31 May 2018—Cancer patients may not be experiencing the full benefit of cancer drugs because they may not receive the same number of cancer treatment cycles as predicted in clinical trials, according to a study reported in MGP’s new journal Specialised Commissioning.
In clinical trials, patients are closely monitored and supported throughout treatment with the optimum number of treatment cycles, therefore achieving the full benefit of a drug. Clinical trial populations also tend to be younger and to have fewer co-morbidities than real-life patients, who can experience severe toxicities and are therefore more likely to require dose adjustment or even premature treatment cessation. This situation reduces the efficacy of the drug and throws into question whether the evidence on which the drug was approved and funded in the first place should be revisited.
The 229 patients in this study* received only 38% of the number of treatment cycles that they were predicted to receive from clinical trials. This suggests that the number of treatment cycles reported in clinical trials does not represent an accurate indication of the number of cycles of treatment that patients will receive in the real-life setting.
‘Clinical outcomes for real-life patients may not be as good as those predicted in clinical trials,’ says the study’s author, oncology pharmacist Jacky Turner. ‘This raises two questions: are patients likely to attain the same clinical benefit as those in clinical trials, and will the introduction of a funding strategy like the Cancer Drugs Fund (CDF) show the clinical outcome benefits expected? Ongoing monitoring through the Systemic Anti Cancer Therapy (SACT) database would record if this is happening.’
Alastair Whitington, Consultant Editor for Specialised Commissioning commented: ‘The uptake of cancer drugs and associated efficacy benefit may not actually carry through to the real-life setting. As many of the cancer drugs approved via the CDF have only shown an average overall survival benefit of just over 3 months it could be that a drug showing marginal benefit could become an ineffective drug in the real-life setting.’
Notes for editors:
* The study identified how many cycles of treatment patients who accessed their medicines through the London CDF in the South East London Cancer Network (SELCN) actually received, compared with the number of cycles predicted in the clinical trial for the particular cancer drug and indication under study.
Specialised Commissioning is a new, quarterly journal for healthcare professionals and managers who have a role or interest in specialised commissioning. It aims to showcase innovation and best practice, provide updates, and stimulate debate. It is available free of charge to clinical directors, medical directors, directors/heads of commissioning, directors of contracting and finance, directors of public health, and other senior professionals with a role or interest in specialised healthcare and commissioning.
MGP Ltd is a specialist healthcare media company which aims to improve patients’ lives by promoting best practice in healthcare. MGP specialises in multichannel content and educational projects based around clinical guidance and evidence-based information through its brands: Guidelines, Guidelines in Practice, Guidelines for Nurses, and Specialised Commissioning.
Jacky Turner worked as the lead cancer pharmacist for Guy’s and St Thomas’ NHS Foundation Trust (2006-2015) and Cancer Commissioning Pharmacist for NHS England, London region from (2013-2015). Jacky was a key member of the London Cancer New Drugs Group and worked with them to lead the implementation of the CDF in London. Jacky was the SE London representative for the Chemotherapy Clinical Reference Group (CRG) and the National CDF panel.
Alastair Whitington is the Consultant Editor for Specialised Commissioning and also a trustee for Neuroblastoma UK. Alastair led NHS England specialised commissioning engagement with providers and eight CCGs in North West London from 2013–2015. He was also Programme of Care Lead for London, responsible for the design and development of the commissioning framework and delivery of national strategies for over 100 specialised services. Alastair previously managed the Cancer Drugs Fund and Individual Funding Request process for specialised services in London.
The Systemic Anti-Cancer Therapy (SACT) database is the national mandatory collection of systemic anti-cancer therapy activity from all NHS England chemotherapy providers. It is designed to provide a clear picture of patterns of systemic anti-cancer therapy, including chemotherapy, being given across England. It aims to support patients and their clinical teams in choosing appropriate treatments and care.
The Cancer Drugs Fund (CDF) is a source of funding for cancer drugs in England. It offers early patient access to the most promising new cancer treatments while uncertainty about a drug’s effectiveness is assessed through data collection. It also offers financial certainty, and a fast-track NICE process for companies to apply for appraisals.
Editor, Specialised Commissioning
Marketing Executive, MGP Ltd