Sorafenib and locoregional deep electro-hyperthermia in advanced hepatocellular carcinoma: A phase II study

Gennaro Gadaleta-Caldarola, Stefania Infusino, Ida Galise, Girolamo Ranieri, Gianluca Vinciarelli, Vito Fazio, Rosa Divella, Antonella Daniele, Gianfranco Filippelli, Cosmo Damiano Gadaleta

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

The standard treatment for advanced hepatocellular carcinoma (HCC) is sorafenib, a multikinase inhibitor of tumor cell proliferation and angiogenesis. Hyperthermia inhibits angiogenesis and promotes apoptosis. Potential synergic antiangiogenic and proapoptotic effects represent the rationale for combining sorafenib with electro-hyperthermia (EHY) in HCC. A total of 21 patients (median age, 64 years; range, 55-73 years) with advanced HCC were enrolled in the current study between February 2009 and September 2010. EHY was achieved by arranging capacitive electrodes with a deep hypothermia radiofrequency field of 13.56 Mhz at 80 W for 60 min, three times per week for six weeks, followed by two weeks without treatment, in combination with sorafenib at a dose of 800 mg every other day. According to the modified Response Evaluation Criteria in Solid Tumors criteria, 50% achieved stable disease, 5% achieved partial response and 45% achieved progressive disease. No complete response was observed. The progression-free survival (PFS) rate at six months was 38%, while the median PFS and overall survival times were 5.2 [95% confidence interval (CI), 4.2-6.2) and 10.4 (95% CI, 10-11) months, respectively. The overall incidence of treatment-related adverse events was 80%, predominantly of grade 1 or 2. Grade 3 toxicity included fatigue, diarrhea, hand-foot skin reaction and hypertension. In the present study, the sorafenib plus EHY combination was feasible and well tolerated, and no major complications were observed. The initial findings indicated that this combination offers a promising option for advanced HCC.

Original languageEnglish
Pages (from-to)1783-1787
Number of pages5
JournalOncology Letters
Volume8
Issue number4
DOIs
Publication statusPublished - 2014

Fingerprint

Hepatocellular Carcinoma
Fever
Disease-Free Survival
Confidence Intervals
Hypothermia
Fatigue
Foot
Diarrhea
Electrodes
Therapeutics
Survival Rate
Hand
Cell Proliferation
Apoptosis
Hypertension
Skin
Survival
sorafenib
Incidence
Neoplasms

Keywords

  • Carcinoma
  • Electro-hyperthermia
  • Hepatocellular
  • Sorafenib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Sorafenib and locoregional deep electro-hyperthermia in advanced hepatocellular carcinoma : A phase II study. / Gadaleta-Caldarola, Gennaro; Infusino, Stefania; Galise, Ida; Ranieri, Girolamo; Vinciarelli, Gianluca; Fazio, Vito; Divella, Rosa; Daniele, Antonella; Filippelli, Gianfranco; Gadaleta, Cosmo Damiano.

In: Oncology Letters, Vol. 8, No. 4, 2014, p. 1783-1787.

Research output: Contribution to journalArticle

Gadaleta-Caldarola, G, Infusino, S, Galise, I, Ranieri, G, Vinciarelli, G, Fazio, V, Divella, R, Daniele, A, Filippelli, G & Gadaleta, CD 2014, 'Sorafenib and locoregional deep electro-hyperthermia in advanced hepatocellular carcinoma: A phase II study', Oncology Letters, vol. 8, no. 4, pp. 1783-1787. https://doi.org/10.3892/ol.2014.2376
Gadaleta-Caldarola, Gennaro ; Infusino, Stefania ; Galise, Ida ; Ranieri, Girolamo ; Vinciarelli, Gianluca ; Fazio, Vito ; Divella, Rosa ; Daniele, Antonella ; Filippelli, Gianfranco ; Gadaleta, Cosmo Damiano. / Sorafenib and locoregional deep electro-hyperthermia in advanced hepatocellular carcinoma : A phase II study. In: Oncology Letters. 2014 ; Vol. 8, No. 4. pp. 1783-1787.
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