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Bevacizumab plus capecitabine in patients with progressive advanced well-differentiated neuroendocrine tumors of the gastro-intestinal (GI-NETs) tract (BETTER trial)--a phase II non-randomised trial
Eur J Cancer
1879-0852 (Electronic)0959-8049 (Linking)
Mitry, EmmanuelWalter, ThomasBaudin, EricKurtz, Jean-EmmanuelRuszniewski, PhilippeDominguez-Tinajero, SophieBengrine-Lefevre, LeilaCadiot, GuillaumeDromain, ClarisseFarace, FrancoiseRougier, PhilippeDucreux, MichelengClinical Trial, Phase IIMulticenter StudyResearch Support, Non-U.S. Gov'tEnglandOxford, England : 19902014/12/03 06:00Eur J Cancer. 2014 Dec;50(18):3107-15. doi: 10.1016/j.ejca.2014.10.001. Epub 2014 Oct 18.
AIM OF THE STUDY: Gastro-intestinal neuroendocrine tumours (GI-NETs) are chemotherapy-resistant tumours. Bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF), has shown promising results in several phase II trials of gastro-entero-pancreatic-NETs. We assessed bevacizumab combined with capecitabine, specifically in GI-NET patients. PATIENTS AND METHODS: BEvacizumab in The Treament of neuroEndocrine tumoRs (BETTER) was a multicentre, open-label, non-randomised, two-group phase II trial. Here we present the group of patients with progressive, metastatic, well-differentiated GI-NETs. Patients Eastern Cooperative Oncology Group-performance status (ECOG-PS)2, Ki-67 proliferation rate <15% and no prior systemic chemotherapy were treated with bevacizumab (7.5 mg/kg/q3w) and capecitabine (1000 mg/m2 twice daily, orally d1-14, resumed on d22) for 6-24 months. The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), response rate, safety and quality of life. RESULTS: Of the 49 patients included, 53% were men, median age was 60 years (41-82), primary tumour site was ileal in 82% patients and Ki-67 was <15% in 48 patients and not available for one patient. After a maximum of 24 month follow-up per patient, the median PFS by investigator assessment was 23.4 months [95% confidence interval (CI): 13.2; not reached] and the overall disease control rate was 88% (18% partial response, 70% stable disease). The 2-year survival rate was 85%. Median OS was not reached. The most frequent grade 3-4 adverse events were hypertension (31%), diarrhoea (14%) and hand-foot syndrome (10%). CONCLUSION: The combination of bevacizumab and capecitabine showed clinical activity and a manageable safety profile in the treatment of GI-NETs that warrant confirmation in a randomised phase III trial.
Administration, Oral, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Bevacizumab, Capecitabine, Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives, Disease-Free Survival, Female, Fluorouracil/administration & dosage/adverse effects/analogs & derivatives, Gastrointestinal Neoplasms/*drug therapy/mortality, Humans, Infusions, Intravenous, Male, Middle Aged, Neuroendocrine Tumors/*drug therapy/mortality, Treatment Outcome
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