Background. Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (HCC). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated. Methods. Patients who experienced disease progression while on sorafenib 400 mg twice daily were randomized to sorafenib 600mgtwice daily (n49) or best supportive care (n52). The primary end point was progression-free survival (PFS). Time to progression, overall survival,andsafetywerealso evaluated. Results. The study did not meet its primary end point. The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). Adverse events were mainly grade 1-2 and similar across both groups. In the sorafenib arm, the most frequent events were diarrhea (80%), weight loss (75%), fatigue (67%), hand-foot-skin reaction (49%), abdominal pain (37%), and stomatitis (26%). Conclusions. Escalated-dose sorafenib in patients with advanced HCC who progressed while on sorafenib, failed to provide any clinical benefit. Second-line treatment still remains an open issue to be explored in appropriate clinical trials

Rimassa, L., Pressiani, T., Boni, C., Carnaghi, C., Rota Caremoli, E., Fagiuoli, S., et al. (2013). A Phase II Randomized Dose Escalation Trial of Sorafenib in Patients With Advanced Hepatocellular Carcinoma. THE ONCOLOGIST, 18(4), 379-380 [10.1634/theoncologist.2012-0221].

A Phase II Randomized Dose Escalation Trial of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Fagiuoli S;
2013

Abstract

Background. Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (HCC). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated. Methods. Patients who experienced disease progression while on sorafenib 400 mg twice daily were randomized to sorafenib 600mgtwice daily (n49) or best supportive care (n52). The primary end point was progression-free survival (PFS). Time to progression, overall survival,andsafetywerealso evaluated. Results. The study did not meet its primary end point. The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). Adverse events were mainly grade 1-2 and similar across both groups. In the sorafenib arm, the most frequent events were diarrhea (80%), weight loss (75%), fatigue (67%), hand-foot-skin reaction (49%), abdominal pain (37%), and stomatitis (26%). Conclusions. Escalated-dose sorafenib in patients with advanced HCC who progressed while on sorafenib, failed to provide any clinical benefit. Second-line treatment still remains an open issue to be explored in appropriate clinical trials
Articolo in rivista - Articolo scientifico
Carcinoma, Hepatocellular; Disease-Free Survival; Dose-Response Relationship, Drug; Drug-Related Side Effects and Adverse Reactions; Humans; Liver Neoplasms; Neoplasm Staging; Niacinamide; Phenylurea Compounds;
English
379
380
2
Rimassa, L., Pressiani, T., Boni, C., Carnaghi, C., Rota Caremoli, E., Fagiuoli, S., et al. (2013). A Phase II Randomized Dose Escalation Trial of Sorafenib in Patients With Advanced Hepatocellular Carcinoma. THE ONCOLOGIST, 18(4), 379-380 [10.1634/theoncologist.2012-0221].
Rimassa, L; Pressiani, T; Boni, C; Carnaghi, C; Rota Caremoli, E; Fagiuoli, S; Foa, P; Salvagni, S; Cortesi, E; Chiara Tronconi, M; Personeni, N; Bozzarelli, S; Chiara Banzi, M; Fanello, S; Romano Lutman, F; Giordano, L; Santoro, A
File in questo prodotto:
File Dimensione Formato  
Rimassa oncologist_2013.pdf

Solo gestori archivio

Dimensione 101.15 kB
Formato Adobe PDF
101.15 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/353705
Citazioni
  • Scopus 27
  • ???jsp.display-item.citation.isi??? 29
Social impact