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Sorafenib Added to Guidelines for Treatment of Hepatocellular Carcinoma: Presented at NCCN

By Ed Susman

HOLLYWOOD, Fla -- March 12, 2008 -- The multi-kinase inhibitor sorafenib has been added to the list of treatment options for patients with hepatocellular carcinoma who are ineligible for transplantation, according to a presentation here at the National Comprehensive Cancer Network (NCCN) 13th Annual Conference on Clinical Practice Guidelines and Quality Cancer Care.

"Sorafenib is the newest addition to the guidelines. It appears to be, for the first time, an effective systemic treatment for hepatocellular carcinoma," said Al B. Benson III, MD, Professor of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, who presented the updated guidelines on March 8th.

"We have placed the use of sorafenib as an option in several places in the treatment algorithm," he said. For individuals who are not transplant candidates, use of sorafenib, ablation techniques, and enrolment in clinical trials, are the major treatment options, he said. The guidelines suggest the use of sorafenib in patients with relatively strong performance status as judged by the Child-Pugh scale.

Sorafenib also is listed as one of the choices for treatment if the patient who is ineligible for transplant is asymptomatic. The guideline authors list a clinical trial as the only option other than sorafenib for this group of patients.

The new drug is also indicated for use in patients who are ineligible for surgery due to poor performance status or comorbidity. In this group, doctors are given the option of prescribing sorafenib whether the patient has cancer-related symptoms or is asymptomatic.

For patients with Child-Pugh class A or B performance status, supportive care and clinical trials are the only options for patients with confirmed metastatic disease.

Dr. Benson said that treatment with sorafenib appears to disrupt many of the multiple cellular signalling pathways that are implicated in the pathogenesis of hepatocellular carcinoma. During developmental testing, sorafenib showed antitumour activity through mechanisms of action that prevented angiogenesis, encouraged apoptosis, and interrupted tumour signalling.

He reviewed the data in a phase 3 trial performed by European researchers that randomised 602 patients to either sorafenib or placebo. About 605 of the patients had disease progression despite having tried other treatment modalities -- surgical resection or locoregional strategies.

Time to progression for the patients taking placebo was 12.3 weeks compared with 24 weeks for patients on sorafenib -- a 73% prolongation for sorafenib (P = .000007). Median overall survival for patients on sorafenib was 46.4 weeks compared with 34.4 weeks for patients taking placebo (P = .00058), representing a 44% increase in overall survival.


[Presentation title: Update: Hepatocellular Carcinoma Guidelines.]

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