GammaTile Surgically Targeted Radiation Therapy (STaRT) Improving Access to Brain Tumor Care without Compromising Outcomes
ABSTRACT
Patients with brain tumors face enormous challenges after diagnosis. Many of these challenges are amplified by issues related to access to care.1‒4 Studies suggest that patients with cancer who live farther from radiation treatment centers have poorer clinical outcomes. In addition, minorities are more likely to perceive longer travel distances as a barrier, which may cause them to forgo needed radiation treatments.1‒4 To address these challenges, the Centers for Medicare & Medicaid Services (CMS) has identified improving access to healthcare for nonurban populations as a key policy priority.
CURRENT STANDARD OF CARE
The current initial standard of care for aggressive brain tumors—either primary brain tumors (ie, tumors that originate inside the brain) or metastatic tumors (ie, tumors from cancers that originate outside of the brain)—is maximum safe surgical resection. After surgery, a follow-up treatment, also referred to as adjuvant treatment, is often recommended to help eliminate any residual tumor cells in or near the surgical resection cavity.6 In the case of brain tumors, more often than not, adjuvant therapy involves using radiation.6
Adjuvant radiation is used either alone or in combination with chemotherapy, and the most common method of radiation treatment is external beam radiation therapy (EBRT).6,7 For EBRT, specialized equipment, typically a linear accelerator, generates radiation beams and focuses them inward to travel through the skin, through the skull, and finally, into the brain.7 Postsurgical wound healing must occur prior to the initiation of EBRT, which can delay radiation treatment for weeks and leave a window for unchecked cell replication and tumor recurrence.8,9 In addition, if the tumor recurs and the patient has already received their maximum safe dose of EBRT, there may not be many other options for effective adjuvant therapy.
GammaTile Therapy is a safe and effective radiation option that requires no capital investment and eliminates the need for multiple treatment visits along with the associated transportation and caregiver burdens
To provide targeted brain EBRT, such as intensity-modulated radiotherapy (IMRT) and stereotactic radiosurgery (SRS), treatment centers must have both the significant fiscal capital equipment investment and the radiation oncologists with the expertise to treat brain tumors. Additionally, EBRT can require extensive postsurgical follow-up treatment, which means the patient must travel (sometimes daily for up to 6 weeks) to the radiation facility
GAMMATILE | SURGICALLY TARGETED RADIATION THERAPY (STaRT)
FDA-cleared in 2018, GammaTile surgically targeted radiation therapy (STaRT) is a form of radiation therapy that is implanted by the neurosurgeon at the time of brain tumor removal. GammaTile Therapy is a safe and effective radiation option that requires no capital investment and eliminates the need for repeat treatments along with the associated transportation and caregiver burdens.11‒14 The therapy not only improves access to care, but it also ensures 100% compliance as patients can go about their daily lives as they receive their “built-in” radiation treatment. The safety and efficacy of GammaTile Therapy has been demonstrated in clinical studies and postapproval use.11‒14 It improves local tumor control in patients with recurrent meningiomas and recurrent brain metastases.11‒14 GammaTile Therapy exhibits the potential to extend overall survival in patients with recurrent glioblastomas.11‒14 GammaTile Therapy is covered by Medicare and most private insurance. It is available in the United States, and can be easily adopted by any neurosurgery center equipped for craniotomies that has a radiation safety officer on staff.
ACCESS TO CARE
This paper identifies the number and locations of US radiation oncology centers with brain tumor treatment expertise, defined as centers with SRS experience for brain tumors. Next, the percentage of residents having at least 30-, 60-, 90-, and 120-minute drive times to these radiation oncology centers was calculated. The findings reveal that rural states have a disproportionally larger percentage of the population who live a longer distance from the identified radiation oncology centers. Also identified are the number and locations of US neurosurgery centers that bill for craniotomies, the procedure required to remove brain tumors, noting that they are centers with the expertise to provide GammaTile Therapy (ie, any facility that can perform a craniotomy is eligible to treat a patient with GammaTile Therapy). There are 135 radiation oncology centers with brain tumor treatment expertise vs 530 neurosurgery centers with the expertise to provide GammaTile Therapy. That is 4 times the number of neurosurgery centers than EBRT centers providing critically needed care. These 530 neurosurgery centers are more geographically dispersed, which could bring the option of GammaTile Therapy much closer to patients in rural areas. Broad adoption of GammaTile Therapy by neurosurgery centers across the country would expand their brain tumor treatment services, bringing a safe and effective treatment option to these currently underserved areas. This would simultaneously improve patient access to care without compromising clinical outcomes.
BACKGROUND
Patients with brain tumors face enormous challenges after diagnosis. Many of these challenges are amplified by access-to-care‒related issues and the lack of options for adjuvant therapy.1‒4,6,10 A comprehensive body of published literature firmly establishes that the burden of travel from a patient’s house to a treatment center has a negative impact on adherence to treatment regimen, timeliness of treatment, prognosis, and quality of life.1‒4 Furthermore, these studies suggest that the poorer outcomes for patients living farther from treating hospitals is likely associated with poor patient compliance and follow-up.
In a 2015 publication entitled Challenges of Rural Cancer Care in the United States, the lack of availability of radiation oncologists and radiation facilities in rural areas is identified as a critical concern.2 In that article, several cited studies substantiate that rural patients receive less-curative radiation than urban patients.2 In addition, they found that longer travel distances are associated with lower rates of guidelineindicated radiotherapy.2 Because repeated visits for adjuvant radiation treatment after surgery are often necessary, distance and transportation logistics are critical hurdles that patients and their caregivers must navigate.2 The extensive travel required for daily radiation treatments presents problems with respect to time lost from work and associated out-of-pocket costs, not to mention the psychological and physical toll that ongoing treatment can take.2 Longer distances may present further obstacles to obtaining timely treatment or even cause patients to forgo radiation therapy.2 Additional supporting evidence from a 2016 publication found a statistically significant decrease in rates of radiotherapy treatment for patients traveling more than 50 miles compared to those traveling less than 12.5 miles for their radiation treatments.
A Guidry et al. study examining barriers to cancer treatment for patients reports that more than 50% of patients do not drive themselves to their radiation treatments and must rely on someone else or public transportation.4 The distance to the radiation treatment center is a perceived barrier for Hispanic minorities (66%) and Black minorities (51%) vs white individuals (37%).4 In addition, 62% of Hispanic individuals and 55% of Black individuals, vs 37% of white individuals, report that finding someone to drive them to their treatment is a barrier that could cause one to forgo treatment.4 The authors conclude, “Overall, the findings point to the transportation-related barriers that patients, especially minorities, may experience in obtaining needed medical treatment.”4 Indeed, CMS has identified improving access to healthcare for nonurban populations as a key policy priority.
With traditional EBRT as an adjuvant therapy for the treatment of brain tumors, access to care is limited by both the significant fiscal capital equipment investment as well as the select expertise of radiation oncologists familiar with this treatment. Additionally, EBRT treatments typically require the patient to travel to a site of care frequently if not daily, often over the course of several weeks. Notably, patients with recurrent brain tumors who have received their maximum safe doses of EBRT may not have any other options for adjuvant therapy.
A safe and effective radiation option, GammaTile Therapy is implanted at the time of surgery by neurosurgeon at any neurosurgical operating room.11‒14 Unlike EBRT, GammaTile Therapy treatment begins immediately and continues as patients resume their daily lives. Consequently, GammaTile Therapy not only improves access to care, ensures 100% compliance and eliminates the need to travel for ongoing radiation treatments, it also provides an option for patients with recurrent brain tumors who have received their maximum safe doses of EBRT.
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