Longitudinal assessment of health-related quality of life in patients with borderline and locally advanced pancreatic cancer undergoing neoadjuvant FOLFIRINOX chemotherapy: results from a prospective multicenter trial.

PURPOSE: Pancreatic ductal adenocarcinoma (PDAC) carries a poor prognosis and significantly affects health-related quality of life (HRQoL). In borderline resectable (BR) and locally advanced (LA) PDAC, neoadjuvant FOLFIRINOX may enable surgical resection, but its toxicity can further compromise HRQoL. Evidence on longitudinal HRQoL changes during FOLFIRINOX in this context remains limited. This study evaluated HRQoL trajectories in patients with BR and LA PDAC receiving neoadjuvant chemotherapy (NACT) within a surgical selection strategy.

METHODS

This longitudinal analysis included patients from the multicenter prospective PeRFormanCe trial (NCT05298722), investigating outcomes in BR and LA PDAC treated with FOLFIRINOX as NACT. HRQoL was assessed at baseline and after 4, 8, and 12 NACT cycles using EORTC QLQ-C30 and PAN26 questionnaires. Changes over time were analyzed using linear mixed-effect models. Clinically meaningful differences were defined as ≥10-point mean changes with 95% confidence intervals.

RESULTS

Twenty patients were included (35% female), 12 (60%) had LA PDAC. The median number of NACT cycles was 8 (IQR 7-12). Sixteen patients (80%) underwent surgical exploration, and 11 (55%) achieved resection. During NACT, patients reported improvements in insomnia, pain, hepatic symptoms, bloating and appetite loss. Muscle weakness, cognitive deterioration, and side effects increased. Among patients completing 12 cycles, weight loss and flatulence decreased, global health status (baseline 64, SE 4.05) and fatigue scores improved.

CONCLUSION

In patients with BR and LA PDAC treated with FOLFIRINOX as NACT, HRQoL can be preserved over time despite variations in symptoms. These findings contribute to informed, patient-centered decision-making in the neoadjuvant setting.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05298722. Date of registration March 28, 2022.