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TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial

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TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial. / Erhardt, Andreas; Kolligs, Frank; Dollinger, Matthias; Schott, Eckart; Wege, Henning; Bitzer, Michael; Gog, Christiane; Lammert, Frank; Schuchmann, Markus; Walter, Clemens; Blondin, Dirk; Ohmann, Christian; Häussinger, Dieter.

in: CANCER CHEMOTH PHARM, Jahrgang 74, Nr. 5, 01.11.2014, S. 947-954.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Erhardt, A, Kolligs, F, Dollinger, M, Schott, E, Wege, H, Bitzer, M, Gog, C, Lammert, F, Schuchmann, M, Walter, C, Blondin, D, Ohmann, C & Häussinger, D 2014, 'TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial', CANCER CHEMOTH PHARM, Jg. 74, Nr. 5, S. 947-954. https://doi.org/10.1007/s00280-014-2568-8

APA

Erhardt, A., Kolligs, F., Dollinger, M., Schott, E., Wege, H., Bitzer, M., Gog, C., Lammert, F., Schuchmann, M., Walter, C., Blondin, D., Ohmann, C., & Häussinger, D. (2014). TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial. CANCER CHEMOTH PHARM, 74(5), 947-954. https://doi.org/10.1007/s00280-014-2568-8

Vancouver

Erhardt A, Kolligs F, Dollinger M, Schott E, Wege H, Bitzer M et al. TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial. CANCER CHEMOTH PHARM. 2014 Nov 1;74(5):947-954. https://doi.org/10.1007/s00280-014-2568-8

Bibtex

@article{4d608fbab4824e3e90585c3fd701c969,
title = "TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial",
abstract = "PURPOSE: The present multicenter phase II trial investigated the combination of TACE and sorafenib for the treatment of HCC.PATIENTS AND METHODS: Eligibility criteria included histologically confirmed, unresectable HCC beyond Milan criteria, no extrahepatic spread, Child-Pugh score ≤ 8 and ECOG PS 0-2. Patients had received no prior therapy for HCC. Sorafenib was given at a dose of 400 mg/bid (interrupted only around TACE). TACE with lipiodol, 50 mg doxorubicin and polyvinyl alcohol (PVA) particles was repeated q6w as long as there was no overall disease progression. Tumor assessment by MRI was performed q6w according to EASL criteria. The primary endpoint was time to progression (TTP).RESULTS: Patients (n = 43) received a mean of 2.6 ± 2.2 TACE interventions (range 0-10). Median TTP was 16.4 months (95 % CI 10.7-∞). Median overall survival (OS) was 20.1 months (95 % CI 17.6-28.2). Disease control rate according to EASL criteria was 74.4 % (7 % complete responses [CRs] + 41.8 % partial responses [PRs] + 25.6 % stable diseases [SDs]). Four patients (9 %) became amenable to either radiofrequency ablation or liver transplantation; 5 (12 %) patients died during the trial. Overall, there were 360 AEs, including 56 grade 3/4 AEs and 39 SAEs.CONCLUSIONS: Combination treatment of TACE and sorafenib in the present trial was tolerable and associated with an interesting response rate, TTP and OS. Combination therapies will probably close gaps in the present mono therapy driven treatment guidelines for locally advanced HCC.",
keywords = "Aged, Antineoplastic Combined Chemotherapy Protocols, Ascites, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Combined Modality Therapy, Doxorubicin, Ethiodized Oil, Fatigue, Hepatic Encephalopathy, Humans, Kaplan-Meier Estimate, Liver Neoplasms, Male, Middle Aged, Niacinamide, Phenylurea Compounds, Treatment Outcome",
author = "Andreas Erhardt and Frank Kolligs and Matthias Dollinger and Eckart Schott and Henning Wege and Michael Bitzer and Christiane Gog and Frank Lammert and Markus Schuchmann and Clemens Walter and Dirk Blondin and Christian Ohmann and Dieter H{\"a}ussinger",
year = "2014",
month = nov,
day = "1",
doi = "10.1007/s00280-014-2568-8",
language = "English",
volume = "74",
pages = "947--954",
journal = "CANCER CHEMOTH PHARM",
issn = "0344-5704",
publisher = "Springer",
number = "5",

