Prospective Multi-institute Study of Gamma Knife Radiosurgery Alone Treatment for Patients with 1-10 Brain Metastases (JLGK0901): Interim Monitoring ReportYoshinori Higuchi1, Toru Serizawa2, Masaaki Yamamoto3, Takashi Shuto4, Astuya Akabane5, Yasunori Sato6, Jun Kawagishi7, Kazuhiro Yamanaka8, Naokatsu Saeki91Chiba, Japan 2Tokyo, Japan 3Ibaraki, Japan 4Kanagawa, Japan 5Gamma Knife Center, Kanto Medical Center, NTT EC, Tokyo, Japan 6Chiba University Hospital Clinical Research Center, Chiba, Japan 7Jiro Suzuki Memorial Gamma House, Furukawa Seiryo Hospital, Furukawa, Japan 8Department of Neurosurgery, Osaka City General Hospital, Osaka, Japan 9 Keywords: brain metastasis, radiosurgery, gamma knife, outcome, brain tumorInteractive ManuscriptAsk Questions of this Manuscript: What is the background behind your study?Radiosurgery without whole brain radiotherapy is increasingly being chosen for brain metastasis care. What is the purpose of your study?To present interim monitoring results of the prospective multi-institute study (JLGK0901) of gamma knife radiosurgery (GKRS) for 1-10 brain metastases without whole brain radiation therapy conducted by the JLGK society. Describe your patient group.As of the end of 2010, 819 patients meeting the following 5 major JLGK0901 inclusion criteria, were evaluated: 1) newly diagnosed, 2) largest tumor less than 3 cm in diameter or 10cc in volume, 3) maximum of 10 brain metastases; 4) no more than 15 cc total tumor volume; 5) no MR findings of CSF dissemination. Primary organs were the lung in 633 patients, breast in 88, colon in 36, kidney in 19, and others in 43. Most cases were RTOG-RPA class II (765 patients, 93.4%), followed by III (28, 3.4%) and I (26, 3.2%). Describe what you did.We collected data from multiple Japanese gamma knife centers. Describe your main findings.Overall median survival time after GKRS was 0.99 years. The tumor progression-free survival (TPFS) rate was 89.8% at one year. There were statistically significant differences in one-year-TPFS rates among three tumor volume groups, 94.9% in 1576 lesions <1 cc, 80.7% in 403 with 1-4 cc lesions and 60.6 % in 173 with 4-10 cc lesions (p<0.0001). Neurological and qualitative survival rates at one year were 94.9% and 91.6%. New lesion-free and salvage GKRS-free survival rates at one year were 39.4% and 56.9%. Among 2152 registered lesions, adverse radiation effects occurred in 45 (2.1%). Mini mental status examination (MMSE) scores pre-GKRS and at the 12th post-GKRS month were obtained in 167 patients. The mean MMSE scores were 27.9 pre-GKRS and 28.1 at the 12th post-GKRS month (n.s). A significant decrease in MMSE score was detected in 9.6% of patients at the 12th post-GKRS month. Describe the main limitation of this study.This was a multicenter retrospective study. There was no control group. Describe your main conclusion.Interim monitoring revealed overall, neurological and qualitative survivals to not be inferior to those of our prior reports. Minimum risk of deteriorating neurocognitive function was confirmed at least up to 12 months after GKRS. Describe the importance of your findings and how they can be used by others.No major adverse effects due to GKRS occurred in this cohort. The JLGK study group continues to recruit and follow-up patients. This interim monitoring report will be updated. Radiosurgery without whole brain radiotherapy is increasingly being chosen for brain metastasis care. To present interim monitoring results of the prospective multi-institute study (JLGK0901) of gamma knife radiosurgery (GKRS) for 1-10 brain metastases without whole brain radiation therapy conducted by the JLGK society. As of the end of 2010, 819 patients meeting the following 5 major JLGK0901 inclusion criteria, were evaluated: 1) newly diagnosed, 2) largest tumor less than 3 cm in diameter or 10cc in volume, 3) maximum of 10 brain metastases; 4) no more than 15 cc total tumor volume; 5) no MR findings of CSF dissemination. Primary organs were the lung in 633 patients, breast in 88, colon in 36, kidney in 19, and others in 43. Most cases were RTOG-RPA class II (765 patients, 93.4%), followed by III (28, 3.4%) and I (26, 3.2%). We collected data from multiple Japanese gamma knife centers. Overall median survival time after GKRS was 0.99 years. The tumor progression-free survival (TPFS) rate was 89.8% at one year. There were statistically significant differences in one-year-TPFS rates among three tumor volume groups, 94.9% in 1576 lesions <1 cc, 80.7% in 403 with 1-4 cc lesions and 60.6 % in 173 with 4-10 cc lesions (p<0.0001). Neurological and qualitative survival rates at one year were 94.9% and 91.6%. New lesion-free and salvage GKRS-free survival rates at one year were 39.4% and 56.9%. Among 2152 registered lesions, adverse radiation effects occurred in 45 (2.1%). Mini mental status examination (MMSE) scores pre-GKRS and at the 12th post-GKRS month were obtained in 167 patients. The mean MMSE scores were 27.9 pre-GKRS and 28.1 at the 12th post-GKRS month (n.s). A significant decrease in MMSE score was detected in 9.6% of patients at the 12th post-GKRS month. This was a multicenter retrospective study. There was no control group. Interim monitoring revealed overall, neurological and qualitative survivals to not be inferior to those of our prior reports. Minimum risk of deteriorating neurocognitive function was confirmed at least up to 12 months after GKRS. No major adverse effects due to GKRS occurred in this cohort. The JLGK study group continues to recruit and follow-up patients. This interim monitoring report will be updated. Project Roles:
Y. Higuchi (), T. Serizawa (), M. Yamamoto (), T. Shuto (), A. Akabane (), Y. Sato (), J. Kawagishi (), K. Yamanaka (), N. Saeki ()
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