The phase 3 Alliance A071801 trial demonstrates that fractionated stereotactic radiosurgery delivered over three to five sessions significantly improves local control and overall survival for patients with large brain metastases compared to single-session treatment. Patients receiving multi-fraction therapy achieved an 87% one-year local control rate and lived a median of nine months longer, without increased side effects. Separately, the ROADS trial shows GammaTile brachytherapy reduces surgical bed recurrence to 1.0%.
Alliance A071801 trial design
- ▪The Alliance A071801 trial randomized 242 patients between 2019 and 2022 who had one to four brain metastases, including at least one surgically removed metastasis larger than 2 centimeters.
- ▪In the Alliance A071801 trial, patients received either single-fraction radiosurgery of 12 to 20 Gy or multi-fraction radiosurgery of 27 Gy in three fractions or 30 Gy in five fractions.
- ▪The Alliance A071801 phase 3 trial compared fractionated stereotactic radiosurgery delivered in three to five sessions to single-session radiosurgery after surgery for patients with large brain metastases.
Alliance A071801 disease control outcomes
- ▪One year after treatment in the Alliance A071801 trial, 87% of patients receiving fractionated radiosurgery remained free from surgical site recurrence, compared to 81% of those receiving single-session radiosurgery.
- ▪The multi-fraction arm in the Alliance A071801 trial showed a 94% rate of freedom from whole-brain radiation at one year, compared to 84% in the single-fraction arm.
- ▪In the Alliance A071801 trial, treated, unresected brain metastases progressed in 4% of patients in the fractionated group compared to 11% in the single-session group.
Survival and follow-up
- ▪Patients treated with fractionated radiosurgery in the Alliance A071801 trial lived a median of 28.6 to 29 months, compared to 20 to 20.2 months, with a 31% lower risk of death (hazard ratio 0.66).
- ▪Researchers followed patients in the Alliance A071801 trial for a median of 48 months.
Adverse events and quality of life
- ▪Researchers did not observe any differences in quality of life between the treatment arms in the Alliance A071801 trial.
- ▪Rates of adverse events did not differ significantly between treatment groups in the Alliance A071801 trial, though radiation necrosis was numerically higher in the multi-fraction arm at 14% versus 10%.
Findings from the ROADS trial
- ▪Approximately 20% of patients assigned to postoperative stereotactic radiotherapy in the ROADS trial did not receive their scheduled radiation due to recovery issues, complications, or travel barriers.
- ▪Patients treated with GammaTile brachytherapy in the ROADS trial had an estimated 24-month survival rate of 61.7%, compared to 35.7% for the stereotactic radiotherapy group.
- ▪The phase 3 ROADS trial randomized 230 patients with newly diagnosed brain metastases to receive either surgery plus stereotactic radiotherapy or surgery plus GammaTile cesium-131 brachytherapy.
- ▪In the ROADS trial, surgical bed recurrence occurred in 1.0% of patients treated with GammaTile brachytherapy compared to 11.9% of patients treated with stereotactic radiotherapy.
Postoperative radiation for brain metastases
- ▪Current medical guidelines recommend treating resected brain metastases with stereotactic radiosurgery rather than whole-brain radiation therapy to preserve cognitive function and quality of life.
- ▪Historically, more than half of patients undergoing surgery for brain metastases without postoperative radiation experienced a recurrence at the surgical site within one year.
Prevalence of brain metastases
- ▪Between 10% and 30% of individuals diagnosed with cancer will eventually develop brain metastases.
- ▪An estimated 200,000 people develop brain metastases annually in the United States, with incidence rising due to cancer treatment advances that extend patient survival.
Debatable claims
- ▪The unexpected survival benefit of fractionated radiosurgery is insufficient to change standard clinical practice
- ▪The survival benefits of fractionated radiosurgery outweigh the patient burden of multiple hospital visits
- ▪Hospitals should prioritize adopting GammaTile brachytherapy over postoperative stereotactic radiotherapy
- ▪The higher rate of radiation necrosis in fractionated radiosurgery poses an unacceptable risk to patients
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