Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors

Japan Interventional Radiology in Oncology Study Group 0701

Hidefumi Mimura, Yasuaki Arai, Koichiro Yamakado, Miyuki Sone, Yoshito Takeuchi, Tsuneharu Miki, Hideo Gobara, Yusuke Sakuhara, Takanobu Yamamoto, Yozo Sato, Susumu Kanazawa

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalCardioVascular and Interventional Radiology
DOIs
Publication statusAccepted/In press - Dec 22 2015

Fingerprint

Interventional Radiology
Japan
Kidney
Neoplasms
Confidence Intervals
Safety
Multicenter Studies

Keywords

  • Ablation
  • Cancer
  • Clinical practice
  • Interventional oncology
  • Kidney/renal
  • Nonvascular interventions
  • Radiofrequency ablation
  • Tumor/tumour/neoplasm

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors : Japan Interventional Radiology in Oncology Study Group 0701. / Mimura, Hidefumi; Arai, Yasuaki; Yamakado, Koichiro; Sone, Miyuki; Takeuchi, Yoshito; Miki, Tsuneharu; Gobara, Hideo; Sakuhara, Yusuke; Yamamoto, Takanobu; Sato, Yozo; Kanazawa, Susumu.

In: CardioVascular and Interventional Radiology, 22.12.2015, p. 1-7.

Research output: Contribution to journalArticle

Mimura, Hidefumi ; Arai, Yasuaki ; Yamakado, Koichiro ; Sone, Miyuki ; Takeuchi, Yoshito ; Miki, Tsuneharu ; Gobara, Hideo ; Sakuhara, Yusuke ; Yamamoto, Takanobu ; Sato, Yozo ; Kanazawa, Susumu. / Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors : Japan Interventional Radiology in Oncology Study Group 0701. In: CardioVascular and Interventional Radiology. 2015 ; pp. 1-7.
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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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T2 - Japan Interventional Radiology in Oncology Study Group 0701

AU - Mimura, Hidefumi

AU - Arai, Yasuaki

AU - Yamakado, Koichiro

AU - Sone, Miyuki

AU - Takeuchi, Yoshito

AU - Miki, Tsuneharu

AU - Gobara, Hideo

AU - Sakuhara, Yusuke

AU - Yamamoto, Takanobu

AU - Sato, Yozo

AU - Kanazawa, Susumu

PY - 2015/12/22

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N2 - 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.

AB - 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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KW - Cancer

KW - Clinical practice

KW - Interventional oncology

KW - Kidney/renal

KW - Nonvascular interventions

KW - Radiofrequency ablation

KW - Tumor/tumour/neoplasm

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