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 language | English |
|---|---|
| Pages (from-to) | 1783-1787 |
| Number of pages | 5 |
| Journal | Oncology Letters |
| Volume | 8 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2014 |
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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 journal › Article
}
TY - JOUR
T1 - Sorafenib and locoregional deep electro-hyperthermia in advanced hepatocellular carcinoma
T2 - A phase II study
AU - Gadaleta-Caldarola, Gennaro
AU - Infusino, Stefania
AU - Galise, Ida
AU - Ranieri, Girolamo
AU - Vinciarelli, Gianluca
AU - Fazio, Vito
AU - Divella, Rosa
AU - Daniele, Antonella
AU - Filippelli, Gianfranco
AU - Gadaleta, Cosmo Damiano
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Carcinoma
KW - Electro-hyperthermia
KW - Hepatocellular
KW - Sorafenib
UR - http://www.scopus.com/inward/record.url?scp=84928887624&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84928887624&partnerID=8YFLogxK
U2 - 10.3892/ol.2014.2376
DO - 10.3892/ol.2014.2376
M3 - Article
AN - SCOPUS:84928887624
VL - 8
SP - 1783
EP - 1787
JO - Oncology Letters
JF - Oncology Letters
SN - 1792-1074
IS - 4
ER -