Real-Life Use and Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer Patients: A Study of the Southeast Netherlands Breast Cancer Consortium

Abstract

Background. The impact of drug prescriptions in real life as opposed to strict clinical trial prescription is only rarely assessed, although it is well recognized that incorrect use may harm patients and may have a significant impact on health care resources. We investigated the use and effectiveness of adjuvant trastuzumab in daily practice compared with the effectiveness in clinical trials. Methods. We included all patients with stage I-III invasive breast cancer, irrespective of human epidermal growth factor receptor 2 (HER2) status, diagnosed in five hospitals in the southeast of The Netherlands in [2005][2006][2007]. We aimed to assess the actual use of adjuvant trastuzumab in early HER2-positive breast and its efficacy in daily practice. Results. Of 2,684 patients included, 476 (17.7%) had a HER2-positive tumor. Of these, 251 (52.7%) patients had an indication for trastuzumab treatment of which 196 (78.1%)

Factors Influencing Decision-Making for or against Adjuvant and Neoadjuvant Chemotherapy in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study

“…This closely approximates the percentage of women who were reported to have an indication for trastuzumab (52.7%) in a study in the Netherlands [29]. While 78.1% of the women in the Netherlands study received trastuzumab, about 15% of these women had no indication for trastuzumab [29].…”

Methodology and results of real-world cost-effectiveness of carfilzomib in combination with lenalidomide and dexamethasone in relapsed multiple myeloma using registry data

“…This is regarded as a strong evidence base to support the applicability of trial HRs in the RW [9]. This methodology has been previously adopted for the estimation of RW cost-effectiveness of health technologies in oncology as well as other disease areas, such as cardiovascular and respiratory diseases; [10,21,22,[24][25][26] the approach has also been accepted by NICE, issuing a positive recommendation for evolocumab for treating primary hypercholesterolaemia or mixed dyslipidaemia in specific patient groups based on an economic model that combined baseline risks of cardiovascular disease from the Clinical Practice Research Datalink registry with reductions in cardiovascular events from a meta-analysis of RCTs [58].…”

“…Data from the intention-to-treat population in the ASPIRE RCT were also used to inform the cost-effectiveness model [15]. These two data sources were combined in such a way that baseline risks of events with Rd treatment were estimated from the RMG, whereas the relative treatment effects of KRd versus Rd were estimated from ASPIRE, as suggested and presented in the literature [9,10,[21][22][23][24][25][26]. A comparison of baseline characteristics of Rd patients in RMG and ASPIRE are presented in the online resources (see Supplementary Table 1).…”

“…Several studies have reported the RW cost-effectiveness of cancer drugs combining data from RCTs and observational databases, reinforcing the validity of the approach described above. For instance, Seferina et al estimated the RW costeffectiveness of trastuzumab plus chemotherapy versus chemotherapy alone in early breast cancer combining RW outcomes for the trastuzumab arm with treatment effect estimates [expressed as hazard ratios (HRs) of trastuzumab versus control arm] from the HERA trial [21,22]. Similarly, van Gils et al analysed the RW cost-effectiveness of oxaliplatin in colon cancer, for which they combined published efficacy data from the MOSAIC trial with RW data from a Dutch populationbased observational study [10].…”

Cardiotoxicity and Cardiac Monitoring During Adjuvant Trastuzumab in Daily Dutch Practice: A Study of the Southeast Netherlands Breast Cancer Consortium

“…This study was part of a large observational study of all patients (N 5 2,684) diagnosed with a stage I-III breast cancer in five hospitals in Southeast Netherlands between January 2005 and December 2007.The results of real-life use and effectiveness of adjuvant trastuzumab in this cohort have been reported elsewhere [26]. Reimbursement of adjuvant trastuzumab in The Netherlands was available as of September 2005; therefore, patients with HER2-positive early breast cancer diagnosed in 2005 were eligible for treatment with trastuzumab following initial adjuvant chemotherapy.…”