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Phase I/II Study of Radiofrequency Ablation for Painful Bone Metastases: Japan Interventional Radiology in Oncology Study Group 0208

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Abstract

Purpose

A prospective multicenter phase I/II trial was performed to evaluate the clinical safety and efficacy of radiofrequency ablation (RFA) for metastatic bone tumors.

Materials and Methods

Thirty-three patients (27 men, 6 women, mean age 61 years) with metastatic bone tumors were enrolled. In phase I, nine patients were enrolled, and the safety of RFA was evaluated. In phase II, 23 patients were included, and an intent-to-treat analysis was performed. The primary endpoint was to evaluate the treatment’s safety. The secondary endpoint was to evaluate the efficacy of pain relief at 1 week after RFA.

Results

RFA was performed in 32 of 33 enrolled patients. No serious complications were observed during the phase I, so phase II was performed. Four patients exhibited adverse events, including one case each of Grade 3 pain and, Grade 2 hypotension, and one patient developed Grade 1 burns at the grounding pad and puncture site. One patient died of liver failure on day 7 after RFA due to the progression of the primary lesion. The efficacy was excellent (no increase in analgesic dosage, post-RFA VAS score of 0–2 or decreased by not less than 5 compared to before RFA) in 20 patients (60.6%), good (no increase in analgesic dosage, post-RFA VAS score decreased by not less than 2 but by < 5 compared to before RFA) in 3 (9.1%), and poor in 10 patients (30.3%). Thus, the response rate was 69.7%.

Conclusion

RFA is a safe and effective method for treating painful metastatic bone tumors.

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References

  1. McGahan JP, Browning PD, Brock JM, et al. Hepatic ablation using radiofrequency electrocautery. Invest Radiol. 1990;25:267–70.

    Article  PubMed  CAS  Google Scholar 

  2. Rossi S, Di Stasi M, Buscarini E, et al. Percutaneous RF interstitial thermal ablation in the treatment of hepatic cancer. AJR. 1996;167:759–68.

    Article  PubMed  CAS  Google Scholar 

  3. Rossi S, Buscarini E, Garbagnati F, et al. Percutaneous treatment of small hepatic tumors by an expandable RF needle electrode. AJR. 1998;170:1015–22.

    Article  PubMed  CAS  Google Scholar 

  4. Livraghi T, Goldberg SN, Lazzaroni S, et al. Small hepatocellular carcinoma: treatment with radio-frequency ablation versus ethanol injection. Radiology. 1999;210:655–61.

    Article  PubMed  CAS  Google Scholar 

  5. Curley SA, Izzo F, Ellis LM, et al. Radiofrequency ablation of hepatocellular cancer in 110 patients with cirrhosis. Ann Surg. 2000;232:381–91.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  6. Tong D, Gillick L, Hendrickson FR. The palliation of symptomatic osseous metastases: final results of the study the radiation therapy oncology group. Cancer. 1982;50:893–9.

    Article  PubMed  CAS  Google Scholar 

  7. Ratanatharathon V, Powers WE, Moss WT, Peres CA. Bone metastasis: review and critical analysis of random allocation trials of local field treatment. Int J Radiat Oncol Phys. 1999;44:1–18.

    Article  Google Scholar 

  8. Di Staso M, Zugaro L, Gravina GL, et al. A feasibility study of percutaneous radiofrequency ablation followed by radiotherapy in the management of painful osteolytic bone metastases. Eur Radiol. 2011;21:2004–10.

    Article  PubMed  Google Scholar 

  9. Dupuy DE, Zagoria RJ, Akerley W, et al. Percutaneous radiofrequency ablation of malignancies in the lung. AJR. 2000;174:57–9.

    Article  PubMed  CAS  Google Scholar 

  10. Putnam JB Jr. New and evolving treatment methods for pulmonary metastases. Semin Thorac Cardiovasc Surg. 2002;14:49–56.

    Article  PubMed  Google Scholar 

  11. Barei DP, Moreau G, Scarborough MT, et al. Percutaneous radiofrequency ablation of osteoid osteoma. Clin Orthop Relat Res. 2000;373:115–24.

    Article  Google Scholar 

  12. Izzo F, Thomas R, Delrio P, et al. Radiofrequency ablation in patients with primary breast carcinoma. Cancer. 2001;92:2036–44.

    Article  PubMed  CAS  Google Scholar 

  13. Dupuy DE, Fernando HC, Hillman S, et al. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015;121:3491–8.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  14. Mimura H, Arai Y, Yamakado K, et al. Phase I/II study of radiofrequency ablation for malignant renal tumors: Japan interventional radiology in Oncology Study Group 0701. Cardiovasc Intervent Radiol. 2016;39:717–23.

    Article  PubMed  Google Scholar 

  15. Miyazaki M, Arai Y, Myoui A, et al. Phase I/II multi-institutional study of percutaneous radiofrequency ablation for painful osteoid osteoma (JIVROSG-0704). Cardiovasc Intervent Radiol. 2016;39:1464–70.

    Article  PubMed  Google Scholar 

  16. Goetz MP, Callstrom MR, Chaboneau JW, et al. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004;22(2):300–6.

    Article  PubMed  Google Scholar 

  17. Kobayashi T, Arai Y, Takeuchi Y, et al. Phase I/II clinical study of percutaneous vertebroplasty (PVP) as palliation for painful malignant vertebral compression fractures (PMVCF): JIVROSG-0202. Ann Oncol. 2009;20:1943–7.

    Article  PubMed  CAS  Google Scholar 

  18. Cancer Therapy Evaluation Program. Common toxicity criteria, version 2.0.1998. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf. Accessed 15 April 2009.

  19. Callstrom MR, Dupuy DE, Solomon SB, et al. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013;119:1033–41.

    Article  PubMed  Google Scholar 

  20. Nakatsuka A, Yamakado K, Maeda M, et al. Radiofrequency ablation combined with bone cement injection for the treatment of bone malignancies. J Vasc Interv Radiol. 2004;15:707–12.

    Article  PubMed  Google Scholar 

  21. Toyota N, Naito A, Kakizawa H, et al. Radiofrequency ablation therapy combined with cementoplasty for painful bone metastases: initial experience. Cardiovasc Intervent Radiol. 2005;28:578–83.

    Article  PubMed  Google Scholar 

  22. Kojima H, Tanigawa N, Kariya S, et al. Clinical assessment of percutaneous radiofrequency ablation for painful metastatic bone tumors. Cardiovasc Interv Radiol. 2006;29:1022–6.

    Article  Google Scholar 

  23. Callstrom MR, Charboneau JW, Goetz MP, et al. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002;224:87–97.

    Article  PubMed  Google Scholar 

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Acknowledgements

This research was supported by the Practical Research for Innovative Cancer Control (16ck0106058h0003) from the Japan Agency for Medical Research and Development (AMED), Health and Labor Sciences Research Grant (H26-055) from the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Center Research and Development Fund (26-A-27).

Author information

Author notes

  1. Koichiro Yamakado

    Present address: Department of Radiology, Hyogo College of Medicine, Hyogo, Japan

  2. Akihiro Hamanaka

    Present address: Department of Radiology, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan

Authors and Affiliations

  1. Department of Radiology, Kansai Medical University, Hirakata, Japan

    Noboru Tanigawa

  2. Department of Diagnostic Radiology, National Cancer Center, Tokyo, Japan

    Yasuaki Arai

  3. Department of Radiology, Mie University, Tsu, Japan

    Koichiro Yamakado

  4. Division of Diagnostic Radiology, Shizuoka Cancer Center, Shizuoka, Japan

    Takeshi Aramaki

  5. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center, Nagoya, Japan

    Yoshitaka Inaba

  6. Department of Radiology, Okayama University, Okayama, Japan

    Susumu Kanazawa

  7. Department of Radiology, Kanazawa University, Ishikawa, Japan

    Osamu Matsui

  8. Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, Maebashi, Japan

    Masaya Miyazaki

  9. Department of Diagnostic Radiology, Teine Keijinkai Hospital, Hokkaido, Japan

    Yoshihisa Kodama

  10. Department of Radiology, Nara Medical University, Kashihara, Japan

    Hiroshi Anai

  11. Department of Diagnostic Radiology, Hyogo Cancer Center, Hyogo, Japan

    Akihiro Hamanaka

Authors
  1. Noboru Tanigawa
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  2. Yasuaki Arai
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  5. Yoshitaka Inaba
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  6. Susumu Kanazawa
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  7. Osamu Matsui
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  8. Masaya Miyazaki
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  9. Yoshihisa Kodama
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  10. Hiroshi Anai
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  11. Akihiro Hamanaka
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Corresponding author

Correspondence to Noboru Tanigawa.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

The ethics committee of the Japanese Society of Interventional Radiology and the Institutional Review Board from each participating hospital approved the study protocol prior to patient entry. All of the patients provided written informed consent.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Cite this article

Tanigawa, N., Arai, Y., Yamakado, K. et al. Phase I/II Study of Radiofrequency Ablation for Painful Bone Metastases: Japan Interventional Radiology in Oncology Study Group 0208. Cardiovasc Intervent Radiol 41, 1043–1048 (2018). https://doi.org/10.1007/s00270-018-1944-x

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  • DOI: https://doi.org/10.1007/s00270-018-1944-x

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