title: The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer: a phase III randomized FONICAP trial. Italian Lung Cancer Task Force.
abstract: OBJECTIVE
  To evaluate the efficacy and treatment compliance in elderly patients with advanced non-small cell lung cancer (NSCLC) of two chemotherapeutic agents with mild toxicity, 153 previously untreated patients aged over 70 years were randomized to receive lonidamine (450 mg daily p.o. until progression), vindesine (3 mg/m2/daily i.v. weekly for 4 weeks and then every 2 weeks until progression), the combination of the two drugs at the same dose and schedule, or supportive therapy only in a four-arm factorial randomized trial.
  
  
  METHODS
  126 patients were included in the final analysis. Their median age was 75 years. Forty percent had stage IV disease and 60% stage III. Most patients were males (85%) and the majority had squamous histology (68%).
  
  
  RESULTS
  Among 104 patients evaluable for response there were only 3 PRs (1/30 in the lonidamine arm and 2/33 in the lonidamine + vindesine arm). Overall, 8.7% and 9.5% of the patients, respectively, progressed or died early, before response evaluation; another 9.4% refused treatment continuation because of poor compliance with the study protocol. Eighty-five patients were fully evaluable for toxicity, which was generally mild. Leukopenia grade 1-3 was found in less than 30% of patients treated with vindesine or vindesine + lonidamine. The most common complaints associated with lonidamine treatment were myalgia (70% of patients), fatigue (55% and 83% of patients treated with lonidamine or lonidamine + vindesine, respectively) and testicular pain in nearly 40% of cases. The overall median survival was 170 days, with no significant impact on survival of either lonidamine or vindesine.
  
  
  CONCLUSIONS
  The low response rate and survival together with the poor treatment compliance, even in the presence of mild toxicity, do not support the usefulness of these "gentle" chemotherapies in elderly NSCLC patients. The standard management of advanced NSCLC in elderly patients remains to be defined. Specifically designed studies to address this issue are warranted.
authors.affiliation: Divisione di Pneumologia Oncologica, Ospedale Forlanini, Roma, Rome, Italy. filippo@sirio-oncology.it
authors.forename: F
authors.initials: F
authors.lastname: De Marinis
authors.forename: M
authors.initials: M
authors.lastname: Rinaldi
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoni
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: M C
authors.initials: MC
authors.lastname: Pennucci
authors.forename: L
authors.initials: L
authors.lastname: Portalone
authors.forename: M
authors.initials: M
authors.lastname: D'Aprile
authors.forename: P
authors.initials: P
authors.lastname: Ripanti
authors.forename: F
authors.initials: F
authors.lastname: Romano
authors.forename: M
authors.initials: M
authors.lastname: Belli
authors.forename: G
authors.initials: G
authors.lastname: Altavilla
authors.forename: M R
authors.initials: MR
authors.lastname: Migliorino
authors.forename: R
authors.initials: R
authors.lastname: Rosso
authors.forename: F
authors.initials: F
authors.lastname: Salvati
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007191:Indazoles; D014751:Vindesine; C016371:lonidamine