Atezolizumab [ATE1]
The first line treatment of locally advanced or metastatic urothelial cancer in patients who are ineligible for cisplatin- based chemotherapy where all the following criteria are met:
- An application has been made by and the first cycle of systemic anti -cancer therapy with atezolizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- 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.
- The patient has histologically or cytologically documented transitional cell carcinoma of the urothelial tract
- The patient has disease that is either locally advanced (ie T4b any N or any T N2-3 disease) or metastatic (any T any N M1 disease)
- The patient has not received previous chemotherapy for inoperable locally advanced or metastatic urothelial cancer
- The patient has EITHER not received previous adjuvant chemotherapy, neoadjuvant chemotherapy or chemo-radiotherapy OR, if previously treated with platinum-based chemotherapy whether as adjuvant chemotherapy or as neoadjuvant chemotherapy or with chemo-radiotherapy, has relapsed more than 12 months since completing the platinum-based chemotherapy* * Patients meeting this criterion are eligible to be considered as treatment naïve for locally advanced/ metastatic disease but must satisfy all other criteria
- The patient has an ECOG performance status (PS) of 0, 1 or 2. Note: treatment of patients of performance status 2 should only proceed with caution as there is limited safety data on PS 2 patients with urothelial cancer treated with atezolizumab.
- The patient is ineligible for platinum-based chemotherapy, due to one or more of the following: * impaired renal function (EDTA-assessed glomerular filtration rate >30 and <60mls/min) * hearing loss of 25dB as assessed by formal audiometry * NCI CTCAE grade 2 or worse peripheral neuropathy * ECOG PS 2
- The patient’s urothelial tumour has undergone PD-L1 testing
- A PD-L1 expression of ≥5% has been recorded and the measurement used for PD-L1 testing is defined as the presence of discernible PD-L1 staining of any intensity in tumour infiltrating immune cells covering ≥5% of tumour area occupied by tumour cells, associated intra-tumoural and contiguous peri-tumoural desmoplastic stroma
- 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
- The patient has no symptomatically active brain metastases or leptomeningeal metastases
- Atezolizumab will be administered as monotherapy 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.
- A formal medical review as to whether treatment with atezolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment
- The patient is to be treated until disease progression and loss of clinical benefit or excessive toxicity or patient choice, whichever is the sooner
- Treatment breaks of up to 12 weeks beyond the expected cycle length are allowed but solely to allow immune toxicities to settle. Where treatment is interrupted any restart and continuation of drug must be in line with the treatment break policy outlined in Specialised Services Circular (SSC) 1918.
- Atezolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 25 January 2022
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