Combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia (CERT) for hepatocellular carcinoma with portal vein tumor thrombosis: Final results of a prospective phase II trial
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Jeong Il Yu1, Hee Chul Park1,6, Sang Hoon Jung1, Changhoon Choi1, Sung Wook Shin2, Sung Ki Cho2, Dong Hyun Sinn3, Yong-Han Paik3, Geum-Youn Gwak3, Moon Seok Choi3, Joon Hyeok Lee3, Kwang Cheol Koh3, Byung Chul Yoo4, Hüseyin Sahinbas5 and Seung Woon Paik3
1Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
4Department of Medicine, Konkuk University Medical Center, Konkuk University, Seoul, Korea
5Institute for Hyperthermia Research, Partner of the Marien Hospital Herne, Hospital of the Ruhr-University Bochum, Bochum, Germany
6Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea
Hee Chul Park, email: email@example.com
Keywords: hepatocellular carcinoma, radiotherapy, hyperthermia, response, complication
Received: December 14, 2016 Accepted: March 13, 2017 Published: April 13, 2017
Background & Aims: This study was designed to evaluate the efficacy and safety of combination transarterial chemoembolization (TACE) followed by radiotherapy (RT) and hyperthermia (CERT) in hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).
Methods: This single-institution, single-arm, prospective phase II study was performed from October 2013 to February 2016. The objective response rate (ORR) was evaluated at 3 months after CERT completion, and overall ORR was the primary end point.
Results: During the study period, 69 of 77 patients who consented to participate underwent at least one session of hyperthermia and RT. More than half of the patients (39, 56.5%) complained of severe hyperthermia-related pain. The overall ORR was 43.5% (30/69), and the ORR of the RT target area was 69.6% (48/69). Liver function status was not significantly affected by CERT. Overall survival, local progression-free survival, and progression-free survival of all enrolled patients at 2 years was 62.9%, 47.6%, and 14.3%, respectively.
Conclusions: An overall ORR of 43.5% was observed after CERT, but a promising ORR of 69.6% was achieved in the RT target area. Toxicities related to CERT were manageable, and pain intolerance to hyperthermia was the main obstacle to treatment maintenance.
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