In the August 2020 issue of the European Journal of Cancer, a group of German investigators reported on the formation of a working group entitled ‘Molecular Diagnostics and Therapy’ with support of the ‘German Cancer Aid’ (Deutsche Krebshilfe [DKH]). Through participation in two workshops supported by the DKH, delegates from the fourteen comprehensive cancer centres in Germany identified key topics essential to implement quality driven, harmonised and adaptable precision cancer medicine. The group aims to use a set of consensus statements as a basis for defining a collaborative strategy to sustain and further improve quality of precision cancer medicine in Germany.
The authors led by C. Benedikt Westphalen of the Department of Internal Medicine III, University Hospital, LMU Munich and Comprehensive Cancer Center in Munich and Sonja Loges of the University Comprehensive Cancer Center Hamburg who has recently transitioned to the University Hospital Mannheim and the German Cancer Research Center (DKFZ) report that precision cancer medicine in Germany is mainly practiced in academic institutions.
As of now, there are some initiatives to initiate national harmonisation, but these efforts are still uncoordinated. To facilitate exchange between academic centres and to develop a strategy for the future directions of precision cancer medicine in Germany, the ‘Molecular Diagnostics and Therapy’ task force was established within the DKH supported comprehensive cancer centres network.
Based on an online questionnaire, the task force defined challenges needed to be addressed for successful implementation of precision cancer medicine. During two workshops, these challenges were discussed by the working group members, who then defined the general framework for a consensus paper.
In total, nine statements covering various aspects of precision cancer medicine were drafted and distributed within the working group. By using a modified Delphi approach, these statements were refined within a stepwise procedure and consented by the working group members. The statements were assumed accepted, if there was an agreement by ≥80% of the participants.
The first consensus statement concerns benefit and limitations of comprehensive genomic profiling and the need for a proper education of physicians in precision cancer medicine.
In the second consensus statement, focus lays on cooperation among treating physicians and molecular pathologists to guarantee state-of-the-art molecular tumour profiling.
The need to reach harmonised reporting of genomic alterations across cancer centres is described in the third consensus statement.
The fourth consensus statement outlines, that clinical implications of genomic alterations should be consented by (molecular) pathologists and clinicians. Additional support can be provided by bioinformaticians and geneticists. This process should preferentially be realised in dedicated interdisciplinary molecular tumour boards. Development of an evidence framework is encouraged through prospective data collection, clinical-molecular registries and early clinical trials.
In the fifth consensus statement, a potential composition of molecular tumour boards with minimal requirements is outlined. According to the authors, a molecular tumour board should include a molecular pathologist, the treating oncologist, oncologists with expertise in different subspecialties and ideally a geneticist, a bioinformatician, as well as a specialist in molecular biology.
The need to ensure access to therapy is outlined in the sixth consensus statement. In this regard, the participants recognised that access to targeted therapy after identification of actionable molecular targets is currently not sufficient. One potential strategy to overcome this problem could be to concentrate precision cancer medicine at specialised centres to provide a rationale to payers to cover ‘off label’ treatment, as well as conducting clinical trials to offer treatment for rare genetic alterations through a network of participating centres.
The seventh consensus statement concerns structured and harmonised collection of patient data in clinico-genomic databases supported by adequate bioinformatics. This real world evidence approach could allow to evaluate the benefit from individualised treatment and to create learning systems.
In the eighth consensus statement, the participants argued that for ensuring high-quality diagnostics, comprehensive medical management and cost-effectiveness and to prevent repetitive diagnostic procedures, precision cancer medicine should preferably be concentrated at specialised centres which should lead a dialogue with payers to establish the reimbursement modalities for all aspects of precision cancer medicine.
In the ninth consensus statement, the participants recommended that extended molecular profiling should be a part of adequate counselling process by the treating oncologist, human geneticist and psycho-oncologist.
The authors concluded that these nine statements could constitute a framework for future collaborative efforts to further develop and expand precision cancer medicine within the comprehensive network to provide optimal care for cancer patients across Germany.
Reference
Westphalen BC, Bokemeyer C, Büttner R, et al. Conceptual framework for precision cancer medicine in Germany: Consensus statement of the Deutsche Krebshilfe working group ‘Molecular Diagnostics and Therapy’. European Journal of Cancer 2020; 135:1-7.