Radiance™ helps to bring in a new breast-cancer treatment standard

Twelve years of monitoring have now shown that for most early breast-cancer patients the administration of a single targeted dose of intraoperative radiation therapy (IORT) after the lumpectomy with Carl Zeiss Meditec International’s INTRABEAM®, incorporating GMV’s Radiance™ planner, is an effective alternative to external beam radiotherapy, with comparable long term efficacy for cancer control and lower non-breast cancer mortality.

This was the conclusion drawn from the 2298-patient trial carried out by the TARGIT group, published on 19 August 2020 in el British Medical Journal (www.bmj.com/content/370/bmj.m2836), using the INTRABEAM® system with built-in Radiance™ as the intraoperative radiotherapy administration method. The trial has shown that it is not only an efficient treatment but also in many ways better than other early breast cancer treatment methods. These results suggest that it should now be considered for selected cases as the new standard for early breast cancer treatment.

Intraoperative radiotherapy (IORT) is a high precision method of administering during the surgery itself a single, targeted high-radiotherapy dose to the tumor bed/microscopic residue or, in the case of unresectable tumors, to the macroscopic tumor. This single dose is targeted directly at the bed to be irradiated without affecting the surrounding healthy tissue.

One of the biggest advantages of single-dose IORT in the operating theater is saving patients daily journeys to the hospital during three to five weeks post-surgery. This has a knock-on effect on physical and mental health and quality of life. Patients are thus exposed to fewer hospital visits and also fewer sessions of external radiotherapy in certain cases, such as early breast cancer with favorable prognosis, while also minimizing secondary effects on healthy tissue.

GMV’s inhouse Radiance™ guarantees the precision of this single IORT dose, helping to personalize treatment and making the work of radiation oncologists and physicists safer.

Radiance™ the world’s only radiosurgery planner

GMV’s inhouse radiosurgery planner Radiance™ determines the exact radiotherapy dose to be administered, thus improving IORT safety and giving clinicians a complete analysis of the patient beforehand. This enables them to make crucial decisions before the surgery, identifying the optimum treatment adapted to suit each particular case.

The algorithms Radiance™ works with provide all necessary data for previous documentation of the surgery to be carried out, calculating the exact parameters to be applied by the clinician in the operating theater before going ahead with the surgery. It also provides high-quality multiplanar reconstruction (MPR) images and a 3D view of the patient, allowing a simulated display beforehand of the treatment result.

The precision and optimization of Radiance™ also means fewer post-surgery hospital visits, helping to make the health system more sustainable. Tumor resection (excision and IORT) is carried out directly in the operating theater, ensuring the precision of the result. In many cases no external radiotherapy is necessary at all. As things stand today, unfortunately, three out of every 10 patients needing radiotherapy never actually receive it, either due to a shortage of equipment or their distance from that equipment. There are cases of patients who have to travel 200 kilometers every day to receive the treatment. Single-dose IORT administration in the operating theater helps to alleviate this situation.

In the words of the radiation oncologist Pedro Lara (*), “Radiance™ technology improves IORT now and will also improve the whole of future surgery. We try to define and register the zone we have treated as accurately as possible but this is often difficult under today’s conditions. Radiance™ expedites positioning of the IORT applicator and helps to maintain future registration”.

The strong points of Radiance™ help to reduce the relapse risk in a good number of tumors, such as breast cancer, while its palliative value is important in difficult-to-treat cancers like pancreatic cancer or in any relapses that might eventually occur.

Where has Radiance™ technology been installed?

Radiance™ has been taken up by Spanish hospitals like Hospital Universitario de Gran Canaria Doctor Negrín (Las Palmas), Hospital Provincial (Castellón), Hospital Central de Asturias (Oviedo) and Hospital General Universitario Gregorio Marañón (Madrid).

Outside Spain Radiance™ is now up and running in the University Cancer Institute of Toulouse Oncopole (France), the Hospital Pugliese Ciaccio (Cantazaro, Italy), the European Institute of Oncology (Milan, Italy), Jackson Memorial Hospital (Miami, USA), New York–Presbyterian Hospital (USA), Mount Sinai Hospital (New York, USA), King Fahad Specialist Hospital (Dammam, Saudi Arabia) and King Fahad Medical City (Riyadh, Saudi Arabia), among others.

Radiance™ has been patented under the number PCT/ES2008/000240 and registered as a brand with the name of intraplan radiance® since 2008. In 2011 Radiance™ obtained the CE marking certificate, clearing it for marketing in all EU member states. Then, in 2012, GMV received Food and Drug Agency clearance for marketing Radiance™ throughout the USA.

(*) Dr. Pedro Lara, chair-holding professor of Radiology and Physical Medicine at the Universidad de Las Palmas de Gran Canaria (UPLPGC). Posts held: President of the Radiotherapy Oncology Group of the European Union Medical Specialists (UEMS); President of the National Radiotherapy Oncology Committee (Comisión Nacional de Oncología Radioterápica) of Spain’s Health Ministry; secretary of the Spanish Clinical Oncology Society (Sociedad Española de Oncología Clínica: SEOC); radiology professor and lecturer at the Universidad Fernando Pessoa Canarias; Oncology Department Head of the Hospital Universitario San Roque; Director of the Canary Cancer Research Institute (Instituto Canario de Investigación del Cáncer).

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