title: Phase II study with fractionated schedule of docetaxel and cisplatin in patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  Docetaxel and cisplatin combination chemotherapy is established first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). We evaluated a weekly schedule of docetaxel and cisplatin for efficacy and tolerability in patients with chemotherapy-naive NSCLC.
  
  
  METHODS
  Patients enrolled in this study had stage IIIB or IV NSCLC with measurable disease, no prior chemotherapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. Treatment consisted of docetaxel 40 mg/m(2) and cisplatin 35 mg/m(2) given on D1 and D8 every 3 weeks. Patients were evaluated for response after every 2 cycles of treatment.
  
  
  RESULTS
  Thirty six patients were enrolled, and 35 underwent treatment. Of these, 29 were males and 7 females, median age was 61 years (range, 38-68). About 31 patients had ECOG PS 0-1 and 4 patients had ECOG PS 2. Fifty seven percentage (20/35) of patients had adenocarcinoma and 74.3% (26/35) had stage IV disease. A total of 153 cycles of chemotherapy were administered. Of the 35 patients treated, 17 (48.6%) achieved partial response, 11 (31.4%) showed stable disease, and 6 (17.1%) had progressive disease. Median duration of response was 5.3 months (95% CI: 4.2-6.2 months), and median time to disease progression was 4.6 months (95% CI: 2.9-6.3 months). Estimated overall survival at 1 year was 65.7%. The major hematologic toxicity was myelosuppression. Grade 3 or 4 anemia occurred in 6 cycles, and grade 3 or 4 neutropenia was observed in four cycles. Major non-hematologic toxicities were grade 3 nausea in three patients and grade 3 fatigue in two patients. Three patients developed pneumonia and one patient had infectious colitis. There were no treatment-related deaths in this study.
  
  
  CONCLUSIONS
  Weekly schedule of docetaxel and cisplatin as first-line treatment for NSCLC had good efficacy and manageable toxicity.
authors.affiliation: Department of Internal Medicine, Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Gangdong gu, Seoul, South Korea.
authors.forename: Jung Hye
authors.initials: JH
authors.lastname: Kwon
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.forename: Jung-Ae
authors.initials: JA
authors.lastname: Lee
authors.forename: Hyun Chun
authors.initials: HC
authors.lastname: Shin
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Hun Ho
authors.initials: HH
authors.lastname: Song
authors.forename: Joo Young
authors.initials: JY
authors.lastname: Jung
authors.forename: Ho Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Dae Ro
authors.initials: DR
authors.lastname: Choi
authors.forename: Hyeong Su
authors.initials: HS
authors.lastname: Kim
authors.forename: Young-Iee
authors.initials: YI
authors.lastname: Park
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D013534:Survival; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin