Originally published as JCO Early Release 10.1200/JCO.2008.19.6329 on March 2 2009

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Multi-Institutional Phase I/II Trial of Stereotactic Body Radiation Therapy for Liver Metastases

From the University of Colorado—Denver, Departments of Radiation Oncology, Pathology, and Medical Oncology, Aurora; and St. Joseph's Hospital Radiation Oncology, Denver, CO; Indiana University Department of Radiation Oncology, Indianapolis, IN; Wake Forest University Department of Radiation Oncology, Winston Salem; and Carolinas Medical Center Radiation Oncology, Charlotte, NC; and Fox Chase Cancer Center Department of Radiation Oncology, Philadelphia, PA.

Corresponding author: Tracey Schefter, MD, Department of Radiation Oncology, University of Colorado—Denver, Campus Mail Stop F-706, 1665 Aurora Court, Suite 1032, Aurora, CO 80045; e-mail: Tracey.schefter{at}ucdenver.edu.

Purpose 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.

Patients and 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.

Conclusion 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.

Supported in part by the American Cancer Society IRC/University of Colorado Cancer Center Seed Grant Award.

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

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• Using a Bigger Hammer: The Role of Stereotactic Body Radiotherapy in the Management of Oligometastases
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  JCO 2009 27: 1537-1539 [Full Text]

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• Have We Established a Stereotactic Body Radiotherapy Regimen for Liver Metastases?
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				X. Mirabel Have We Established a Stereotactic Body Radiotherapy Regimen for Liver Metastases? J. Clin. Oncol., August 1, 2009; 27(22): e40 - e40. [Full Text] [PDF]

				E. Ben-Josef and T. S. Lawrence Using a Bigger Hammer: The Role of Stereotactic Body Radiotherapy in the Management of Oligometastases J. Clin. Oncol., April 1, 2009; 27(10): 1537 - 1539. [Full Text] [PDF]