title: A phase II study of first-line biweekly capecitabine and bevacizumab in elderly patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  This phase II study was conducted to determine the efficacy and safety of capecitabine and bevacizumab in untreated elderly metastatic colorectal cancer patients.
  
  
  METHODS
  Patients received 1500 mg/m(2)/dose of capecitabine twice daily x 7 days and bevacizumab at 5mg/kg on day 1, in 2 week-cycles.
  
  
  RESULTS
  The study was closed early, due to poor accrual, after a total of 16 patients enrolled. Four patients had an objective response and 11 patients had stable disease. The median time to progression and overall survival were 9.5 and 21.2 months, respectively. The most common grade >or= 3 toxicities included diarrhea (13%) and hand and foot syndrome (25%). Three patients had an arterial thrombotic event and one patient developed a bowel perforation.
  
  
  CONCLUSIONS
  In this underpowered phase II study in elderly patients with metastatic colorectal cancer, capecitabine plus bevacizumab was associated with considerable clinical activity but at an increased risk of hand and foot syndrome and arterial thrombotic events.
authors.affiliation: Department of Medicine at Roswell Park Cancer Institute, United States. ajithkumar.puthillath@roswellpark.org
authors.forename: Ajithkumar
authors.initials: A
authors.lastname: Puthillath
authors.forename: Terry
authors.initials: T
authors.lastname: Mashtare
authors.forename: Gregory
authors.initials: G
authors.lastname: Wilding
authors.forename: Nikhil
authors.initials: N
authors.lastname: Khushalani
authors.forename: Lynn
authors.initials: L
authors.lastname: Steinbrenner
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Ross
authors.forename: Karen
authors.initials: K
authors.lastname: Romano
authors.forename: Michelle
authors.initials: M
authors.lastname: Wisniewski
authors.forename: Marwan G
authors.initials: MG
authors.lastname: Fakih
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D000068258:Bevacizumab; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil