Author/Editor		Cunningham, David; Lang, Istvan; Marcuello, Eugenio; Lorusso, Vito; Ocvirk, Janja; Shin, Dong Bok; Jonker, Derek J.; Osborne, Stuart; Andre, Niko Alexander; Waterkamp, Daniel; Saunders, Mark
Title		Bevacizumab plus capecitabine versus capecitabine alone inelderly patients with previously untreated metastatic colorectal cancer (AVEX)
Type		članek
Vol. and No.		Letnik 14, št. 11
Publication year		2013
Volume		str. 1077-1085
ISSN		1470-2045 - The lancet oncology
Language		eng
Abstract		Background Elderly patients are often under-represented in clinical trials of metastatic colorectal cancer. We aimed toassess the effi cacy and safety of bevacizumab plus capecitabine compared with capecitabine alone in elderly patientswith metastatic colorectal cancer. Methods For this open-label, randomised phase 3 trial, patients aged 70 years and older with previously untreated,unresectable, metastatic colorectal cancer, who were not deemed to be candidates for oxaliplatin-based or irinotecanbasedchemotherapy regimens, were randomly assigned in a 1:1 ratio via an interactive voice-response system, stratifi edby performance status and geographical region. Treatment consisted of capecitabine (1000 mg/m orally twice a day ondays 114) alone or with bevacizumab (75 mg/kg intravenously on day 1), given every 3 weeks until disease progression,unacceptable toxic eff ects, or withdrawal of consent. Effi cacy analyses were based on the intention-to-treat population. The primary endpoint was progression-free survival. The trial is registered with ClinicalTrials.gov, number NCT00484939.Findings From July 9, 2007, to Dec 14, 2010, 280 patients with a median age of 76 years (range 7087) were recruitedfrom 40 sites across ten countries. Patients were randomly assigned to receive either bevacizumab plus capecitabine(n=140) or capecitabine only (n=140). Progression-free survival was signifi cantly longer with bevacizumab andcapecitabine than with capecitabine alone (median 91 months [95% CI 73114] vs 51 months [4263]; hazardratio 053 [041069]; p<00001). Treatment-related adverse events of grade 3 or worse occurred in 53 (40%) patientsin the combination group and 30 (22%) in the capecitabine group, and treatment-related serious adverse events in19 (14%) and 11 (8%) patients. The most common grade 3 or worse adverse events of special interest for bevacizumabor chemotherapy were hand-foot syndrome (21 [16%] vs nine [7%]), diarrhoea (nine [7%] vs nine [7%]), and venousthromboembolic events (11 [8%] vs six [4%]). Treatment-related deaths occurred in fi ve patients in the combinationgroup and four in the capecitabine group. The most common any-grade adverse event of special interest forbevacizumab was haemorrhage (34 [25%] vs nine [7%]).Interpretation The combination of bevacizumab and capecitabine is an eff ective and well-tolerated regimen for elderlypatients with metastatic colorectal cancer.
Keywords		rak debelega črevesa in danke metastaze kemoterapija starejši bolniki colorectal cancer metastatic colorectal cancer elderly patients chemotherapy