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Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

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Abstract

Purpose

This multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.

Methods

Thirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.

Results

The RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).

Conclusion

The current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

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Acknowledgments

This work was supported by the Health and Labour Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare.

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Authors and Affiliations

  1. Department of Radiology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, 216-8511, Japan

    Hidefumi Mimura

  2. Department of Radiology, Okayama University Medical School, 2-5-1 Shikata, Kita-ku, Okayama, 700-8558, Japan

    Hidefumi Mimura, Hideo Gobara & Susumu Kanazawa

  3. Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Yasuaki Arai, Miyuki Sone & Yoshito Takeuchi

  4. Department of Interventional Radiology, Mie University School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan

    Koichiro Yamakado

  5. Department of Radiology, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan

    Miyuki Sone

  6. Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajiichi, Hirokoji agaru, Kawaramachi–douri, Kamijo-ku, Kyoto, 602-8566, Japan

    Tsuneharu Miki

  7. Department of Diagnostic and Interventional Radiology, Hokkaido University School of Medicine, 7 Nishi, 15-jo Kita, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan

    Yusuke Sakuhara

  8. Department of Radiology, Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, Tochigi, 320-0834, Japan

    Takanobu Yamamoto

  9. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1 Kanokogoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan

    Yozo Sato

Authors
  1. Hidefumi Mimura
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  2. Yasuaki Arai
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  3. Koichiro Yamakado
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  4. Miyuki Sone
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  5. Yoshito Takeuchi
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  6. Tsuneharu Miki
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  7. Hideo Gobara
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  8. Yusuke Sakuhara
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  9. Takanobu Yamamoto
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  10. Yozo Sato
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  11. Susumu Kanazawa
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Corresponding author

Correspondence to Hidefumi Mimura.

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Conflict of interest

HM, KY, TM, HG, and TY reported grants from the Japanese Ministry of Health, Labour and Welfare as mentioned above during the conduct of the study. All remaining authors have declared no conflicts of interest.

Statement of Informed Consent

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

Statement of Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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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 39, 717–723 (2016). https://doi.org/10.1007/s00270-015-1275-0

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  • DOI: https://doi.org/10.1007/s00270-015-1275-0

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