SPIRIT 2 Article - Dr Kaczmarski
I have been a keen supporter of the SPIRIT CML studies since SPIRIT 1 was launched in 2005. In fact we entered the first 2 patients and a total of 7 overall. SPIRIT 1 was hard-going for our patients, owing in part to having had 4/7 randomised to Imatinib 400mg + IFN and 3/7 to Imatinib 800mg. I believe also we had the only SUSAR in the study!
It was therefore with some relief that SPIRIT 2 opened to recruitment in late 2008 and I have just entered our 7th patient who drew Dasatinib. Overall we have 5 patients on Dasatinib, 2 patients on Imatinib. Unlike its forerunner, SPIRIT 2 is a very straight forward study to explain to patients, justify the rationale and obtain consent. Whereas a number of patients declined entry to SPIRIT 1, to date no patients have refused to participate in SPIRIT 2. Along with the simple study design, patients can also be confident that their disease undergoes regular monitoring for response against study milestones. Managing patients in clinic is simplified by following the trial protocol for monitoring investigations as well as dose adjustment for any toxicity. In my own experience, patients appear to tolerate Dasatinib well and I have not seen the reported toxicity from studies that used the higher 70mg bd dosing of Dasainib on the 100mg daily dose. We have a data manager to complete the eCRF and act as a point of contact for trial-related issues.
I am also Lead Clinician for the West London Cancer Research Network. I thus promote participation in all NCRI portfolio studies to meet national targets. With the change in R&D funding which now reflects individual Trust’s contribution to NCRI activity, recruitment of patients to these studies has become crucial to maintaining (and in many cases increasing) Trust R&D income. This income, which comes through the Comprehensive Local Research Networks, should be used directly to employ the staff to support NCRI clinical trials activity.
Getting PCT support to fund any excess treatment costs for NCRI studies remains a significant obstacle in my part of the country. This has been a particular issue for funding Myelotarg in AML 17 and is an ongoing issue for Lenalidomide funding in Myeloma XI. Many PCTs and Commissioners are not familiar or even aware of their obligations to fund these costs under the ARCO (Attributing Revenue Costs of Research) Guidance 2005. I am therefore delighted to see that in March 2010, the Department of Health has updated this guidance in a document ‘Guidance on the attribution of NHS non-commercial Research costs, Support Costs and Treatment Costs (ReSeT Guidance).
However SPIRIT 2 is an example of a study where participation in the study saves the NHS a significant amount of money where patients are randomised to Dasatinib. Each patient randomised to Dasatinib is guaranteed at least 5 years’ treatment, and with the study planned to recruit over 3 years, patients could receive up to 8 years of free drug. At today’s list price for Imatinib (since this represents standard treatment), this represents a saving to the NHS of between £96,300 - £154,000 per patient over the 5-8 year study period. Thus in my own PCT we are saving nearly £100,000 per year on treating CML. This is a powerful weapon to use in any discussions about agreeing to the funding of studies which do incur excess treatment costs.
My Registrar has just bought in a GP count and film of another likely new CML. Our patients do seem to arrive in clusters! Another potential candidate for SPIRIT 2.
Dr Richard Kaczmarski
Consutlant Haematologist and Lead Clinician West London Cancer Research Network
Last modified: Fri, 20 Jan 2017 13:21:23 GMT