Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma

Analisi finale dello studio GIDEON in Italia

Translated title of the contribution: Therapeutic decisions and treatment with sorafenib in hepatocellular carcinoma: Final analysis of GIDEON study in Italy

Salvatore D'Angelo, Domenico Germano, Teresa Zolfino, Domenico Sansonno, Lydia Giannitrapani, Antonio Benedetti, Vincenzo Montesarchio, Adolfo Attili, Angela Buonadonna, Sandro Barni, Antonio Gasbarrini, Michela E. Burlone, Umberto Cillo, Simona Marenco, Erica Villa, Petros Giovanis, Ilaria Proserpio, Carlo Saitta, Giulia Magini, Rita Cengarle & 18 others Giammarco Fava, Filiana Cuttone, Nicola Calvani, Mario Angelico, Francesco Di Costanzo, Alfonso Noto, Guido Poggi, Massimo Marignani, Stefano Cascinu, Domenico Amoroso, Vincenzo Palmieri, Elena Massa, Lory Saveria Crocè, Antonio Picardi, Salvatore Tumulo, Claudia Erminero, Riccardo Lencioni, Vito Lorusso

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Introduction. Sorafenib, an oral multikinase inhibitor, is the only targeted agent approved for the treatment of patients with hepatocellular carcinoma (HCC) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) is the largest, global, non-interventional, prospective study of patients with uHCC (n>3200) treated with sorafenib in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of patients. Methods. Patients with unresectable HCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Patients demographics disease characteristics and treatment history were recorded at baseline visit. Sorafenib dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study. Results. In the Italian cohort of the GIDEON study 278 patients were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were diarrhea (24%), fatigue (23%), dermatological (14%), rash/exfoliation (10%), hypertension (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 patients (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 patients (41%) with a 30% of disease control rate. Discussion. The safety profile of sorafenib in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.

Original languageItalian
Pages (from-to)217-226
Number of pages10
JournalRecenti Progressi in Medicina
Volume106
Issue number5
DOIs
StatePublished - May 1 2015
Externally publishedYes

Fingerprint

Italy
Hepatocellular Carcinoma
Therapeutics
Safety
Survival
sorafenib
Exanthema
Fatigue
Gastrointestinal Tract
Diarrhea
Cohort Studies
Survival Rate
History
Placebos
Demography
Prospective Studies
Hemorrhage
Hypertension
Liver
Pharmaceutical Preparations

Keywords

  • GIDEON study
  • Hepatocellular carcinoma
  • Sorafenib

ASJC Scopus subject areas

  • Medicine(all)

Cite this

D'Angelo, S., Germano, D., Zolfino, T., Sansonno, D., Giannitrapani, L., Benedetti, A., ... Lorusso, V. (2015). Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma: Analisi finale dello studio GIDEON in Italia. Recenti Progressi in Medicina, 106(5), 217-226. https://doi.org/10.1701/1868.20406

Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma : Analisi finale dello studio GIDEON in Italia. / D'Angelo, Salvatore; Germano, Domenico; Zolfino, Teresa; Sansonno, Domenico; Giannitrapani, Lydia; Benedetti, Antonio; Montesarchio, Vincenzo; Attili, Adolfo; Buonadonna, Angela; Barni, Sandro; Gasbarrini, Antonio; Burlone, Michela E.; Cillo, Umberto; Marenco, Simona; Villa, Erica; Giovanis, Petros; Proserpio, Ilaria; Saitta, Carlo; Magini, Giulia; Cengarle, Rita; Fava, Giammarco; Cuttone, Filiana; Calvani, Nicola; Angelico, Mario; Di Costanzo, Francesco; Noto, Alfonso; Poggi, Guido; Marignani, Massimo; Cascinu, Stefano; Amoroso, Domenico; Palmieri, Vincenzo; Massa, Elena; Crocè, Lory Saveria; Picardi, Antonio; Tumulo, Salvatore; Erminero, Claudia; Lencioni, Riccardo; Lorusso, Vito.

In: Recenti Progressi in Medicina, Vol. 106, No. 5, 01.05.2015, p. 217-226.

