[Therapeutic decisions and treatment with sorafenib in hepatocellular carcinoma: final analysis of GIDEON study in Italy].
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Ошибки и ограничения
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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
Аннотация
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.