Digital Technology and Big Data are Advancing Personalized Treatments for Blood Cancer Patients
Now in its final year of work, the HARMONY Alliance has shared its research results from the last five years at its annual General Assembly, which was held on October 24th and 25th in Palma de Mallorca, Spain. Application of big data to the field of medical research has been accelerating, as a way to increase analytical capacities and improve the precision of research results. Thanks to the use of big data, the HARMONY Alliance is designing the first European map of hematologic diseases, with the aim of producing promising results for patients with any type of blood cancer. Multinational technology firm GMV has been providing its technology to public and private health care centers in Europe, as well as to pharmaceutical laboratories, to help improve their analytical capacities and increase the precision of their research into pathologies of this type.
The HARMONY technological platform allows researchers to be much more precise, and to establish which characteristics are the most relevant when classifying the illness and its risks. This improved precision translates into direct benefits for patients, because if they are able obtain a more accurate profile of the stage their disease has reached, they can receive better treatment that increases their possibilities for recovery.
As explained by bioinformatics specialist and GMV health analyst Miguel Ferreiro, “one of the most important benefits of the HARMONY Alliance project is the ability to complete the map of the illness. Diseases of this type are polygenic in origin, and this can create a scenario where it is very difficult for physicians and researchers to identify the best treatment. However, by increasing the amount of information available, we are getting closer to solving this problem. The ability to compare genetic information from thousands of patients can lead us to conclusions about which genes have the greatest weight in terms of prognosis, and it can also help us discard those that only have an insignificant presence in the general population.”
Data Standardization
Myelodysplastic syndromes (MDS) are a group of blood cancers that have a characteristic in common: the stem cells in the patient’s bone marrow, which are responsible for producing all of the blood cells, have a defect that causes them to produce abnormal cells. The most frequent causes of hematologic malignancies are chromosome abnormalities, which means that these must be the exclusive focus of diagnosis and treatment. Some of them can be classified by cytogenetics3 or by using an immunophenotype of the malignant cells, but in order to establish the factors affecting prognosis, an extensive, high-quality database must be available. The data must also be processed to ensure that the required quality level can be achieved, and technology is an essential part of this procedure.
At the HARMONY Alliance’s annual General Assembly, GMV explained the data standardization work that must be performed before physicians and researchers can make use of the data. This work has been performed under the common European data model known as the Observational Medical Outcomes Partnership (OMOP), which allows systematic analysis of databases even when there are differences in the observations they record. During their presentation, Miguel Ferreiro and GMV data scientist Laura Tur described the long road being traveled to help advance this scientific pursuit, which has the goal of improving patient prognoses: “from collecting the data at the source, performing quality control and harmonization work, through to the operating procedures and regulatory compliance, and finally, the advanced analyses and research performed by the scientists. All of this is important for achieving the proposed objectives, which are to prolong and even save the lives of the patients.”
GMV’s Manager of Digital Health, Inmaculada Pérez Garro, emphasized that “reconciliation of the clinical variables facilitates the sharing of data among various hospitals and countries, and this results in improvements for the machine learning algorithms and analytical models.” In summary, “standardizing the data structures and their semantics helps drive discoveries and improves the precision of medical treatments. It also provides support for decision-making and orientation for new clinical trials.”
As of June 2022, more than 119,622 patient datasets had been identified (https://www.harmony-alliance.eu/bigdata-platform/databarometer), and by using specific algorithms generated by the experts at GMV, this data is contributing to the search for new knowledge in relation to hematologic malignancies, with more than 62,000 datasets already compiled on this subject. HARMONY is one of the largest databases of its type, and its aim is to produce benefits for society by making shared data available, so that new, more accurate clinical trials can be performed and costs can be reduced.
Advances in Myelodysplastic Syndromes
One line of research with great importance for the Alliance is related to patients with myelodysplastic syndromes (MDS) who are considered to have a high risk of progression to acute myeloid leukemia (AML). The optimal treatment path for these patients is not entirely clear, which means that analyzing data from a large group of them can help clarify the best therapeutic focus. The databases currently being used for this work include patients from a total of nine European countries: France, Austria, Belgium, Germany, Italy, the Netherlands, Sweden, Spain, and the United Kingdom.
Approximately 3,000 patients with MDS were recruited, in order to add additional datasets to the HARMONY big data platform. This will allow the patients’ characteristics to be correlated with overall survival, with specific analysis of the characteristics of those who are able to exceed the current average of two years. The large size of the database will also allow analysis of the factors affecting prognosis in various subgroups of patients. The results of this project are intended to identify patients with the most aggressive myelodysplastic syndromes who are more likely to respond to treatment with chemotherapy drugs, and who will therefore experience a prolonged duration of therapeutic response.
Multiple Myeloma and Acute Myeloid Leukemia
The HARMONY researchers are proposing a revision of the staging system applied to multiple myeloma. The various stages are used to indicate the extent of the myeloma and its potential to produce complications. An improved staging system known as R2‑ISS can help oncologists more accurately determine the prognosis of patients with newly diagnosed multiple myeloma. They can use the improved system to more reliably identify high-risk patients, and this will give them the ability to make better-informed treatment decisions in the future.
Pieter Sonneveld, a member of the HARMONY Alliance from Erasmus University Medical Center, explains that “the new R2‑ISS is a simple prognostic staging system, which provides better staging for recently diagnosed multiple myeloma patients with an intermediate risk level. The contribution made by this new classification encourages its future implementation with new prognostic variables.”
Dr. Alberto Hernández-Sánchez of the University of Salamanca Hospital also presented the results of the project investigating gene-gene interactions in acute myeloid leukemia. The HARMONY researchers studied anonymized data from 1,001 patients who had a mutation on the NPM1 gene. Based on their analysis, these researchers are proposing a new genetic staging model for this subgroup of patients, distinguishing three risk groups with differing rates of general survival and relapse-free survival. Their model improves upon the existing risk staging model, with the ability to reclassify 33% of the patients into their proper risk category. Doctors can now apply this new model to more reliably identify high-risk patients, as a way to help improve their future treatment options.
About the HARMONY Alliance
The HARMONY Alliance is led by two Spanish physicians: Dr. Jesús María Hernández, a specialist from the Hematology Department at the University of Salamanca Hospital, and Dr. Guillermo Sanz, Head of the Clinical Hematology Division at the La Fe University Hospital in Valencia. The project brings together the research efforts of more than 150 experts in hematologic malignancies, who represent more than 100 public and private organizations in 18 European countries. It consists of the HARMONY and HARMONY PLUS projects, which have been formalized within the framework of the European Union’s Innovative Medicines Initiative (IMI).
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