Prostate cancer cell. Credit: LRI EM Unit.
A hormone therapy has been rejected as a treatment for some adults with newly-diagnosed, advanced prostate cancer by the National Institute of Health and Care Excellence (NICE).
As it stands, doctors in England can only prescribe the hormone therapy abiraterone for men whose prostate cancer has spread to other parts of the body, once standard hormone treatment or chemotherapy has failed.
Clinical trial data suggests that combining abiraterone with either steroids or steroids and hormone therapies as a first-line treatment improves survival compared with the current standard of care for newly-diagnosed patients. However, NICE raised concerns that the drug’s effectiveness was overestimated in these trials.
Emlyn Samuel, head of policy development at Cancer Research UK, said NICE had questioned whether abiraterone could be more effective if used at a later stage of patients’ treatment, but noted the decision would still be “enormously disappointing” for people affected by the disease.
Abiraterone works by stopping the body making testosterone, which can help slow the grow of hormone-sensitive prostate cancers.
“Our research played a leading role in the discovery and development of abiraterone,” Samuel commented, “and clinical trials have shown that using abiraterone as a patient’s first treatment can slow down cancer growth, improve survival, and help maintain their quality of life.”
Combining abiraterone with prednisone or prednisolone plus androgen deprivation therapy has been trialled as a treatment for adults with high risk, hormone sensitive prostate cancer that’s spread to other parts of the body.
The current standard care for this group of newly-diagnosed patients is another hormone therapy, or a combination of hormone therapy plus the chemotherapy drug docetaxel. Around 2 in 3 patients have hormone therapy by itself, either because they are not fit enough to have chemotherapy, or they choose not to.
Clinical trial results suggest that abiraterone combinations increase both the time it takes for the cancer to grow significantly (progression-free survival) and overall survival, compared to hormone therapy by itself.
The treatment also improves progression-free survival, but not overall survival, when compared to hormone therapy plus docetaxel.
Concerns over effectiveness
But looking at the trials, NICE raised concerns that these results may overestimate the effectiveness of abiraterone, noting that some treatments offered after disease progression in the trials were not considered as effective as what is offered on the NHS.
NICE also noted that using abiraterone early on in the treatment pathway, instead of standard therapy, would limit options for patients whose cancer comes back or continues to grow, as they wouldn’t be able to be treated with abiraterone again later.
In addition to the uncertainties about the drug’s effectiveness, NHS England and the manufacturer were unable to agree a pricing arrangement that would make abiraterone a cost-effective use of NHS resources.
NICE were therefore unable to recommend the use of abiraterone for treating patients with newly-diagnosed prostate cancer, and there are currently no plans to review this decision again in NICE’s current review of the drug’s effectiveness.
However, Samuel expressed hope that conversations could continue, and make the treatment available for patients in the future if this was found to be beneficial. “We urge NHS England, NICE and the manufacturer to continue working together to help resolve these uncertainties and ensure all patients can be offered the best possible treatment.”
NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so the decision is likely to affect patients in all 3 nations. But in Scotland, abiraterone has been available for patients with newly-diagnosed advanced prostate cancer since January.
NICE (2020) Abiraterone for treating newly diagnosed high risk metastatic hormone-naive prostate cancer [ID945]