Result card

  • ETH6: Does the use of uPA/PAI-1, Oncotype or Mammaprint challenge or change professional values, ethics or traditional roles?
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Does the use of uPA/PAI-1, Oncotype or Mammaprint challenge or change professional values, ethics or traditional roles?

Authors: Dario Sacchini, Roberta Minacori, Pietro Refolo

Internal reviewers: Petra Schnell-Inderst, Mirella Marlow, Narine Sahakyan

The purpose of the tests being evaluated is to replace or supplement prognostic guidelines and tools in current use, such as Adjuvant! Online. These involve cut-off values for risk classification which provide a gateway to further treatment or advice. Cut-off values are based on scientific evidence but their implementation affects the stage at which patients access treatment, as well as the overall number being treated. They therefore involve normative concerns beyond the clinical evidence on which they are based that are rarely explained transparently to patients. Implementing a cut-off value in a new group of patients, or a new cut-off for an existing group, may change the traditional professional approach of clinical staff, for example by causing them to deny treatment to individual patients who do not fall into the right risk category.  

These new tests raise the question of the extent to which patients are prepared to participate in informed decision making about their care.

Information about the risk of breast cancer recurrence from these tests should play a significant role in women’s breast cancer treatment decisions. One study using data from existing risk indicators showed that reducing the risk of dying from breast cancer by even 0.5% to 1% would make adjuvant chemotherapy acceptable to patients {20}. Breast cancer patients often do not understand basic information about their prognosis, including their risk of recurrence {21}. Many women even have difficulty in understanding  their risk of breast cancer {22} even after risk counselling {23}. There are few studies that indicate whether patients understand genomic tests and their results adequately to be informed decision makers when using them.

In one study assessing interest in genomic tests to determine the risk of recurrence of breast cancer in women previously treated for early-stage breast cancer {24}, most participants indicated that they would have been interested in this genomic testing. The women stated that they preferred an active role in decision making about treatment and would have wanted the results incorporated into treatment planning. In this study a scenario, less likely to happen in practice, such as a physician’s recommendation to have chemotherapy in response to a test result that indicated a low risk of recurrence was also used to elicit participants’ reactions to a situation that presented conflicting information. The results underscore the considerable weight that participants placed on their physicians’ recommendations and the importance of patient education about how clinicians incorporate genomic risk of recurrence information into decision making about treatment. Indeed, the value placed on testing by the physician, and how this is conveyed, will likely be critical to patients’ decision-making processes.

However, among early-stage breast cancer patients who received Oncotype DX, it seems that there is low knowledge about many aspects of genomic recurrence risk testing. Few patients understood that the test shows the likelihood of metastasis assuming additional treatment and does not provide information about the familial risk of breast cancer {25}.

One potential reason for misunderstanding risk is low health literacy. The U.S. Department of Health and Human Services defines health literacy as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions” {26}. Some studies show that health literacy is fundamental to women’s understanding and capacity to learn about the new breast cancer recurrence risk genomic tests as well as their desire for active participation in medical care: women with lower health literacy recalled less of the information provided about the recurrence risk test than women with higher health literacy. Health literacy was not related to the amount of additional information women desired. Women with higher health literacy preferred to have a more active role in decisions about the test. Health literacy may affect women’s capacity to learn about the new genomic tests as well as their desire for informed participation in their medical care {27, 28}.

Given the possible misinterpretation of specific (genomic) terminology as well as less specific terminology (e.g. “not done”, “not interpretable”) {29}, it is imperative that more attention should be paid to information issues in this field. Studies show that most patients prefer to be involved in medical decisions that affect their care {30,31} and that patients who are active participants in their medical decisions are better adjusted psychologically; they report being more satisfied with their decisions, and are more likely to adhere to their treatment regimens {32, 33, 34}. These new tests raise important new issues for the clinicians about how to communicate with patients about their recurrence risks.

Acknowledgement by clinicians of the potential problems and subsequent clarification of any misconceptions should prevent or relieve patients’ anxieties and help them to cope with the situation.

Therefore, in addition to giving us insights into their understanding of this new procedure, the participants in a study also provided insights into the ways clinicians may be able to help them. Two specific points in particular that need to be improved in clinical practice emerge. Firstly, healthcare professionals should explain to patients the difference between genomic signatures and genetic testing, and should emphasise that the analysis focuses solely on the tumour genes and has nothing to do with whether or not the disease is hereditary. Secondly, the disclosure of “not done” and “not interpretable” results should be handled with care because of the potentially negative implications of these terms. Physicians should explain that these expressions refer to technical problems that have arisen, and not to the tumour itself. Improving the quality of the information with which patients are provided about these new methods – by taking more time to explain what they involve, favouring discussions and eliciting feedback from the patients – will enable them to play an active role in the decision-making process about their treatment and ensure that those who agree to have gene analysis performed on their tumours are satisfied with the procedure {26}.

These findings have practical implications. When communicating recurrence risk test information to patients, clinicians and others health professionals should pay attention to patient health literacy and numeracy, and perhaps adjust the delivery of and time spent on communication of risk information to patients.

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Sacchini D et al. Result Card ETH6 In: Sacchini D et al. Ethical analysis In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

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