Evaluation of Maintenance Capecitabine Therapy After First-Line Chemotherapy in Metastatic Pancreatic Cancer.

Objective

To assess the clinical impact of maintenance capecitabine following first-line modified FOLFIRINOX in patients with metastatic pancreatic cancer (mPC), focusing on progression-free survival (PFS), overall survival (OS), quality of life (QoL), and the toxicity profile.

Methods

This phase II prospective trial, 60 patients with histologically confirmed stage IV pancreatic adenocarcinoma (ECOG PS ≤1, normal organ function, and measurable metastatic disease) who were enrolled after completing modified FOLFIRINOX. Participants were randomized into two groups: Arm A received maintenance capecitabine, and Arm B underwent observation only.

Results

Baseline patient and disease characteristics were comparable between both groups. The pancreatic head was the predominant tumor site (73.3% in Arm A vs. 86.7% in Arm B). After six months of maintenance therapy, stable disease was reported in 33.3% of Arm A and 0% of Arm B. Toxicity levels were not significantly different. Patients in Arm B demonstrated earlier deterioration in QoL, with median time to decline of 3.2 months compared with 6.9 months in Arm A. Median PFS and OS favored the capecitabine arm (6.13 vs. 3.57 months and 14.20 vs. 10.97 months, respectively). Multivariate Cox regression confirmed treatment arm as the most independent prognostic factor influencing both PFS and OS.

Conclusion

Maintenance capecitabine after first-line modified FOLFIRINOX in mPC was well tolerated and may enhance PFS and OS while maintaining an acceptable quality of life.