Phase I/II clinical study of percutaneous vertebroplasty (PVP) as palliation for painful malignant vertebral compression fractures (PMVCF): JIVROSG-0202.
BACKGROUND
The safety and efficacy of percutaneous vertebroplasty (PVP), a new treatment modality for painful malignant vertebral compression fractures (PMVCF) using interventional radiology techniques, were evaluated prospectively.


METHODS
After confirming the absence of safety issues in phase 1, a total of 33 cases were registered up to and including phase 2. Safety and efficacy were evaluated by National Cancer Institute-Common Toxicity Criteria version 2 and Visual Analogue Scale (VAS) at 1 week after PVP. Based on VAS score decreases, efficacy was classified into significantly effective (SE; > or = 5 or reached 0-2), moderately effective (ME; 2-4), or ineffective (NE; <2 or increase).


RESULTS
Procedures were completed in all 33 patients (42 vertebrae). Thirty days after PVP, two patients died of primary disease progression, but no major adverse reactions (>grade 2) were observed. Response rate was 70% (95% confidence interval 54% to 83%) [61% (n = 20) with SE, 9% (n = 3) with ME, and 30% (n = 10) with NE] and increased to 83% at week 4. Median time to response was 1 day (mean 2.4). Median pain-mitigated survival period was 73 days.


CONCLUSIONS
For PMVCF, PVP is a safe and effective treatment modality with immediate onset of action.
Kobayashi
T
T
Department of Diagnostic and Interventional Radiology, Ishikawa Prefectual Central Hospital, Kanazawa-shi, Ishikawa, Japan. kobaken@ipch.jp
Arai
Y
Y
Takeuchi
Y
Y
Nakajima
Y
Y
Shioyama
Y
Y
Sone
M
M
Tanigawa
N
N
Matsui
O
O
Kadoya
M
M
Inaba
Y
Y
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000150:complications*; D005260:Female; D050815:Fractures, Compression / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D016103:Spinal Fractures / Q000150:complications / Q000628:therapy*; D054854:Vertebroplasty / Q000009:adverse effects