52);RMST: ADT: 50.4m, ADT + AAP: 60.6m, p = 6.6 x 10-9. Conclusions: ENZ + AAP need not be combined for mHSPC. Clinically important improvements in OS when adding AAP to ADT are maintained at 7 yr. Clinical trial identification: NCT00268476. Legal entity responsible for the study: Medical Research Council Clinical Trials Unit at University College London. Funding: Cancer Research UK, Medical Research Council, Janssen, Astellas. Disclosure: G. Attard: Financial Interests, Personal, Invited Speaker: Janssen, Astellas, AstraZeneca;Financial Interests, Personal, Advisory Board: Janssen, Astellas, Novartis, Bayer, AstraZeneca, Pfizer, Sanofi, Sapience, Orion;Financial Interests, Personal, Royalties, Included in list of rewards to discoverers of abiraterone: Institute of Cancer Research;Financial Interests, Institutional, Research Grant: Janssen, Astellas;Non-Financial Interests, Principal Investigator: Janssen, Astellas;Non-Financial Interests, Advisory Role: Janssen, AstraZeneca. W.R. Cross: Financial Interests, Personal, Invited Speaker, Speaker fee: Myriad Genetics, Janssen, Astellas;Financial Interests, Personal, Advisory Board, Advisory Board fee: Bayer;Financial Interests, Institutional, Research Grant, Research grant: Myriad Genetics. S. Gillessen: Financial Interests, Personal, Advisory Board, 2018: Sanofi, Roche;Financial Interests, Personal, Advisory Board, 2018, 2019: Orion;Financial Interests, Personal, Invited Speaker, 2019 Speaker's Bureau: Janssen Cilag;Financial Interests, Personal, Advisory Board, 2020: Amgen;Financial Interests, Personal, Invited Speaker, 2020: ESMO;Financial Interests, Personal, Other, Travel Grant 2020: ProteoMEdiX;Financial Interests, Institutional, Advisory Board, 2018, 2019, 2022: Bayer;Financial Interests, Institutional, Advisory Board, 2020: Janssen Cilag, Roche, MSD Merck Sharp & Dohme, Pfizer;Financial Interests, Institutional, Advisory Board, 2018: AAA International, Menarini Silicon Biosystems;Financial Interests, Institutional, Advisory Board, 2019, 2020: Astellas Pharma;Financial Interests, Institutional, Advisory B ard, 2019: Tolero Pharmaceuticals;Financial Interests, Personal, Invited Speaker, 2021, 2022: SAKK, DESO;Financial Interests, Institutional, Advisory Board, 2021: Telixpharma, BMS, AAA International, Novartis, Modra Pharmaceuticas Holding B.V.;Financial Interests, Institutional, Other, Steering Committee 2021: Amgen;Financial Interests, Institutional, Advisory Board, 2021, 2022: Orion, Bayer;Financial Interests, Personal, Invited Speaker, 2021: SAKK, SAKK, SAMO - IBCSG (Swiss Academy of Multidisciplinary oncology);Financial Interests, Personal, Advisory Board, 2021: MSD Merck Sharp & Dhome;Financial Interests, Personal, 2021: RSI (Televisione Svizzera Italiana);Financial Interests, Institutional, Invited Speaker, 2021: Silvio Grasso Consulting;Financial Interests, Institutional, Other, Faculty activity 2022: WebMD-Medscape;Financial Interests, Institutional, Advisory Board, 2022: Myriad genetics, AstraZeneca;Financial Interests, Institutional, Invited Speaker, 2022: TOLREMO;Financial Interests, Personal, Other, Travel support 2022: AstraZeneca;Financial Interests, Institutional, Funding, 2021, Unrestricted grant for a Covid related study as co-investigator: Astellas;Non-Financial Interests, Advisory Role, 2019: Menarini Silicon Biosystems, Aranda;Non-Financial Interests, Advisory Role, Continuing: ProteoMediX. C. Pezaro: Financial Interests, Personal, Advisory Board, Ad board Dec 2020: Advanced Accelerator Applications;Financial Interests, Personal, Advisory Board, Aug 2021: Astellas;Financial Interests, Personal, Advisory Board, Oct 2021: Bayer;Financial Interests, Personal, Invited Speaker, Sept-Oct 2020: AstraZeneca;Financial Interests, Personal, Invited Speaker, Oct 2020: Janssen;Financial Interests, Personal, Advisory Board, July-Sept 2022: Pfizer. Z. Malik: Financial Interests, Personal, Advisory Board, advisry board for new hormonal therapy for breast cancer: sanofi;Financial Interests, Institutional, Invited Speaker, research grant for CHROME study: sanofi;Other, Other, support to attend meetings or advisory boards in the past: Astellas,Jaansen,Bayer;Other, Other, Sponsorship to attend ASCO meeting 2022: Bayer. M.R. Sydes: Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training sessions for clinicians (no discussion of particular drugs): Janssen;Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training session for clinicians (no discussion of particular drugs): Eli Lilly;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Astellas, Janssen, Novartis, Pfizer, Sanofi;Financial Interests, Institutional, Research Grant, Educational grant and biomarker costs for STAMPEDE trial: Clovis Oncology. L.C. brown: Financial Interests, Institutional, Research Grant, £170k educational grant for the FOCUS4-C Trial from June 2017 to Dec 2021: AstraZeneca;Financial Interests, Institutional, Funding, Various grants awarded to my institution for work undertaken as part of the STAMPEDE Trial: janssen pharmaceuticals;Non-Financial Interests, Other, I am a member of the CRUK CERP funding advisory panel and my Institution also receive grant funding from CRUK for the STAMPEDE and FOCUS4 trials: Cancer Research UK. M.K. Parmar: Financial Interests, Institutional, Full or part-time Employment, Director at MRC Clinical Trials Unit at UCL: Medical Research Council Clinical Trials Unit at UCL;Financial Interests, Institutional, Research Grant: AstraZeneca, Astellas, Janssen, Clovis;Non-Financial Interests, Advisory Role, Euro Ewing Consortium: University College London;Non-Financial Interests, Advisory Role, rEECur: University of Birmingham;Non-Financial Interests, Advisory Role, CompARE Trial: University of Birmingham. N.D. James: Financial Interests, Personal, Advisory Board, Advice around PARP inhibitors: AstraZeneca;Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Janssen, Clovis, Novartis;Financial Interests, Institutional, Expert Testimony, Assisted with submissions regarding licencing for abiraterone: Janssen;Financial Interests, Personal, Advisory Board, Docetaxel: Sanofi;Financial Interests, Institutional, Expert Testimony, Providing STAMPEDE trial data to facilitate licence extensions internationally for docetaxel: Sanofi;Financial Interests, Personal, Advisory Board, Bladder cancer therapy: Merck;Financial Interests, Personal, Advisory Board, Advice around novel hormone therapies for prostate cancer: Bayer;Financial Interests, Personal, Invited Speaker, Lecture tour in Brazil August 2022 - speaking on therapy for advanced prostate cancer: Merck Sharp & Dohme (UK) Limited;Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Janssen, Astellas;Financial Interests, Institutional, Invited Speaker, Funding for RADIO trial bladder cancer: AstraZeneca. All other authors have declared no conflicts of interest.
ABSTRACT
Background: The Phase III PROpel (NCT03732820) trial demonstrated at interim analysis a statistically significant clinical benefit from combining ola + abi in the first-line (1L) mCRPC setting vs placebo (pbo) + abi. Benefit was seen irrespective of a pt's homologous recombination repair mutation (HRRm) status;median radiographic progression-free survival (rPFS) 24.8 for ola + abi vs 16.6 months for pbo + abi (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54-0.81;P<0.0001). The safety profile of ola + abi was shown to be consistent with that for the individual drugs. We report additional interim safety analysis from PROpel. Methods: Eligible pts were ≥18 years with mCRPC, had received no prior chemotherapy or next-generation hormonal agent treatment at mCRPC stage, and were unselected by HRRm status. Pts were randomized 1:1 to abi (1000 mg qd) plus prednisone/prednisolone with either ola (300 mg bid) or pbo. Primary endpoint was investigator-assessed rPFS. Safety was assessed in all pts receiving ≥1 dose of study treatment by adverse event (AE) reporting (CTCAE v4.03). Results: 398 pts received ola + abi and 396 pbo + abi (safety analysis set). At data cut-off (July 30, 2021), median total duration of exposure for ola was 17.5 vs 15.7 months for pbo, and for abi 18.2 months in the ola + abi arm and 15.7 in the pbo + abi arm. Anemia (n=183) was the most common AE in the ola + abi arm, and 34% of these 183 events were managed by dose interruption, 23% by dose reduction, and 8% resulted in treatment discontinuation. Anemia and pulmonary embolism (PE) were the only Grade ≥3 AEs in ≥5% of pts (anemia: ola + abi, 15.1% vs pbo + abi, 3.3%;PE: 6.5% vs 1.8%, respectively). Most PEs were detected incidentally on radiographic imaging (69.2% and 71.4% in the ola + abi and pbo + abi arms, respectively) and no pts discontinued. More pts in the ola + abi arm experienced venous thromboembolism (Table). Arterial thromboembolism and cardiac failure AEs were balanced between the treatment arms. No AE of myelodysplastic syndrome/acute myeloid leukemia was reported in either treatment arm. COVID-19 was reported more frequently with ola + abi (8.3% vs 4.5%). Conclusions: PROpel demonstrated a predictable safety profile for ola + abi given in combination to pts with 1L mCRPC unselected by HRRm status. AEs of cardiac failure and arterial thromboembolism were reported at similar frequency in both treatment arms. The majority of PEs were asymptomatic. The safety profile of abiraterone was not adversely impacted by its combination with olaparib.
ABSTRACT
With proportionally low rates of infection and deaths, Norway is depicted as a country with an effective health and safety policy for the current coronavirus pandemic. High levels of trust between the governors and the governed, and between the public and legacy media, resulted in general consensus around the infection control strategy for the most part of what was referred to as the "second wave" of the pandemic. This study examines newspaper articles from two Norwegian newspapers during two months in the autumn of 2020, when the corona situation was recognised as becoming a long-term concern. We document that as the authorities tried to deal with the situation by calling for a dugnad (collective effort) among the public, there was a conspicuous lack of journalism that questioned the policies of those authorities. In the absence of regular critical journalism, how does the press handle the relationship between necessary consensus to keep contagion down, and necessary debate about the policy and its effects? We present an overview of the general trends and patterns during the second wave of the pandemic in the autumn of 2020, with a particular emphasis on three cases where select Norwegian media diverged from merely reporting national health policy.
ABSTRACT
Background: Patients (pts) with high-risk M0 PCa are treated with ADT and when indicated, local radiotherapy (RT). Intensifying hormone treatment with AAP, ENZ or apalutamide continuous to progression improves outcomes of metastatic PCa but its efficacy in M0 PCa starting ADT is unknown. Methods: STAMPEDE is a multi-arm, multi-stage trial that, as part of 2 separate comparisons randomised PCa pts with M0 node positive or high-risk node negative (>1 T3/4, PSA ≥40ng/ml, Gleason 8-10 or relapsing) 1:1 to ADT (control) vs ADT with AAP (1000mg AA + 5mg P od) or ADT vs ADT with AAP + ENZ (160mg od) for 2 years (y), unless RT was omitted when treatment could be to progression. The primary end-point was metastasis-free survival (MFS, time to death or distant metastases). The sub-group of pts who received ADT +/- AAP was partially reported with metastatic pts in 2017 so one-sided type 1 error rate was set to 1.25%. All analyses were pre-specified, pooled using meta-analyses methods and stratified as described previously. Data frozen 3rd August 2021. Results: 1974 M0 pts at 113 sites in UK & Switzerland were randomised, 914 (Nov 2011 to Jan 2014) to ADT +/- AAP & 1060 (Mar 2016 to Jul 2014) to ADT +/- AAP + ENZ. Groups were well balanced: median age 68 y, range 43-86;median PSA 34 ng/ml, range 0.4-2773;Gleason 8-10, 79%;node positive 39%;planned for RT 85%. Median months to stopping AAP, 23.7 (IQR: 17.6-24.1);AAP when given with ENZ, 20.7 (IQR: 4.4-24);ENZ, 23.2 (IQR: 6.3-24). 180 MFS events occurred in the research group and 306 in the control group. AAP-based therapy improved MFS (HR 0.53, 95% CI 0.44-0.64, P=2.9×10- 11) & survival (HR 0.60, 95% CI 0.48-0.73, P=9.3×10-7): 6-y MFS from 69% to 82%, 6-y survival from 77% to 86%. Treatment effect was consistent in major subgroups and between AAP & AAP + ENZ randomisation periods (MFS HR=0.54, 95% CI 0.43-0.68;HR=0.53, 95% CI 0.39-0.71 respectively;interaction HR = 1.02, 95% CI: 0.70-1.50, p=0.908). Conclusions: 2 y of AAP-based therapy significantly improves MFS & survival of high-risk M0 PCa starting ADT and should be considered a new standard of care. Clinical trial identification: NCT00268476. Legal entity responsible for the study: Medical Research Council Clinical Trials Unit at University College London. Funding: Cancer Research UK, Medical Research Council, Astellas, Janssen. Disclosure: G. Attard: Financial Interests, Personal, Invited Speaker: Janssen;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Personal, Invited Speaker: Astellas;Financial Interests, Personal, Advisory Board: Astellas;Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Sanofi;Financial Interests, Personal, Advisory Board: Sapience;Financial Interests, Personal, Advisory Board: Orion;Financial Interests, Personal, Royalties: Janssen;Financial Interests, Institutional, Research Grant: Janssen;Financial Interests, Institutional, Research Grant: Astellas;Non-Financial Interests, Principal Investigator: Janssen;Non-Financial Interests, Advisory Role: Janssen;Non-Financial Interests, Advisory Role: AstraZeneca;Non-Financial Interests, Principal Investigator: Astellas. L.C. Brown: Financial Interests, Institutional, Research Grant, FOCUS4-C Trial from June 2017 to Dec 2021: AstraZeneca. N. Clarke: Financial Interests, Personal, Invited Speaker: Astellas;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Invited Speaker: Ferring;Financial Interests, Personal, Invited Speaker: Janssen;Financial Interests, Personal, Advisory Board: Astellas;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Ferring;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Inst tutional, Research Grant: AstraZeneca. W. Cross: Financial Interests, Personal, Invited Speaker, Speaker fee: Myriad Genetics;Financial Interests, Personal, Invited Speaker, Speaker fee: Janssen;Financial Interests, Personal, Advisory Board, Advisory Board fee: Bayer;Financial Interests, Personal, Invited Speaker, Speaker fee: Astellas;Financial Interests, Institutional, Research Grant, Research grant: Myriad Genetics. R. Jones: Financial Interests, Personal, Advisory Board, advisory board attendance: AstraZeneca;Financial Interests, Personal, Advisory Board, advisory board attendance: Astellas;Financial Interests, Personal, Invited Speaker, Honoraria for speaking: Astellas;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Invited Speaker: Bayer;Financial Interests, Personal, Advisory Board: Clovis;Financial Interests, Personal, Advisory Board: Exelixis;Financial Interests, Personal, Advisory Board: Ipsen;Financial Interests, Personal, Invited Speaker: Ipsen;Financial Interests, Personal, Advisory Board: Bristol Myers Squipp;Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb;Financial Interests, Personal, Advisory Board: Merck Serono;Financial Interests, Personal, Invited Speaker: Merck Serono;Financial Interests, Personal, Advisory Board: Merck Sharpe Dome;Financial Interests, Personal, Invited Speaker: Merck Sharpe Dome;Financial Interests, Personal, Invited Speaker: Pfizer;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Institutional, Other, IDMC membership: Roche;Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Personal, Invited Speaker: Janssen;Financial Interests, Institutional, Other, IDMC member: Stab;Financial Interests, Personal, Advisory Board: Novartis / AAA;Financial Interests, Institutional, Invited Speaker: Janssen;Financial Interests, Institutional, Invited Speaker: Pfizer;Financial Interests, Institutional, Invited Speaker: Tail;Financial Interests, Institutional, Invited Speaker: AstraZeneca;Financial Interests, Institutional, Invited Speaker: BioXcel;Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb;Financial Interests, Institutional, Invited Speaker: Novartis / AAA;Financial Interests, Institutional, Invited Speaker: Roche;Financial Interests, Institutional, Invited Speaker: MSK. S. Gillessen: Financial Interests, Personal, Advisory Board, 2018: Sanofi;Financial Interests, Personal, Advisory Board, 2018, 2019: Orion;Financial Interests, Personal, Advisory Board, 2018: Roche;Financial Interests, Personal, Invited Speaker, 2019 Speaker's Bureau: Janssen Cilag;Financial Interests, Personal, Advisory Board, 2020: Amgen;Financial Interests, Personal, Invited Speaker, 2020: ESMO;Financial Interests, Personal, Other, Travel Grant 2020: ProteoMEdiX;Financial Interests, Institutional, Advisory Board, 2018, 2019: Bayer;Financial Interests, Institutional, Advisory Board, 2020: Janssen Cilag;Financial Interests, Institutional, Advisory Board, 2020: Roche;Financial Interests, Institutional, Advisory Board, 2018: AAA International;Financial Interests, Institutional, Advisory Board, 2018: Menarini Silicon Biosystems;Financial Interests, Institutional, Advisory Board, 2019, 2020: Astellas Pharma;Financial Interests, Institutional, Advisory Board, 2019: Tolero Pharmaceuticals;Financial Interests, Institutional, Advisory Board, 2020: MSD Merck Sharp & Dohme;Financial Interests, Institutional, Advisory Board, 2020: Pfizer;Financial Interests, Personal, Invited Speaker, 2021: SAKK;Financial Interests, Institutional, Advisory Board, 2021: Telixpharma;Financial Interests, Institutional, Other, Steering Committee 2021: Amgen;Financial Interests, Institutional, Invited Speaker, 2021: DESO;Financial Interests, Institutional, Advisory Board, 2021: BMS;Financial Interests, Institutional, Advisory Board, 2021: AAA International;Financial Interests, Institutional, Advisory Board, 2021: Orion;F nancial Interests, Personal, Invited Speaker, 2021: SAKK;Financial Interests, Personal, Invited Speaker, 2021: SAKK;Financial Interests, Institutional, Advisory Board, 2021: Bayer;Financial Interests, Personal, Advisory Board, 2021: MSD Merck Sharp & Dhome;Financial Interests, Personal, Other, 2021: RSI (Televisione Svizzera Italiana);Financial Interests, Personal, Invited Speaker, 2021: SAMO - IBCSG;Financial Interests, Institutional, Funding, 2021, Unrestricted grant for a Covid related study as co-investigator: Astellas;Non-Financial Interests, Advisory Role, 2019: Menarini Silicon Biosystems;Non-Financial Interests, Advisory Role, 2019: Aranda;Non-Financial Interests, Advisory Role, Continuing: ProteoMediX. S. Chowdhury: Financial Interests, Personal, Advisory Board: Astellas;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Personal, Invited Speaker: Janssen;Financial Interests, Personal, Advisory Board: Huma;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Invited Speaker: Bayer;Financial Interests, Personal, Advisory Board: Novartis/AAA;Financial Interests, Personal, Advisory Board: Beigene;Financial Interests, Personal, Advisory Board: Remedy Bio;Financial Interests, Personal, Advisory Board: Athenex;Financial Interests, Personal, Advisory Board: Telix;Financial Interests, Personal, Advisory Board: Clovis Oncology;Financial Interests, Personal, Stocks/Shares: Curve Life;Financial Interests, Institutional, Research Grant: Clovis Oncology;Non-Financial Interests, Advisory Role, Non-compensated advice: NHS England;Non-Financial Interests, Advisory Role: NICE NHS England. Z. Malik: Financial Interests, Personal, Advisory Board, advisry board for new hormonal therapy for breast cancer:Sanofi;Other, support to attend meetings or advisory boards in the past: Astellas, Jaansen, Bayer. C. Parker: Financial Interests, Personal, Advisory Board, Education Steering Committee: Bayer;Financial Interests, Personal, Invited Speaker, Speaker at prostate cancer educational events: Janssen;Financial Interests, Personal, Advisory Board, Advisory board on apalutamide: Janssen;Financial Interests, Personal, Advisory Board, Advisory board: Clarity Pharmaceuticals;Financial Interests, Personal, Advisory Board, Advisory board on relugolix: Myovant;Financial Interests, Personal, Advisory Board, Advisory board: ITM Oncologics. M.R. Sydes: Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training sessions for clinicians (no discussion of particular drugs): Janssen;Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training session for clinicians (no discussion of particular drugs): Eli Lilly;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Astellas;Financial Interests, Institutional, Research Grant, Educational grant and biomarker costs for STAMPEDE trial: Clovis Oncology;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Janssen;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Novartis;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Pfizer;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Sanofi. M.K. Parmar: Financial Interests, Institutional, Research Grant: AstraZeneca, Astellas, Janssen, Clovis. N.D. James: Financial Interests, Personal, Advisory Board, Advice around PARP inhibitors: AstraZeneca;Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Janssen;Financial Interests, Institutional, Expert Testimony, Assisted with submissions regarding licencing for abiraterone: Janssen;Financial Interests, Personal, Advisory Board, Docetaxel: Sanofi;Financial Interests, Institutional, Expert Testimony, Providing STAMPEDE trial data to facili ate licence extensions internationally for docetaxel: Sanofi;Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Clovis;Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Novartis;Financial Interests, Personal, Advisory Board, Bladder cancer therapy: Merck;Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Janssen;Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Astellas;Financial Interests, Institutional, Invited Speaker, Funding for RADIO trial bladder cancer: AstraZeneca. All other authors have declared no conflicts of interest.
ABSTRACT
Introduction: The COVID-19 pandemic has had a profound impact on cancer care. We evaluated the impact on the diagnosis and treatment of men with prostate cancer (PCa) in England. Patients/Methods: Patients diagnosed with PCa in the English NHS between 1st January 2019 and 30th June 2020 (N=58,749) were identified in the Rapid Cancer Registration dataset. Patient-level linkage to the Cancer Waiting Times dataset provided information on radical surgery and radiotherapy within 12 months of diagnosis. Follow-up was available to 31st July 2020. Changes in monthly diagnoses and treatments following the start of the UK lockdown on 23rd March 2020 were compared with the corresponding month in 2019. Results: Overall, there was a 56% reduction in diagnoses compared with 2019 (55% in April, 62% in May and 51% in June). Radical surgery also declined (by 61% in April, 60% in May) with a relatively greater reduction in radiotherapy (by 75% in April, 69% in May) compared with 2019. Radical treatment activity increased from June with a one third reduction compared with 2019 in radical surgery (34%) and radiotherapy (33%) by July. Conclusion: Diagnostic and radical treatment activity fell significantly following the UK lockdown. There was evidence of a recovery in surgical and radiotherapy activity in June although this was not complete by the end of July 2020. Follow-up to September 2020 and linkage to routine hospital datasets (HES, RTDS and SACT) will allow further exploration of treatment patterns and their recovery. These analyses will be completed by the time of presentation.