Atezolizumab in combination with bevacizumab [ATE8]

For the first-line systemic treatment of adult patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with atezolizumab in combination with bevacizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies and hepatitis.
  3. The patient has a diagnosis of hepatocellular carcinoma and that one of the following applies to the patient (please tick appropriate box below as to which option applies):
  • either option 1 applies in which case the patient has a confirmed histological diagnosis of hepatocellular carcinoma (HCC)
  • or option 2 applies in which case a biopsy is deemed to be very high risk or technically not feasible in the patient and both the criteria a and b below are also all met: a: the decision not to biopsy has been made and documented by a specialist HCC multi-disciplinary team meeting and b: the tumour meets the non-invasive diagnostic criteria of HCC as set out below* It is expected that option 2 will only apply in exceptional circumstances. Please mark below which of these 2 clinical scenarios applies to this patient: Option 1: the patient has a confirmed histological diagnosis of hepatocellular carcinoma or Option 2: the patient cannot be biopsied on account of high risk or technical lack of feasibility and the above criteria for option 2 all apply. *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.
  1. The patient has metastatic or locally advanced disease that is ineligible for or has failed surgical or loco-regional therapies.
  2. The patient has Child-Pugh A liver function.
  3. The patient has not received previous systemic therapy for his/her hepatocellular carcinoma unless the combination of atezolizumab and bevacizumab has been received via the EAMS scheme. Please mark below which of these two scenarios applies to this patient: the patient has not received any previous systemic therapy for his/her hepatocellular carcinoma or the patient has been previously treated with the combination of atezolizumab and bevacizumab and this has been accessed via a previous registration for the EAMS for atezolizumab plus bevacizumab. Note: previous systemic treatment with sorafenib or lenvatinib or regorafenib or any immunotherapy or any systemic chemotherapy is not allowed.
  4. The patient has an ECOG performance status score of 0 or 1.
  5. The prescribing clinician is aware of the risk of variceal bleeding due to bevacizumab and will comply with the recommendation that an oesophago-gastro-duodenoscopy (OGD) be considered in patients at high risk of variceal bleeding and that all sizes of varices be assessed and treated as per local standard of care prior to treatment with atezolizumab and bevacizumab.
  6. Treatment with atezolizumab in combination with bevacizumab will continue until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. If either atezolizumab or bevacizumab has to be discontinued on account of toxicity and the patient is otherwise benefitting from therapy, treatment should continue with the remaining agent until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent.
  7. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  8. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
  9. Atezolizumab will be administered either subcutaneously at a dose of 1875mg every 3 weeks or intravenously at a dose of 1200mg every 3 weeks or 1680 mg every 4 weeks.
  10. A formal medical review as to how treatment with atezolizumab in combination with bevacizumab is being tolerated and whether treatment with the combination should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  11. Where a treatment break of more than 12 weeks beyond the expected 3-weekly cycle length is needed, I will complete a treatment break form to restart treatment, including an indication as appropriate if the patient had an extended break because of COVID 19.
  12. On discontinuation of the combination of atezolizumab and bevacizumab on account of loss of clinical benefit or treatment intolerance and if the patient is fit for further systemic therapy, the next line of treatment would be a choice of either sorafenib or lenvatinib.
  13. Atezolizumab and bevacizumab will otherwise be used as set out in their respective Summary of Product Characteristics (SPCs).

[NHS funded]{.badge .rounded-pill .bg-success} From: 15 January 2021

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CDF Managed Access: NA

NICE Technology Appraisal: TA666 (16 December 2020)

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