Entry Detail
| General information | |
| Database: | DB00870 |
| Objective: | There is no standard of care for adjuvant therapy for patients with hepatocellular carcinoma. This trial was designed to assess the efficacy and safety of sorafenib versus placebo as adjuvant therapy in patients with hepatocellular carcinoma after surgical resection or local ablation. |
| Authors: | Bruix J, et al |
| Title: | Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, doubleblind, placebocontrolled trial. |
| Journal: | Lancet Oncol. |
| Year: | 2015 |
| PMID: | 26361969 |
| Trial Design | |
| Clinical Trial Id: | NCT00692770 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase III, randomised, doubleblind, placebocontrolled trial |
| Key Patients Feature: | patients with hepatocellular carcinoma with a complete radiological response after surgical resection (n=900) or local ablation (n=214) in 202 sites (hospitals and research centres) in 28 countries |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib versus placebo |
| Treatment Info: | Patients were randomly assigned (1:1) to receive 400 mg oral sorafenib or placebo twice a day, for a maximum of 4 years, according to a block randomisation scheme (block size of four) using an interactive voiceresponse system. |
| Primary End Point: | recurrencefree survival assessed after database cutoff on Nov 29, 2013. |
| Secondary End Point: | NA |
| Patients Number: | 1602 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 33.3 months in the sorafenib group vs 33.7 months in the placebo group; hazard ratio [HR] 0.940; 95% CI 0.7801.134; onesided p=0.26 |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | Overall, 545 (97%) of 559 patients who received sorafenib and 491 (90%) of 548 patients who received placebo had an adverse event. The overall incidence of drugrelated adverse events was higher in the sorafenib group than in the placebo group (526 [94%] vs 254 [46%]). In the sorafenib group, adverse events were mainly grade 1 or grade 2 in severity, and were gastrointestinal, constitutional, or dermatological in nature ( table 4). The most commonly reported drugrelated adverse events in patients given sorafenib were handfoot skin reaction, diarrhoea, and alopecia. Grade 3 adverse events in patients given sorafenib included handfoot skin reaction, diarrhoea, and hypertension (table 4). Adverse events leading to a dose modification were recorded in 439 (79%) patients in the sorafenib group and 111 (20%) patients in the placebo group. The number of reported serious adverse events, of any attribution, was similar between the groups (225 [40%] in the sorafenib group vs 228 [42%] in the placebo group). Of note, patients who were admitted to hospital within 30 days of the last dose of study drug because of any procedure related to hepatocellular carcinoma recurrence (eg, resection) were categorised as having a serious adverse event, thereby somewhat confounding this result. Drugrelated serious adverse events were noted in 52 (9%) patients in the sorafenib group and 14 (3%) in the placebo group. In the sorafenib group the most commonly reported drugrelated serious adverse events were handfoot skin reaction, abnormal hepatic function, and fatigue ( table 4). |
| Conclusions: | Our data indicate that sorafenib is not an effective intervention in the adjuvant setting for hepatocellular carcinoma following resection or ablation |