GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib): Second interim analysis

Riccardo Lencioni, M. Kudo, S. L. Ye, J. P. Bronowicki, X. P. Chen, L. Dagher, J. Furuse, J. F. Geschwind, L. Ladrón De Guevara, C. Papandreou, T. Takayama, S. K. Yoon, K. Nakajima, R. Lehr, S. Heldner, A. J. Sanyal

Research output: Contribution to journalArticle

131 Citations (Scopus)

Abstract

Background GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials. Methods Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months. Results Of the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population. Conclusions Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.

Original languageEnglish (US)
Pages (from-to)609-617
Number of pages9
JournalInternational Journal of Clinical Practice
Volume68
Issue number5
DOIs
StatePublished - 2014
Externally publishedYes

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Hepatocellular Carcinoma
Liver Neoplasms
Drug-Related Side Effects and Adverse Reactions
Safety
Therapeutics
Patient Safety
sorafenib
Demography
Clinical Trials
Guidelines
Physicians
Incidence
Population

ASJC Scopus subject areas

  • Medicine(all)

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GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) : Second interim analysis. / Lencioni, Riccardo; Kudo, M.; Ye, S. L.; Bronowicki, J. P.; Chen, X. P.; Dagher, L.; Furuse, J.; Geschwind, J. F.; De Guevara, L. Ladrón; Papandreou, C.; Takayama, T.; Yoon, S. K.; Nakajima, K.; Lehr, R.; Heldner, S.; Sanyal, A. J.

In: International Journal of Clinical Practice, Vol. 68, No. 5, 2014, p. 609-617.

Research output: Contribution to journalArticle

Lencioni, R, Kudo, M, Ye, SL, Bronowicki, JP, Chen, XP, Dagher, L, Furuse, J, Geschwind, JF, De Guevara, LL, Papandreou, C, Takayama, T, Yoon, SK, Nakajima, K, Lehr, R, Heldner, S & Sanyal, AJ 2014, 'GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib): Second interim analysis', International Journal of Clinical Practice, vol. 68, no. 5, pp. 609-617. https://doi.org/10.1111/ijcp.12352
Lencioni, Riccardo ; Kudo, M. ; Ye, S. L. ; Bronowicki, J. P. ; Chen, X. P. ; Dagher, L. ; Furuse, J. ; Geschwind, J. F. ; De Guevara, L. Ladrón ; Papandreou, C. ; Takayama, T. ; Yoon, S. K. ; Nakajima, K. ; Lehr, R. ; Heldner, S. ; Sanyal, A. J. / GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) : Second interim analysis. In: International Journal of Clinical Practice. 2014 ; Vol. 68, No. 5. pp. 609-617.
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title = "GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib): Second interim analysis",
abstract = "Background GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials. Methods Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months. Results Of the 1571 patients evaluable for safety, 61{\%} had Child-Pugh A status and 23{\%} Child-Pugh B. The majority of patients (74{\%}) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population. Conclusions Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.",
author = "Riccardo Lencioni and M. Kudo and Ye, {S. L.} and Bronowicki, {J. P.} and Chen, {X. P.} and L. Dagher and J. Furuse and Geschwind, {J. F.} and {De Guevara}, {L. Ladr{\'o}n} and C. Papandreou and T. Takayama and Yoon, {S. K.} and K. Nakajima and R. Lehr and S. Heldner and Sanyal, {A. J.}",
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T1 - GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib)

T2 - Second interim analysis

AU - Lencioni, Riccardo

AU - Kudo, M.

AU - Ye, S. L.

AU - Bronowicki, J. P.

AU - Chen, X. P.

AU - Dagher, L.

AU - Furuse, J.

AU - Geschwind, J. F.

AU - De Guevara, L. Ladrón

AU - Papandreou, C.

AU - Takayama, T.

AU - Yoon, S. K.

AU - Nakajima, K.

AU - Lehr, R.

AU - Heldner, S.

AU - Sanyal, A. J.

PY - 2014

Y1 - 2014

N2 - Background GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials. Methods Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months. Results Of the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population. Conclusions Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.

AB - Background GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials. Methods Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months. Results Of the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population. Conclusions Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.

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