Abstract
Aim: Sorafenib, a multi-targeted tyrosine kinase inhibitor, is a first-line systemic treatment for advanced hepatocellular carcinoma (HCC). However, possible predictors of the efficacy of sorafenib treatment in HCC patients remain unclear. Methods: We conducted a nationwide survey to examine the situation of patients with HCC treated with sorafenib who obtained a complete response (CR) according to the modified response evaluation criteria in solid tumors (mRECIST). The investigation was intended to collect clinical information regarding CR patients and to compare this data with an interim report examining all-patient surveillance for sorafenib use in Japan, which was released in May 2012. Results: Among the 3047 patients who were treated at institutions belonging to the Liver Cancer Study Group of Japan, 18 patients (0.6%) obtained a CR. Significant factors in the CR group were a female sex, a low bodyweight (<59kg), an early clinical stage and a small initial dose of sorafenib (P<0.05). Furthermore, specific adverse events (palmar-plantar erythrodysesthesia syndrome, hypertension, diarrhea, alopecia, fatigue, nausea and anorexia) were frequently observed in the CR group (P<0.05). Conclusion: This study identified the characteristics of CR patients during sorafenib treatment. The evaluation of patients receiving sorafenib, including the investigation of biomarkers, warrants further exploration in future clinical studies to identify a population in which sorafenib treatment is remarkably effective.
| Original language | English |
|---|---|
| Pages (from-to) | 1268-1276 |
| Number of pages | 9 |
| Journal | Hepatology Research |
| Volume | 44 |
| Issue number | 13 |
| DOIs | |
| Publication status | Published - 2014 |
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Keywords
- Adverse drug event
- Complete response
- Data collection
- Hepatocellular carcinoma
- Population characteristics
- Sorafenib
ASJC Scopus subject areas
- Hepatology
- Infectious Diseases
Cite this
Characteristics of 18 patients with hepatocellular carcinoma who obtained a complete response after treatment with sorafenib. / Shiba, Satoshi; Okusaka, Takuji; Ikeda, Masafumi; Saito, Hidetsugu; Ichida, Takafumi.
In: Hepatology Research, Vol. 44, No. 13, 2014, p. 1268-1276.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Characteristics of 18 patients with hepatocellular carcinoma who obtained a complete response after treatment with sorafenib
AU - Shiba, Satoshi
AU - Okusaka, Takuji
AU - Ikeda, Masafumi
AU - Saito, Hidetsugu
AU - Ichida, Takafumi
PY - 2014
Y1 - 2014
N2 - Aim: Sorafenib, a multi-targeted tyrosine kinase inhibitor, is a first-line systemic treatment for advanced hepatocellular carcinoma (HCC). However, possible predictors of the efficacy of sorafenib treatment in HCC patients remain unclear. Methods: We conducted a nationwide survey to examine the situation of patients with HCC treated with sorafenib who obtained a complete response (CR) according to the modified response evaluation criteria in solid tumors (mRECIST). The investigation was intended to collect clinical information regarding CR patients and to compare this data with an interim report examining all-patient surveillance for sorafenib use in Japan, which was released in May 2012. Results: Among the 3047 patients who were treated at institutions belonging to the Liver Cancer Study Group of Japan, 18 patients (0.6%) obtained a CR. Significant factors in the CR group were a female sex, a low bodyweight (<59kg), an early clinical stage and a small initial dose of sorafenib (P<0.05). Furthermore, specific adverse events (palmar-plantar erythrodysesthesia syndrome, hypertension, diarrhea, alopecia, fatigue, nausea and anorexia) were frequently observed in the CR group (P<0.05). Conclusion: This study identified the characteristics of CR patients during sorafenib treatment. The evaluation of patients receiving sorafenib, including the investigation of biomarkers, warrants further exploration in future clinical studies to identify a population in which sorafenib treatment is remarkably effective.
AB - Aim: Sorafenib, a multi-targeted tyrosine kinase inhibitor, is a first-line systemic treatment for advanced hepatocellular carcinoma (HCC). However, possible predictors of the efficacy of sorafenib treatment in HCC patients remain unclear. Methods: We conducted a nationwide survey to examine the situation of patients with HCC treated with sorafenib who obtained a complete response (CR) according to the modified response evaluation criteria in solid tumors (mRECIST). The investigation was intended to collect clinical information regarding CR patients and to compare this data with an interim report examining all-patient surveillance for sorafenib use in Japan, which was released in May 2012. Results: Among the 3047 patients who were treated at institutions belonging to the Liver Cancer Study Group of Japan, 18 patients (0.6%) obtained a CR. Significant factors in the CR group were a female sex, a low bodyweight (<59kg), an early clinical stage and a small initial dose of sorafenib (P<0.05). Furthermore, specific adverse events (palmar-plantar erythrodysesthesia syndrome, hypertension, diarrhea, alopecia, fatigue, nausea and anorexia) were frequently observed in the CR group (P<0.05). Conclusion: This study identified the characteristics of CR patients during sorafenib treatment. The evaluation of patients receiving sorafenib, including the investigation of biomarkers, warrants further exploration in future clinical studies to identify a population in which sorafenib treatment is remarkably effective.
KW - Adverse drug event
KW - Complete response
KW - Data collection
KW - Hepatocellular carcinoma
KW - Population characteristics
KW - Sorafenib
UR - http://www.scopus.com/inward/record.url?scp=84927575845&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84927575845&partnerID=8YFLogxK
U2 - 10.1111/hepr.12297
DO - 10.1111/hepr.12297
M3 - Article
AN - SCOPUS:84927575845
VL - 44
SP - 1268
EP - 1276
JO - Hepatology Research
JF - Hepatology Research
SN - 1386-6346
IS - 13
ER -