Nexavar — Proven Efficacy and Manageable Safety Profile in the SHARP Trial

SHARP: Sorafenib HCC Assessment Randomized Protocol Trial

A randomised, double-blind, placebo-controlled, international, multicentre, phase III study in patients with HCC¹^,9

A primary end point was overall survival (OS)
A secondary end point was time to tumour progression (TTP)
Patient inclusion criteria included
- Histologically proven HCC
- Advanced HCC
- Eastern Cooperative Oncology Group Performance Status
  (ECOG PS) 0-2
- > 1 measurable untreated lesions
- Child-Pugh class A (mild hepatic impairment)
- No prior systemic treatment
Patients continued therapy with Nexavar until a criterion was met for stopping therapy*
- In the event of radiologic progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST), patients were allowed to continue to receive Nexavar
^{* Death, disease progression, or adverse event that required discontinuation.}

Child-Pugh classification of liver function

A scoring system developed for evaluating surgical risk in patients with cirrhosis from alcohol use¹⁰

Child-Pugh scoring system

^aGrade 0: normal consciousness, personality, neurological examination, and electroencephalogram; 1: restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5-Hz waves; 2: lethargic, time disoriented, inappropriate, asterixis, ataxia, slow triphasic waves; 3: somnolent, stuporous, place disoriented, hyperactive reflexes, rigidity, slower waves; 4: unrousable coma, no personality/behavior, decerebrate, slow 2- to 3-Hz delta activity.

Class A (good operative risk): 5 or 6 points
Class B (moderate risk): 7 to 9 points
Class C (poor risk): 10 to 15 points

SHARP design⁹

SHARP study design

Demographics and baseline characteristics of SHARP study participants¹

Demographics and baseline characteristics of SHARP study participants

^aNo significant difference between groups (P>.05).
^bOne patient in the Nexavar group was BCLC stage D and Child-Pugh class C.
^cPatients may have received <1 type of therapy.
^dRadiotherapy applied to extrahepatic metastatic lesions except in 3 placebo and 5 Nexavar patients.

BCLC=Barcelona Clinic Liver Cancer; TACE=transarterial chemo-embolisation; PEI=percutaneous ethonal injection; RFA=radiofrequency ablation.

The entry criteria of SHARP included primarily Child-Pugh class A patients. This study design was established to avoid the confounding effects of underlying cirrhosis on OS.¹

Next: Nexavar Efficacy in HCC

Term

Explanation for term.