}

RIS

TY - JOUR

T1 - TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial

AU - Erhardt, Andreas

AU - Kolligs, Frank

AU - Dollinger, Matthias

AU - Schott, Eckart

AU - Wege, Henning

AU - Bitzer, Michael

AU - Gog, Christiane

AU - Lammert, Frank

AU - Schuchmann, Markus

AU - Walter, Clemens

AU - Blondin, Dirk

AU - Ohmann, Christian

AU - Häussinger, Dieter

PY - 2014/11/1

Y1 - 2014/11/1

N2 - PURPOSE: The present multicenter phase II trial investigated the combination of TACE and sorafenib for the treatment of HCC.PATIENTS AND METHODS: Eligibility criteria included histologically confirmed, unresectable HCC beyond Milan criteria, no extrahepatic spread, Child-Pugh score ≤ 8 and ECOG PS 0-2. Patients had received no prior therapy for HCC. Sorafenib was given at a dose of 400 mg/bid (interrupted only around TACE). TACE with lipiodol, 50 mg doxorubicin and polyvinyl alcohol (PVA) particles was repeated q6w as long as there was no overall disease progression. Tumor assessment by MRI was performed q6w according to EASL criteria. The primary endpoint was time to progression (TTP).RESULTS: Patients (n = 43) received a mean of 2.6 ± 2.2 TACE interventions (range 0-10). Median TTP was 16.4 months (95 % CI 10.7-∞). Median overall survival (OS) was 20.1 months (95 % CI 17.6-28.2). Disease control rate according to EASL criteria was 74.4 % (7 % complete responses [CRs] + 41.8 % partial responses [PRs] + 25.6 % stable diseases [SDs]). Four patients (9 %) became amenable to either radiofrequency ablation or liver transplantation; 5 (12 %) patients died during the trial. Overall, there were 360 AEs, including 56 grade 3/4 AEs and 39 SAEs.CONCLUSIONS: Combination treatment of TACE and sorafenib in the present trial was tolerable and associated with an interesting response rate, TTP and OS. Combination therapies will probably close gaps in the present mono therapy driven treatment guidelines for locally advanced HCC.

AB - PURPOSE: The present multicenter phase II trial investigated the combination of TACE and sorafenib for the treatment of HCC.PATIENTS AND METHODS: Eligibility criteria included histologically confirmed, unresectable HCC beyond Milan criteria, no extrahepatic spread, Child-Pugh score ≤ 8 and ECOG PS 0-2. Patients had received no prior therapy for HCC. Sorafenib was given at a dose of 400 mg/bid (interrupted only around TACE). TACE with lipiodol, 50 mg doxorubicin and polyvinyl alcohol (PVA) particles was repeated q6w as long as there was no overall disease progression. Tumor assessment by MRI was performed q6w according to EASL criteria. The primary endpoint was time to progression (TTP).RESULTS: Patients (n = 43) received a mean of 2.6 ± 2.2 TACE interventions (range 0-10). Median TTP was 16.4 months (95 % CI 10.7-∞). Median overall survival (OS) was 20.1 months (95 % CI 17.6-28.2). Disease control rate according to EASL criteria was 74.4 % (7 % complete responses [CRs] + 41.8 % partial responses [PRs] + 25.6 % stable diseases [SDs]). Four patients (9 %) became amenable to either radiofrequency ablation or liver transplantation; 5 (12 %) patients died during the trial. Overall, there were 360 AEs, including 56 grade 3/4 AEs and 39 SAEs.CONCLUSIONS: Combination treatment of TACE and sorafenib in the present trial was tolerable and associated with an interesting response rate, TTP and OS. Combination therapies will probably close gaps in the present mono therapy driven treatment guidelines for locally advanced HCC.

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Ascites

KW - Carcinoma, Hepatocellular

KW - Chemoembolization, Therapeutic

KW - Combined Modality Therapy

KW - Doxorubicin

KW - Ethiodized Oil

KW - Fatigue

KW - Hepatic Encephalopathy

KW - Humans

KW - Kaplan-Meier Estimate

KW - Liver Neoplasms

KW - Male

KW - Middle Aged

KW - Niacinamide

KW - Phenylurea Compounds

KW - Treatment Outcome

U2 - 10.1007/s00280-014-2568-8

DO - 10.1007/s00280-014-2568-8

M3 - SCORING: Journal article

C2 - 25173458

VL - 74

SP - 947

EP - 954

JO - CANCER CHEMOTH PHARM

JF - CANCER CHEMOTH PHARM

SN - 0344-5704

IS - 5

ER -