Fatal events during clinical trials: an evaluation of deaths during breast cancer studies

Furlanetto J, von Minckwitz G, Lederer B, Möbus V, Schneeweiss A, Huober J, Fasching P, Gerber B, Bauerfeind I, Nitz U, Lück HJ, Hanusch C, Thomssen C, Untch M, Nekljudova V, Mehta K, Loibl S (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Breast Cancer Springer Verlag (Germany)

DOI: 10.1007/s12282-019-00990-3

Abstract

Background: Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials. Methods: Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies. Results: From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35–84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m2; 65.9% 1–3 and 22.7% ≥ 4 comorbidities; 61.4% 1–2 cardiovascular risk factors (CRFs); 26.4% took > 3 drugs; 81.7% had ECOG 0; 50.0% stage III, 76.7% luminal BC. The main causes of death were infection (38.6%; of those, 82.3% sepsis, 17.6% pneumonia), heart failure (14.8%), and pulmonary embolism (13.6%). Fatal events mainly occurred within the first 4 therapy cycles (55.7%), in the investigational arm (66.7%) and under anthracycline–taxane-based chemotherapy (51.1%). A relationship with the treatment was declared in 27.3% of the cases. An autopsy was performed in 13.6% of patients. Conclusions: Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

GBG Forschungs GmbH (German Breast Group) DE Germany (DE) Universitätsklinikum Düsseldorf DE Germany (DE) Klinikum Landshut DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) HELIOS Kliniken DE Germany (DE) Gynäkologisch-Onkologische Praxis Hannover DE Germany (DE) Klinikum Frankfurt Höchst DE Germany (DE) Martin-Luther-Universität Halle-Wittenberg (MLU) DE Germany (DE) Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg DE Germany (DE) Universitätsmedizin Rostock DE Germany (DE)

How to cite

APA:

Furlanetto, J., von Minckwitz, G., Lederer, B., Möbus, V., Schneeweiss, A., Huober, J.,... Loibl, S. (2019). Fatal events during clinical trials: an evaluation of deaths during breast cancer studies. Breast Cancer. https://dx.doi.org/10.1007/s12282-019-00990-3

MLA:

Furlanetto, Jenny, et al. "Fatal events during clinical trials: an evaluation of deaths during breast cancer studies." Breast Cancer (2019).

BibTeX: Download