title: Docetaxel versus docetaxel plus cisplatin as front-line treatment of patients with advanced non-small-cell lung cancer: a randomized, multicenter phase III trial.
abstract: OBJECTIVE
  To compare the overall survival (OS) of patients with advanced non-small-cell lung cancer (NSCLC) treated with docetaxel plus cisplatin (DC) or docetaxel (D) alone.
  
  
  METHODS
  Chemotherapy-naïve patients with advanced/metastatic NSCLC were randomly assigned to receive either DC (n = 167; docetaxel 100 mg/m(2) on day 1, cisplatin 80 mg/m(2) on day 2, and recombinant human granulocyte colony-stimulating factor (rhG-CSF) 150 microg/m(2)/d on days 3 to 9) or D (n = 152; 100 mg/m(2) on day 1 without rhG-CSF) every 3 weeks.
  
  
  RESULTS
  The overall response rates were 36.5% for DC (three complete responses and 58 partial responses) and 21.7% for D (one complete response and 32 partial responses; P =.004). The median OS was 10.5 months (range, 0.5 to 41 months) and 8.0 months (range, 0.5 to 41 months) for DC and D, respectively (P =.200). The 1- and 2-year survival rates were 44% and 19% for DC and 43% and 15% for D, respectively. Median times to tumor progression were 4.0 and 2.5 months for DC and D, respectively (P =.580). Grade 2/3 anemia was significantly higher with DC than with D (33% v 16%; P =.0001). Fifteen (9%) DC and 12 (8%) D patients developed febrile neutropenia. Grade 3/4 nausea/vomiting (P =.0001), diarrhea (P =.007), neurotoxicity (P =.017), and nephroroxicity (P =.006) were significantly more common with DC than with D. There were five treatment-related deaths in the DC group and one in the D (P =.098).
  
  
  CONCLUSIONS
  DC regimen resulted in a higher response rate but without improvement in median time to tumor progression or OS compared with D. D could be a reasonable front-line chemotherapy for patients who cannot tolerate cisplatin.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece. georgoul@med.uoc.gr
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Alexandros
authors.initials: A
authors.lastname: Ardavanis
authors.forename: Athina
authors.initials: A
authors.lastname: Agelidou
authors.forename: Maria
authors.initials: M
authors.lastname: Agelidou
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.forename: Emilia
authors.initials: E
authors.lastname: Tsaroucha
authors.forename: Michael
authors.initials: M
authors.lastname: Toumbis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kouroussis
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Syrigos
authors.forename: Aristidis
authors.initials: A
authors.lastname: Polyzos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Samaras
authors.forename: Pavlos
authors.initials: P
authors.lastname: Papakotoulas
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christofilakis
authors.forename: Nicolaos
authors.initials: N
authors.lastname: Ziras
authors.forename: Athanasios
authors.initials: A
authors.lastname: Alegakis
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel