title: Vinorelbine and prednisone in frail elderly patients with intermediate-high grade non-Hodgkin's lymphomas.
abstract: BACKGROUND
  Frail patients with non-Hodgkin's lymphoma (NHL) are generally excluded from clinical trials and not even treated. The aim of this study was to evaluate the efficacy and tolerability of vinorelbine and prednisone in frail elderly patients with NHL.
  
  
  METHODS
  Thirty consecutive frail elderly patients were entered in a phase II study with vinorelbine 25 mg/m2 i.v. on days 1 and 8 and oral prednisone 30 mg total dose on days 1-8 for six cycles. Criteria of frailty were age > or =80 years, or age > or =70 years and three or more comorbidities of grade 3 or at least one comorbidity of grade 4 according to the Cumulative Illness Rating Scale (CIRS), or not self-sufficient or the presence of one or more geriatric syndromes.
  
  
  RESULTS
  Of 30 evaluable patients, three (10.0%) achieved a complete response (CR), nine (30.0%) showed a partial response (PR), while 10 presented with stable disease and eight with progressive disease. The median duration of CR was 29 months (range 5-36 months), and the median duration of PR was 1 month (range 1-22 months). Three patients had grade 3 neutropenia and one had grade 4. One grade 4 neurotoxicity was observed. Three patients died because of heart failure within 28 days of therapy, and one patient died after 4 days because of rapid progression. The median overall survival was only 10 months.
  
  
  CONCLUSIONS
  Vinorelbine and prednisone is a relatively non-toxic combination with modest activity in frail patients with NHL. If initial aggressive chemotherapy has been excluded, this combination could be tried to obtain a temporary palliation.
authors.affiliation: Division of Medical Oncology, Azienda Ospedale Università, Padova. silvio.monfardini@unipd.it
authors.forename: S
authors.initials: S
authors.lastname: Monfardini
authors.forename: S M L
authors.initials: SM
authors.lastname: Aversa
authors.forename: V
authors.initials: V
authors.lastname: Zoli
authors.forename: L
authors.initials: L
authors.lastname: Salvagno
authors.forename: A
authors.initials: A
authors.lastname: Bianco
authors.forename: R
authors.initials: R
authors.lastname: Bordonaro
authors.forename: G
authors.initials: G
authors.lastname: Benevolo
authors.forename: M
authors.initials: M
authors.lastname: Crugnola
authors.forename: G
authors.initials: G
authors.lastname: Crivellari
authors.forename: P
authors.initials: P
authors.lastname: Vivaldi
authors.forename: U
authors.initials: U
authors.lastname: Basso
authors.forename: V
authors.initials: V
authors.lastname: Torri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D016330:Frail Elderly; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011241:Prednisone / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077235:Vinorelbine; D011241:Prednisone