Molecular Marker Testing: What Information is Important?

Those practicing in oncology recognize the alphabet soup that is part of routine oncology care. Acronyms such as FOLFOX, R-CHOP, ABVD, and AC, which are used to describe various chemotherapy regimens, are routinely part of the oncology jargon. Recently, clinicians have noticed other types of important acronyms appearing in the oncology lexicon: genes or proteins described by the results of molecular marker testing (e.g., BCR-ABL, EGFR, KRAS, etc.). Molecular marker testing is becoming increasingly important in the care for patients with cancer, but it is clear that many challenges exist in this maturing area. Recently, an expert roundtable panel at the NCCN 16th Annual Conference discussed these challenges of molecular tests in oncology. From this conversation, it can be concluded that more information about these tests would be helpful to clinicians and other stakeholders to make appropriate treatment decisions.

To better understand the needs surrounding molecular testing in oncology, the National Comprehensive Cancer Network® (NCCN®) surveyed attendees at the 2011 NCCN 16th Annual Conference. This NCCN Trends Survey™ was conducted from March 10-11, 2011, and a convenience sample of 240 conference attendees responded to the survey. Respondents consisted of physicians (n = 110), nurses (n = 66), pharmacists (n = 31), and other types of clinicians or non-practicing clinicians (n = 33). Survey participants were asked three questions, all related to what information regarding molecular marker tests is useful when making clinical decisions.

The first question asked what information is considered critical when making a decision to order a new molecular test. The vast majority (about three quarters of respondents) indicated that evidence and specific purpose of the test (e.g., whether it is for prediction, prognosis, etc.) was important to have (Figure 1). Additionally, just over half of respondents indicated that information about sensitivity/specificity, whether the test is included in a guideline, and the cost of the test are critical pieces of information. The least important piece of information was the code for the specific lab test, with only 10% of respondents selecting this as important.

Respondents were also asked to select the criteria that would help them decide between two different technologies for assessing the same biomarker (e.g., FISH versus conventional cytogenetics for translocations; FISH versus IHC for HER2). In this case, the sensitivity/specificity of the different techniques was most important (77% of respondents), followed by what guidelines recommend (73% of respondents). Cost was selected as an important parameter by just over half of the respondents (Figure 2).

Lastly, the survey asked respondents to contemplate what information would be helpful in a molecular marker testing compendium. As expected, the majority (i.e., over two-thirds of respondents) considered level of evidence, the test's purpose (e.g., for diagnosis, prognosis, or treatment selection), and guideline recommendations as helpful pieces of information to include. Slightly fewer respondents (60% of respondents) thought that mentioning the limitations of tests (e.g., sensitivity and specificity information) would be helpful. Once again, cost was selected by almost half of respondents (Figure 3).

In summary, it appears that clinicians believe that information about a test's clinical evidence (including evidence rating), the sensitivity/specificity, and guideline recommendation will be helpful when making clinical decisions. Interestingly, this survey suggests that information about the cost of these tests is of moderate importance; about half of respondents indicated that cost was an important parameter in each of the three questions. Moving forward, the cost of these tests will likely be part of future debates, as described by the aforementioned expert roundtable discussion. One forum for this discussion will be hosted by NCCN at the invitation-only NCCN Oncology Policy Summit: Molecular Testing, where reimbursement and coverage policy issues will be discussed among other topics. While cost is an important part of the conversation, it appears (based on the survey results) that clinicians are focused on the clinical utility of these tests. Ultimately, clinicians desire the type of information that will help them provide evidence-based care directed at improving patient outcomes.

Figure 1. Which of the following factors do you think are critical to have when making a decision about ordering a new molecular test? Please select all that apply. (n = 240)

Figure 2. If two technologies exist for assessing the same tumor marker (example: FISH versus conventional cytogenetics for translocations, or FISH versus IHC for HER2), what criteria are most important when deciding between technologies? Please select all that apply. (n = 240)

Figure 3. What elements of a testing compendium would be most helpful to you in your current clinical practice? Please select all that apply. (n = 238)