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Cited by 1,447Brain Metastases and TreatmentManagement of metastatic bone diseaseGlioma Diagnosis and Treatment

Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study

Yamamoto, Masaaki, Serizawa, Toru, Shuto, Takashi, Akabane, Atsuya, Higuchi, Yoshinori, Kawagishi, Jun, Yamanaka, Kazuhiro, Sato, Yasunori +25 more·2014·The Lancet Oncology
DOI 10.1016/s1470-2045(14)70061-0
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Abstract

Background We aimed to examine whether stereotactic radiosurgery without whole-brain radiotherapy (WBRT) as the initial treatment for patients with five to ten brain metastases is non-inferior to that for patients with two to four brain metastases in terms of overall survival.Methods This prospective observational study enrolled patients with one to ten newly diagnosed brain metastases (largest tumour <10 mL in volume and <3 cm in longest diameter; total cumulative volume ≤15 mL) and a Karnofsky performance status score of 70 or higher from 23 facilities in Japan. Standard stereotactic radiosurgery procedures were used in all patients; tumour volumes smaller than 4 mL were irradiated with 22 Gy at the lesion periphery and those that were 4-10 mL with 20 Gy. The primary endpoint was overall survival, for which the non-inferiority margin for the comparison of outcomes in patients with two to four brain metastases with those of patients with five to ten brain metastases was set as the value of the upper 95% CI for a hazard ratio (HR) of 1·30, and all data were analysed by intention to treat. The study was finalised on Dec 31, 2012, for analysis of the primary endpoint; however, monitoring of stereotactic radiosurgery-induced complications and neurocognitive function assessment will continue for the censored subset until the end of 2014. This study is registered with the University Medical Information Network Clinical Trial Registry, number 000001812.Findings We enrolled 1194 eligible patients between March 1, 2009, and Feb 15, 2012. Median overall survival after stereotactic radiosurgery was 13·9 months [95% CI 12·0-15·6] in the 455 patients with one tumour, 10·8 months [9·4-12·4] in the 531 patients with two to four tumours, and 10·8 months [9·1-12·7] in the 208 patients with five to ten tumours. Overall survival did not differ between the patients with two to four tumours and those with five to ten (HR 0·97, 95% CI 0·81-1·18 [less than non-inferiority margin], p=0·78; pnon-inferiority<0·0001). Stereotactic radiosurgery-induced adverse events occurred in 101 (8%) patients; nine (2%) patients with one tumour had one or more grade 3-4 event compared with 13 (2%) patients with two to four tumours and six (3%) patients with five to ten tumours. The proportion of patients who had one or more treatment-related adverse event of any grade did not differ significantly between the two groups of patients with multiple tumours (50 [9%] patients with two to four tumours vs 18 [9%] with five to ten; p=0·89). Four patients died, mainly of complications relating to stereotactic radiosurgery (two with one tumour and one each in the other two groups).Interpretation Our results suggest that stereotactic radiosurgery without WBRT in patients with five to ten brain metastases is non-inferior to that in patients with two to four brain metastases. Considering the minimal invasiveness of stereotactic radiosurgery and the fewer side-effects than with WBRT, stereotactic radiosurgery might be a suitable alternative for patients with up to ten brain metastases.Funding Japan Brain Foundation.

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Authors
Yamamoto, M., Serizawa, T., Shuto, T., Akabane, A., Higuchi, Y., Kawagishi, J., Yamanaka, K., Sato, Y., Jokura, H., Yomo, S., Nagano, O., Kenai, H., Moriki, A., Suzuki, S., Kida, Y., Iwai, Y., Hayashi, M., Onishi, H., Gondo, M., Sato, M., Akimitsu, T., Kubo, K., Kikuchi, Y., Shibasaki, T., Goto, T., Takanashi, M., Mori, Y., Takakura, K., Saeki, N., Kunieda, E., Aoyama, H., Momoshima, S., & Tsuchiya, K.
Affiliations
  • Tsukiji Neurological Clinic (JP)
  • Yokohama Rosai Hospital (JP)
  • NTT (Japan) (JP)
  • Chiba University (JP)
  • Osaka City University (JP)
  • Chiba Cerebral and Cardiovascular Center (JP)
  • Nagatomi Neurosurgical Hospital (JP)
  • Nippon Steel Yawata Memorial Hospital (JP)
  • Komaki City Hospital (JP)
  • Osaka City General Hospital (JP)
  • Tokyo Women's Medical University (JP)
  • Asanogawa General Hospital (JP)
  • Southern Tohoku General Hospital (JP)
  • Hidaka Hospital (JP)
  • Saiseikai Kumamoto Hospital (JP)
  • Nagoya Kyouritsu Hospital (JP)
  • Tokai University (JP)
  • Niigata University (JP)
  • Keio University (JP)
  • Kyorin University (JP)
Corresponding author
Yamamoto, Masaaki
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2014-04
Volume
15
Issue
4
Pages
387-395
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(14)70061-0
OpenAlex
W2127199535
Cited by
1,447
References
35
Citations by year
2026: 68 · 2025: 106 · 2024: 125 · 2023: 142 · 2022: 158 · 2021: 146 · 2020: 140 · 2019: 131 · 2018: 135 · 2017: 118 · 2016: 87 · 2015: 54 · 2014: 32
FWCI
77.67
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Oncology (publishedVersion)
  • PubMed (publishedVersion)
Funders
American Society for Radiation Oncology
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Brain Metastases and Treatment
  • Health Sciences › Medicine › Surgery › Management of metastatic bone disease
  • Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
Keywords
stereotactic radiosurgery, brain metastases, whole brain radiotherapy, non-inferiority, overall survival, number of brain metastases, neurocognitive function, Karnofsky performance status, tumor volume, radiation-induced brain necrosis
MeSH terms
Adult, Aged, Aged, 80 and over, Brain Neoplasms, Female, Humans, Japan, Male, Middle Aged, Radiation Dosage, Retrospective Studies, Risk Factors, Time Factors, Proportional Hazards Models, Radiosurgery, Treatment Outcome, Karnofsky Performance Status, Patient Selection, Tumor Burden, Kaplan-Meier Estimate

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