First-line maintenance strategies are a current matter of debate in the management of mCRC. Their impact on patient's health related quality of life (HRQOL) has not yet been evaluated. The objective of this study was to assess whether differences in HRQOL during any active maintenance treatment compared to no maintenance treatment exist.
837 patients with mCRC were enrolled in the AIO KRK 0207 trial. 472 underwent randomization after 24 weeks of induction treatment into one of the maintenance arms: FP plus Bev (arm A), Bev (arm B) or no active treatment (arm C). HRQOL were assessed every 6 weeks during induction and maintenance treatment independent from treatment stop, delay, or treatment modification (e.g. also including assessment after progression), using the EORTC QLQ-C30, QLQ-CR29. The mean value of the global quality of life dimension (GHS/QoL) of the EORTC QLQ-C30, calculated as the average of all available time points after randomization was considered as primary endpoint. Additionally, EORTC QLQ-C30 response scores were analyzed.
For HRQOL analysis, 413 patients were eligible (arm A: 136; arm B: 142, arm C: 135). Compliance rate with HRQOL questionnaires was 95% at time of randomization and remained high during maintenance (98%, 99%, 97% and 97% at week 6, 12, 18 and 24). No significant difference in the mean GHS/QoL scores at week 6, 12, 18, and 24 were observed between treatment arms. GHS/QoL scores deterioration (decrease by 10 points or more) was observed in 20.5%; 17.2 % and 20.7% of the patients, whereas an improvement of at least 10 GHS/QOL scores occurred in 36.1%; 43.8% and 42.1% (arms A, B, C). Compared to PD, non-PD patients had a favorable GHS/Qol score in all arms.
Continuation of an active maintenance treatment with FP/Bev after intensively induction treatment was neither associated with a detrimental effect on GHS/QoL scores when compared to both, less active treatment with Bev alone or no active treatment.
Clinical trial identification
Legal entity responsible for the study
AIO trail with foundation from Roche Pharma
All authors have declared no conflicts of interest.