title: Weekly paclitaxel in elderly patients (aged > or = 70 years) with advanced non-small-cell lung cancer: an alternative choice? Results of a phase II study.
abstract: OBJECTIVE
  Paclitaxel and platinum-based chemotherapy is considered to be a standard approach for locally advanced and metastatic non-small-cell lung cancer (NSCLC). In recent years, weekly paclitaxel has been widely used for its safety profile, especially in breast and ovarian cancer. Otherwise, only a few studies are available in NSCLC. The aim of our study was to investigate the activity and safety of weekly paclitaxel in elderly patients with locally advanced (stage IIIB) and metastatic (stage IV) NSCLC.
  
  
  METHODS
  Twenty-seven patients entered the study; 10 had stage IIIB disease (5 "wet" and 5 "dry"), and 17 had stage IV disease. Median age was 73 years (range, 70-83 years). Sixteen patients (59%) presented with comorbidities. The schedule was weekly paclitaxel 80 mg/m2 for 6 weeks with 2 weeks of rest (1 cycle).
  
  
  RESULTS
  All patients were evaluable for response and toxicity; a median of 1 cycle was administered (range, 1-5 cycles). Partial responses were recorded in 9 patients (37.5%; 33.3%, according to intention-to- treat analysis; 95% CI, 15.5%-51.1%); 7 had stable disease (29%), and 8 had progressive disease (33.5%). Median time to progression was 5 months (range, 1-23 months), and median survival was 12 months (range, 1-36 months). Grade 2/3 asthenia was the main toxicity in 7 patients (29%); a hypersensitivity reaction presented in 1 patient. No other episode of grade 3/4 toxicity was recorded.
  
  
  CONCLUSIONS
  Our study confirmed that paclitaxel 80 mg/m2 weekly is active in patients with locally advanced and metastatic NSCLC with a good safety profile; this schedule might be considered an alternative choice to gemcitabine or vinorelbine as first-line treatment in elderly patients, particularly patients with comorbidities. Phase III studies that compare these third-generation drugs are warranted to draw definitive conclusion about the best approach in these patients.
authors.affiliation: Oncology Unit, S. Salvatore Hospital, Pesaro, Italy. d.rossi63@libero.it
authors.forename: David
authors.initials: D
authors.lastname: Rossi
authors.forename: Donatella
authors.initials: D
authors.lastname: Dennetta
authors.forename: Marcello
authors.initials: M
authors.lastname: Ugolini
authors.forename: Paolo
authors.initials: P
authors.lastname: Alessandroni
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Stefano Luzi
authors.initials: SL
authors.lastname: Fedeli
authors.forename: Paolo
authors.initials: P
authors.lastname: Giordani
authors.forename: Virginia
authors.initials: V
authors.lastname: Casadei
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Baldelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Graziano
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Catalano
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001932:Brain Neoplasms / Q000188:drug therapy / Q000556:secondary; D002277:Carcinoma / Q000188:drug therapy / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000556:secondary; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008297:Male; D017239:Paclitaxel / Q000627:therapeutic use*; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel