First patient in PropAngio-trial for angiosarcoma
Brussels – A clinical trial designed to treat angiosarcoma, an aggressive and rare cancer type, included the first patient in the Netherlands. The trial evaluates the activity of the β-blocker propranolol as monotherapy before standard anticancer treatment in patients with cutaneous angiosarcoma.
Angiosarcoma arises in the inner lining of blood and lymph vessels. Though it can occur anywhere in the body, angiosarcoma occurs most often on the skin of the head, neck or breasts. This rare cancer type has a high risk of spreading. Standard treatment for localised cutaneous angiosarcoma is to surgically remove the entire tumour, sometimes combined with radiation. However, despite optimal disease management approximately half of the patients relapse.
Although the role of chemotherapy before or after surgery remains controversial for localised disease, neoadjuvant chemotherapy (before surgery) is sometimes administered for locally advanced angiosarcoma. Several chemotherapies have shown activity in the locally advanced and metastatic setting, but none have shown a beneficial effect in terms of prolonged survival or time to relapse when used in a neoadjuvant fashion among patients with operable angiosarcoma.
By improving the neoadjuvant treatment of this disease and effectively treating micro-metastases at an early stage, the number of local and distant recurrences might be reduced, potentially leading to higher survival rates. Therefore, the Anticancer Fund supports this PropAngio-trial.
The Netherlands Cancer Institute - Antoni van Leeuwenhoek hospital has enrolled the first patient in this single-arm neoadjuvant window of opportunity phase II study to explore the activity of propranolol in angiosarcoma. Propranolol will be administered as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. 14 patients with newly diagnosed, recurrent or metastatic cutaneous angiosarcoma will be recruited. The results of the trial are expected end 2021. (*)
Propranolol, a drug used to treat high blood pressure and now being repurposed for a rare cancer, was granted Orphan Drug Designation in 2017 by the European Commission (EC) at the request of the Anticancer Fund.
The Anticancer Fund got interested in the potential of propranolol after data from experiments with cell lines and animal models showed that propranolol could fight angiosarcoma and remarkably reduce the growth of tumours. In the meantime, there have also been case reports of patients with angiosarcoma who were successfully treated with propranolol with little to no side effects.
“Our ultimate objective is to have propranolol, if proven effective, fully licensed as a new standard of care treatment for angiosarcoma. Nevertheless, under the current regulation on application for “label extension”, further dialogue with the regulators and/or the producers will be mandatory to make the drug officially available for cancer patients. We are looking forward to the results of the Amsterdam trial. This study will tell us if propranolol can really play a role in the treatment.”, concludes Dr. Gauthier Bouche, Director of Clinical Research at the Anticancer Fund.
The Anticancer Fund granted almost 170,000 euro to the PropAngio-trial, or 90 percent of the total study cost. Our special thanks go to Ockier & Partners Advocaten and Vansteelandt BV – Plan 3D that donated 10,000 euro of this amount after a fundraiser in Kortrijk, in presence of entrepreneur Bart Verhaeghe.
The Anticancer Fund decided to fund this trial as repurposing drugs for new cancer treatments is one of the main missions of the foundation.
Following the coronavirus outbreak, the Netherlands Cancer Institute (NKI) has taken some measures to safeguard the health of their employees and patients. For the PropAngio trial, inclusion of new patients will be temporarily put on hold – until further notice. For the first patient enrolled in the trial, all necessary treatments, site visits, study related procedures and administrations will continue. If needed it can be considered to stop treatment for safety reasons.