PMID- 31628959
OWN - NLM
STAT- MEDLINE
DCOM- 20200214
LR  - 20200214
IS  - 1879-355X (Electronic)
IS  - 0360-3016 (Linking)
VI  - 106
IP  - 2
DP  - 2020 Feb 1
TI  - A Phase 2 Study of Post-Operative Stereotactic Body Radiation Therapy (SBRT) for 
      Solid Tumor Spine Metastases.
PG  - 261-268
LID - S0360-3016(19)33892-1 [pii]
LID - 10.1016/j.ijrobp.2019.10.011 [doi]
AB  - PURPOSE: In patients with spinal instability, cord compression, or neurologic 
      deficits, the standard of care is surgery followed by radiation therapy (RT). 
      Recurrence rates after conventional RT remain high. The purpose of this study is 
      to prospectively examine the efficacy of postoperative stereotactic body RT 
      (SBRT) in patients who have undergone surgical intervention for spine metastases. 
      We hypothesize that postoperative SBRT to the spine would be associated with 
      higher local control than historical rates after conventional RT. METHODS AND 
      MATERIALS: Thirty-five adult patients with a Karnofsky Performance Status score 
      >/=40 and spine metastases from solid tumors with no prior overlapping RT and 
      target volumes </=3 consecutive vertebral levels were enrolled. Thirty-three 
      patients were treated. Two patients underwent treatment to 2 target volumes for a 
      total of 35 target volumes. All patients received SBRT 30 Gy in 5 fractions. 
      Patients were followed with neurological examinations and computed tomography 
      and/or magnetic resonance imaging every 3 months. Neurologic function was 
      assessed at the same time points using the American Spinal Injury Association 
      (ASIA) impairment score. Pain was rated according to the 10-point visual analogue 
      scale and MD Anderson Cancer Center brief pain index. Toxicity was recorded 
      according to National Cancer Institute Common Toxicity Criteria for Adverse 
      Events Version 4. The primary objective was the rate of radiographic local 
      recurrence at 12 months after completion of SBRT. RESULTS: Patient 
      characteristics were as follows: 34.3% had radioresistant primaries; 71.4% were 
      ASIA E and the remainder ASIA D; and the median baseline Karnofsky Performance 
      Status score was 70 (range, 50-100). Radiographic and symptomatic local control 
      at 1 year were 90% (95% confidence interval, 76%-98%). The median time to 
      recurrence in these 3 patients was 3.5 months (range, 3.4-5.8 months), all had 
      radiosensitive tumors, and all recurrences were epidural. No patients experienced 
      wound dehiscence, hardware failure, or spinal cord myelopathy. The median time to 
      return to systemic therapy was 0.5 months (range, 0-9.4 months). CONCLUSIONS: 
      This prospective study of postoperative spine SBRT demonstrates excellent local 
      control with low toxicity. These data suggest superior rates of local control 
      compared with conventional RT; however, a formal comparative study is warranted.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Redmond, Kristin J
AU  - Redmond KJ
AD  - Department of Radiation Oncology and Molecular Radiation Sciences, The John 
      Hopkins University, Baltimore, Maryland. Electronic address: kjanson3@jhmi.edu.
FAU - Sciubba, Daniel
AU  - Sciubba D
AD  - Neurological Surgery, The John Hopkins University, Baltimore, Maryland.
FAU - Khan, Majid
AU  - Khan M
AD  - Radiology, The John Hopkins University, Baltimore, Maryland.
FAU - Gui, Chengcheng
AU  - Gui C
AD  - Department of Radiation Oncology and Molecular Radiation Sciences, The John 
      Hopkins University, Baltimore, Maryland.
FAU - Lo, Sheng-Fu Larry
AU  - Lo SL
AD  - Neurological Surgery, The John Hopkins University, Baltimore, Maryland.
FAU - Gokaslan, Ziya L
AU  - Gokaslan ZL
AD  - Department of Neurological Surgery, The Warren Alpert Medical School of Brown 
      University, Providence, Rhode Island.
FAU - Leaf, Brianne
AU  - Leaf B
AD  - Department of Radiation Oncology and Molecular Radiation Sciences, The John 
      Hopkins University, Baltimore, Maryland.
FAU - Kleinberg, Lawrence
AU  - Kleinberg L
AD  - Department of Radiation Oncology and Molecular Radiation Sciences, The John 
      Hopkins University, Baltimore, Maryland.
FAU - Grimm, Jimm
AU  - Grimm J
AD  - Department of Radiation Oncology and Molecular Radiation Sciences, The John 
      Hopkins University, Baltimore, Maryland.
FAU - Ye, Xiaobu
AU  - Ye X
AD  - Neurological Surgery, The John Hopkins University, Baltimore, Maryland.
FAU - Lim, Michael
AU  - Lim M
AD  - Neurological Surgery, The John Hopkins University, Baltimore, Maryland.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191016
PL  - United States
TA  - Int J Radiat Oncol Biol Phys
JT  - International journal of radiation oncology, biology, physics
JID - 7603616
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cancer Pain/diagnosis
MH  - Disease Progression
MH  - Dose Fractionation, Radiation
MH  - Female
MH  - Humans
MH  - Karnofsky Performance Status
MH  - Male
MH  - Middle Aged
MH  - *Neoplasm Recurrence, Local/diagnostic imaging
MH  - Neurologic Examination/statistics & numerical data
MH  - Pain Measurement/methods
MH  - Postoperative Period
MH  - Prospective Studies
MH  - Radiation Tolerance
MH  - Radiosurgery/adverse effects/*methods
MH  - Spinal Neoplasms/diagnostic imaging/*radiotherapy/*secondary/surgery
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2019/10/20 06:00
MHDA- 2020/02/15 06:00
CRDT- 2019/10/20 06:00
PHST- 2019/05/14 00:00 [received]
PHST- 2019/09/20 00:00 [revised]
PHST- 2019/10/01 00:00 [accepted]
PHST- 2019/10/20 06:00 [pubmed]
PHST- 2020/02/15 06:00 [medline]
PHST- 2019/10/20 06:00 [entrez]
AID - S0360-3016(19)33892-1 [pii]
AID - 10.1016/j.ijrobp.2019.10.011 [doi]
PST - ppublish
SO  - Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):261-268. doi: 
      10.1016/j.ijrobp.2019.10.011. Epub 2019 Oct 16.