Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone

Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using mic...

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Vydané v:	Journal of clinical oncology Ročník 34; číslo 17; s. 2046 - 2053
Hlavní autori:	Brown, Karen T, Do, Richard K, Gonen, Mithat, Covey, Anne M, Getrajdman, George I, Sofocleous, Constantinos T, Jarnagin, William R, D'Angelica, Michael I, Allen, Peter J, Erinjeri, Joseph P, Brody, Lynn A, O'Neill, Gerald P, Johnson, Kristian N, Garcia, Alessandra R, Beattie, Christopher, Zhao, Binsheng, Solomon, Stephen B, Schwartz, Lawrence H, DeMatteo, Ronald, Abou-Alfa, Ghassan K
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 10.06.2016
Predmet:	Aged Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - adverse effects Carcinoma, Hepatocellular - blood supply Carcinoma, Hepatocellular - pathology Carcinoma, Hepatocellular - therapy Chemoembolization, Therapeutic - adverse effects Chemoembolization, Therapeutic - methods Doxorubicin - administration & dosage Doxorubicin - adverse effects Female Humans Liver Neoplasms - blood supply Liver Neoplasms - pathology Liver Neoplasms - therapy Male Microspheres Single-Blind Method
ISSN:	1527-7755
On-line prístup:	Zistit podrobnosti o prístupe
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Abstract	Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.
AbstractList	Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC. PURPOSETransarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres.MATERIALS AND METHODSAt a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual.RESULTSBetween December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively.CONCLUSIONThere was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.
Author	Allen, Peter J Solomon, Stephen B Zhao, Binsheng Jarnagin, William R Do, Richard K Getrajdman, George I Gonen, Mithat Abou-Alfa, Ghassan K Sofocleous, Constantinos T D'Angelica, Michael I Brody, Lynn A Brown, Karen T Erinjeri, Joseph P Schwartz, Lawrence H O'Neill, Gerald P DeMatteo, Ronald Covey, Anne M Johnson, Kristian N Garcia, Alessandra R Beattie, Christopher
Author_xml	– sequence: 1 givenname: Karen T surname: Brown fullname: Brown, Karen T email: brown6@mskcc.org organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. 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Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 7 givenname: William R surname: Jarnagin fullname: Jarnagin, William R organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 8 givenname: Michael I surname: D'Angelica fullname: D'Angelica, Michael I organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. 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Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 10 givenname: Joseph P surname: Erinjeri fullname: Erinjeri, Joseph P organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 11 givenname: Lynn A surname: Brody fullname: Brody, Lynn A organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 12 givenname: Gerald P surname: O'Neill fullname: O'Neill, Gerald P organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 13 givenname: Kristian N surname: Johnson fullname: Johnson, Kristian N organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 14 givenname: Alessandra R surname: Garcia fullname: Garcia, Alessandra R organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 15 givenname: Christopher surname: Beattie fullname: Beattie, Christopher organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 16 givenname: Binsheng surname: Zhao fullname: Zhao, Binsheng organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 17 givenname: Stephen B surname: Solomon fullname: Solomon, Stephen B organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 18 givenname: Lawrence H surname: Schwartz fullname: Schwartz, Lawrence H organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 19 givenname: Ronald surname: DeMatteo fullname: DeMatteo, Ronald organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY – sequence: 20 givenname: Ghassan K surname: Abou-Alfa fullname: Abou-Alfa, Ghassan K organization: Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY
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Snippet	Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization... PURPOSETransarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of...
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SubjectTerms	Aged Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - adverse effects Carcinoma, Hepatocellular - blood supply Carcinoma, Hepatocellular - pathology Carcinoma, Hepatocellular - therapy Chemoembolization, Therapeutic - adverse effects Chemoembolization, Therapeutic - methods Doxorubicin - administration & dosage Doxorubicin - adverse effects Female Humans Liver Neoplasms - blood supply Liver Neoplasms - pathology Liver Neoplasms - therapy Male Microspheres Single-Blind Method
Title	Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone
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