SO-6 The influence of liver function on the outcomes of phase II trial of sorafenib vs. hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma

Abstract

We conducted the Scoop-II trial: a randomized phase II study of sequential hepatic arterial infusion chemotherapy (HAIC) and sorafenib versus sorafenib (SOR) alone as initial therapy for advanced hepatocellular carcinoma (HCC). One-year survival rate as the primary endpoint was 46% and 58%, respectively. It is reported that the efficacy of SOR is dependent on the patient’s liver function while the efficacy of HAIC may not be. We retrospectively evaluated the efficacy of SOR and HAIC according to liver function in Scoop-II. Sixty-eight patients with advanced HCC were randomized 1:1 to receive 400 mg of SOR twice daily or sequential HAIC with cisplatin followed by SOR as the initial therapy. Eligible patients had ECOG PS of 0 or 1, Child-Pugh score (C-P) of 7 or less. Patients with extrahepatic metastasis, in whom the lesions were determined by the attending physicians to not being determinants of the prognosis, were allowed to participate in this study. Stratification factors were institute, presence of major vascular invasion (MVI), and presence of extrahepatic hepatic metastasis (EHS). The primary endpoint was 1-year survival rate. In this subanalysis, we evaluated the mALBI grade at baseline and compared the efficacy of SOR and HAIC in the subgroup of mALBI grade 1–2a and 2b. For the primary endpoint, 1-year survival rates were 46% in the HAIC group and 58% in the SOR group. In the SOR and HAIC groups, the number of patients with mALBI grade of 1–2a was 16 and 24, and those with mALBI grade of 2b was 17 and 11, respectively. Median OS in SOR and HAIC group was 15.2 months (95% CI, 6.1–24.3) and 18.3 months (95% CI, 2.5–34.0) in mALBI grade of 1+2a group with p-value of 0.66, and 15.1 months (95% CI, 8.4–21.7) and 7.4 months (95% CI, 5.8–8.9) in mALBI grade of 2b group with p-value of 0.093, respectively. TTP of first-line treatment was not different between the SOR and HAIC groups in each subgroup: 3.8 months (95% CI, 2.3–5.2) and 5.3 months (95%CI, 1.0–9.6) in mALBI grade of 1–2a group (p = 0.65), and 2.8 months (95% CI, 1.3–4.3) and 2.6 months (95% CI, 0.5–4.8) in mALBI grade of 2b group (p = 0.24), respectively. Regarding second-line treatment in patients with mALBI grade of 1+2a and 2b, HAIC was used in 11 (28%) and 7 (25%) in the SOR group while SOR was used in 17 (43%) and 7 (25%) in HAIC group, respectively. More patients in mALBI grade of 2b had AFP >400 ng/mL and EHS than those in mALBI grade of 1-2a with p = 0.051 and 0.050, respectively. The imbalances of background other than liver function may affect the results of this subanalysis. SOR may be better to initiate compared with HAIC for patients with advanced HCC, especially in patients with deterioration of liver function who will become ineligible for SOR after failure of first-line treatment. In contrast, patients who have good liver function can have a choice of HAIC as well as SOR for first-line treatment in advanced HCC.