title: Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies.
abstract: BACKGROUND
  Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers.
  
  
  METHODS
  A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan-Meier method and the Cox proportional hazards model was used to control for prognostic variables.
  
  
  RESULTS
  SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5).
  
  
  CONCLUSIONS
  SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway.
  
  
  BACKGROUND
  Case Comprehensive Cancer Center.
authors.affiliation: Department of Radiation Oncology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine Cleveland, OH, USA.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Kunos
authors.forename: James
authors.initials: J
authors.lastname: Brindle
authors.forename: Steven
authors.initials: S
authors.lastname: Waggoner
authors.forename: Kristine
authors.initials: K
authors.lastname: Zanotti
authors.forename: Kimberly
authors.initials: K
authors.lastname: Resnick
authors.forename: Nancy
authors.initials: N
authors.lastname: Fusco
authors.forename: Ramon
authors.initials: R
authors.lastname: Adams
authors.forename: Robert
authors.initials: R
authors.lastname: Debernardo