title: Pilot study of an outpatient-based approach for advanced lymphoma using vinorelbine, gemcitabine and filgrastim.
abstract: BACKGROUND
  Vinorelbine and gemcitabine have demonstrable single-agent activity against lymphoma, show differing toxicity profiles and can be given in an outpatient setting.
  
  
  OBJECTIVE
  We have evaluated the feasibility of an outpatient-based combination of vinorelbine and gemcitabine with filgrastim support (VGF) in patients with advanced lymphoma.
  
  
  METHODS
  An open-label, single-arm study of 40 consecutive patients with relapsed (n = 24) or refractory (n = 16) lymphoma was undertaken. The median number of prior regimens was three (range 1-11) and 12 had undergone prior stem cell transplantation. Patients received vinorelbine 25 mg/m(2) and gemcitabine 1000 mg/m(2) on days 1 and 8 of each 21-day cycle. Patients showing no response after two cycles (early response) were offered alternative therapy. Responding patients received two more cycles. Primary end-points were the early and overall response rates.
  
  
  RESULTS
  One hundred and sixteen cycles of therapy were delivered. Hospital admissions were required following 27 treatment cycles (24%), predominantly following cycle 1. Febrile neutropenia followed 6% of cycles. The early and overall response rates on an intention-to-treat basis were 60 and 53%, respectively. Responses for peripheral T-cell lymphoma and Hodgkin lymphoma were particularly encouraging, 70 and 75%, respectively. With a median follow up of 34 months overall survival for the entire cohort at 2 years is 50%. Furthermore, for the 23 patients who did not receive high-dose consolidative therapy 2-year survival was 35%.
  
  
  CONCLUSIONS
  Vinorelbine and gemcitabine with filgrastim support can be safely delivered in an outpatient setting and shows clinically meaningful activity against a range of advanced lymphoma subtypes.
authors.affiliation: Clinical Haematology and BMT, Alfred Hospital, and Myeloma Research Group, Alfred Hospital, Melbourne, Victoria, Australia. aspencer@netspace.net.au
authors.forename: A
authors.initials: A
authors.lastname: Spencer
authors.forename: K
authors.initials: K
authors.lastname: Reed
authors.forename: C
authors.initials: C
authors.lastname: Arthur
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010865:Pilot Projects; D011994:Recombinant Proteins; D016879:Salvage Therapy; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D011994:Recombinant Proteins; D003841:Deoxycytidine; D016179:Granulocyte Colony-Stimulating Factor; D014747:Vinblastine; D000069585:Filgrastim; D000077235:Vinorelbine; D000093542:Gemcitabine