Differences in Trial and Real-world Populations in the Dutch Castration-resistant Prostate Cancer Registry

Westgeest, Hans M.; Groot, Carin A. Uyl–de; Moorselaar, R. Jeroen A. van; Wit, Ronald de; Bergh, Alfons C.M. van den; Coenen, Jules L.L.M.; Beerlage, Harrie P.; Hendriks, Mathijs P.; Bos, Monique M.E.M.; Berg, Pieter van den; Wouw, Agnès J. van de; Spermon, Roan; Boerma, M. O.; Geenen, Maud M.; Tick, Lidwine W.; Polée, Marco B.; Bloemendal, Haiko J.; Cordia, I.; Peters, F. P. J.; Vos, Aad I. de; Bosch, Jackie; Eertwegh, Alphonsus J. M. van den; Gerritsen, Winald R.

doi:10.1016/j.euf.2016.09.008

Cited by 46 publications

(62 citation statements)

References 16 publications

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“…This would enable better replication of methods and offer deeper, more meaningful insights. Nevertheless, the prognostic significance of the patient characteristics as identified in this study also corresponds with previously published results based on observational data 11‐13 , 30,31 …”

Section: Discussionsupporting

confidence: 91%

Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Baillie

Mueller

Pan

et al. 2020

Pharmacoepidemiology and Drug

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Purpose New treatments are introduced into standard care based on clinical trial results. However, it is not clear if these benefits are reflected in the broader population. This study analysed the clinical outcomes of patients with metastatic castration‐resistant prostate cancer, treated with abiraterone and enzalutamide, within the Scottish National Health Service. Methods Retrospective cohort study using record linkage of routinely collected healthcare data (study period: February 2012 to February 2017). Overall survival (OS) was analysed using Kaplan‐Meier methods and Cox Proportional Hazard models; a subgroup analysis comprised potentially trial‐eligible patients. Results Overall, 271 patients were included and 73.8% died during the study period. Median OS was poorer than in the pivotal trials, regardless of medication and indication: 10.8 months (95% confidence interval [CI] 8.6‐15.1) and 20.9 months (95% CI 14.9‐29.0) for abiraterone, and 12.6 months (95% CI 10.5‐18.2) and 16.0 months (95% CI 9.8—not reached) for enzalutamide, post and pre chemotherapy, respectively. Only 46% of patients were potentially “trial eligible” and in this subgroup OS improved. Factors influencing survival included baseline performance status, and baseline prostate‐specific antigen, alkaline phosphatase, and albumin levels. Conclusions Poorer prognostic features of non‐trial eligible patients impact real‐world outcomes of cancer medicines. Electronic record linkage of routinely collected healthcare data offers an opportunity to report outcomes on cancer medicines at scale and describe population demographics. The availability of such observational data to supplement clinical trial results enables patients and clinicians to make more informed treatment decisions, and policymakers to contextualise trial findings.

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Section: Discussionsupporting

confidence: 91%

Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Baillie

Mueller

Pan

et al. 2020

Pharmacoepidemiology and Drug

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“…The current analysis included unselected patients in a real‐world setting, while one of the comparator studies included selected patients who were participating in experimental trials 1. This is relevant as data show that clinical trial participants are typically younger and healthier than the overall cancer population, resulting in differences in OS between trial participants and real‐world patients 25, 26. Indeed, the median age in the current analysis was 66 years, compared with 62 years in the comparator study undertaken in clinical trial participants 1.…”

Section: Discussionmentioning

confidence: 99%

Validation of multiple myeloma risk stratification indices in routine clinical practice: Analysis of data from the Czech Myeloma Group Registry of Monoclonal Gammopathies

et al. 2018

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This study used data from the Czech Myeloma Group Registry of Monoclonal Gammopathies to validate the International Myeloma Working Group (IMWG) and revised International Staging System (R‐ISS) indices for risk stratification in patients with multiple myeloma (MM) in clinical practice. Patients were included if they had symptomatic MM, complete data allowing R‐ISS and IMWG staging (including cytogenetic information regarding t(4;14), t(14;16), and del(17p)), and key parameters for treatment evaluation. Median overall survival (OS) in included patients (n = 550) was 47.7 (95% CI: 39.5‐55.9) and 46.2 (95% CI: 38.9‐53.5) months from diagnosis and initiation of first‐line therapy, respectively. Patients categorized as higher vs lower risk had reduced survival; median OS from diagnosis was 35.4 (95% CI: 30.5‐40.3) vs 58.3 (95% CI: 53.8‐62.9) months in high‐risk vs other patients (IMWG; P = .001) and 34.1 (95% CI: 30.2‐38.0) vs 47.2 (95% CI: 43.4‐51.0) months in Stage III vs Stage II patients (R‐ISS; P < .001). In conclusion, IMWG and R‐ISS risk stratification indices are applicable to patients with MM in a real‐world setting.

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“…Population-based PC outcomes, including predictors of time to metastases in CRPC [16], treatment patterns in mCRPC [17,18] and clinical course in patients without metastases at initiating ADT [19] have been described in multiple studies. However, there are limited data focusing on the impact of metastases at initial diagnosis on survival outcomes in CRPC outside of clinical trials [20]. Understanding the real-world impact of metastases in CRPC has become especially important with the availability of recently approved antiandrogens for treating nmCRPC.…”

Section: Introductionmentioning

confidence: 99%

Survival in patients diagnosed with castration-resistant prostate cancer: a population-based observational study in Sweden

Aly

Levál

Schain

et al. 2020

Scandinavian Journal of Urology

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Background: This study investigated prostate cancer (PC)-specific survival and overall survival (OS) in a population-based castration-resistant PC (CRPC) cohort. Methods: Data from Stockholm Prostate-Specific Antigen (PSA) and Biopsy Register patients with increasing PSA despite gonadotropin-releasing hormone treatment or surgical castration (n ¼ 1,712) included PSA values and biopsies from 2003 to 2015 and were linked to the National Prostate Cancer Register and Prescribed Drug Register. Kaplan-Meier method estimated PC-specific survival and OS, stratified by metastasis at PC diagnosis, and Cox regression estimated hazard ratios (HRs) for Gleason score and T-stage at PC diagnosis and for age and calendar period at CRPC onset by metastasis status at diagnosis. Results: Median OS after CRPC onset was 23.2 months (95% CI ¼ 21.0-25.9) among patients without metastases (M0) at primary diagnosis, and 13.2 months (11.3-14.5) among patients with metastases (M1). Median PC-specific survival from CRPC onset was 30.3 (27.5-34.1) months and 13.3 (12.1-15.8) months for M0 and M1 patients, respectively. Biopsy Gleason score 8 was associated with higher all-cause mortality than 6 (HR ¼ 2.07 [95% CI ¼ 1.43-3.01]) and PC-specific mortality (2.07 [1.27-3.40]) after CRPC among patients with M0 disease. Patients developing CRPC from 2012 onward had lower all-cause mortality (HR ¼ 0.71 [95%

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Differences in Trial and Real-world Populations in the Dutch Castration-resistant Prostate Cancer Registry

Abstract: We observed that patients treated in clinical trials differed from patients who were not. We concluded that this may lead to differential treatment and survival. Caution is warranted when real-world outcomes are compared with trial results.

Cited by 46 publications

References 16 publications

Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Validation of multiple myeloma risk stratification indices in routine clinical practice: Analysis of data from the Czech Myeloma Group Registry of Monoclonal Gammopathies

Survival in patients diagnosed with castration-resistant prostate cancer: a population-based observational study in Sweden

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