title: The efficiency of single agent docetaxel in patients with platinum-refractory non-small cell lung carcinoma.
abstract: BACKGROUND
  To evaluate the efficiency of docetaxel as second line chemotherapy in patients with platinum-refractory non-small cell lung carcinoma (NSCLC).
  
  
  METHODS
  Fifty-two patients with locally advanced or metastatic NSCLC who had platinum-refractory disease (progressed through or within 3 months of completion of first line therapy) and an Eastern Cooperative Oncology Group performance (ECOG) status 0-2 were treated with second-line chemotherapy consisting of single agent docetaxel (100 mg/m(2), intravenously, on day 1 of a 21-day cycle). The median number of treatment cycles was 4 (2-6). Disease-free (DFS) and overall survival (OS), response rates and toxicity were evaluated.
  
  
  RESULTS
  The median progression-free survival of patients was 3 months (95% CI: 0.01-5.99) and overall survival was 7.2 months (95% CI: 2.2-9.5). One-year overall survival rate was 29%. Disease control (complete response, partial response, or stable disease) was achieved in 25 patients (48%) and overall response rate was 13% (7 patients). There were no complete responses. Seventeen patients (33%) had stable disease and twenty-seven patients (52%) had progressive disease. Age, gender, stage at diagnosis (IIIB vs. IV), performance status at initiation of second-line therapy (0-1 vs. 2) histopathological type (epidermoid vs. others), grade, LDH, albumin, weight loss were evaluated as prognostic factors; however, none of these had a significant affect on survivals. The protocol was well tolerated and there were no toxic deaths. Grade III-IV anemia was present in 8 patients (15%) and thrombopenia in 12 (23%) patients. The most frequent grade 3-4 toxicities were leucopenia (52%) and neutropenia (48%). Febril neutropenia occurred in 14 patients (26%). No patients experienced grade III-IV mucositis and diarrhea. Totally, the need of a dose reduction was about 25% and treatment delay (4-9 days) occurred in 5 patients (10%) and 7 patients (13%), respectively, because of toxicity.
  
  
  CONCLUSIONS
  Second-line chemotherapy with single-agent docetaxel offers a small but significant survival advantage with acceptable toxicity for patients with advanced NSCLC who have platinum-refractory disease.
authors.affiliation: Faculty of Medicine, Medical Oncology Department, Kocaeli University, Kocaeli, Turkey.
authors.forename: Kazim
authors.initials: K
authors.lastname: Uygun
authors.forename: Gorkem
authors.initials: G
authors.lastname: Aksu
authors.forename: Irfan
authors.initials: I
authors.lastname: Cicin
authors.forename: Hakan
authors.initials: H
authors.lastname: Karagol
authors.forename: Zafer
authors.initials: Z
authors.lastname: Kocak
authors.forename: Merdan
authors.initials: M
authors.lastname: Fayda
authors.forename: Ahmet
authors.initials: A
authors.lastname: Binici
authors.forename: Fernaz
authors.initials: F
authors.lastname: Uzunoglu
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use; D016879:Salvage Therapy / Q000379:methods; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D017671:Platinum Compounds; D043823:Taxoids; D000077143:Docetaxel