Back to Search
Start Over
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
- Source :
- European Journal of Cancer. 50:3107-3115
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- 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.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 rate15% 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.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 was15% 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%).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.
- Subjects :
- Adult
Male
Oncology
Cancer Research
medicine.medical_specialty
Bevacizumab
Administration, Oral
Neuroendocrine tumors
Antibodies, Monoclonal, Humanized
Deoxycytidine
Disease-Free Survival
Capecitabine
chemistry.chemical_compound
Quality of life
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
In patient
Infusions, Intravenous
Aged
Gastrointestinal Neoplasms
Aged, 80 and over
Response rate (survey)
business.industry
Middle Aged
medicine.disease
Well differentiated
Vascular endothelial growth factor
Neuroendocrine Tumors
Treatment Outcome
chemistry
Female
Fluorouracil
business
medicine.drug
Subjects
Details
- ISSN :
- 09598049
- Volume :
- 50
- Database :
- OpenAIRE
- Journal :
- European Journal of Cancer
- Accession number :
- edsair.doi.dedup.....4b4d57c23ac59fb4526b37799e9f87fc