Phase i dose-escalation study of stereotactic body radiotherapy in patients with hepatic metastases

William Rule, Robert Timmerman, Liyue Tong, Ramzi Abdulrahman, Jeffrey Meyer, Thomas Boike, Roderich E. Schwarz, Paul Weatherall, L. Chinsoo Cho

Research output: Contribution to journalArticlepeer-review

142 Scopus citations


Purpose: To identify a tolerable and effective dose for 5- fraction stereotactic body radiotherapy for hepatic metastases. Methods: Patients were enrolled onto three dose-escalation cohorts: 30 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 5 fractions. Eligible patients had one to five hepatic metastases, ability to spare a critical hepatic volume (volume receiving <21 Gy) of 700 ml, adequate baseline hepatic function, no concurrent antineoplastic therapy, and a Karnofsky performance score of ≥60. Doselimiting toxicity included treatment-related grade 3 toxicity in the gastrointestinal, hepatobiliary/pancreas, and metabolic/ laboratory categories. Any grade 4 or 5 event attributable to therapy was defined as a dose-limiting toxicity. Local control (LC) and complete plus partial response rates were assessed. Results: Twenty-seven patients, 9 in each cohort, with 37 lesions were enrolled and treated: 17 men and 11 women; median age 62 (range 48-86) years; most common site of primary disease, colorectal (44.4%). Median follow-up was 20 (range 4-53) months. There was no grade 4 or 5 toxicity or treatment-related grade 3 toxicity. Actuarial 24-month LC rates for the 30-, 50-, and 60-Gy cohorts were 56%, 89%, and 100%, respectively. There was a statistically significant difference for LC between the 60- and 30-Gy cohorts (P = 0.009) but not between the 60- and 50-Gy cohorts (P = 0.56) or the 50- and 30-Gy cohorts (P = 0.091). The maximum tolerated dose was not reached. Conclusions: A dose of 60 Gy in 5 fractions can be safely delivered to selected patients with hepatic metastases as long as the critical liver volume is respected. A dose of 60 Gy in 5 fractions yields an excellent level of LC.

Original languageEnglish (US)
Pages (from-to)1081-1087
Number of pages7
JournalAnnals of surgical oncology
Issue number4
StatePublished - Apr 2011
Externally publishedYes

ASJC Scopus subject areas

  • Surgery
  • Oncology


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