RESULTS FROM MABEL- QUALITY OF LIFE OF PATIENTS WITH METASTATIC COLORECTAL CARCINOMA (MCRC)
Author(s)
Stephen J Ralston, MSc, Director of Health Policy1, Rob Glynne - Jones, FRCP, FRCR, Consultant Clinical Oncologist, Macmillan Lead Clinician in Gastro-Intestinal Cancer2, Regina Esser, MD, Senior Medical Affairs Advisor31Merck Serono, Feltham, Middlesex, United Kingdom; 2 Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; 3 Merck KGaA, Darmstadt, Germany
OBJECTIVES: The MABEL study is an open label, uncontrolled, multi-centre, study of cetuximab in combination with irinotecan in patients with EGFR expressing mCRC and having progressed on a recent irinotecan-based treatment regimen. A study objective was to assess quality of life (QoL). This abstract will report on findings on 126 patients from 28 UK sites. METHODS: QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EQ-5D. The QLQ-C30 questionnaire comprises 30 items, organised into global health status, functionality, symptomatology and single items. The EQ-5D questionnaire consists of the EQ-5D descriptive system and the Visual Analogue Scale (VAS). QoL changes were assessed on patients with a baseline and at least one post-baseline assessment. RESULTS: At the 6 week assessment, 88 [69.8%] patients completed at least one QoL item, with 71 [56.3%] patients at 12 weeks, and 41 [32.5%] patients at the end of the study visit. Given the loss of two thirds of data by the end of study, the following results will assess data over a 12 week period. Between baseline and 12 weeks the EORTC QLQ-C30 global health score increased slightly from 65.3 – 68.9. Symptomatic scales reported a similar trend with the exception of diarrhoea and financial difficulties single items. The EQ-5D index and VAS also reported a trend for a slight improvement between baseline (0.73 and 0.90 respectively) and 12 weeks (0.77 and 0.93 respectively.) CONCLUSION: It is important to consider these results in context of patient prognosis and treatment administered. The data suggests that patient QoL is maintained following the introduction of cetuximab plus irinotecan over 12 weeks. However, we must be mindful of the population of patients assessed/ followed up, the lack of comparator information and the issues of open label studies.
Conference/Value in Health Info
2007-10, ISPOR Europe 2007, Dublin, Ireland
Value in Health, Vol. 10, No. 6 (November/December 2007)
Code
PCN65
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology