Abstract
tumor
DISEASE PROGRESSION, TUMOR, ADVERSE EVENTS, BRAIN METASTASES, ADVANCED CANCER, BRAIN METASTASES
Amit K. Garg and Mike Hernandez authors contributed equally to this work.Stereotactic radiation therapy yields high rates of local control for brain metastases, but patients in rural or suburban areas face geographic and socioeconomic barriers to its access. We conducted a phase II clinical trial of frameless, fractionated stereotactic radiation therapy for brain metastases in an integrated academic satellite network for patients 18 years of age or older with 4 or fewer brain metastases. Dose was based on gross tumor volume: less than 3.0 cm, 27 Gy in 3 fractions and 3.0 to 3.9 cm, 30 Gy in 5 fractions. Median follow-up was 10 months for 73 evaluable patients, with a median age of 68 years. Median intracranial progression-free survival was 7.1 months (95% confidence interval = 5.3 to not reached), and median survival was 7.2 months (95% confidence interval = 5.4 to not reached); there were no serious adverse events. Outcomes of this trial compare favorably with contemporary trials, and this treatment strategy provides opportunities to expand stereotactic radiation therapy access to underserved populations.Brain metastases are a common manifestation of advanced cancer, seen in more than 100 000 patients in the United States annually (Institutional review board approval was obtained for this prospective, multi-institutional, prospective phase II clinical trial, as shown in Frameless, fractionated stereotactic radiation therapy phase II clinical trial profile.A total of 78 patients consented to participate in the trial, of whom 1 patient withdrew, 1 patient was removed due to disease progression, and 3 patients were removed who did not meet entry criteria (
In summary, we conducted a pragmatic phase II clinical trial evaluating 3- to 5-fraction frameless, fractionated stereotactic RT for intraparenchymal brain metastases in an integrated academic satellite network for patients in suburban and rural communities. This frameless, fractionated stereotactic RT regimen succeeded in achieving the hypothesis pertaining to the primary trial endpoint. It is notable that both the local control and overall survival rates observed in this trial compare favorably to contemporary clinical trials for this patient population (