Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma

Abstract

Background Pancreatic endocrine carcinomas are rare and heterogeneous. Published results concerning treatment of advanced tumours are inconsistent and responses to standard chemotherapy remain unsatisfactory. Aim To investigate the ability of the FOLFIRI regimen to manage progressive unresectable metastatic well-differentiated endocrine carcinomas of the pancreas as first-line chemotherapy. Methods 20 patients with metastatic or advanced well-differentiated endocrine carcinomas of the pancreas and progressive disease were enrolled in a prospective multicentre phase II trial to receive chemotherapy with FOLFIRI schedule (irinotecan 180 mg/m 2 infusion combined with simplified LV5FU2) every 14 days. The primary end point was the non-progression rate at 6 months. Results The 6-month non-progression rate was 80% (95% confidence interval [56–94%]), with stabilisation in 15 patients and 1 objective response. Overall survival at 24 months was 65% [40–82%]. Median progression-free survival was 9.1 months [6.5–17.3 months]. The median number of administered cycles was 12 [range 1–28]. Grade 3/4 haematologic toxicity occurred in 5 patients (25%) and grade 3 digestive toxicity in 11. Conclusion The FOLFIRI regimen, as first-line chemotherapy, achieved stabilisation in most patients whose tumours had been progressing and was well-tolerated. It could be an alternative therapy for advanced well-differentiated endocrine carcinomas of the pancreas.