title: Gemcitabine and paclitaxel combination as second-line chemotherapy in patients with small-cell lung cancer: a phase II study.
abstract: BACKGROUND
  Although small-cell lung cancer is a chemosensitive malignancy, most patients rapidly relapse. Results of second-line treatment are generally poor. We conducted a phase II study to evaluate the activity and toxicity of a combination of gemcitabine and paclitaxel as second-line chemotherapy.
  
  
  METHODS
  Eligible patients were refractory or relapsed small-cell lung cancer, with an Eastern Cooperative Oncology Group performance status of 0-2 and measurable disease. Paclitaxel was administered at 135 mg/m(2) days 1 and 8 immediately followed by gemcitabine at 1000 mg/m(2) every 3 weeks up to 6 courses. Restaging of disease was scheduled every 3 courses.
  
  
  RESULTS
  Forty-one patients were enrolled. The median age was 65 years. Nineteen patients were considered refractory (progressive disease during or within 90 days from completion of first-line treatment), whereas 22 patients were chemotherapy sensitive. A total of 135 courses was administered (range, 1-6; median, 3). Nine patients achieved a partial remission (partial response, 22%), and 10 patients had stable disease (24%), with a disease control rate (partial response + stable disease) of 46%: in 12 (55%) of 22 patients who were sensitive and in 7 (37%) of 19 patients with refractory disease, respectively. All partial responses but one were observed in the sensitive group. The median duration of response was 5 months. The most-frequent severe toxicities were neutropenia grade 3-4 and neurologic grade 3 in 24% and 7% of delivered courses, respectively.
  
  
  CONCLUSIONS
  The combination of gemcitabine and paclitaxel investigated in our study achieved a high disease control rate, but the schedule we adopted appeared to be quite toxic.
authors.affiliation: IRST: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC), Italy. c.dazzi@ausl.ra.it
authors.forename: Claudio
authors.initials: C
authors.lastname: Dazzi
authors.forename: Anna
authors.initials: A
authors.lastname: Cariello
authors.forename: Claudia
authors.initials: C
authors.lastname: Casanova
authors.forename: Alberto
authors.initials: A
authors.lastname: Verlicchi
authors.forename: Marco
authors.initials: M
authors.lastname: Montanari
authors.forename: Giorgio
authors.initials: G
authors.lastname: Papiani
authors.forename: Eva
authors.initials: E
authors.lastname: Freier
authors.forename: Valentina
authors.initials: V
authors.lastname: Mazza
authors.forename: Carlo
authors.initials: C
authors.lastname: Milandri
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gamboni
authors.forename: Maximilian
authors.initials: M
authors.lastname: Papi
authors.forename: Maurizio
authors.initials: M
authors.lastname: Leoni
authors.forename: Giorgio
authors.initials: G
authors.lastname: Cruciani
authors.forename: Bernadette
authors.initials: B
authors.lastname: Vertogen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009422:Nervous System Diseases / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine