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Analysis of 2000 cases treated with gamma knife surgery: validating eligibility criteria for a prospective multi-institutional study of stereotactic radiosurgery alone for treatment of patients with 1-10 brain metastases (JlGk0901) in Japan
Toru Serizawa, Yoshinori Higuchi, Osamu Nagano, Yasunori Sato, Masaaki Yamamoto, Junichi Ono, Naokatsu Saeki, Akifumi Miyakawa and Tatsuo Hirai

Objective: The Japan Leksell Gamma Knife (JLGK) Society has conducted a prospective multi-institute study (JLGK0901, UNIN000001812) for selected patients in order to prove the effectiveness of stereotactic radiosurgery (SRS) alone using the gamma knife (GK) for 1-10 brain lesions. Herein, we verify the validity of 5 major patient selection criteria for the JLGK0901 trial.

Materials and Methods: Between 1998 and 2010, 2246 consecutive cases with 10352 brain metastases treated with GK were analyzed to determine the validity of the following 5 major JLGK0901 criteria; 1) 1-10 brain lesions, 2) less than 10 cm3 volume of the largest tumor, 3) no more than 15 cm3 total tumor volume, 4) no cerebrospinal fluid (CSF) dissemination, 5) Karnofsky performance status (KPS) score ≥70.

Results: For cases with >10 brain metastases, salvage treatments for new lesions were needed more frequently. The tumor control rate for lesions larger than 10 cm3 was significantly lower than that of tumors <10 cm3. Overall, neurological and qualitative survivals (OS, NS, QS) of cases with >15 cm3 total tumor volume or positive magnetic resonance imaging findings of CSF were significantly poorer. Outcomes in cases with KPS <70 were significantly poorer in terms of OS.

Conclusions: Our retrospective results of 2246 GK treated cases verified the validity of the 5 major JLGK0901 criteria. The inclusion criteria for the JLGK0901 study are apparently good indications for SRS.

Keywords: Metastatic brain tumor, stereotactic radiosurgery, gamma knife surgery, whole brain radiation therapy

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