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- Title
A prospective multi-institute observational study of gamma knife alone treatment for 1-10 brain metastases (jlgk0901) has evidence for the efficacy of srs for 5-10 brain metastases been established?
- Authors
T. Serizawa; M. Yamamoto; Y. Higuchi; Y. Sato; J. Kawagishi; T. Shuto; K. Yamanaka; A. Akabane; H. Jokura; S. Yomo
- Abstract
Introduction: By the end of 2012, we will have finished a multi-institute observational prospective study (abbreviation; JLGK0901, UMIN ID; 1812, http: /www. umin.ac.jp/), which is designed to prove the non-inferiority of gamma knife surgery (GKS) alone treatment for patients with 5-10 brain metastases (BM) versus 2-4 BM. Methods: 1206 patients with 1-10 newly diagnosed BM (<10 cc volume of the largest BM, <15 cc total tumor volume, no findings of CSF dissemination and KPS <70%) were enrolled at 23 facilities in Japan between March 2009 and February 2012. No attempt at pre-treatment randomization was made. The primary endpoint was overall survival (OS); other endpoints were tumor control, new distant lesion(s), salvage treatment, functional preservation including neuro-cognitive function, toxicities and cause of death. Results: There were 480 females, 726 males, with a mean age of 66 (range; 30-91) years. The primary organs were the lung in 918 patients (76.1%), breast in 125 (10.4%), colon in 54 (4.5%), kidney in 36 (3.0%) and others in 73 (6.1%). BM number was one in 460 (38.1%), 2-4 in 536 (44.4%) and 5-10 in 210 (17.4%) patients. As of August 2012, the median post-GKS follow-up time among censored observations (447 patients) was 15.4 (range; 0.8-41.0) months, and 739 patients (62.3%) had died. The median survival time was 12.1 (95% confidence interval; 11-13.1) months. The tumor control rates at one year were 95.5% for tiny (<1cc), 80.9% for small (1-4cc) and 66.5% for medium-sized (4-1 0cc) BM. New lesion-free and salvage treatment-free survival rates at 1 year were 41.1%, 58.9%. Functional preservation rates were 88.5% at 1 year, 79.9% at 2 years and 74.5% at 3 years. Neurological deaths were verified in 59 patients and neurological death-free rates were 95.3% at 1 year, 88.0% at 2 years and 86.2% at 3 years. Conclusions: Based on our previous retrospective investigations, the JLGK0901 study is anticipated to prove the non-inferiority of GKS as the sole treatment for patients with 5-10 brain BM as compared to those with 2-4 in terms of OS (Serizawa et al. JNS 113: 48-52, 2010). Interim analysis comparing groups according to BM numbers in this on-going study is prohibited by the protocol. However, the final results comparing OS between the 2-4 and 5-10 BM groups will be disclosed at this meeting. Disclosure: No significant relationships.
- Subjects
RADIOSURGERY; BRAIN metastasis; CANCER diagnosis; SALVAGE therapy; TUMOR treatment
- Publication
Journal of Radiosurgery & SBRT, 2013, Vol 2, p5
- ISSN
2156-4639
- Publication type
Article