title: A phase II study of concurrent chemoradiation with weekly docetaxel, carboplatin, and radiation therapy followed by consolidation chemotherapy with docetaxel and carboplatin for locally advanced inoperable non-small cell lung cancer (NSCLC).
abstract: BACKGROUND
  The current standard of care for good performance status patients with locally advanced non-small cell lung carcinoma is concurrent chemoradiation, although a clearly superior regimen has not been identified. Docetaxel has been shown to possess good single-agent activity against non-small cell lung cancer (NSCLC) and radiosensitizing properties, both alone and synergistically with carboplatin. We undertook this phase II study to determine the safety and efficacy of weekly docetaxel-carboplatin and concurrent radiation therapy followed by docetaxel-carboplatin consolidation for the treatment of locally advanced NSCLC.
  
  
  METHODS
  Sixty-seven patients having previously untreated stage IIIA or IIIB unresectable NSCLC were enrolled, with 61 patients evaluated for endpoints. Docetaxel 20 mg/m IV infusion over 30 minutes followed by carboplatin area under the curve = 2 over 30 minutes was administered weekly during concurrent thoracic radiotherapy. After 3 week rest, consolidation docetaxel 75 mg/m(2) IV infusion over 60 minutes and carboplatin area under the curve = 6 over 30 minutes was administered every 3 weeks for two cycles. Concurrent thoracic radiation consisted of 45 Gy (1.8 Gy fractions 5 d/wk for first 5 weeks) followed by 18 Gy boost (2.0 Gy fractions 5 d/wk for 2 weeks) for a total dose of 63 Gy.
  
  
  RESULTS
  One and 2 years overall survival rates were 45 and 20%, respectively. Progression free survival at 1 year was 27%. Median survival time was 12 months. Median time to progression was 8 months. The primary hematologic toxicity was leukopenia. The primary nonhematologic toxicity was esophagitis.
  
  
  CONCLUSIONS
  The administered regimen of weekly docetaxel-carboplatin and concurrent radiation therapy followed by docetaxel-carboplatin consolidation has acceptable toxicity profile. However, the overall survivals at 1 and 2 years are somewhat disappointing.
authors.affiliation: Department of Radiation Oncology, UT Southwestern Medical Center at Dallas, Dallas, TX, USA.
authors.forename: Anshu K
authors.initials: AK
authors.lastname: Jain
authors.forename: Randall S
authors.initials: RS
authors.lastname: Hughes
authors.forename: Alan B
authors.initials: AB
authors.lastname: Sandler
authors.forename: Afshin
authors.initials: A
authors.lastname: Dowlati
authors.forename: Lee S
authors.initials: LS
authors.lastname: Schwartzberg
authors.forename: Tracy
authors.initials: T
authors.lastname: Dobbs
authors.forename: Larry
authors.initials: L
authors.lastname: Schlabach
authors.forename: Jean
authors.initials: J
authors.lastname: Wu
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Muldowney
authors.forename: Hak
authors.initials: H
authors.lastname: Choy
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D003131:Combined Modality Therapy; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin