Impact of imatinib rechallenge on health-related quality of life in patients with TKI-refractory gastrointestinal stromal tumours: Sub-analysis of the placebo-controlled, randomised phase III trial (RIGHT).

INTRODUCTION

The RIGHT trial demonstrated that resumption of imatinib significantly improves progression-free survival in patients with tyrosine-kinase inhibitor-refractory gastrointestinal stromal tumours. The impact of imatinib on health-related quality of life (QoL) was assessed in a preplanned sub-analysis.

METHOD AND MATERIALS

QoL was assessed at baseline and every 4 weeks using European Organization for Research and Treatment Quality of Life Questionnaire C30, version 3.0. QoL data were collected only during the double-blind treatment period. The evolution of QoL parameters over time was assessed by analysis of variance with repeated measures, and comparisons between the two arms at each treatment cycle were performed by analysis of covariance after adjusting for baseline values.

RESULTS

At baseline, 4 weeks, and 8 weeks after treatment, 35 (88% of enrolled patients), 32 (82%), and 21 (95%) patients in the placebo arm and 37 (90%), 33 (85%), and 25 (83%) patients in the imatinib arm, respectively, were evaluable for QoL analysis. In the longitudinal comparison, no differences in global health status/QoL, functioning and other symptom scales were observed between the two groups, although insomnia was significantly worse in the placebo group (p = 0.02). Cross-sectionally, at 8 weeks, pain was better (p = 0.04) and nausea/vomiting, appetite loss, and diarrhoea were worse (p = 0.002, p = 0.01, and p = 0.04, respectively) in the imatinib group than in the placebo group, with no differences in global health status/QoL and functional scales.

CONCLUSION

Despite the toxicity of imatinib, QoL was not impaired in this fragile patient population. The benefits of imatinib rechallenge outweigh its toxicities, supporting its clinical relevance for patients without active treatment options.