The Cancer Tablets study (CaTS)
Background & Scientific Rationale:
One quarter (28.8%) of UK deaths are from cancer: as the population ages, the incidence of cancer is increasing. Patient expectations of treatment are also rising. Current guidelines set out when to start treatment and in which patients, but not when to stop treatment as disease progresses and death approaches. Currently, most cytotoxic chemotherapy is administered intravenously; the majority of the new generation targeted anticancer drugs are oral, and are widely used for incurable cancers such as lung, prostate, kidney and melanoma, where there is evidence of survival benefit of a few months. These biological agents (mostly tyrosine kinase inhibitors or TKIs) are an order of magnitude more expensive than conventional IV drugs (between £2K and £7K per month), patients receiving treatment for 6 months or longer in some cases.
These high cost oral agents are causing commissioners concern: the National Cancer Drugs Fund has been phased out and Value-Based Pricing has yet to be clarified. Around 20% of chemotherapy prescriptions include an oral anticancer agent and this proportion is set to increase over time, since most new cancer drugs currently under development are oral agents. In clinical practice, there is a perception that these oral drugs are easier to start and harder to stop. They are generally not as highly suppressive of the bone marrow (the key toxicity of most cytotoxic agents) but may cause injury to the skin, heart, lungs, liver and eyes. In general, patients attend Oncology clinics monthly and self-administer between visits, unlike IV chemotherapy which is usually administered intermittently by specialist trained staff in a hospital environment. The issues addressed in this study are central to current and future cancer care, and have been endorsed by Oncologists across the Region, the AHSN Cancer Group, Macmillan Cancer Support and Marie Curie Care.
The study aimed to investigate decision-making concerning the stopping of the newer targeted molecular drugs used to treat cancer. These are taken by mouth, have fewer severe side effects than conventional intravenous chemotherapy but are extremely expensive to the NHS.
To study investigated the use of oral TKIs in the palliation of cancer with respect to:
1. The lived experiences of patients in the final months of life and their lay carers: their understanding of treatment goals, psychological and physical effects and involvement in decisions to stop treatment. (No information concerning stopping TKIs published from clinical practice outside of clinical trial protocols)
2. The perceptions of health professionals and commissioners concerning decisions to start and stop TKIs. (No published data concerning TKIs. Oral agents are further blurring the boundaries between Oncology and Palliative Care practice)
3. Investigation of NHS resource utilization related to TKI use in a financially-constrained NHS. (No UK information published on resource utilisation with regards to TKIs or other high cost oral cancer drugs)
Key findings and outputs:
- Publication: Clarke G, Johnston S, Corrie P , Kuhn I, and Barclay S. “Withdrawal of anticancer therapy in advanced disease: a systematic literature review.” BMC Cancer 2015 15:892 doi 10.1186/s12885-015-1862-0 (PDF).