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Ann Oncol. 2009 Dec;20(12):1943-7. doi: 10.1093/annonc/mdp242. Epub 2009 Jul 1.

Phase I/II clinical study of percutaneous vertebroplasty (PVP) as palliation for painful malignant vertebral compression fractures (PMVCF): JIVROSG-0202.

Author information

1
Department of Diagnostic and Interventional Radiology, Ishikawa Prefectual Central Hospital, Kanazawa-shi, Ishikawa, Japan. kobaken@ipch.jp

Abstract

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.

MATERIALS AND 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.

CONCLUSION:

For PMVCF, PVP is a safe and effective treatment modality with immediate onset of action.

PMID:
19570963
DOI:
10.1093/annonc/mdp242
[Indexed for MEDLINE]

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