title: Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with one to three hepatic metastases.
  
  
  METHODS
  Patients with one to three hepatic lesions and maximum individual tumor diameters less than 6 cm were enrolled and treated on a multi-institutional, phase I/II clinical trial in which they received SBRT delivered in three fractions. During phase I, the total dose was safely escalated from 36 Gy to 60 Gy. The phase II dose was 60 Gy. The primary end point was local control. Lesions with at least 6 months of radiographic follow-up were considered assessable for local control. Secondary end points were toxicity and survival.
  
  
  RESULTS
  Forty-seven patients with 63 lesions were treated with SBRT. Among them, 69% had received at least one prior systemic therapy regimen for metastatic disease (range, 0 to 5 regimens), and 45% had extrahepatic disease at study entry. Only one patient experienced grade 3 or higher toxicity (2%). Forty-nine discrete lesions were assessable for local control. Median follow-up for assessable lesions was 16 months (range, 6 to 54 months). The median maximal tumor diameter was 2.7 cm (range, 0.4 to 5.8 cm). Local progression occurred in only three lesions at a median of 7.5 months (range, 7 to 13 months) after SBRT. Actuarial in-field local control rates at one and two years after SBRT were 95% and 92%, respectively. Among lesions with maximal diameter of 3 cm or less, 2-year local control was 100%. Median survival was 20.5 months.
  
  
  CONCLUSIONS
  This multi-institutional, phase I/II trial demonstrates that high-dose liver SBRT is safe and effective for the treatment of patients with one to three hepatic metastases.
authors.affiliation: University of Colorado Denver, Department of Radiation Oncology, Pathology, and Medical Oncology, Aurora, CO 80045, USA.
authors.forename: Kyle E
authors.initials: KE
authors.lastname: Rusthoven
authors.forename: Brian D
authors.initials: BD
authors.lastname: Kavanagh
authors.forename: Higinia
authors.initials: H
authors.lastname: Cardenes
authors.forename: Volker W
authors.initials: VW
authors.lastname: Stieber
authors.forename: Stuart H
authors.initials: SH
authors.lastname: Burri
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Feigenberg
authors.forename: Mark A
authors.initials: MA
authors.lastname: Chidel
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Pugh
authors.forename: Wilbur
authors.initials: W
authors.lastname: Franklin
authors.forename: Madeleine
authors.initials: M
authors.lastname: Kane
authors.forename: Laurie E
authors.initials: LE
authors.lastname: Gaspar
authors.forename: Tracey E
authors.initials: TE
authors.lastname: Schefter
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000401:mortality / Q000556:secondary* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016634:Radiosurgery / Q000009:adverse effects / Q000379:methods*
chemical_list: D000970:Antineoplastic Agents