title: Bevacizumab in Combination with Capecitabine plus Irinotecan as First-Line Therapy in Metastatic Colorectal Cancer: A Pooled Analysis of 2 Phase II Trials.
abstract: BACKGROUND
  Although phase III studies have investigated the effect of adding bevacizumab to the 3-weekly capecitabine plus irinotecan (XELIRI) combination in the first-line treatment of metastatic colorectal cancer (mCRC), no phase III studies investigating the effects of adding bevacizumab to biweekly XELIRI have been published.
  
  
  METHODS
  A retrospective pooled analysis of 2 single-arm phase II studies was performed. Previously untreated patients with mCRC received irinotecan 175 mg/m(2) on day 1 followed by capecitabine 1,000 mg/m(2) twice daily on days 2-8 every 2 weeks with or without bevacizumab 5 mg/kg on day 1.
  
  
  RESULTS
  In total, 53 patients received XELIRI, and 46 patients received XELIRI plus bevacizumab. There was a statistically significant increase in partial response rate with XELIRI plus bevacizumab (63 vs. 26% for XELIRI; p = 0.0002) and overall response rate (67 vs. 32%; p = 0.0005). Median time to disease progression was significantly longer with XELIRI plus bevacizumab (12.3 vs. 9.0 months for XELIRI; p = 0.012); median overall survival did not differ significantly between treatments (23.7 vs. 19.3 months; p = 0.4997). The proportion of patients experiencing at least 1 grade 3/4 adverse event was similar with both treatments (XELIRI, 47%; XELIRI plus bevacizumab, 44%).
  
  
  CONCLUSIONS
  This retrospective pooled analysis suggests that XELIRI plus bevacizumab has an acceptable tolerability profile and improves efficacy outcomes compared with XELIRI in the first-line treatment of mCRC.
authors.affiliation: Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain. pgarcaalfonso@gmail.com
authors.forename: Pilar
authors.initials: P
authors.lastname: García Alfonso
authors.forename: Andrés
authors.initials: A
authors.lastname: Muñoz Martin
authors.forename: Sonsoles
authors.initials: S
authors.lastname: Alvarez Suarez
authors.forename: Monserrat
authors.initials: M
authors.lastname: Blanco Codeidido
authors.forename: Rebeca
authors.initials: R
authors.lastname: Mondejar Solis
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Tapia Rico
authors.forename: Pilar
authors.initials: P
authors.lastname: López Martín
authors.forename: Miguel
authors.initials: M
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000068258:Bevacizumab; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D015897:Comorbidity; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D064420:Drug-Related Side Effects and Adverse Reactions / Q000401:mortality*; D019317:Evidence-Based Medicine; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin