Phase I trial of vertebral intracavitary cement and samarium (VICS): novel technique for treatment of painful vertebral metastasis.
OBJECTIVE
Kyphoplasty is an effective procedure to alleviate pain in vertebral metastases. However, it has no proven anticancer activity. Samarium-153-ethylene diamine tetramethylene phosphonate ((153)Sm-EDTMP) is used for palliative treatment of bone metastases. A standard dose of 1 mCi/kg is administrated intravenously. The present study was conducted to determine the feasibility of intravertebral administration of (153)Sm with kyphoplasty.


METHODS
A total of 33 procedures were performed in 26 patients. Of these 26 patients, 7 underwent procedures performed at two vertebral levels. The mean age of the cohort was 64 years (range, 33-86). The kyphoplasty procedure was performed using a known protocol; 1-4 mCi of (153)Sm was admixed with the bone cement and administered under tight radiation safety measures. Serial nuclear body scans were obtained. Pain assessment was evaluated using a visual analog pain score.


RESULTS
All patients tolerated the procedure well. No procedure-related morbidities were noted. No significant change had occurred in the blood counts at 1 month after the procedure. One case was not technically satisfactory. Nuclear scans revealed clear radiotracer uptake in the other 32 vertebrae injected. Except for the first patient, no radiation leakage was encountered. The mean pain score using the visual analog scale improved from 8.6 before to 2.8 after the procedure (p < .0001). Follow-up bone scans demonstrated a 43% decrease in the tracer uptake.


CONCLUSIONS
The results of our study have shown that the combination of intravertebral administration of (153)Sm and kyphoplasty is well tolerated with adequate pain control. No hematologic adverse effects were found. A reduction of the bone scan tracer uptake was observed in the injected vertebrae. Longer follow-up is needed to study the antineoplastic effect of the procedure.
Department of Radiation Oncology, New York Methodist Hospital, Weill Medical College, Cornell University, 506 6th Street, Brooklyn, NY 11215, USA. haa9002@nyp.org
Hani
H
Ashamalla
Erico
E
Cardoso
Mark
M
Macedon
Adel
A
Guirguis
Lijun
L
Weng
Shamsah
S
Ali
Bahaa
B
Mokhtar
Michael
M
Ashamalla
Nokul
N
Panigrahi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D001843:Bone Cements / Q000627:therapeutic use*; D005240:Feasibility Studies; D006801:Humans; D015552:Injections, Intralesional / Q000379:methods; D008279:Magnetic Resonance Imaging / Q000379:methods; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D009943:Organophosphorus Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011877:Radionuclide Imaging; D013125:Spinal Neoplasms / Q000000981:diagnostic imaging / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D054854:Vertebroplasty / Q000009:adverse effects / Q000379:methods*
D018712:Analgesics, Non-Narcotic; D001843:Bone Cements; D009942:Organometallic Compounds; D009943:Organophosphorus Compounds; C061972:samarium Sm-153 lexidronam