Sorafenib [SOR3]
Treatment of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma where the following criteria are met:
- An application has been made by and the first cycle of systemic anti-cancer therapy is to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
- ONE of the following applies to the patient: the patient has a confirmed histological diagnosis of hepatocellular carcinoma or a biopsy is deemed to be very high risk or technically not feasible in the patient AND the criteria below are met: a. The decision not to biopsy has been made and documented by a specialist HCC MDM b. The tumour meets the non-invasive diagnostic criteria of hepatocellular carcinoma* c. Data is submitted as part of the ongoing Sorafenib Audit 2. It is expected that OPTION 2 will only apply in exceptional circumstances and it should be noted that responses will be reviewed regularly to ensure that this is the case. *EASL–EORTC Clinical Practice Guidelines: Management, Journal of Hepatology 2012 vol. 56 p 908–943. Non-invasive criteria can only be applied to cirrhotic patients and are based on imaging techniques obtained by 4-phase multidetector CT scan or dynamic contrast-enhanced MRI. Diagnosis should be based on the identification of the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases). While one imaging technique is required for nodules beyond 1 cm in diameter a more conservative approach with 2 techniques is recommended in suboptimal settings.
- Patient must have either metastatic disease or locally advanced disease that is ineligible for or failed surgical or locoregional therapies
- Either the patient has not received any previous systemic therapy for hepatocellular carcinoma (option 1) or the patient has had to discontinue lenvatinib within 3 months of starting lenvatinib and solely because of toxicity (i.e. there was lenvatinib toxicity which could not be managed by dose delay or dose modification) and there has been no disease progression whilst on lenvatinib (option 2) or if the patient has received atezolizumab+bevacizumab as 1st line treatment (option 3)
- Patient must have Child-Pugh liver function class A
- Patient has a performance status of 0-2
- Sorafenib is to be used as a single agent
- Sorafenib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment
- No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve)
- Sorafenib to be otherwise used as set out in its Summary of Product Characteristics
NHS funded From: 05 December 2017
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