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. 2023 Jun;163(2):385-395.
doi: 10.1007/s11060-023-04358-8. Epub 2023 Jun 7.

Retrospective non-inferiority study of stereotactic radiosurgery for more than ten brain metastases

Naoya Nagai  1   2 , Yutaro Koide  3 , Yurika Shindo  1   2 , Shingo Hashimoto  1 , Hiroyuki Tachibana  1 , Takeshi Kodaira  1 , Shunichi Ishihara  2 , Shinji Naganawa  2
Affiliations

Retrospective non-inferiority study of stereotactic radiosurgery for more than ten brain metastases

Naoya Nagai et al. J Neurooncol. 2023 Jun.

Abstract

Aim: This study aimed to investigate the clinical benefits of stereotactic radiosurgery (SRS) in patients with > 10 brain metastases (BM) compared to patients with 2-10 BM.

Methods: The study included multiple BM patients who underwent SRS between 2014 and 2022, excluding patients who underwent whole brain radiotherapy, had a Karnofsky Performance Status score < 60, suspected leptomeningeal disease, or a single BM lesion. Patients were divided into two groups (2-10 and > 10 BM groups) and matched 2:1 based on propensity scores. The primary endpoint was overall survival (OS) in the matched dataset, with intracranial progression-free survival (PFS) as the secondary endpoint. Non-inferiority was established if the upper limit of the 95% confidence interval (CI) of the adjusted hazard ratio was below 1.3.

Results: Of the 1042 patients identified, 434 met eligibility criteria. After propensity score matching, 240 patients were analyzed (160 in the BM 2-10 group and 80 in the > 10 BM group). The median OS was 18.2 months in the 2-10 BM group and 19.4 months in the > 10 BM group (P = 0.60). The adjusted hazard ratio was 0.86 (95% CI: 0.59-1.24), indicating non-inferiority. PFS was not significantly different between the groups (4.8 months vs. 4.8 months, P = 0.94). The number of BM did not significantly impact OS or PFS.

Conclusions: SRS for selected patients with > 10 BM was non-inferior in terms of OS compared to those with 2-10 BM in a propensity score-matched dataset.

Keywords: Brain metastases; Non-inferiority study; Stereotactic radiosurgery; Stereotactic radiotherapy; Whole brain radiotherapy.

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