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STORM: A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Sorafenib is a multikinase inhibitor with proven efficacy in unresectable HCC. We evaluated the efficacy and safety of adjuvant sorafenib for HCC. Methods: Patients who had undergone surgical resection or local ablation with curative intent and had an intermediate or high recurrence risk were eligible. Main inclusion criteria were Child-Pugh score 5–7, ECOG PS 0, and no residual disease confirmed by CT or MRI. Exclusion criteria included recurrent HCC, ascites, extrahepatic spread, macrovascular invasion, and prior systemic therapy for HCC. Patients were stratified by curative treatment, geographic region, recurrence risk, and Child-Pugh status and randomized 1:1 to treatment with sorafenib 400 mg orally twice a day or placebo for a maximum of 4 yrs. The primary endpoint was recurrence-free survival (RFS) by independent review. Secondary endpoints included time to recurrence (TTR) and overall survival (OS). Results: A total of 1114 patients were randomized (n=556 sorafenib; n=558 placebo). Baseline characteristics were balanced between groups. Median age was 59 yrs, 62% were Asian, 81% had resection, 97% were Child-Pugh A, and 46% had high recurrence risk. The analysis was based on a total of 464 RFS events. No differences in RFS, TTR, and OS were observed (Table). The sorafenib group had a shorter median treatment duration (12.5 vs 22.2 mos) and lower mean daily dose (578 vs 778 mg). Discontinuation rates with sorafenib were higher due to treatment-emergent adverse events (TEAE) (24% vs 7%) and consent withdrawal (17% vs 6%). Most common grade (Gr) 3–4 sorafenib TEAEs occurring more frequently vs placebo were hand-foot skin reaction (28%), hypertension (7%), and diarrhea (6%). Conclusions:The primary endpoint of the trial was not met. Adverse events are consistent with the known sorafenib safety profile and no new safety findings were observed. Clinical trial information: NCT00692770.
|Sorafenib||Placebo||Hazard Ratio (95% CI)||P*|
|RFS||33.4||33.8||0.940 (0.780 – 1.134)||0.26|
|TTR||38.6||35.8||0.891 (0.735 – 1.081)||0.12|
|OS||NR||NR||0.995 (0.761 – 1.300)||0.48|
|Drug-related, all Gr||94||46|
*One sided; NR, not reached.
Abstracts by Jordi Bruix:
Tumor and plasma biomarker analysis from the randomized controlled phase II trial (RCT) of tivantinib in second-line hepatocellular carcinoma (HCC).Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 197
RESORCE: An ongoing randomized, double-blind, phase III trial of regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing on sorafenib (SOR).Meeting: 2014 ASCO Annual Meeting | Abstract No: TPS4156^