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Eur J Cancer. 2014 Mar;50(5):902-11. doi: 10.1016/j.ejca.2013.12.011. Epub 2014 Jan 17.

Capecitabine and streptozocin ± cisplatin in advanced gastroenteropancreatic neuroendocrine tumours.

Author information

1
Neuroendocrine Tumour Unit, The Royal Free Hospital, Pond Street, London, UK; UCL Cancer Institute, London, UK.
2
Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit - Cancer Theme, Addenbrooke's Hospital, Cambridge, UK; Medical Research Council Biostatistics Unit Hub for Trials Methodology, Cambridge, UK.
3
Neuroendocrine Tumour Unit, The Royal Free Hospital, Pond Street, London, UK.
4
Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit - Cancer Theme, Addenbrooke's Hospital, Cambridge, UK.
5
Department of Medical Oncology, The Christie, Manchester, UK.
6
Oxford Neuroendocrine Tumour Centre, Churchill Hospital, Oxford, UK.
7
Gastrointestinal Unit, The Royal Marsden, London, UK.
8
Beatson Oncology Centre, Glasgow, UK.
9
Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.
10
Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit - Cancer Theme, Addenbrooke's Hospital, Cambridge, UK; Oncology Centre, Addenbrooke's Hospital, Cambridge, UK. Electronic address: pippa.corrie@addenbrookes.nhs.uk.

Abstract

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=4-27.4%) 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.

KEYWORDS:

Capecitabine; Chemotherapy; Cisplatin; Neuroendocrine tumour; Phase II; Randomised clinical trial; Streptozocin

PMID:
24445147
DOI:
10.1016/j.ejca.2013.12.011
[Indexed for MEDLINE]
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