title: Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG).
abstract: BACKGROUND
  Colorectal cancer (CRC) is a disease of the elderly. However, geriatric patients are often excluded from clinical trials. The combination of capecitabine, oxaliplatin and bevacizumab (XELOX/BEV) has not been assessed in an elderly population.
  
  
  METHODS
  We conducted a phase II study of XELOX plus bevacizumab combination as first line treatment in elderly patients with metastatic CRC. Treatment consisted of capecitabine 750 mg/m2 twice a day during days 1-7, oxaliplatin 85 mg/m2 and bevacizumab 5 mg/kg on day 1. Treatment was repeated every 14 days. The primary endpoint was overall response rate.
  
  
  RESULTS
  In the 48 enrolled patients response rate according was 46.8% (95% CI: 32.54%-61.07%), while 13 patients had stable disease, for an overall disease control rate of 74.4% (95% CI: 57.8-91.2). Progression free survival was 7.9 months (95% CI: 5.9-9.8 months) and the median overall survival 20.1 months (95% CI: 15.6-25.7 months). Response rate and progression free survival has been correlated with baseline albumin and haemoglobin levels. There was one treatment-related death. Grade 3-4 toxicities were asthenia (4.2%), neurotoxicity (2.1%) and diarrhea 6.3%).
  
  
  CONCLUSIONS
  The combination of capecitabine, oxaliplatin and bevacizumab is an effective and safe combination for the treatment of elderly patients with metastatic CRC.
  
  
  BACKGROUND
  Clinical trials NCT01024504, 26 November 2010.
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Alexios
authors.initials: A
authors.lastname: Matikas
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karampeazis
authors.forename: Dora
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: Stelios
authors.initials: S
authors.lastname: Kakolyris
authors.forename: Charalampos
authors.initials: C
authors.lastname: Christophylakis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Boukovinas
authors.forename: Aris
authors.initials: A
authors.lastname: Polyzos
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470 Athens, Greece. johnsougl@gmail.com.
authors.forename: John
authors.initials: J
authors.lastname: Souglakos
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil
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