5239 - Health-related quality of life in patients with advanced soft tissue sarcoma (ASTS): Results from the TSAR randomized phase III trial of the French Sarcoma Group

Background

The randomized phase III TSAR trial (NCT02672527) showed a statistically significant progression-free survival (PFS) benefit with trabectedin compared to best supportive care (BSC) in pretreated patients with ASTS. Our objective is to report health-related quality of life (HRQoL) which was one of the secondary endpoints of the trial.

Methods

A total of 103 patients with ASTS who failed at least one anthracycline-containing chemotherapy regimen were randomized in the TSAR study. Patients allocated to BSC could receive trabectedin in case of progressive disease. The median follow-up was 26 months. HRQoL was assessed by the EORTC QLQ-C30 questionnaire administered at randomization and every 6 to 8 weeks thereafter. Scores range from 0 to 100. A high score for functional scales or global dimensions represents a high level of functioning/QoL whereas a high score for symptom scales represents poorer outcomes. All QLQ-C30 mean scores were estimated using mixed models for repeated measures adjusted for age, gender and histology.

Results

The rate of completion decreased over time from 92% at randomization to 60% at 8 month. There were no statistical differences between the two arms for any domain. The adjusted mean global health status score over the complete follow-up was 60 [95% CI: 55-65] in trabectedin arm and 63 [95% CI: 58-68] in BSC arm. Adjusted mean scores for functioning scales indicated good HRQoL (> 65) in both arms over the study period. Physical functioning adjusted mean scores was 71 in both therapeutic arms, 64 and 67 for role functioning in trabectedin and BSC arms respectively, 77 and 73 for emotional functioning, 84 and 83 for cognitive functioning and 71 and 78 for social functioning. Adjusted mean scores for functioning scales were stable over the study period. Adjusted mean scores for symptoms were below 30 for most items except for fatigue (42 for trabectedin and 43 for BSC) and pain (34 in both therapeutic arms).

Conclusions

This study suggests that trabectedin allows increasing PFS without impairing HRQoL in patients with ASTS. However, HRQoL did not differ whether or not patients received trabectedin earlier in the treatment pathway.

Clinical trial identification

NCT02672527.

Legal entity responsible for the study

Gustave Roussy.

Funding

PharmaMar.

Editorial Acknowledgement

Disclosure

A. Le Cesne: Advisory boards: Pfizer, Bayer, Lilly, Amgen, Novartis, PharmaMar. J. Bonastre: Advisory boards: BMS, MSD. All other authors have declared no conflicts of interest.