A comparison of long-term TKI treatment costs versus TFR in CML.
Research type
Research Study
Full title
A COMPARISON OF LONG-TERM TREATMENT COSTS VERSUS TREATMENT FREE REMISSION FOR CHRONIC MYELOID LEUKAEMIA PATIENTS.
IRAS ID
260636
Contact name
Dragana Milojkovic
Contact email
Sponsor organisation
AHSC Joint Research Compliance Office
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
CML has become a chronic disease that is managed effectively by tyrosine kinase inhibitors (TKI) like imatinib that cause irreversible side-effects. The life expectancy of CML patients is very close to that of the general population, hence there is now a need to study the quality of life (QoL) and economic aspects of CML more closely.
CML patients who have been on therapy for at least 3 years and have had a confirmed and sustained deep molecular response for at least 2 years would have been candidates for stopping treatment. Additionally, other patients would have been forced to stop their TKI treatment due to long-term toxicity. Such patients will be invited to participate regardless of the outcome of their treatment-free remission (TFR) attempt.
Patients will be informed about the study either in one of their regular clinic appointments or by having the study information and questionnaires posted to them. If agreeable to participate they can provide their written informed consent either during their appointment or by post. The study will not alter the treatment course for any patient, and will only invite CML patients who have already attempted to discontinue their treatment.
According to published literature on treatment stopping clinical trials, approximately half of these patients are expected to have relapsed after stopping treatment and would have resumed therapy, while the other half will have remained in TFR.
Patients in both of these cohorts will be invited to participate. Study participants will have their medical data interrogated to extract information on (a) the cost saving from their therapy interruption, and (b) the extra cost of the more frequent monitoring of their disease status and additional intervention that may have been required in case of complications of a TKI withdrawal syndrome.
Participants will be asked to complete four health questionnaires:
1. EORTC QLQ-C30 (both cohorts, validated questionnaire)
2. Hospital Anxiety and Depression Scale (both cohorts, validated questionnaire)
3. TKI withdrawal symptom survey (both cohorts, created for this study)
4. EORTC QLQ-CML24 (only for participants who had to resume TKI therapy, validated questionnaire)REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0109
Date of REC Opinion
4 Apr 2019
REC opinion
Favourable Opinion