Literature DB >> 19570963

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

T Kobayashi1, Y Arai, Y Takeuchi, Y Nakajima, Y Shioyama, M Sone, N Tanigawa, O Matsui, M Kadoya, Y Inaba.   

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.

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Year:  2009        PMID: 19570963     DOI: 10.1093/annonc/mdp242

Source DB:  PubMed          Journal:  Ann Oncol        ISSN: 0923-7534            Impact factor:   32.976


  6 in total

Review 1.  Clinical trials of interventional oncology.

Authors:  Yasuaki Arai
Journal:  Int J Clin Oncol       Date:  2012-07-27       Impact factor: 3.402

Review 2.  Combined Vertebral Augmentation and Radiofrequency Ablation in the Management of Spinal Metastases: an Update.

Authors:  Ning Mao Kam; Julian Maingard; Hong Kuan Kok; Dinesh Ranatunga; Duncan Brooks; William C Torreggiani; Peter L Munk; Michael J Lee; Ronil V Chandra; Hamed Asadi
Journal:  Curr Treat Options Oncol       Date:  2017-11-16

3.  Transarterial chemoembolization for pain relief in patients with hypervascular painful metastatic spinal tumors refractory to percutaneous vertebroplasty.

Authors:  Yi Chen; Zhiping Yan; Jianhua Wang; Xiaolin Wang; Jiemin Cheng; Gaoquan Gong; Jianjun Luo
Journal:  J Cancer Res Clin Oncol       Date:  2013-05-16       Impact factor: 4.553

4.  Clinical effectiveness of percutaneous vertebroplasty in conjunction with postoperative radiotherapy in the treatment of spinal metastases.

Authors:  Miaoman Lin; Mingjia Qu; Wei Huang; Tao Liu; Ruimeng Duan; Yashuai Yuan; Junxiao Gao; Meng Zhang; Xiaobing Yu
Journal:  J Cancer Res Clin Oncol       Date:  2020-09-02       Impact factor: 4.553

Review 5.  Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review.

Authors: 
Journal:  Ont Health Technol Assess Ser       Date:  2016-05-01

6.  Phase I clinical trial of percutaneous cryoablation for osteoid osteoma.

Authors:  Masaya Miyazaki; Kenichi Saito; Takashi Yanagawa; Hirotaka Chikuda; Yoshito Tsushima
Journal:  Jpn J Radiol       Date:  2018-08-14       Impact factor: 2.374

  6 in total

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