Saint John’s is the first company to use a revolutionary brain tumor treatment

SANTA MONICA, CA — A team of multidisciplinary specialists at the Pacific Neuroscience Institute became the first in the country to treat a patient with recurrent glioblastoma — an aggressive form of cancer in the brain — with electronic intraoperative radiation therapy during a procedure last month at Providence’s Saint Johns Health Center in Santa Monica.

Glioblastoma is the cancer that killed US Senator John McCain (R-Arizona), US Senator Ted Kennedy (D-Massachusetts) and Beau Biden, son of President Joe Biden. It is the most common and aggressive type of malignant primary brain tumor with a median survival time of 10-12 months.

In 2020, 308,102 new cases of brain and nervous system tumors were diagnosed worldwide.

The therapy, known as IORT, allows radiation oncologists and surgeons to work together to give the patient radiation treatment during the same surgery to remove the tumor. The treatment greatly speeds up access to radiation treatment, which would normally begin a few weeks after surgery.

“Treating a patient suffering from glioblastoma with IORT is an incredible achievement for everyone involved, especially PNI and our Saint John’s Cancer Institute who work tirelessly to push the frontiers of innovation in the medical field,” said Michael Ricks, Chief Executive of Providence Saint John in a statement.

During the procedure, Saint John’s team of highly trained surgeons and radiation oncologists used the Xoft Axxent electronic brachytherapy system. After surgical removal of the tumor, Xoft’s flexible balloon-shaped applicator and Xoft’s miniature X-ray source were temporarily placed in the tumor cavity. After the applicator was inserted into the cavity, a single dose of radiation was delivered directly to the tumor bed. Both the applicator and the x-ray source were removed after radiation treatment.

“Xoft Brain IORT is a novel approach that may provide patients with quality of life benefits compared to traditional treatment,” said Garni Barkhoudarian, MD, Fellow of the American Association of Neurological Surgeons and Assistant Professor of Neurosurgery and Neuroscience at Saint John’s Cancer Institute.

“By reducing exposure times from weeks to just a day, Xoft not only offers a more convenient treatment option, but it can also result in fewer side effects and complications compared to other treatments,” Barkhoudarian said.

The procedure was also part of the international multi-center GLIOX study led by principal investigator and world-renowned neuro-oncologist Santosh Kesari, MD. He is currently Chair and Professor of the Department of Translational Neuroscience and Neurotherapy at the PNI.

The GLIOX study is designed to compare Xoft IORT plus Avastin (bevacizumab) to the investigational arm of RTOG-1205 (EBRT plus bevacizumab). Researchers hope this study will validate the intriguing initial results of a prospective, two-center comparative study at the European Medical Center in Moscow, which included 15 patients with recurrent glioblastoma treated with maximally safe resection and Xoft IORT and 15 patients treated with maximally were assessed safe resection and other modalities (control group), from June 2016 and June 2019.

As of March 2021, patients treated with Xoft Brain IORT lived up to 54 months after treatment without glioblastoma recurrence, while patients in the control group had glioblastoma recurrence within 10 months and lived up to 22.5 months after treatment. The researchers also found that there were fewer complications, such as radionecrosis, in the IORT group. Radionecrosis refers to the breakdown of normal body tissue near the original tumor site following radiation therapy.

One patient from the IORT group was still alive as of fall 2021, while none of the patients in the control group survived, hospital officials said.

The Xoft System is FDA cleared, CE marked and approved in a growing number of countries to treat cancer anywhere in the body. It uses the world’s smallest X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, targeting cancer cells while minimizing the risk of damaging healthy tissue in nearby areas of the body. For the treatment of certain types of tumors – including brain tumors – IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of postoperative external beam radiation therapy with a single radiation fraction.

“Patients with this type of cancer have extremely limited treatment options and unfortunately recurrences are quite common. Xoft Brain IORT can give patients and their families new hope for an additional treatment option that can attack the area right after the cancer is removed, rather than weeks after surgery,” said Stacey Stevens, President and new CEO of iCAD, Inc., of Xoft’s parent company.

“We hope this study will add to the body of data supporting IORT with the Xoft system for the treatment of various types of tumors, including recurrent GBM,” said Stevens.

This clinical study aims to pave the way for a new treatment for this type of brain tumor.

“Starting a clinical trial under normal circumstances is no small feat, but the COVID pandemic presented additional challenges that needed to be addressed,” said Naveed Wagle, MD., the study’s local principal investigator and associate professor of neuroscience at Saint John’s Cancer Institute.

“It’s really been a tremendous achievement and we’re excited to be able to offer it to patients now,” said Wagle.

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