KEY TAKEAWAYS
- The FIGHT study (NCT03694522) was a randomized, double-blind phase II trial that evaluated the effects of incorporating Fentanyl BEMA into the mFOLFOX6 regimen on HRQoL.
- HRQoL was assessed through the EORTC QLQ-C30 and EQ-5D-5L surveys at various intervals during the treatment period.
- Incorporating BEMA into mFOLFOX6 exhibited enhanced clinical outcomes while maintaining the quality of life without any decline in HRQoL.
- The QLQ-C30 and EQ-5D questionnaires exhibited high completion rates (>90%) in both treatment groups, and the mean differences were obtained.
- The assessment of HRQoL will be subjected to further evaluation during the ongoing confirmatory phase III FORTITUDE-101 trial (NCT05052801).
The randomized, double-blind phase II FIGHT study (NCT03694522) revealed that the median progression-free survival (PFS) at primary analysis (data cutoff [DCO] September 2020) was 9.5 months (m) with BEMA + mFOLFOX6 compared to 7.4m with PBO + mFOLFOX6 (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.44–1.04). During the DCO in February 2021, the median overall survival (OS) was observed to be 19.2 months compared to 13.5 months, respectively. The hazard ratio (HR) was 0.60, with a 95% confidence interval (CI) of 0.38-0.94. The study evaluated the effects of incorporating BEMA into the mFOLFOX6 regimen on Health-Related Quality of Life (HRQoL) in the FIGHT trial.
The post-hoc analyses of the patient’s health-related quality of life (HRQoL) conducted in February 2021 were founded on the EORTC QLQ-C30 and EQ-5D-5L surveys. These surveys were given to the patient before or on the first day of the study, six weeks after the first day, and subsequently every eight weeks during the treatment period. The surveys were also conducted during the final treatment visit. The alterations in QLQ-C30 scales and EQ-5D (visual analog scale [VAS]), and Utility Index were assessed through mixed models for repeated measures. The TTD in the QLQ-C30 scales was evaluated using Kaplan-Meier estimates and Cox models. This assessment was conducted to determine when the patient’s condition deteriorated by 10 points or more or resulted in death.
A total of 155 patients were subjected to randomization in the Fentanyl Buccal Tablet (BEMA) study, with 77 patients assigned to the BEMA arm and 78 patients assigned to the placebo (PBO) arm. Per the established protocol, the QLQ-C30 and EQ-5D questionnaires exhibited high completion rates (>90%) in both treatment groups. The mean differences obtained through the least squares method from the baseline in QLQ-C30 and EQ-5D were comparable between the treatment groups. Notably, the BEMA arm showed numerical superiority in various scales such as social, role, cognitive, and emotional functioning, as well as VAS after six weeks. The study arms exhibited similarity in terms of time to disease deterioration (TTD). Incorporating BEMA into mFOLFOX6 exhibited enhanced clinical outcomes while maintaining the quality of life without any decline in HRQoL. The assessment of HRQoL will be subject to further evaluation during the ongoing confirmatory phase III FORTITUDE-101 trial (NCT05052801).
Source: https://oncologypro.esmo.org/meeting-resources/esmo-congress/health-related-quality-of-life-hrqol-in-fgfr2b-overexpressing-advanced-gastric-or-gastroesophageal-junction-cancer-g-gejc-results-from-the-fi
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT03694522
Z.A. Wainberg, P.C. Enzinger, S. Qin, K. Yamaguchi, A. Gnanasakthy, A. Jamotte, I. Majer, Y. Kang/ Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): Results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6/ ESMO Congress | OncologyPRO. (n.d.). Oncologypro.esmo.org. Retrieved April 30, 2023, from https://oncologypro.esmo.org/meeting-resources/esmo-congress/health-related-quality-of-life-hrqol-in-fgfr2b-overexpressing-advanced-gastric-or-gastroesophageal-junction-cancer-g-gejc-results-from-the-fi
