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doi: 10.1227/NEU.0000000000000325
Research-Human-Clinical Trials: Editor's Choice

A Prospective Phase II Trial of Fractionated Stereotactic Intensity Modulated Radiotherapy With or Without Surgery in the Treatment of Patients With 1 to 3 Newly Diagnosed Symptomatic Brain Metastases

Ammirati, Mario MD, MBA*,‡; Kshettry, Varun R. MD§; Lamki, Tariq MD*; Wei, Lai PhD; Grecula, John C. MD

Editor's Choice
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BACKGROUND: Several studies have demonstrated that omitting the routine use of adjuvant whole-brain radiation therapy for patients with newly diagnosed brain metastases may be a reasonable first-line strategy. Retrospective evidence suggests that fractionated stereotactic radiotherapy (fSRT) may have a lower level of toxicity with equivalent efficacy in comparison with radiosurgery.

OBJECTIVE: To study the phase II efficacy of using a focally directed treatment strategy for symptomatic brain metastases by the use of fSRT with or without surgery and omitting the routine use of adjuvant whole-brain radiation therapy.

METHODS: We used a Fleming single-stage design of 40 patients. Patients were eligible if they presented with 1 to 3 newly diagnosed symptomatic brain metastases, Karnofsky performance scale (KPS) greater than 60, and histological confirmation of primary disease. Patients underwent fSRT with the use of a dose of 30 Gy in 5 intensity-modulated fractions as primary or adjuvant treatment after surgical resection. The primary end point was the proportion of patients who experienced neurological death. Secondary end points were overall survival, time to KPS <70, and progression-free survival.

RESULTS: Of 40 patients accrued, 39 were eligible for analysis. The proportion of patients dying of neurological causes was 13% (5 patients), which includes 3 patients with an unknown cause of death. Median overall survival, time to KPS <70, and progression-free survival were 16 (95% confidence interval, 9-23), 14 (95% confidence interval, 7-20), and 11 (95% confidence interval, 4-21) months, respectively.

CONCLUSION: A focally directed treatment strategy using fSRT with or without surgery appears to be an effective initial strategy. Based on the results of this phase II clinical trial, further study is warranted.

ABBREVIATIONS: CI, confidence interval

CTV, clinical target volume

fSRT, fractionated stereotactic radiotherapy

GTV, gross tumor volume

KPS, Karnofsky performance status

OS, overall survival

PFS, progression-free survival

PTV, planning target volume

RPA, recursive partition analysis

SRS, stereotactic radiosurgery

WBRT, whole-brain radiation therapy

Copyright © by the Congress of Neurological Surgeons


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