title: Combination treatment of trans-arterial chemo-embolisation, radiotherapy and hyperthermia (CERT) for hepatocellular carcinoma with portal vein tumour thrombosis: Interim analysis of prospective phase II trial.
abstract: Objectives This study evaluated the objective response to and toxicity of trans-arterial chemo-embolisation (TACE) followed by radiotherapy and hyperthermia (CERT) in hepatocellular carcinoma patients with portal vein tumour thrombosis. Methods The study design was a single-centre prospective phase II trial. Patients were first treated with TACE, with the first hyperthermia session 1 week later. Respiration-gated radiotherapy (RT) was delivered in 10 fractions of 3-5 Gy after another week. Six sessions of hyperthermia were delivered twice a week according to an energy escalation protocol. Response evaluation was planned at 1 month after RT completion using the modified Response Evaluation Criteria in Solid Tumors (RECIST). Toxicity was determined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Results Interim analysis was conducted on patients enrolled from October 2013 to November 2014. During this period, 46 patients (90.2%) who received at least one hyperthermia session were eligible and enrolled. Median follow-up was 6.7 months (range 2.0-15.0 months). Complete response was observed in 10 (21.7%) patients and partial response in 27 (47.8%). Most toxicities were grade I or II. One death was related to severe pneumonia of unknown cause in the left lung and one patient could not complete planned treatment because of continuous elevation of bilirubin after TACE. Late, asymptomatic gastroduodenal toxicities were noticed in 13 (28.3%) patients. Conclusion Preliminary evaluation of CERT showed a promising response rate with acceptable toxicities.
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Jeong Il
authors.initials: JI
authors.lastname: Yu
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;|b Department of Medical Device Management and Research , SAIHST, Sungkyunkwan University , Seoul ;
authors.forename: Hee Chul
authors.initials: HC
authors.lastname: Park
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Dongryul
authors.initials: D
authors.lastname: Oh
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Jae Myoung
authors.initials: JM
authors.lastname: Noh
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Jung
authors.affiliation: a Department of Radiation Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Hye Yeong
authors.initials: HY
authors.lastname: Kim
authors.affiliation: c Department of Radiology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Sung Wook
authors.initials: SW
authors.lastname: Shin
authors.affiliation: c Department of Radiology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Sung Ki
authors.initials: SK
authors.lastname: Cho
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Dong Hyun
authors.initials: DH
authors.lastname: Sinn
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Yong-Han
authors.initials: YH
authors.lastname: Paik
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Geum-Youn
authors.initials: GY
authors.lastname: Gwak
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Moon Seok
authors.initials: MS
authors.lastname: Choi
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Joon Hyeok
authors.initials: JH
authors.lastname: Lee
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Kwang Cheol
authors.initials: KC
authors.lastname: Koh
authors.affiliation: d Department of Medicine , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul ;
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Paik
authors.affiliation: e Department of Medicine , Konkuk University Medical Centre, Konkuk University , Seoul , Korea.
authors.forename: Byung Chul
authors.initials: BC
authors.lastname: Yoo
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D006528:Carcinoma, Hepatocellular / Q000532:radiotherapy / Q000628:therapy; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000532:radiotherapy / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011169:Portal Vein; D020246:Venous Thrombosis / Q000532:radiotherapy / Q000628:therapy
chemical_list: D000970:Antineoplastic Agents
keywords: Complication; hepatocellular carcinoma; hyperthermia; radiotherapy; response