title: Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer.
abstract: BACKGROUND
  We conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers.
  
  
  METHODS
  Patients were assigned to dose-finding cohorts of day 1 carboplatin (AUC 2 or 4) and gemcitabine (600 or 800 mg/m(2)) followed by day 2 to day 4 Cyberknife SABR (8 Gy × three consecutive daily doses). Toxicities were graded prospectively by common terminology criteria for adverse events, version 4.0. SABR target and best overall treatment responses were recorded according to response evaluation criteria in solid tumors, version 1.1.
  
  
  RESULTS
  The maximum tolerated dose of chemotherapy preceding SABR was carboplatin AUC 4 and gemcitabine 600 mg/m(2). One patient experienced manageable, dose-limiting grade 4 neutropenia, grade 4 hypokalemia, and grade 3 nausea attributed to study treatment. One patient had a late grade 3 rectovaginal fistula 16 months after trial therapy. Among 28 SABR targets, 22 (79%) showed a partial response and 6 (21%) remained stable.
  
  
  CONCLUSIONS
  Systemic chemotherapy may be given safely prior to abdominopelvic robotic SABR with further investigation warranted.
authors.affiliation: Department of Radiation Oncology, Summa Cancer Institute, Summa Health System , Akron, OH , USA.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Kunos
authors.affiliation: Department of Radiation Oncology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Tracy M
authors.initials: TM
authors.lastname: Sherertz
authors.affiliation: Department of Radiation Oncology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Mazen
authors.initials: M
authors.lastname: Mislmani
authors.affiliation: Department of Radiation Oncology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Rodney J
authors.initials: RJ
authors.lastname: Ellis
authors.affiliation: Department of Radiation Oncology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Simon S
authors.initials: SS
authors.lastname: Lo
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Waggoner
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Kristine M
authors.initials: KM
authors.lastname: Zanotti
authors.affiliation: Department of Radiology, Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine , Cleveland, OH , USA.
authors.forename: Karin
authors.initials: K
authors.lastname: Herrmann
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Case Comprehensive Cancer Center, Cleveland Clinic , Cleveland, OH , USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Debernardo
keywords: carboplatin; cervix cancer; endometrial cancer; gemcitabine; ovarian cancer; radiation; stereotactic radiosurgery