open access

Vol 25, No 4 (2020)
Reviews
Published online: 2020-07-01
Submitted: 2020-01-30
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Radiosurgery dose reduction for brain metastases on immunotherapy (RADREMI): A prospective phase I study protocol

Shearwood McClelland, Tim Lautenschlaeger, Yong Zang, Nasser H. Hanna, Kevin Shiue, Aaron P. Kamer, Namita Agrawal, Susannah G. Ellsworth, Ryan M. Rhome, Gordon A. Watson
DOI: 10.1016/j.rpor.2020.04.007
·
Rep Pract Oncol Radiother 2020;25(4):500-506.

open access

Vol 25, No 4 (2020)
Reviews
Published online: 2020-07-01
Submitted: 2020-01-30

Abstract

Introduction

Up to 20% of patients with brain metastases treated with immune checkpoint inhibitor (ICI) therapy and concomitant stereotactic radiosurgery (SRS) suffer from symptomatic radiation necrosis. The goal of this study is to evaluate Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI) on six-month symptomatic radiation necrosis rates.

Methods

This study is a prospective single arm Phase I pilot study which will recruit patients with brain metastases receiving ICI delivered within 30 days before SRS. All patients will be treated with RADREMI dosing, which involves SRS doses of 18 Gy for 0−2 cm lesions, 14 Gy for 2.1−3 cm lesions, and 12 Gy for 3.1−4 cm lesions. All patients will be monitored for six-month symptomatic radiation necrosis (defined as a six-month rate of clinical symptomatology requiring steroid administration and/or operative intervention concomitant with imaging findings consistent with radiation necrosis) and six-month local control. We expect that RADREMI dosing will significantly reduce the symptomatic radiation necrosis rate of concomitant SRS + ICI without significantly sacrificing the local control obtained by the present RTOG 90−05 SRS dosing schema. Local control will be defined according to the Response Assessment in Neuro-Oncology (RANO) criteria.

Discussion

This study is the first prospective trial to investigate the safety of dose-reduced SRS in treatment of brain metastases with concomitant ICI. The findings should provide fertile soil for future multi-institutional collaborative efficacy trials of RADREMI dosing for this patient population.

Trial Registration

Clinicaltrials.gov identifier: NCT04047602 (registration date: July 25, 2019).

Abstract

Introduction

Up to 20% of patients with brain metastases treated with immune checkpoint inhibitor (ICI) therapy and concomitant stereotactic radiosurgery (SRS) suffer from symptomatic radiation necrosis. The goal of this study is to evaluate Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI) on six-month symptomatic radiation necrosis rates.

Methods

This study is a prospective single arm Phase I pilot study which will recruit patients with brain metastases receiving ICI delivered within 30 days before SRS. All patients will be treated with RADREMI dosing, which involves SRS doses of 18 Gy for 0−2 cm lesions, 14 Gy for 2.1−3 cm lesions, and 12 Gy for 3.1−4 cm lesions. All patients will be monitored for six-month symptomatic radiation necrosis (defined as a six-month rate of clinical symptomatology requiring steroid administration and/or operative intervention concomitant with imaging findings consistent with radiation necrosis) and six-month local control. We expect that RADREMI dosing will significantly reduce the symptomatic radiation necrosis rate of concomitant SRS + ICI without significantly sacrificing the local control obtained by the present RTOG 90−05 SRS dosing schema. Local control will be defined according to the Response Assessment in Neuro-Oncology (RANO) criteria.

Discussion

This study is the first prospective trial to investigate the safety of dose-reduced SRS in treatment of brain metastases with concomitant ICI. The findings should provide fertile soil for future multi-institutional collaborative efficacy trials of RADREMI dosing for this patient population.

Trial Registration

Clinicaltrials.gov identifier: NCT04047602 (registration date: July 25, 2019).

Get Citation

Keywords

Stereotactic radiosurgery; Immunotherapy; Brain metastases; Gamma knife; Linear accelerator; Symptomatic radiation necrosis

About this article
Title

Radiosurgery dose reduction for brain metastases on immunotherapy (RADREMI): A prospective phase I study protocol

Journal

Reports of Practical Oncology and Radiotherapy

Issue

Vol 25, No 4 (2020)

Pages

500-506

Published online

2020-07-01

DOI

10.1016/j.rpor.2020.04.007

Bibliographic record

Rep Pract Oncol Radiother 2020;25(4):500-506.

Keywords

Stereotactic radiosurgery
Immunotherapy
Brain metastases
Gamma knife
Linear accelerator
Symptomatic radiation necrosis

Authors

Shearwood McClelland
Tim Lautenschlaeger
Yong Zang
Nasser H. Hanna
Kevin Shiue
Aaron P. Kamer
Namita Agrawal
Susannah G. Ellsworth
Ryan M. Rhome
Gordon A. Watson

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