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German Task Force Makes Nine Suggestions for Bringing Precision Oncology Into Clinical Practice

NEW YORK – A task force consisting of delegates from 14 comprehensive cancer centers in Germany has published a framework in the European Journal of Cancer detailing the necessary elements of a collaborative and harmonized precision oncology model.

The task force, whose work was supported by Germany's non-profit German Cancer Aid, published the framework aiming to facilitate dialogue between academic centers and outline a future direction for precision oncology in Germany. The authors, led by Benedikt Westphalen of Ludwig Maximilian University of Munich, acknowledged that although the approach to precision oncology "seems intuitive," myriad structural challenges have prevented its broad implementation into clinical practice. The published framework includes strategies for surmounting these barriers.

Specifically, the conceptual framework consists of nine consensus statements, devised through a combination of workshops and online questionnaires. Task force members were able to accept, amend, and edit the statements, and ultimately, the task force accepted each statement if more than 80 percent of participants agreed.

The first statement focused on "proper measures of [precision oncology] education" for treating physicians, asserting that physicians should be aware of the limitations of diagnostic modalities so they can offer the right testing to patients and communicate these limitations to their patients clearly. "Interpretation of [genomic testing] results often requires detailed knowledge of molecular alterations in the context of a given malignancy," the authors wrote, acknowledging that currently in Germany, "molecular oncology is not sufficiently covered by curricula of medical schools." Going forward, medical school curricula will need to integrate molecular oncology topics, they wrote.

The second statement underscored the need for cooperation between treating physicians and pathologists. Due to the rapidly evolving nature of the tools used in molecular tumor profiling, the authors wrote, a close cooperation between pathologists and physicians will become even more essential going forward. Collaboration will guarantee that test results are adequately translated into clinical practice or clinical trials, Westphalen and colleagues said.

In their third statement, the authors pointed out the need in Germany for a harmonized reporting system for genetic test results. The task force cited algorithms and shared clinico-genomics databases as ways to allow for an exchange of reports between academic centers.

Both the fourth and fifth statements focused on the need for integrated molecular tumor boards. These tumor boards, which the task force agreed should consist of a broad spectrum of experts, including molecular pathologists and biologists, as well as clinicians, are essential to determining the clinical implications of genomic and transcriptional alterations found from testing. Ideally, geneticists and bioinformaticians should also be involved in these tumor boards. The treatment decisions from these molecular tumor boards should draw on prospectively collected data, clinical registries, and early clinical trials, the authors suggested.

The sixth statement highlighted issues in the payor model for precision oncology. The authors noted that even when comprehensive genomic profiling and molecular tumor boards identify alterations that can be targeted by treatments, payors tend to consider these treatment options "off-label" or investigational and refuse to cover them. "Payors, authorities, and [precision care medicine] centers could engage in strategic partnerships to ensure management of cancer patients in a scientific and structured environment," they wrote. "Such constructs could allow for concentration of patients at expert centers and strengthen the faith in [precision cancer medicine]."

In their seventh statement, the authors discussed the importance of collecting evidence that can bolster payors and other stakeholders' confidence that precision cancer medicine is benefitting patients. However, standardizing the collection of this data, they admitted, is challenging. They posited that the challenges could be addressed by setting up clinical trial registries where oncologists could submit core data sets, as well as real world data.

The task force recognized in their eighth statement that precision cancer medicine is expensive and the need for cost-effective strategies. In this regard, the authors wrote that inappropriate care and unnecessary diagnostic procedures could be avoided by concentrating precision cancer medicine services at specialized cancer centers. "These centers should enter a dialogue with payors to establish reimbursement modalities for all aspects (molecular diagnostics, patient management, and counseling, as well as personalized treatment) of [precision cancer medicine]," they wrote.

Finally, in the ninth statement, the authors emphasized the importance of embedding genetic counseling into precision oncology to adequately inform patients about the potential outcomes of their genomic testing, as well as the potential for discovering inherited disease risk alterations. "Patients need to be informed upfront about the possibility of incidental findings and counseled appropriately," wrote the authors.

They suggested further that in addition to patients being counseled by their treating oncologists, they may also benefit from being counseled by other experts, such as human geneticists and psycho-oncologists. Counseling should effectively communicate to patients that many novel molecularly driven treatment approaches do not have the same robust evidence base as other, more established treatment modalities. "These issues have to be addressed by counseling offered by experienced oncologists and/or psycho-oncologists," the authors concluded.