Lenvatinib [LNV3]
Treatment of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma where the following criteria are met:
- This application has been made by and the first cycle of systemic anti -cancer therapy with lenvatinib will 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, either:
- option 1 in which the patient has a confirmed histological diagnosis of hepatocellular carcinoma (HCC) or
- option 2 in which a biopsy is deemed to be very high risk or technically not feasible in the patient and the criteria below are also all met: a. the decision not to biopsy has been made and documented by a specialist HCC multi-disciplinary team meeting b. the tumour meets the non-invasive diagnostic criteria of HCC* c. data is submitted as part of the ongoing ‘Systemic Therapy Audit, previously known as the Sorafenib Audit 2’. It is expected that option 2 will only apply in exceptional circumstances and it should be noted that audit of non-biopsy rates will be reviewed regularly. *EASL-EORTC Clinical Practice Guidelines: Management, Journal of Hepatology 2012 vol 56 p908-943. 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 1cm in diameter, a more conservative approach with 2 techniques is recommended in suboptimal settings.
- The patient has either metastatic disease or locally advanced disease that is ineligible for or failed surgical or loco-regional therapies
- Either: the patient has not received any previous systemic therapy for hepatocellular carcinoma (option 1) or the patient has had to discontinue sorafenib within 3 months of starting sorafenib and solely because of toxicity (i.e. there was sorafenib toxicity which could not be managed by dose delay or dose modification) and there has been no disease progression whilst on sorafenib (option 2) or if the patient has received atezolizumab+bevacizumab as 1st line treatment (option 3)
- The patient has Child-Pugh liver function class A
- The patient has an ECOG performance status of 0 or 1. Lenvatinib is not commissioned in patients of ECOG performance status of 2 or more
- Lenvatinib is to be used as monotherapy.
- The prescribing clinician is aware of the differing starting doses of lenvatinib according to the patient body weight being above or below 60Kg
- A formal medical review as to whether treatment with lenvatinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment
- Lenvatinib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment.
- The prescribing clinician is aware that no treatment breaks of greater than six weeks beyond the expected cycle length are permitted (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).
- Lenvatinib will be otherwise used as set out in its Summary of Product Characteristics.
[NHS funded]{.badge .rounded-pill .bg-success} From: 19 March 2019
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