UMIN-CTR Clinical Trial

The response rate was significantly higher in patients treated with HAIC (37.5%) compared to that in patients treated with sorafenib (no response). The median overall survival (18.6 and 11.7 months) and progression-free survival (4.0 and 5.0 months) were similar between the sorafenib and HAIC groups, respectively. In the sorafenib group, 58.3% of the patients discontinued treatment compared to none in the HAIC group.

Advanced HCC

We retrospectively analyzed data from elderly patients with advanced unresectable HCC, who were treated at our hospital between March, 2002 and June, 2013. Eligible patients included those aged 70 years and more with histologically or clinically confirmed advanced HCC. HCC was considered as unresectable in patients who presented with severe vascular invasion or multiple intrahepatic lesions (i.e., 5 and more nodules), or in those with progressive disease (PD) following surgical or locoregional therapy intervention. A total of 20 eligible patients were identified.

A total of 7 patients (58.3%) in the sorafenib group discontinued treatment due to grade 3 AEs [4 patients, anorexia; and 1 patient each with hand-foot (HF) syndrome, ascites and hepatic encephalopathy], whereas no patients demonstrated intolerance to HAIC. The discontinuation rate in the sorafenib group was significantly higher compared to that in the HAIC group (P=0.015). Among sorafenib-treated patients, the most frequent AEs were mild in severity (grade 1/2) and included HF syndrome, anorexia, hypoalbuminemia and diarrhea. Grade 3 AEs included HF syndrome, anorexia and hypertension. One Child-Pugh class A patient developed hepatic failure (hepatic encephalopathy) and sorafenib was discontinued. There were no grade 4 AEs. Among HAIC group patients, the most frequent AEs were mostly mild in severity (grade 1/2) and included decreased platelet count, anemia, fever, malaise, anorexia, hypoalbuminemia, decreased white blood cell count and decreased neutrophil count. In total, 6 hematological AEs of grade 3/4 were recorded in 4 patients. In the HAIC group, 1 patient (12.5%) experienced catheter occlusion as a catheter-related complication. In addition, 5 patients in the sorafenib group changed Child-Pugh class from A to B, whereas none of the patients in the HAIC group changed Child-Pugh class. These changes were mostly caused by the development of hypoalbuminemia in sorafenib-treated patients; there was no significant change in the prothrombin time-international normalized ratio (PT-INR).

The mean daily dose and duration of sorafenib treatment were 544 mg and 5.3 months, respectively. The mean number of treatment cycles in the HAIC group was 1.8 (~2.2 months). The treatment responses are summarized in Table II. The RR was significantly different between the two groups, as patients in the sorafenib group failed to respond to treatment (P=0.049). However, there was no significant difference in TCR between the two groups. Two patients in the HAIC group achieved a sustained CR after receiving addi- tional RFA: one initially achieved a CR in response to HAIC and the other initially demonstrated a PR in response to HAIC.