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Phase II Trial of Radiosurgery for One to Three Newly Diagnosed Brain Metastases From Renal Cell Carcinoma, Melanoma, and Sarcoma: An Eastern Cooperative Oncology Group Study (E 6397)

From the University of Wisconsin, Madison, WI; Dana-Farber Cancer Institute, Boston, MA; Yale University, New Haven, CT; Thomas Jefferson University Hospital, Philadelphia, PA; University Hospitals of Cleveland, Cleveland, OH; Penn State Cancer Institute, Hershey, PA; and the University of Texas M.D. Anderson Cancer Center, Houston, TX.

Address reprint requests to Minesh Mehta, MD, K4/B3, 600 Highland Ave, Madison, WI 53792; e-mail: mehta{at}humonc.wisc.edu

PURPOSE: Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively.

PATIENTS AND METHODS: Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression.

RESULTS: Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95% CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8% and 48.3%. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3% and 16.2% (3 months) and 32.2% and 32.2% (6 months), respectively. Approximately 38% of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS.

CONCLUSION: Intracranial failure rates without WBRT were 25.8% and 48.3% at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.

Presented as an oral presentation at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5–8, 2004, New Orleans, LA.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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