Annals of Oncology Advance Access originally published online on July 1, 2009
Annals of Oncology 2009 20(12):1943-1947; doi:10.1093/annonc/mdp242
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supportive and palliative care |
Phase I/II clinical study of percutaneous vertebroplasty (PVP) as palliation for painful malignant vertebral compression fractures (PMVCF): JIVROSG-0202
1 Department of Diagnostic and Interventional Radiology, Ishikawa Prefectual Central Hospital, Ishikawa
2 Department of Diagnostic Radiology Division, National Cancer Center Hospital, Tokyo
3 Department of Radiology, St. Marianna University, Yokohama
4 Department of Radiology, Dokkyo Medical University, Tochigi
5 Department of Radiology, Iwate Medical University, Iwate
6 Department of Radiology, Kansai Medical University, Isaka
7 Department of Radiology, Kanazawa University, Ishikawa
8 Department of Radiology, Shinshu University, Matsumoto
9 Department of Diagnostic and Interventional Radiology, Aichi Cancer Center, Aichi, Japan
* Correspondence to: Dr T. Kobayashi, Department of Diagnostic and Interventional Radiology, Ishikawa Prefectual Central Hospital, Kuratsukihigashi 2-1, Kanazawa-shi, Ishikawa Prefecture, 920-8530, Japan. Tel: +81-76-237-8211; Fax: +81-76-238-2337; E-mail: kobaken{at}ipch.jp
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; 
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.
Key words: percutaneous vertebroplasty, interventional radiology, pain relief, vertebral metastasis, percutaneous cement plasty
Received for publication May 8, 2008. Revision received November 18, 2008. Revision received March 18, 2009. Accepted for publication March 26, 2009.