title: Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first-line therapy in advanced nonsmall cell lung cancer.
abstract: BACKGROUND
  There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall-cell lung cancer (NSCLC).
  
  
  METHODS
  Consenting patients with advanced NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) on Day 1, plus 3-weekly (75 mg/m(2) on Day 1) or weekly (35 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle) docetaxel, for up to 6 cycles.
  
  
  RESULTS
  Of 86 patients accrued, 41 patients were treated with 3-weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3-weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3-weekly and 39% with the weekly arm (P = .74). The median progression-free survival was 4.3 months in the 3-weekly arm and 3.9 months in the weekly arm (P = .08) and the median survival was 10.3 and 10.0 months, respectively (P = .76). Quality of life data showed no relevant difference between the arms.
  
  
  CONCLUSIONS
  The weekly schedule of docetaxel plus cisplatin combination as first-line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3-weekly regimen.
authors.affiliation: Division of Oncology and Pulmonology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Soo Jin
authors.initials: SJ
authors.lastname: Choi
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kyung
authors.forename: Chang Hyeok
authors.initials: CH
authors.lastname: An
authors.forename: Sang Pyo
authors.initials: SP
authors.lastname: Lee
authors.forename: Jeong Woong
authors.initials: JW
authors.lastname: Park
authors.forename: Sung Hwan
authors.initials: SH
authors.lastname: Jeong
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jae
authors.initials: J
authors.lastname: Hoon Lee
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin