title: Treatment of metastatic renal carcinoma patients with the combination of gemcitabine, capecitabine and bevacizumab at a tertiary cancer centre.
abstract: OBJECTIVE
  • To investigate the effect of combining gemcitabine plus capecitabine (GX) with bevacizumab (A) in patients with metastatic RCC previously treated with cytokines and targeted agents.
  
  
  METHODS
  • The combination of GX + A was evaluated in patients with metastatic RCC using institutional databases. • Data included demographics, previous therapies, number of metastatic sites, Memorial Sloan-Kettering Cancer Center risk stratification variables, and previous nephrectomy status. • Descriptive statistics and survival analysis were employed for data analysis.
  
  
  RESULTS
  • Between January 2005 and October 2008, 28 patients were identified. Mean age was 55.7 years. Fifteen (53.57%) patients had been given tyrosine kinase inhibitor (TKI) previously. Nine (32.14%) patients had clear cell histology, 10 (35.71%) patients had sarcomatoid features on histopathology, and 19 patients (67.86%) had a prior nephrectomy. • Initial treatment consisted of G (mean dose 786.07 mg/m²) every 2 weeks, X (mean dose 2.73 g/day), and A (mean dose 10 mg/kg) every 2 weeks. Median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 10.4 months. • In patients with previous TKI therapy, median PFS was 6.2 months and median OS was 11.7 months. • In patients with sarcomatoid features, median PFS was 3.9 months and OS was 9.0 months. • Three patients discontinued one or more of the drugs because of adverse reactions.
  
  
  CONCLUSIONS
  • The combination of GX + A shows potential efficacy and acceptable tolerability in patients with intermediate and poor prognosis metastatic RCC. • Based on these observations, a phase II trial is now underway assessing this combination in patients with sarcomatoid RCC.
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Jonasch
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Lincy S
authors.initials: LS
authors.lastname: Lal
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Atkinson
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Stacey DaCosta
authors.initials: SD
authors.lastname: Byfield
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Lesley Ann
authors.initials: LA
authors.lastname: Miller
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Lance C
authors.initials: LC
authors.lastname: Pagliaro
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Chun
authors.initials: C
authors.lastname: Feng
authors.affiliation: Genitourinary Medical OncologyClinical Pharmacy Services, Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston, TXHealth Economics and Outcomes, i3 Innovus, Eden Prairie, MNUS Outcomes Research, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Nizar M
authors.initials: NM
authors.lastname: Tannir
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D002173:Cancer Care Facilities; D000069287:Capecitabine; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine