Mini Review on the Use of Clinical Cancer Registers for Prostate Cancer: The National Prostate Cancer Register (NPCR) of Sweden

Given the increasing prevalence of cancer, it is vital to systematically collect data in order to monitor disease trends and quality of cancer care. For this purpose, clinical cancer registries have been developed in some countries. These registers are intended to be used as a basis for quality assurance and quality improvement, but they also constitute a rich resource of real world data for research. The aim of this mini-review was to describe the structure and the organization of the National Prostate Cancer Register (NPCR) with some examples on how data in NPCR have affected prostate cancer care in Sweden

Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Background Metastatic castration-resistant prostate cancers are enriched for DNA repair gene defects (DRDs) that can be susceptible to synthetic lethality through inhibition of PARP proteins. We evaluated the anti-tumour activity and safety of the PARP inhibitor niraparib in patients with metastatic castration-resistant prostate cancers and DRDs who progressed on previous treatment with an androgen signalling inhibitor and a taxane. Methods In this multicentre, open-label, single-arm, phase 2 study, patients aged at least 18 years with histologically confirmed metastatic castration-resistant prostate cancer (mixed histology accepted, with the exception of the small cell pure phenotype) and DRDs (assessed in blood, tumour tissue, or saliva), with progression on a previous next-generation androgen signalling inhibitor and a taxane per Response Evaluation Criteria in Solid Tumors 1.1 or Prostate Cancer Working Group 3 criteria and an Eastern Cooperative Oncology Group performance status of 0–2, were eligible. Enrolled patients received niraparib 300 mg orally once daily until treatment discontinuation, death, or study termination. For the final study analysis, all patients who received at least one dose of study drug were included in the safety analysis population; patients with germline pathogenic or somatic biallelic pathogenic alterations in BRCA1 or BRCA2 (BRCA cohort) or biallelic alterations in other prespecified DRDs (non-BRCA cohort) were included in the efficacy analysis population. The primary endpoint was objective response rate in patients with BRCA alterations and measurable disease (measurable BRCA cohort). This study is registered with ClinicalTrials.gov, NCT02854436. Findings Between Sept 28, 2016, and June 26, 2020, 289 patients were enrolled, of whom 182 (63%) had received three or more systemic therapies for prostate cancer. 223 (77%) of 289 patients were included in the overall efficacy analysis population, which included BRCA (n=142) and non-BRCA (n=81) cohorts. At final analysis, with a median follow-up of 10·0 months (IQR 6·6–13·3), the objective response rate in the measurable BRCA cohort (n=76) was 34·2% (95% CI 23·7–46·0). In the safety analysis population, the most common treatment-emergent adverse events of any grade were nausea (169 [58%] of 289), anaemia (156 [54%]), and vomiting (111 [38%]); the most common grade 3 or worse events were haematological (anaemia in 95 [33%] of 289; thrombocytopenia in 47 [16%]; and neutropenia in 28 [10%]). Of 134 (46%) of 289 patients with at least one serious treatment-emergent adverse event, the most common were also haematological (thrombocytopenia in 17 [6%] and anaemia in 13 [4%]). Two adverse events with fatal outcome (one patient with urosepsis in the BRCA cohort and one patient with sepsis in the non-BRCA cohort) were deemed possibly related to niraparib treatment. Interpretation Niraparib is tolerable and shows anti-tumour activity in heavily pretreated patients with metastatic castration-resistant prostate cancer and DRDs, particularly in those with BRCA alterations

Population-based study on use of chemotherapy in men with castration resistant prostate cancer

BACKGROUND. Chemotherapy prolongs life and relieves symptoms in men with castration resistant prostate cancer (CRPC). There is limited information on a population level on the use of chemotherapy for CRPC. MATERIAL AND METHODS. To assess the use of chemotherapy in men with CRPC we conducted a register-based nationwide population-based study in Prostate Cancer data Base Sweden (PCBaSe) and a nationwide in-patient drug register (SALT database) between May 2009 and December 2010. We assumed that men who died of prostate cancer (PCa) underwent a period of CRPC before they died. RESULTS. Among the 2677 men who died from PCa during the study inclusion period, 556 (21%) had received chemotherapy (intravenous or per oral) detectable within the observation period in SALT database. Specifically, 239 (61%) of men < 70 years had received chemotherapy, 246 (30%) of men between 70 and 79 years and 71 (5%) men older than 80 years. The majority of men 465/556 (84%) had received a docetaxel-containing regimen. Among chemotherapy treated men, 283/556 (51%) received their last dose of chemotherapy during the last six months prior to death. Treatment with chemotherapy was more common among men with little comorbidity and high educational level, as well as in men who had received curatively intended primary treatment. CONCLUSION. A majority of men younger than 70 years with CRPC were treated with chemotherapy in contrast to men between 70 and 79 years of whom half as many received chemotherapy. Chemotherapy treatment was often administered shortly prior to death. The low uptake of chemotherapy in older men with CRPC may be caused by concerns about tolerability of treatment, as well as treatment decisions based on chronological age rather than global health status

The Value of Real-World Data in Understanding Prostate Cancer Risk and Improving Clinical Care : Examples from Swedish Registries

Simple Summary Real-world data (RWD), i.e., data reflecting normal clinical practice collected outside the constraints of randomised controlled trials, provide important insights into our understanding of prostate cancer and its management. Clinical cancer registries are an important source of RWD. Depending on their scope and the potential linkage to other data sources, registry-based data can be utilised to address a variety of questions including risk factors, healthcare utilisation, treatment effectiveness, adverse effects, disparities in healthcare access, quality of care and healthcare economics. This review describes the various registry-based RWD sources for prostate cancer research in Sweden (namely the National Prostate Cancer Register, the Prostate Cancer data Base Sweden (PCBaSe) and the Patient-overview Prostate Cancer) and documents their utility for better understanding prostate cancer aetiology and improving clinical care. Abstract Real-world data (RWD), that is, data from sources other than controlled clinical trials, play an increasingly important role in medical research. The development of quality clinical registers, increasing access to administrative data sources, growing computing power and data linkage capacities have contributed to greater availability of RWD. Evidence derived from RWD increases our understanding of prostate cancer (PCa) aetiology, natural history and effective management. While randomised controlled trials offer the best level of evidence for establishing the efficacy of medical interventions and making causal inferences, studies using RWD offer complementary evidence about the effectiveness, long-term outcomes and safety of interventions in real-world settings. RWD provide the only means of addressing questions about risk factors and exposures that cannot be “controlled”, or when assessing rare outcomes. This review provides examples of the value of RWD for generating evidence about PCa, focusing on studies using data from a quality clinical register, namely the National Prostate Cancer Register (NPCR) Sweden, with longitudinal data on advanced PCa in Patient-overview Prostate Cancer (PPC) and data linkages to other sources in Prostate Cancer data Base Sweden (PCBaSe)

Prostatacancercentrum – navet i framtidens prostatacancersjukvård - En vision som är i linje med det nationella vårdprogrammets riktlinjer : En vision som är i linje med det nationella vårdprogrammets riktlinjer

Prostate cancer units - hubs in the future care of men with prostate cancer Prostate cancer is the most common form of cancer in Sweden. The past decade has seen a tremendous development of new methods for diagnosing, staging, treating and rehabilitating men with suspicious or confirmed prostate cancer. This development necessitates a multidisciplinary and multiprofessional approach to the management of men with suspicious or confirmed prostate cancer. A recent survey showed that currently few Swedish men with prostate cancer receive the quality of care that is outlined in the national clinical guidelines. Specialised prostate cancer units are increasingly common in Europe, but as yet there are no such units in Sweden. We believe that the creation of prostate cancer units in Sweden would be an essential step forward, towards an improved future care of men with prostate cancer

Prostatacancercentrum - navet i framtidens prostatacancersjukvård

Prostate cancer is the most common form of cancer in Sweden. The past decade has seen a tremendous development of new methods for diagnosing, staging, treating and rehabilitating men with suspicious or confirmed prostate cancer. This development necessitates a multidisciplinary and multiprofessional approach to the management of men with suspicious or confirmed prostate cancer. A recent survey showed that currently few Swedish men with prostate cancer receive the quality of care that is outlined in the national clinical guidelines. Specialised prostate cancer units are increasingly common in Europe, but as yet there are no such units in Sweden. We believe that the creation of prostate cancer units in Sweden would be an essential step forward, towards an improved future care of men with prostate cancer

Prostatacancercentrum - navet i framtidens prostatacancersjukvård

Prostate cancer is the most common form of cancer in Sweden. The past decade has seen a tremendous development of new methods for diagnosing, staging, treating and rehabilitating men with suspicious or confirmed prostate cancer. This development necessitates a multidisciplinary and multiprofessional approach to the management of men with suspicious or confirmed prostate cancer. A recent survey showed that currently few Swedish men with prostate cancer receive the quality of care that is outlined in the national clinical guidelines. Specialised prostate cancer units are increasingly common in Europe, but as yet there are no such units in Sweden. We believe that the creation of prostate cancer units in Sweden would be an essential step forward, towards an improved future care of men with prostate cancer

Time difference in retrieving clinical information in Patient-overview Prostate Cancer compared to electronic health records

Background Patients with advanced prostate cancer (PCa) typically undergo numerous lines of treatment leading to large amounts of information in Electronic Health Records (EHRs). The Patient-overview Prostate Cancer (PPC) presents clinical information in a graphical overview. The aim of this study was to measure time spent on retrieving clinical information in PPC compared to EHRs, to assess if retrieved data was correct and to explore usability of PPC. Material and methods Oncologists, urologists and nurses in three hospitals in Sweden were timed when filling out questionnaires about patients using PPC and two different EHRs; Melior and COSMIC. Time and number of errors were analysed using linear mixed models (LMMs). Usability of PPC was measured with the System Usability Scale. Results The LMM showed a significantly shorter time to retrieve information in PPC compared to EHRs. The estimated time to complete one questionnaire was 8 minutes (95% CI = 6-10, p &lt; 0.001) in PPC compared to 25 minutes in Melior and 21 minutes in COSMIC. Compared to PPC, the estimated time difference was 17 minutes longer in Melior (95% CI = 14-20, p &lt; 0.001) and 13 minutes longer in COSMIC (95% CI = 10-17, p &lt; 0.001). The LMM showed significantly fewer errors in PPC compared to Melior. No significant difference in the number of errors was found between PPC and COSMIC. The usability of PPC was rated as excellent by oncologists, urologists and nurses. Conclusion A graphical overview of a patient's medical history, as in PPC, gives health staff rapid access to relevant information with a high degree of usability

Set-up and preliminary results from the Patient-overview Prostate Cancer : Longitudinal registration of treatment of advanced prostate cancer in the National Prostate Cancer Register of Sweden

Introduction: Novel drugs have been shown to prolong life in men with metastatic prostate cancer (PCa) and castration resistant Pca (CRPC). The aim of Patient-overview Prostate cancer (PPC) is to register and report these treatments and their effect. Material and methods: In PPC, a new part of the National Prostate Cancer Register of Sweden data on start and stop of treatments, imaging, prostate specific antigen, clinical assessment of progression and patient reported outcome measures (PROM) are registered from initiation of hormonal treatment. Data are displayed in a graph to inform clinical decisions for individual patients. For research, data in PPC are linked to PCBaSe with information from NPCR and a number of health care registers. Results: In December 2019, 7 882 men had been registered in PPC out of whom 3 912 had reached the CRPC state. Median time to start of androgen receptor targeted drugs (ART) from start of ADT was 4 years (interquartile range IQR 6) for men with primary ADT, and 9 years (IQR 6) and for men with secondary ADT. Out of all men in PCBaSe with a prescription for ART in 2016-2017, PPC captured 1 480/4 055 (36%). There were small differences between men registered/not registered in PPC for cancer characteristics, primary treatment, comorbidity, and time on ADT before start of ART. Conclusion: In PPC, use and effects of novel therapies for advanced Pca are assessed in a real-life setting. PPC data are used as a decision aid, for quality assurance, and in research

Public online reporting from a nationwide population-based clinical prostate cancer register

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