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01.03.2012 | Original Article

Phase II trial of sorafenib in combination with 5-fluorouracil infusion in advanced hepatocellular carcinoma

verfasst von: Iacopo Petrini, Monica Lencioni, Miriam Ricasoli, Mauro Iannopollo, Cinzia Orlandini, Filippo Oliveri, Carlo Bartolozzi, Sergio Ricci

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 3/2012

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Abstract

Purpose

Sorafenib improves overall survival and time to progression of advanced hepatocellular (aHCC) patients such as demonstrated in 2 phase III trials. However, aHCC patients’ outcome is still poor despite these results. In order to improve the efficacy of systemic treatment for aHCC, we evaluated the combination of sorafenib plus 5-fluorouacil infusion in a phase II trial.

Methods

Patients with aHCC not eligible for loco-regional therapies, Child-Pugh A-B, ECOG-PS 0-1, and without history of anti-cancer systemic treatment were enrolled. Treatment schedule was: sorafenib 400 mg/bid continuously and continuum infusion of 5-fluorouracil 200 mg/sqm/daily day 1–14 every 3 weeks.

Results

Thirty-nine patients were enrolled: ECOG-PS 0-1: 29-10, Child-Pugh A-B: 36-3. Grade 3/4 (%) toxicities included: diarrhea 5.1/0, mucositis 20.5/2.6, hand foot skin reaction 20.5/0, skin rash 10.5/0, hypertension 10.3/0, hyperbilirubinemia 5.1/2.6, glutamic-oxaloacetic transaminase increase 10.3/0, glutamic-pyruvic transaminase increase 7.7/0, cardiac toxicity (one heart failure, two atrial fibrillation cases) 7.7/0, and bleeding (melena) in 2.6/0. One partial response was observed. Stable disease was obtained in 46.2% of patients with a median duration of 16.2 months. Median time to progression was 8 months (CI 95% = 5.7–10.4), and median overall survival was 13.7 months (CI 95% = 9.5–17.9).

Conclusions

The results show an encouraging disease control rate, time to progression, and overall survival. The combination of sorafenib and 5-fluorouracil was feasible, and the side effects were manageable for patients carefully selected for liver function and performance status.

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Titel: Phase II trial of sorafenib in combination with 5-fluorouracil infusion in advanced hepatocellular carcinoma
verfasst von: Iacopo Petrini
Monica Lencioni
Miriam Ricasoli
Mauro Iannopollo
Cinzia Orlandini
Filippo Oliveri
Carlo Bartolozzi
Sergio Ricci
Publikationsdatum: 01.03.2012
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 3/2012
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-011-1753-2

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Phase II trial of sorafenib in combination with 5-fluorouracil infusion in advanced hepatocellular carcinoma

Abstract

Purpose

Methods

Results

Conclusions

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Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

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Methods

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