05 Mar 2014
Chemotherapy is widely used for metastatic, unresectable pancreatic and other foregut neuroendocrine tumours (NETs). The most commonly used regimen combines 5-fluorouracil with steptozocin. The NET-01 trial was designed to investigate whether capecitabine combined with streptozocin was superior without adding cisplatin.
Previous retrospective studies assessing Cis combined with step and 5-FU in 49 patients with pNETs demonstrated a 38% objective response rate. However, to date no prospective trials of cisplatin containing chemotherapy regimens in NETs have been undertaken.
86 patients with metastatic unresectable NET of pancreatic, gastrointestinal foregut or unknown primary site were randomised to receive three weekly capecitabine twice daily orally, streptozocin i.v on day 1 with or without cisplatin on day 1. The primary outcome was objective response, secondary measures included progression free survival, quality of life and overall survival.
Objective response was demonstrated in 12% with capecitabine and streptozocin and 16% with capecitabine, streptozocin and cisplatin. The disease control rate (stable disease) in 80% and 74% respectively. The time to progression was 10.2 for capecitabine and streptozocin and 9.7 months for with capecitabine, streptozocin and cisplatin.
There was no significant difference in response between capecitabine and streptozocin vs. capecitabine, streptozocin and cisplatin. However, capecitabine and streptozocin was better tolerated.
Source: European Journal of Cancer (published study)