PMID- 16982549
OWN - NLM
STAT- MEDLINE
DCOM- 20070216
LR  - 20210417
IS  - 0284-186X (Print)
IS  - 0284-186X (Linking)
VI  - 45
IP  - 7
DP  - 2006
TI  - Interim analysis of a prospective phase I/II trial of SBRT for liver metastases.
PG  - 848-55
AB  - Stereotactic Body Radiation Therapy (SBRT) is a potent means of systemic 
      cytoreductive therapy for selected patients with metastatic cancer. We here 
      report an interim analysis of a prospective Phase I/II study of SBRT for liver 
      metastases. Eligible patients with liver metastases met these criteria: (1) 
      maximum tumor diameter < 6 cm; (2) < or =3 discrete lesions; (3) treatment 
      planning confirmed > or = 700 cm3 of normal liver receives < or =15 Gy. The gross 
      tumor volume (GTV) was expanded 5-10 mm to yield the planning target volume, 
      which received 60 Gy in 3 fractions of SBRT over 3-14 days in the Phase II 
      component of the trial. As of July, 2006, 36 patients have been enrolled: 18 in 
      Phase I, 18 in Phase II. The median age was 58 years (range 27-91); the M:F ratio 
      was 20:16. The most common primary sites were lung (n = 10), colorectal (n = 9), 
      and breast (n = 4). Among 21 pts with > or = 6 months post-SBRT follow-up (median 
      19 months, range 6-29), one instance of SBRT-related grade 3 toxicity occurred in 
      subcutaneous tissue superficial to the liver. No grade IV toxicity occurred. For 
      28 discrete lesions treated (median GTV 14 cm3, range 1-98) the 18 month 
      actuarial local control estimate is 93%. This interim analysis indicates that a 
      very high rate of durable in-field tumor control can be safely achieved with SBRT 
      to 1-3 liver lesions as administered in this protocol, to a prescription dose of 
      60 Gy in 3 fractions.
FAU - Kavanagh, Brian D
AU  - Kavanagh BD
AD  - Department of Radiation Oncology, University of Colorado, Aurora, Colorado 80045, 
      USA. Brian.Kavanagh@uchsc.edu
FAU - Schefter, Tracey E
AU  - Schefter TE
FAU - Cardenes, Higinia R
AU  - Cardenes HR
FAU - Stieber, Volker W
AU  - Stieber VW
FAU - Raben, David
AU  - Raben D
FAU - Timmerman, Robert D
AU  - Timmerman RD
FAU - McCarter, Martin D
AU  - McCarter MD
FAU - Burri, Stuart
AU  - Burri S
FAU - Nedzi, Lucien A
AU  - Nedzi LA
FAU - Sawyer, Timothy E
AU  - Sawyer TE
FAU - Gaspar, Laurie E
AU  - Gaspar LE
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - Sweden
TA  - Acta Oncol
JT  - Acta oncologica (Stockholm, Sweden)
JID - 8709065
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Carcinoma/diagnostic imaging/*secondary/*surgery/therapy
MH  - Combined Modality Therapy/adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Liver Neoplasms/diagnostic imaging/*secondary/*surgery/therapy
MH  - Male
MH  - Middle Aged
MH  - Positron-Emission Tomography
MH  - Radiography
MH  - Radiosurgery/adverse effects/*methods
MH  - Radiotherapy/adverse effects
MH  - Radiotherapy Dosage
MH  - Salvage Therapy
MH  - Whole Body Imaging
EDAT- 2006/09/20 09:00
MHDA- 2007/02/17 09:00
CRDT- 2006/09/20 09:00
PHST- 2006/09/20 09:00 [pubmed]
PHST- 2007/02/17 09:00 [medline]
PHST- 2006/09/20 09:00 [entrez]
AID - V383JQ33614Q00H7 [pii]
AID - 10.1080/02841860600904870 [doi]
PST - ppublish
SO  - Acta Oncol. 2006;45(7):848-55. doi: 10.1080/02841860600904870.