Several years ago, a combination of hormone therapy with CDK4/6 inhibitors was shown to be more effective than hormone therapy alone. For women with metastatic breast cancer, it makes a big difference whether you add these inhibitors to the treatment from the start or at a later timepoint. Starting immediately means using these drugs longer, and therefore experiencing associated side effects, like fatigue and diarrhea, for a longer period. The SONIA study is investigating which treatment sequence is most effective and has the least impact on patients’ quality of life. No fewer than 73 Dutch hospitals, including Amsterdam UMC, are participating in the study which involves 1,050 patients. The success of enrolling patients from so many different hospitals in the clinical trial was one of the reasons why ZonMw awarded a ‘Parel’ prize to the principal investigators of the SONIA study. Additional reasons were the involvement of the research team with the participating patients, and the intensive collaboration with other partners such as the Netherlands Comprehensive Cancer Organisation (IKNL )and the Dutch Breast Cancer Association (BVN).
Broad support
Unique to the study is the coordination within the Dutch Breast Cancer Research Group (BOOG), in which all Dutch hospitals are represented. “Intensive collaboration between all parties involved is extremely important for a national study that includes so many patients and hospitals. Think of the data management by IKNL, or the support of patients’ backing groups like BVN. Every cog in the whole is crucial,” says Dr. Inge Konings, one of the SONIA principle investigators. It is also crucial that the Patient Advice Group (PAG) was already closely involved during the project’s preparation phase. According to the research team, this ultimately leads to better implementation of the results, because of the support base that has been built up during the project.
Funding for new studies
An important result of the award-winning study approach is cost savings due to the project itself. Because CDK4/6 inhibitors are very expensive, conducting the study saves 25 million euros in drug expenses (due to the lesser duration of combination therapy in half of the patients). This cost-reduction was a reason for Dutch health insurer companies to contribute financially to SONIA, in addition to the ZonMw subsidy. The SONIA team is urging for a so-called revolving fund, a fund in which money saved is used to launch comparable studies. The Ministry of Health, Welfare and Sport is working on a scheme to allow the savings from SONIA and other studies to be used for new clinical studies, as current laws do not allow insurers to use collective premium funds for research studies.
- The SONIA study is an initiative of oncologists Dr. Inge Konings (Amsterdam UMC), Prof. Gabe Sonke (Antoni van Leeuwenhoek) and Dr. Agnes Jager (Erasmus MC). They represent the Dutch breast cancer oncologists in the Breast Cancer Research Group (BOOG).
- The study is being conducted in close collaboration with the Breast Cancer Association of the Netherlands, the Netherlands Comprehensive Cancer Organisation and the Health Care Policy & Management Institute of Erasmus University. For more information, visit the ’Parel’ page of ZonMw.
- ZonMw is the organization that distributes medical research money on behalf of the Dutch government. Every year, the most striking projects receive a ‘Parel’ as a token of appreciation.
From left to right: Elise van Leeuwen-Stok (director of BOOG), Mirjam Velting (representative of BVN), Astrid Swinkels (central data manager IKNL), Gabe Sonke (principal investigator), Agnes Jager (principal investigator), Noor Wortelboer (study coordinator), Inge Konings (principal investigator), Annemiek van Ommen-Nijhof (study coordinator), and Veronique Timmerhuis (director of ZonMw). Photo: Jeroen van Eijndhoven.
For more information contact Dr. Inge Konings.