title: 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).
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Wisconsin, Madison, USA.
authors.forename: Rafael
authors.initials: R
authors.lastname: Manon
authors.forename: Anne
authors.initials: A
authors.lastname: O'Neill
authors.forename: Jonathan
authors.initials: J
authors.lastname: Knisely
authors.forename: Maria
authors.initials: M
authors.lastname: Werner-Wasik
authors.forename: Hillard M
authors.initials: HM
authors.lastname: Lazarus
authors.forename: Henry
authors.initials: H
authors.lastname: Wagner
authors.forename: Mark
authors.initials: M
authors.lastname: Gilbert
authors.forename: Minesh
authors.initials: M
authors.lastname: Mehta
mesh_terms: D000328:Adult; D001921:Brain / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D001932:Brain Neoplasms / Q000401:mortality / Q000556:secondary* / Q000601:surgery*; D002292:Carcinoma, Renal Cell / Q000556:secondary / Q000601:surgery; D003071:Cognition / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007680:Kidney Neoplasms / Q000473:pathology; D008297:Male; D008545:Melanoma / Q000473:pathology; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D016634:Radiosurgery / Q000009:adverse effects / Q000379:methods*; D012509:Sarcoma / Q000473:pathology; D016019:Survival Analysis; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome