Health-related quality of life (HRQoL) of patients with advanced gastrointestinal stromal tumors (GIST) treated with regorafenib (REG) vs placebo (P) in the phase III GRID trial
Background: The GRID trial demonstrated significant improvement in PFS for REG vs P in pts with metastatic GIST after progression on at least imatinib and sunitinib. Exploratory analyses were conducted to assess the effect of treatment on HRQoL.
Methods: The HRQoL analyses were selected a priori based on clinical relevance; the global health status/QoL (QL) and the physical functioning (PF) scales of the EORTC QLQ-C30 questionnaire were used. A linear mixed-effects model was used to examine the treatment effect on HRQoL and trends over time, assuming that missing data were missing at random. Pattern-mixture models were applied to assess the treatment effect while accounting for potentially informative missing data. Time-to-deterioration (TTD) of HRQoL and responder analyses were conducted to determine the treatment effect based on timing and proportion of patients reaching a minimal important difference (MID) change in QL/PF (?10 points).
Results: The QL and PF changes over time were numerically similar between REG and P based on the linear mixed-effects model. The pattern- mixture models grouped patients based on timing of last HRQoL assessment ( P (QL: 6.5 vs 4.0; PF 8.0 vs 4.0 weeks, respectively). Median TTD was comparable between treatments after removing disease progression from the definition. The responder analyses showed that a similar proportion of patients achieved an improvement in MID in REG vs P (QL: 26.2% vs 25.4%; PF: 18.0% vs 15.3%, respectively).
Conclusion: The findings of this exploratory analysis demonstrate that HRQoL is similar for REG and P groups, indicating that REG prolongs PFS vs P while maintaining at least comparable HRQoL.
Bauer, S., Chang, J., Casali, PG., Reichardt, P., Kang, YK., Blay, JY., ... Demetri, GD. (2014). Health-related quality of life (HRQoL) of patients with advanced gastrointestinal stromal tumors (GIST) treated with regorafenib (REG) vs placebo (P) in the phase III GRID trial. Oncology Research and Treatment, 37(Suppl. 1), 58-58.