How Do Patients Experience Individualized Medicine? A Qualitative Interview-based Study of Gene Expression Analyses in the Treatment of Breast Cancer

Abstract

Introduction In recent years, the hopes and expectations associated with so-called individualized medicine have been the subject of intense debate as has the medical potential of this approach. Questions about the uses of gene expression analyses for decisions on adjuvant systemic treatment options for patients with breast cancer have played a prominent role in this debate. There are a number of empirical studies on the effect of gene expression tests on the therapy decisions of physicians and the potentially conflicted decisions for patients. Very little attention has been paid to how patients perceive such approaches, the extent to which they feel included in the therapy decision, and the expectations they associate with such an approach.

Material and Methods Using qualitative explorative interviews, the study looked at how well patients with breast cancer understood the individualized treatment approaches and examined patientsʼ experiences and expectations with regard to gene expression analyses. The sample consisted of 8 patients who were diagnosed with primary hormone receptor-positive, HER2-negative breast cancer between 2013 and 2014 and who underwent gene expression analyses as part of their adjuvant therapy planning.

Results Patients were found to have a quite realistic view of the benefits of gene expression analyses, although it also became clear that the treatment could also raise false hopes. The statements by the interviewed women also illustrated the necessity of continuing to explore the possibilities and limits to joint decision-making in such complex medical contexts as individualized molecular genomic medicine. And finally, the interviews reflected the hope for individualized treatment in the broadest sense of the word.

Conclusion The results of the study highlight the challenge of taking psychosocial aspects of medical treatment sufficiently into consideration, given the ever increasing options for molecular genomic individualization.

Key words

joint decision-making - gene expression analyses - medical benefit - molecular genomic individualization

^* Shared first authorship

• References/Literatur

• 1 Collins FS. The Language of Life. DNA and the Revolution in personalized Medicine. New York: HarperCollins; 2010
• 2 Schildmann J, Vollmann J. Personalized Medicine: conceptual, ethical, and empirical Challenges. In: Schramme T, Edwards S. eds. Handbook of the Philosophy of Medicine. Vol. 2. Berlin: Springer; 2017: 903-913
• 3 Snyderman R, Williams RS. Prospective medicine: the next health care transformation. Acad Med 2003; 78: 1079-1084
• 4 Gorini A, Pravettoni G. P5 medicine: a plus for a personalized approach to oncology. Nat Rev Clin Oncol 2011; 8: 444
• 5 Pravettoni G, Gorini A. A P5 cancer medicine approach: why personalized medicine cannot ignore psychology. J Eval Clin Pract 2011; 17: 594-596
• 6 Burnette R, Simmons LA, Snyderman R. Personalized health care as a pathway for the adoption of genomic medicine. J Personalized Med 2012; 2: 232-240
• 7 Cornetta K, Brown CG. Perspective: balancing personalized medicine and personalized care. Acad Med 2013; 88: 309
• 8 Horwitz RI, Cullen MR, Abell J. et al. (De)personalized medicine. Science 2013; 339: 1155-1156
• 9 Heusser P. Towards Integration of personalised and ‘person-centred’ Medicine: The Concept of ‘integrative and personalised Health Care’. In: Vollmann J, Sandow V, Wäscher S, Schildmann J. eds. The Ethics of personalised Medicine. Farnham: Ashgate; 2015: 77-84
• 10 Ludwig WD. Möglichkeiten und Grenzen der stratifizierenden Medizin am Beispiel von prädiktiven Biomarkern und, „zielgerichteten“ʼ medikamentösen Therapien in der Onkologie. ZEFQ 2012; 106: 11-22
• 11 Vollmann J. Ein trügerisches Versprechen. Frankf Allg Ztg 2012; 105: 10
• 12 Vollmann J. Persönlicher – besser – kostengünstiger? Kritische medizinethische Anfragen an die „personalisierte Medizin“. Ethik Med 2013; 25: 233-241
• 13 Schleidgen S, Marckmann G. Alter Wein in neuen Schläuchen? Ethische Implikationen der Individualisierten Medizin. Ethik Med 2013; 25: 223-231
• 14 Schleidgen S, Klingler C, Bertram T. et al. What is personalized medicine? Sharpening a vague term based on a systematic literature review. BMC Med Eth 2013; 14: 55
• 15 Langanke M, Lieb W, Erdmann P. et al. Was ist Individualisierte Medizin? Zur terminologischen Justierung eines schillernden Begriffs. ZME 2012; 58: 295-314
• 16 Schleidgen S. Individualisieren durch technisieren? Anmerkungen zur Biomarker-basierten Medizin. In: Aurenque D, Friedrich O. Hrsg. Medizinphilosophie oder philosophische Medizin? Philosophisch-ethische Beiträge zu Herausforderungen technisierter Medizin. Stuttgart: Frommann-Holzboog; 2013: 265-285
• 17 Browmann G, Virani A, Vollmann J. et al. Improving the quality of ‘personalized medicine’ research and practice through an ethical lens. Pers Med 2014; 11: 413-423
• 18 Kreienberg R, Albert U, Follmann M. et al. Interdisziplinäre S3-Leitlinie für die Diagnostik, Therapie und Nachsorge des Mammakarzinoms: Kurzversion 3.0. Online: http://www.awmf.org/uploads/tx_szleitlinien/032-045OL_k_S3__Brustkrebs_Mammakarzinom_Diagnostik_Therapie_Nachsorge_2012-07.pdf last access: 04.05.2017
• 19 Wolters R, Wockel A, Wischnewsky M. et al. Auswirkungen leitlinienkonformer Therapie auf das Überleben von Patientinnen mit primärem Mammakarzinom: Ergebnisse einer retrospektiven Kohortenstudie. Z Evid Fortbild Qual Gesundhwes 2011; 105: 468-475
• 20 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Biomarkerbasierte Tests zur Entscheidung für oder gegen eine adjuvante systemische Chemotherapie beim primären Mammakarzinom. IQWiG-Berichte – Nr. 457. Online: https://www.iqwig.de/download/D14-01_Abschlussbericht_Biomarker-bei-Mammakarzinom.pdf last access: 04.05.2017
• 21 Paik S, Shak S, Tang G. et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004; 351: 2817-2826
• 22 Paik S, Tang G, Shak S. et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006; 24: 3726-3734
• 23 Knauer M, Mook S, Rutgers EJT. et al. The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer. Breast Cancer Res Treat 2010; 120: 655-661
• 24 Dowsett M, Sestak I, Lopez-Knowles E. et al. Comparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J Clin Oncol 2013; 31: 2783-2790
• 25 Degenhardt T, Harbeck N, Wuerstlein R. Individuelle Tumortherapie beim Mammakarzinom – Möglichkeiten der Vermeidung von Über- und Untertherapie unter besonderer Berücksichtigung zielgerichteter Therapien. DZO 2015; 47: 57-65
• 26 Eiermann W, Rezai M, Kümmel S. et al. The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use. Ann Oncol 2013; 24: 618-624
• 27 Wuerstlein R, Sotlar K, Gluz O. et al. The West German Study Group Breast Cancer Intrinsic Subtype study: a prospective multicenter decision impact study utilizing the Prosigna assay for adjuvant treatment decision-making in estrogen-receptor-positive, HER2-negative early-stage breast cancer. CMRO 2016; 32: 1217-1224
• 28 Harbeck N, Wuerstlein R. Mammakarzinom. Individualisierte Therapiekonzepte. Internist 2013; 54: 154-200
• 29 Kuckartz U. Qualitative Evaluation. Der Einstieg in die Praxis. Wiesbaden: VS Verlag für Sozialwissenschaften; 2007
• 30 Mayring P. Qualitative Inhaltsanalyse. Grundlagen und Techniken. Weinheim und Basel: Beltz; 2010
• 31 Singh JA, Sloan JA, Atherton PJ. et al. Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the control preferences scale. Am J Manag Care 2010; 16: 688-696
• 32 Tariman JD, Berry DL, Cochrane B. et al. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol 2010; 21: 1145-1151
• 33 Brown R, Butow P, Wilson-Genderson M. et al. Meeting the decision-making preferences of patients with breast cancer in oncology consultations: impact on decision-related outcomes. J Clin Oncol 2012; 30: 857-862