O3-006 - A Phase II Trial of Gemcitabine for Chemo-Naive Metastatic Pancreatic Endocrine Tumor

Abstract

ABSTRACT Background Pancreatic endocrine carcinoma (PEC) is a fairly rare, heterogeneous disease entity. Gemcitabine is generally well tolerated and is active against pancreatic carcinoma and a wide range of malignancies including small-cell lung carcinoma, which shares many clinicopathological features with neuroendocrine carcinoma. Therefore, we conducted a phase II study of gemcitabine for chemo-naive metastatic pancreatic endocrine carcinoma. Methods Histologically proven chemo-naive PEC patients with an inoperable metastatic clinical stage were enrolled. Gemcitabine (1000 mg/m2) was administered as an intravenous 30-min infusion on days 1, 8, and 15 every 28 days. The primary end point of this study was an objective response. Results Fifteen patients were enrolled between January 2005 and December 2010. The median patient age was 59 years (range, 40–69 years). Ten patients (67%) had well-differentiated endocrine carcinoma (WDEC), and five patients (33%) had poorly differentiated endocrine carcinoma (PDEC, WHO 2004). The most common grade 3 or 4 adverse reactions were neutropenia (47%) and leukocytopenia (27%), although all the adverse reactions were tolerable and reversible. One confirmed radiologic response in a PDEC was observed (7% of all eligible patients and 20% of PDEC). Fourteen of the patients had stable diseases, and none of the patients had progressive disease. The median progression-free survival time and overall survival time of WDEC were 10.6 and 50.4 months. The median progression-free survival time and overall survival time of PDEC were 3.2 and 8.5 months, respectively. Conclusion Gemcitabine monotherapy revealed an insufficient response rate. However, gemcitabine seems to have some potentiality of activity in PDEC. In view of the favorable toxicity profile, its evaluation in combination with other agents might be of particular interest in improving the therapeutic results.