Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice

Final analysis of gideon

Jean François Geschwind, Masatoshi Kudo, Jorge A. Marrero, Alan P. Venook, Xiao Ping Chen, Jean Pierre Bronowicki, Lucy Dagher, Junji Furuse, Laura Ladrón De Guevara, Christos Papandreou, Arun J. Sanyal, Tadatoshi Takayama, Sheng Long Ye, Seung Kew Yoon, Keiko Nakajima, Robert Lehr, Stephanie Heldner, Riccardo Lencioni

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate transarterial chemoembolization (TACE) use prior to and concomitantly with sorafenib in patients with unresectable hepatocellular carcinoma (HCC) across different global regions. Materials and Methods: GIDEON is an observational registry study of more than 3000 HCC patients. Patients with histologically, cytologically, or radiographically diagnosed HCC, and for whom a decision had been made to treat with sorafenib, were eligible. Patients were enrolled into the registry from 39 countries beginning in January 2009, with the last patient follow-up in April 2012. Detailed data on treatment history, treatment patterns, adverse events, and outcomes were collected. All treatment decisions were at the discretion of the treating physicians. Documented approval from local ethics committees was obtained, and all patients provided signed informed consent. Descriptive statistics, including minimum, median, and maximum, were calculated for metric data, and frequency tables for categorical data. Kaplan-Meier estimates with 95% confidence intervals were calculated for survival end points. Results: A total of 3202 patients were eligible for safety analysis, of whom 2631 (82.2%) were male. Median age was 62 years (range, 15-98 years). A total of 1511 (47.2%) patients underwent TACE prior to sorafenib; 325 (10.1%) underwent TACE concomitantly. TACE prior to sorafenib was more common in Japan and Asia-Pacific compared with all other regions (362 [71.3%] and 560 [60.3%] vs 12-209 [13.3%-37.1%]). Adverse events were reported in 2732 (85.3%) patients overall, with no notable differences in the incidence of adverse events, regardless of TACE treatment history. Overall survival was 12.7 months in prior-TACE patients, 9.2 months in non-prior-TACE patients, 21.6 months in concomitant-TACE patients, and 9.7 months in non-concomitant-TACE patients. Conclusion: Global variation exists in TACE use in sorafenib-treated HCC patients. The combination of TACE with sorafenib appears to be a well-tolerated and viable therapeutic approach.

Original languageEnglish (US)
Pages (from-to)630-640
Number of pages11
JournalRadiology
Volume279
Issue number2
DOIs
StatePublished - May 1 2016

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Hepatocellular Carcinoma
Therapeutics
sorafenib
Registries
History
Ethics Committees
Survival
Kaplan-Meier Estimate
Informed Consent
Observational Studies
Japan
Confidence Intervals
Physicians
Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Geschwind, J. F., Kudo, M., Marrero, J. A., Venook, A. P., Chen, X. P., Bronowicki, J. P., ... Lencioni, R. (2016). Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice: Final analysis of gideon. Radiology, 279(2), 630-640. https://doi.org/10.1148/radiol.2015150667

Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice : Final analysis of gideon. / Geschwind, Jean François; Kudo, Masatoshi; Marrero, Jorge A.; Venook, Alan P.; Chen, Xiao Ping; Bronowicki, Jean Pierre; Dagher, Lucy; Furuse, Junji; De Guevara, Laura Ladrón; Papandreou, Christos; Sanyal, Arun J.; Takayama, Tadatoshi; Ye, Sheng Long; Yoon, Seung Kew; Nakajima, Keiko; Lehr, Robert; Heldner, Stephanie; Lencioni, Riccardo.

In: Radiology, Vol. 279, No. 2, 01.05.2016, p. 630-640.

Research output: Contribution to journalArticle

Geschwind, JF, Kudo, M, Marrero, JA, Venook, AP, Chen, XP, Bronowicki, JP, Dagher, L, Furuse, J, De Guevara, LL, Papandreou, C, Sanyal, AJ, Takayama, T, Ye, SL, Yoon, SK, Nakajima, K, Lehr, R, Heldner, S & Lencioni, R 2016, 'Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice: Final analysis of gideon', Radiology, vol. 279, no. 2, pp. 630-640. https://doi.org/10.1148/radiol.2015150667
Geschwind, Jean François ; Kudo, Masatoshi ; Marrero, Jorge A. ; Venook, Alan P. ; Chen, Xiao Ping ; Bronowicki, Jean Pierre ; Dagher, Lucy ; Furuse, Junji ; De Guevara, Laura Ladrón ; Papandreou, Christos ; Sanyal, Arun J. ; Takayama, Tadatoshi ; Ye, Sheng Long ; Yoon, Seung Kew ; Nakajima, Keiko ; Lehr, Robert ; Heldner, Stephanie ; Lencioni, Riccardo. / Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice : Final analysis of gideon. In: Radiology. 2016 ; Vol. 279, No. 2. pp. 630-640.
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abstract = "Purpose: To evaluate transarterial chemoembolization (TACE) use prior to and concomitantly with sorafenib in patients with unresectable hepatocellular carcinoma (HCC) across different global regions. Materials and Methods: GIDEON is an observational registry study of more than 3000 HCC patients. Patients with histologically, cytologically, or radiographically diagnosed HCC, and for whom a decision had been made to treat with sorafenib, were eligible. Patients were enrolled into the registry from 39 countries beginning in January 2009, with the last patient follow-up in April 2012. Detailed data on treatment history, treatment patterns, adverse events, and outcomes were collected. All treatment decisions were at the discretion of the treating physicians. Documented approval from local ethics committees was obtained, and all patients provided signed informed consent. Descriptive statistics, including minimum, median, and maximum, were calculated for metric data, and frequency tables for categorical data. Kaplan-Meier estimates with 95{\%} confidence intervals were calculated for survival end points. Results: A total of 3202 patients were eligible for safety analysis, of whom 2631 (82.2{\%}) were male. Median age was 62 years (range, 15-98 years). A total of 1511 (47.2{\%}) patients underwent TACE prior to sorafenib; 325 (10.1{\%}) underwent TACE concomitantly. TACE prior to sorafenib was more common in Japan and Asia-Pacific compared with all other regions (362 [71.3{\%}] and 560 [60.3{\%}] vs 12-209 [13.3{\%}-37.1{\%}]). Adverse events were reported in 2732 (85.3{\%}) patients overall, with no notable differences in the incidence of adverse events, regardless of TACE treatment history. Overall survival was 12.7 months in prior-TACE patients, 9.2 months in non-prior-TACE patients, 21.6 months in concomitant-TACE patients, and 9.7 months in non-concomitant-TACE patients. Conclusion: Global variation exists in TACE use in sorafenib-treated HCC patients. The combination of TACE with sorafenib appears to be a well-tolerated and viable therapeutic approach.",
author = "Geschwind, {Jean Fran{\cc}ois} and Masatoshi Kudo and Marrero, {Jorge A.} and Venook, {Alan P.} and Chen, {Xiao Ping} and Bronowicki, {Jean Pierre} and Lucy Dagher and Junji Furuse and {De Guevara}, {Laura Ladr{\'o}n} and Christos Papandreou and Sanyal, {Arun J.} and Tadatoshi Takayama and Ye, {Sheng Long} and Yoon, {Seung Kew} and Keiko Nakajima and Robert Lehr and Stephanie Heldner and Riccardo Lencioni",
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T1 - Tace treatment in patients with sorafenib-treated unresectable hepatocellular carcinoma in clinical practice

T2 - Final analysis of gideon

AU - Geschwind, Jean François

AU - Kudo, Masatoshi

AU - Marrero, Jorge A.

AU - Venook, Alan P.

AU - Chen, Xiao Ping

AU - Bronowicki, Jean Pierre

AU - Dagher, Lucy

AU - Furuse, Junji

AU - De Guevara, Laura Ladrón

AU - Papandreou, Christos

AU - Sanyal, Arun J.

AU - Takayama, Tadatoshi

AU - Ye, Sheng Long

AU - Yoon, Seung Kew

AU - Nakajima, Keiko

AU - Lehr, Robert

AU - Heldner, Stephanie

AU - Lencioni, Riccardo

PY - 2016/5/1

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N2 - Purpose: To evaluate transarterial chemoembolization (TACE) use prior to and concomitantly with sorafenib in patients with unresectable hepatocellular carcinoma (HCC) across different global regions. Materials and Methods: GIDEON is an observational registry study of more than 3000 HCC patients. Patients with histologically, cytologically, or radiographically diagnosed HCC, and for whom a decision had been made to treat with sorafenib, were eligible. Patients were enrolled into the registry from 39 countries beginning in January 2009, with the last patient follow-up in April 2012. Detailed data on treatment history, treatment patterns, adverse events, and outcomes were collected. All treatment decisions were at the discretion of the treating physicians. Documented approval from local ethics committees was obtained, and all patients provided signed informed consent. Descriptive statistics, including minimum, median, and maximum, were calculated for metric data, and frequency tables for categorical data. Kaplan-Meier estimates with 95% confidence intervals were calculated for survival end points. Results: A total of 3202 patients were eligible for safety analysis, of whom 2631 (82.2%) were male. Median age was 62 years (range, 15-98 years). A total of 1511 (47.2%) patients underwent TACE prior to sorafenib; 325 (10.1%) underwent TACE concomitantly. TACE prior to sorafenib was more common in Japan and Asia-Pacific compared with all other regions (362 [71.3%] and 560 [60.3%] vs 12-209 [13.3%-37.1%]). Adverse events were reported in 2732 (85.3%) patients overall, with no notable differences in the incidence of adverse events, regardless of TACE treatment history. Overall survival was 12.7 months in prior-TACE patients, 9.2 months in non-prior-TACE patients, 21.6 months in concomitant-TACE patients, and 9.7 months in non-concomitant-TACE patients. Conclusion: Global variation exists in TACE use in sorafenib-treated HCC patients. The combination of TACE with sorafenib appears to be a well-tolerated and viable therapeutic approach.

AB - Purpose: To evaluate transarterial chemoembolization (TACE) use prior to and concomitantly with sorafenib in patients with unresectable hepatocellular carcinoma (HCC) across different global regions. Materials and Methods: GIDEON is an observational registry study of more than 3000 HCC patients. Patients with histologically, cytologically, or radiographically diagnosed HCC, and for whom a decision had been made to treat with sorafenib, were eligible. Patients were enrolled into the registry from 39 countries beginning in January 2009, with the last patient follow-up in April 2012. Detailed data on treatment history, treatment patterns, adverse events, and outcomes were collected. All treatment decisions were at the discretion of the treating physicians. Documented approval from local ethics committees was obtained, and all patients provided signed informed consent. Descriptive statistics, including minimum, median, and maximum, were calculated for metric data, and frequency tables for categorical data. Kaplan-Meier estimates with 95% confidence intervals were calculated for survival end points. Results: A total of 3202 patients were eligible for safety analysis, of whom 2631 (82.2%) were male. Median age was 62 years (range, 15-98 years). A total of 1511 (47.2%) patients underwent TACE prior to sorafenib; 325 (10.1%) underwent TACE concomitantly. TACE prior to sorafenib was more common in Japan and Asia-Pacific compared with all other regions (362 [71.3%] and 560 [60.3%] vs 12-209 [13.3%-37.1%]). Adverse events were reported in 2732 (85.3%) patients overall, with no notable differences in the incidence of adverse events, regardless of TACE treatment history. Overall survival was 12.7 months in prior-TACE patients, 9.2 months in non-prior-TACE patients, 21.6 months in concomitant-TACE patients, and 9.7 months in non-concomitant-TACE patients. Conclusion: Global variation exists in TACE use in sorafenib-treated HCC patients. The combination of TACE with sorafenib appears to be a well-tolerated and viable therapeutic approach.

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