Journal
EUROPEAN JOURNAL OF CANCER
Volume 50, Issue 5, Pages 902-911Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2013.12.011
Keywords
Neuroendocrine tumour; Randomised clinical trial; Chemotherapy; Capecitabine; Streptozocin; Cisplatin; Phase II
Categories
Funding
- UKI NETS
- National Institute for Health Research, through the National Cancer Research Network
- MRC [MC_UP_1302/2] Funding Source: UKRI
- Medical Research Council [MC_UP_1302/2] Funding Source: researchfish
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Background: Cytotoxic chemotherapy is widely used for advanced, unresectable pancreatic and other gastrointestinal foregut neuroendocrine tumours (NETs) and the most commonly used regimen combines 5-fluorouracil with streptozocin. The NET01 trial was designed to investigate whether capecitabine combined with streptozocin was an acceptable regimen with or without adding cisplatin. Methods: Patients with advanced, unresectable NETs of pancreatic, gastrointestinal foregut or unknown primary site were randomised to receive three-weekly capecitabine (Cap) 625 mg/m(2) twice daily orally, streptozocin (Strep) 1.0 g/m(2) intravenously on day 1, with or without cisplatin (Cis) 70 mg/m(2) intravenously on day 1. The primary outcome measure was objective response. Secondary outcome measures included progression-free and overall survival, quality of life, toxicity and biochemical response. Results: 86 (44 CapStrep, 42 CapStrepCis) patients were randomised. Best objective response rate was 12% (95% confidence interval (CI) = 2-22%) with CapStrep and 16% (95% CI = 4-27%) with CapStrepCis. Disease-control rate was 80% with CapStrep and 74% with CapStrepCis. The estimated median progression-free and overall survival were 10.2 and 26.7 months for CapStrep and 9.7 and 27.5 months for CapStrepCis. 44% of CapStrep and 68% of CapStrepCis patients experienced grade >= 3 adverse events. Interpretation: The efficacies of the novel CapStrep +/- Cis regimens were very similar. CapStrep was better tolerated than CapStrepCis. The trial was registered as EudraCT: 2004-005202-71 and ISRCTN: 35124268. (C) 2014 Elsevier Ltd. All rights reserved.
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