التفاصيل البيبلوغرافية
| العنوان: |
Sorafenib and bevacizumab combination targeted therapy in advanced neuroendocrine tumour: A phase II study of Spanish Neuroendocrine Tumour Group (GETNE0801). |
| المؤلفون: |
Castellano, Daniel1 cdanicas@hotmail.es, Capdevila, Jaume2, Sastre, Javier3, Alonso, Vicente4, Llanos, Marta5, García-Carbonero, Rocío6, Manzano Mozo, José Luis7, Sevilla, Isabel8, Durán, Ignacio9, Salazar, Ramón10 |
| المصدر: |
European Journal of Cancer. Dec2013, Vol. 49 Issue 18, p3780-3787. 8p. |
| مصطلحات موضوعية: |
*ANTINEOPLASTIC agents, *CANCER chemotherapy, *COMBINATION drug therapy, *CLINICAL trials, *NEUROENDOCRINE tumors, *BEVACIZUMAB, *DESCRIPTIVE statistics |
| مستخلص: |
Abstract: Background: Sorafenib and bevacizumab as single agents have shown efficacy and acceptable toxicity in NETs phase II trials. Sorafenib and bevacizumab combination has shown manageable toxicity in phase I trials in solid tumours. The purpose of this study was to evaluate the safety and efficacy of the combination of sorafenib and bevacizumab in patients with advanced neuroendocrine tumours. Methods: Open-label, uncontrolled, multicenter, phase II clinical trial. Eligibility criteria: age⩾18years, histologically confirmed measurable advanced NETs; 1 prior chemotherapy allowed; ECOG-PS 0–2. Patients were treated during 6months and followed up for an additional 6months. Treatment: sorafenib 200mg bid (days 1–5 of each week) and bevacizumab 5mg/kg once every 2weeks (day 1, week 1). Tumour response was performed according to RECIST (v1.0) every 2months during the treatment period. Adverse events were graded according to CTCAE (v3.0). Findings: 44 Patients enrolled, 59.1% men, median age 60years (range 32–76). 70.5% carcinoid tumours, 29.5% pancreatic tumour. Baseline target lesions mainly in the liver (86.4%). Global PFSR was 90.9% (91.7% carcinoid tumours and 88.9% pancreatic tumours). Median PFS was 12.4months, median TTP was 14.5months, ORR was 9.4% and DCR was 95.1%. Most common grade 3–4 toxicities: asthenia (11.4%) and hand–foot skin reaction (15.9%). Interpretation: Sorafenib and bevacizumab combination showed clinical benefit but unfavourable safety results compared with drugs in monotherapy. Further development of this combination is not warranted and a sequential approach is recommended instead. [Copyright &y& Elsevier] |
| قاعدة البيانات: |
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