Phase 2 Study of Combined Sorafenib and Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.

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Title: Phase 2 Study of Combined Sorafenib and Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
Authors: Chen, Shang-Wen1,2,3 sjfchiou@gmail.com, Lin, Li-Ching2,4, Kuo, Yu-Cheng1,5, Liang, Ji-An1,3, Kuo, Chia-Chun6, Chiou, Jeng-Fong2,6
Source: International Journal of Radiation Oncology, Biology, Physics. Apr2014, Vol. 88 Issue 5, p1041-1047. 7p.
Subjects: Niacin, Cancer radiotherapy, Liver cancer patients, Liver cancer, Diagnostic imaging, Hand-foot syndrome, Therapeutics
Abstract: Purpose: This phase 2 study evaluated the efficacy of radiation therapy (RT) with concurrent and sequential sorafenib therapy in patients with unresectable hepatocellular carcinoma (HCC). Methods and Materials: Forty patients with unresectable HCC unfit for transarterial chemoembolization were treated with RT with concurrent and sequential sorafenib. Sorafenib was administered from the commencement of RT at a dose of 400 mg twice daily and continued to clinical or radiologic progression, unacceptable adverse events, or death. All patients had underlying Child-Pugh A cirrhosis. The maximal tumor diameter ranged from 3.0 cm to 15.5 cm. Coexisting portal vein thrombosis was found in 24 patients and was irradiated simultaneously. The cumulative RT dose ranged from 40 Gy to 60 Gy (median, 50 Gy). Image studies were done 1 month after RT and then every 3 months thereafter. Results: Thirty-three (83%) completed the allocated RT. During RT, the incidence of hand-foot skin reactions ≥ grade 2 and diarrhea were 37.5% and 25%, respectively, and 35% of patients had hepatic toxicities grade ≥2. Twenty-two (55.0%) patients achieved complete or partial remission at the initial assessment, and 18 (45%) had stable or progressive disease. The 2-year overall survival and infield progression-free survival (IFPS) were 32% and 39%, respectively. A Cancer of the Liver Italian Program (CLIP) score ≥2 was associated with an inferior outcome in overall survival. Six patients (15%) developed treatment-related hepatic toxicity grade ≥3 during the sequential phase, and 3 of them were fatal. Conclusions: When RT and sorafenib therapy were combined in patients with unresectable HCC, the initial complete or partial response rate was 55% with a 2-year IFPS of 39%. A CLIP score ≥2 was associated with an inferior outcome in overall survival. Hepatic toxicities are a major determinant of the safety; the combination should be used with caution and needs further investigation. [Copyright &y& Elsevier]
Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Phase 2 Study of Combined Sorafenib and Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
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  Data: <searchLink fieldCode="AR" term="%22Chen%2C+Shang-Wen%22">Chen, Shang-Wen</searchLink><relatesTo>1,2,3</relatesTo><i> sjfchiou@gmail.com</i><br /><searchLink fieldCode="AR" term="%22Lin%2C+Li-Ching%22">Lin, Li-Ching</searchLink><relatesTo>2,4</relatesTo><br /><searchLink fieldCode="AR" term="%22Kuo%2C+Yu-Cheng%22">Kuo, Yu-Cheng</searchLink><relatesTo>1,5</relatesTo><br /><searchLink fieldCode="AR" term="%22Liang%2C+Ji-An%22">Liang, Ji-An</searchLink><relatesTo>1,3</relatesTo><br /><searchLink fieldCode="AR" term="%22Kuo%2C+Chia-Chun%22">Kuo, Chia-Chun</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Chiou%2C+Jeng-Fong%22">Chiou, Jeng-Fong</searchLink><relatesTo>2,6</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22International+Journal+of+Radiation+Oncology%2C+Biology%2C+Physics%22">International Journal of Radiation Oncology, Biology, Physics</searchLink>. Apr2014, Vol. 88 Issue 5, p1041-1047. 7p.
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  Data: <searchLink fieldCode="DE" term="%22Niacin%22">Niacin</searchLink><br /><searchLink fieldCode="DE" term="%22Cancer+radiotherapy%22">Cancer radiotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22Liver+cancer+patients%22">Liver cancer patients</searchLink><br /><searchLink fieldCode="DE" term="%22Liver+cancer%22">Liver cancer</searchLink><br /><searchLink fieldCode="DE" term="%22Diagnostic+imaging%22">Diagnostic imaging</searchLink><br /><searchLink fieldCode="DE" term="%22Hand-foot+syndrome%22">Hand-foot syndrome</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Purpose: This phase 2 study evaluated the efficacy of radiation therapy (RT) with concurrent and sequential sorafenib therapy in patients with unresectable hepatocellular carcinoma (HCC). Methods and Materials: Forty patients with unresectable HCC unfit for transarterial chemoembolization were treated with RT with concurrent and sequential sorafenib. Sorafenib was administered from the commencement of RT at a dose of 400 mg twice daily and continued to clinical or radiologic progression, unacceptable adverse events, or death. All patients had underlying Child-Pugh A cirrhosis. The maximal tumor diameter ranged from 3.0 cm to 15.5 cm. Coexisting portal vein thrombosis was found in 24 patients and was irradiated simultaneously. The cumulative RT dose ranged from 40 Gy to 60 Gy (median, 50 Gy). Image studies were done 1 month after RT and then every 3 months thereafter. Results: Thirty-three (83%) completed the allocated RT. During RT, the incidence of hand-foot skin reactions ≥ grade 2 and diarrhea were 37.5% and 25%, respectively, and 35% of patients had hepatic toxicities grade ≥2. Twenty-two (55.0%) patients achieved complete or partial remission at the initial assessment, and 18 (45%) had stable or progressive disease. The 2-year overall survival and infield progression-free survival (IFPS) were 32% and 39%, respectively. A Cancer of the Liver Italian Program (CLIP) score ≥2 was associated with an inferior outcome in overall survival. Six patients (15%) developed treatment-related hepatic toxicity grade ≥3 during the sequential phase, and 3 of them were fatal. Conclusions: When RT and sorafenib therapy were combined in patients with unresectable HCC, the initial complete or partial response rate was 55% with a 2-year IFPS of 39%. A CLIP score ≥2 was associated with an inferior outcome in overall survival. Hepatic toxicities are a major determinant of the safety; the combination should be used with caution and needs further investigation. [Copyright &y& Elsevier]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/j.ijrobp.2014.01.017
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      – Code: eng
        Text: English
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        PageCount: 7
        StartPage: 1041
    Subjects:
      – SubjectFull: Niacin
        Type: general
      – SubjectFull: Cancer radiotherapy
        Type: general
      – SubjectFull: Liver cancer patients
        Type: general
      – SubjectFull: Liver cancer
        Type: general
      – SubjectFull: Diagnostic imaging
        Type: general
      – SubjectFull: Hand-foot syndrome
        Type: general
      – SubjectFull: Therapeutics
        Type: general
    Titles:
      – TitleFull: Phase 2 Study of Combined Sorafenib and Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
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            NameFull: Chen, Shang-Wen
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              M: 04
              Text: Apr2014
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              Y: 2014
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