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Reuters Health Information (2012-05-24): REFILE: Sorafenib benefits select HCC patients with cirrhosis


REFILE: Sorafenib benefits select HCC patients with cirrhosis

Last Updated: 2012-05-24 19:35:07 -0400 (Reuters Health)

[Refiles story posted earlier today (May 24) as 20120524clin017, with no changes to text, to address technical problem related to coding.]

NEW YORK (Reuters Health) - Single-agent sorafenib improves outcomes for select patients with advanced hepatocellular carcinoma (HCC) and underlying Child-Pugh B liver cirrhosis, researchers from Hong Kong report in the April 19th online issue of Cancer.

"I would only recommend prescribing sorafenib to patients with score 7 instead of 8-9, as most benefits are seen in score 7 patients," Dr. Thomas Yau from Queen Mary Hospital, Hong Kong, China told Reuters Health in an email.

Although sorafenib is FDA-approved as first-line treatment for advanced HCC, its efficacy and tolerability remain largely unknown for patients with suboptimal liver function.

Dr. Yau and colleagues explored that question in a retrospective study of three groups of patients with advanced HCC: 108 with Child-Pugh A cirrhosis (CPA), 37 with Child-Pugh B disease and a score of 7 (CPB7), and 27 with scores of Child-Pugh B and scores of 8-9 (CPB8-9).

Patients in Child-Pugh class A have well compensated disease. Child-Pugh B indicates significant functional compromise. (Child-Pugh class C patients, not included here, have decompensated liver disease.)

The overall clinical benefit rates (complete response + partial response + stable disease) did not differ significantly between patients with CPA, CPB7, or CPB8-9 (23.3%, 32.4%, and 14.8%; p=0.23).

Median progression-free survival was also similar -- 3.2 months for CPA, 3.2 months for CPB7, and 2.3 months for CPB8-9 -- but median overall survival was significantly greater for CPA and CPB7 than for CPB8-9 (6.1 and 5.4 vs 2.7 months; p=0.02).

Rates of most nonhematological and hematological adverse events were comparable in the three groups. There were, however, significantly more GI bleeding events and hepatic encephalopathy in CPB patients than CPA patients.

More CPB than CPA patients had drug termination due to adverse events, primarily related to more cirrhotic complications in CPB (15.6%) than CPA (5.6%) patients during sorafenib treatment.

"Therefore," the researchers suggest, "when sorafenib is routinely used to treat advanced HCC patients with CPB cirrhosis, more vigilant surveillance and follow-up is advisable."

"The on-going GIDEON (Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib) study will certainly provide us more information about the efficacy and safety of sorafenib use in patients with Child Pugh B cirrhosis," Dr. Yau said. "We are planning to explore the potential benefits and safety of using sorafenib in other advanced HCC subgroups, such as patients with ECOG 3/4."

The study was supported by the University of Hong Kong hepatocellular carcinoma research fund.


Cancer 2012.

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