Research output: Contribution to journalArticle

D'Angelo, S, Germano, D, Zolfino, T, Sansonno, D, Giannitrapani, L, Benedetti, A, Montesarchio, V, Attili, A, Buonadonna, A, Barni, S, Gasbarrini, A, Burlone, ME, Cillo, U, Marenco, S, Villa, E, Giovanis, P, Proserpio, I, Saitta, C, Magini, G, Cengarle, R, Fava, G, Cuttone, F, Calvani, N, Angelico, M, Di Costanzo, F, Noto, A, Poggi, G, Marignani, M, Cascinu, S, Amoroso, D, Palmieri, V, Massa, E, Crocè, LS, Picardi, A, Tumulo, S, Erminero, C, Lencioni, R & Lorusso, V 2015, 'Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma: Analisi finale dello studio GIDEON in Italia', Recenti Progressi in Medicina, vol. 106, no. 5, pp. 217-226. https://doi.org/10.1701/1868.20406
D'Angelo, Salvatore ; Germano, Domenico ; Zolfino, Teresa ; Sansonno, Domenico ; Giannitrapani, Lydia ; Benedetti, Antonio ; Montesarchio, Vincenzo ; Attili, Adolfo ; Buonadonna, Angela ; Barni, Sandro ; Gasbarrini, Antonio ; Burlone, Michela E. ; Cillo, Umberto ; Marenco, Simona ; Villa, Erica ; Giovanis, Petros ; Proserpio, Ilaria ; Saitta, Carlo ; Magini, Giulia ; Cengarle, Rita ; Fava, Giammarco ; Cuttone, Filiana ; Calvani, Nicola ; Angelico, Mario ; Di Costanzo, Francesco ; Noto, Alfonso ; Poggi, Guido ; Marignani, Massimo ; Cascinu, Stefano ; Amoroso, Domenico ; Palmieri, Vincenzo ; Massa, Elena ; Crocè, Lory Saveria ; Picardi, Antonio ; Tumulo, Salvatore ; Erminero, Claudia ; Lencioni, Riccardo ; Lorusso, Vito. / Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma : Analisi finale dello studio GIDEON in Italia. In: Recenti Progressi in Medicina. 2015 ; Vol. 106, No. 5. pp. 217-226.
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T2 - Analisi finale dello studio GIDEON in Italia

AU - D'Angelo, Salvatore

AU - Germano, Domenico

AU - Zolfino, Teresa

AU - Sansonno, Domenico

AU - Giannitrapani, Lydia

AU - Benedetti, Antonio

AU - Montesarchio, Vincenzo

AU - Attili, Adolfo

AU - Buonadonna, Angela

AU - Barni, Sandro

AU - Gasbarrini, Antonio

AU - Burlone, Michela E.

AU - Cillo, Umberto

AU - Marenco, Simona

AU - Villa, Erica

AU - Giovanis, Petros

AU - Proserpio, Ilaria

AU - Saitta, Carlo

AU - Magini, Giulia

AU - Cengarle, Rita

AU - Fava, Giammarco

AU - Cuttone, Filiana

AU - Calvani, Nicola

AU - Angelico, Mario

AU - Di Costanzo, Francesco

AU - Noto, Alfonso

AU - Poggi, Guido

AU - Marignani, Massimo

AU - Cascinu, Stefano

AU - Amoroso, Domenico

AU - Palmieri, Vincenzo

AU - Massa, Elena

AU - Crocè, Lory Saveria

AU - Picardi, Antonio

AU - Tumulo, Salvatore

AU - Erminero, Claudia

AU - Lencioni, Riccardo

AU - Lorusso, Vito

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AB - Introduction. Sorafenib, an oral multikinase inhibitor, is the only targeted agent approved for the treatment of patients with hepatocellular carcinoma (HCC) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) is the largest, global, non-interventional, prospective study of patients with uHCC (n>3200) treated with sorafenib in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of patients. Methods. Patients with unresectable HCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Patients demographics disease characteristics and treatment history were recorded at baseline visit. Sorafenib dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study. Results. In the Italian cohort of the GIDEON study 278 patients were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were diarrhea (24%), fatigue (23%), dermatological (14%), rash/exfoliation (10%), hypertension (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 patients (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 patients (41%) with a 30% of disease control rate. Discussion. The safety profile of sorafenib in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.

KW - GIDEON study

KW - Hepatocellular carcinoma

KW - Sorafenib

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