title: A phase II study of capecitabine, oxaliplatin, and bevacizumab in the treatment of metastatic esophagogastric adenocarcinomas.
abstract: BACKGROUND
  Esophageal and gastric cancers often present at an advanced stage. Systemic chemotherapy is the mainstay of treatment, but survival with current regimens remains poor. We evaluated the safety, tolerability, and efficacy of the combination capecitabine, oxaliplatin, and bevacizumab in the treatment of metastatic esophagogastric adenocarcinomas.
  
  
  METHODS
  Thirty-seven patients with metastatic or unresectable gastric/gastroesophageal junction tumors were enrolled and treated with capecitabine 850 mg/m(2) BID on days 1-14, and oxaliplatin 130 mg/m(2) with bevacizumab 15 mg/kg on day 1 of a 21-day cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints included response rate (RR) and overall survival (OS). Neuropilin-1 (NRP1) and -2 (NRP2) mRNA expression was evaluated in archived tumor.
  
  
  RESULTS
  Thirty-five patients were evaluable for efficacy. Median PFS was 7.2 months; median OS was 10.8 months. RR was estimated at 51.4%. The regimen was tolerable with expected drug class-related toxicities. NRP2 mRNA levels significantly correlated with PFS (p = 0.042) and showed a trend toward significance with OS (p = 0.051). Nonsignificant trends for NRP1 were noted for higher expression levels and worse outcome.
  
  
  CONCLUSIONS
  Bevacizumab can be given safely with chemotherapy in patients with metastatic esophagogastric adenocarcinomas. The combination of capecitabine, oxaliplatin, plus bevacizumab has activity comparable to other bevacizumab-containing regimens in metastatic gastroesophageal cancer.
authors.affiliation: Duke Cancer Institute, Durham, North Carolina 27710, USA.
authors.forename: Hope E
authors.initials: HE
authors.lastname: Uronis
authors.forename: Johanna C
authors.initials: JC
authors.lastname: Bendell
authors.forename: Ivy
authors.initials: I
authors.lastname: Altomare
authors.forename: Gerard C
authors.initials: GC
authors.lastname: Blobe
authors.forename: S David
authors.initials: SD
authors.lastname: Hsu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Morse
authors.forename: Herbert
authors.initials: H
authors.lastname: Pang
authors.forename: S Yousuf
authors.initials: SY
authors.lastname: Zafar
authors.forename: Paul
authors.initials: P
authors.lastname: Conkling
authors.forename: Justin
authors.initials: J
authors.lastname: Favaro
authors.forename: Christy C
authors.initials: CC
authors.lastname: Arrowood
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Cushman
authors.forename: Kellen L
authors.initials: KL
authors.lastname: Meadows
authors.forename: John C
authors.initials: JC
authors.lastname: Brady
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Nixon
authors.forename: Herbert I
authors.initials: HI
authors.lastname: Hurwitz
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004943:Esophagogastric Junction / Q000473:pathology*; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil