TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer

Abstract

TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer Declared competing interests of authors: Professor James reports trial support (free trial drug for the Phase II part of the trial and a grant awarded to investigation sites for recruitment of Phase III patients with trial numbers 301-700) and lecturing fees from Sanofi-aventis. He also reports free trial drug for the Phase II part of the trial followed by a trial-linked discount for sites ordering trial drug for Phase III patients and lecturing fees from Novartis Pharmaceuticals UK Ltd. In addition, there was a trial-linked discount for sites ordering trial drug from GE Healthcare. Professor James also reports trial support, consultancy work and lecture fees from Sanofi-aventis and Novartis Pharmaceuticals UK Ltd who were directly related and consultancy work and lecture fees from Bayer HealthCare, Algeta, Amgen, Janssen, Astellas Pharma and Affinity OncoGeneX Pharmaceuticals Inc. who were related to prostate cancer but not the drugs in this study. Dr Pope reports trial support (free trial drug for the Phase II part of the trial and a grant awarded to investigation sites for recruitment of Phase III patients with trial numbers 301-700) from Sanofi-aventis; trial support (free trial drug for the Phase II part of the Phase III patients) from Novartis Pharmaceuticals UK Ltd; and trial support (trial-linked discount for sites ordering trial drug) from GE Healthcare from GP Health Care, during the conduct of the study. Dr Parker reports personal fees from Bayer HealthCare, BN ImmunoTherapeutics Inc. (BNIT), Astellas Pharma, Janssen, Sanofi-aventis and Takeda UK Ltd, outside the submitted work. Dr Stanley reports that Teva Pharmaceutical Industries Ltd supported his attendance at European Society for Medical Oncology, he received personal fees from Calgene, Inc., and Amgen, Inc. supported part of his attendance at British Oncology Pharmacy Association, outside the submitted work. Dr Brown reports personal fees and non-financial support from Novartis Pharmaceuticals UK Ltd for advisory board in different cancer and writing assistance for different cancer outside the submitted work. Dr Billingham reports personal fees from Eli Lilly, and from Pfizer, both for expenses paid for contributing to educational events, outside the submitted work. This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for th...

Cost‐effectiveness of zoledronic acid and strontium‐89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate‐refractory prostate cancer: results from theTRAPEZEtrial (ISRCTN12808747)

“…The TRAPEZE trial design is described in detail elsewhere . Briefly, this was a randomised open label phase III study using a 2 × 2 factorial design aiming to compare ZA vs no ZA (stratified for Sr89) and Sr89 vs no Sr89 (stratified for ZA).…”

Cost-Effectiveness of Treatments for the Management of Bone Metastases: A Systematic Literature Review

“…Twenty of the identified studies [18, 19, 22-29, 31, 32, 34-41] focus on a single country, while four studies report results for more than one country [20,21,30,33]. Of the studies focusing on a single country, ten were conducted in Europe (seven in the UK [18,19,23,24,26,29,34] and one in each of Greece [41], the Netherlands [38] and Switzerland [27]), nine in North America (seven in the United States [28, 31, 35-37, 39, 40], two in Canada [25,32]) and one in New Zealand [22]. Among studies reporting results for more than one country, three [20,21,30] had a focus on a small number of European countries, while one study pooled information from 17 countries, including Argentina, Australia, Brazil, Italy and Sweden [33].…”

“…evidence published in the literature, estimates drawn from patient-level data, expert opinion and other secondary sources) through some form of a decision analytic structure. The remaining six studies [18,27,29,32,33,38] involved using statistical methods to analyse patient-level data collected from a single clinical trial (most often randomised clinical trials (RCTs)).…”

“…A time horizon that is long enough to capture all the costs and benefits is typically recommended [42,43] though, in the reviewed studies, this was often dictated by the follow-up period in clinical studies which provided data for the economic evaluations. One study reported results over time horizon shorter than 12 months [27], eight studies [19-21, 23, 24, 33, 39, 40] looked at costs and benefits accruing between 12 and 24 months, eight studies reported results over time horizons equal to or longer than 24 months [18,19,28,29,31,[34][35][36], while four studies [22,30,32,37] produced results over a lifetime horizon. One study analysed costs and benefits accruing over different lengths of time [38], while in another study, by Yfantopoulos and colleagues [41], the length of time horizon varied according to the type of primary cancer investigated.…”

“…outpatient appointments, hospitalisation for skeletal related events). In eight studies [18,19,22,28,29,33,34,38], costs extended to use of primary and community care services. Figure 4 shows the split between studies in terms of key outcomes reported.…”