title: Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial.
abstract: OBJECTIVE
  Recent studies have suggested the superiority of concurrent chemoradiotherapy and the efficacy of paclitaxel/carboplatin in advanced non-small-cell lung cancer (NSCLC). In view of those results, we sought to examine the safety and efficacy of administration of radiosensitizing paclitaxel twice weekly and carboplatin weekly with concurrent thoracic radiation therapy (XRT) followed by consolidation paclitaxel and carboplatin for stage III NSCLC in a multi-institutional phase II trial.
  
  
  METHODS
  Induction chemoradiotherapy consisted of paclitaxel 30 mg/m2 delivered intravenously (IV) for 1 hour twice weekly for 6 weeks, carboplatin at a dose based on an area under the concentration-time curve (AUC) of 1.5 mg/mL x min, given IV once weekly for 6 weeks, and concomitant XRT of 1.8 to 2.0 Gy daily for a total of 61 Gy. Patients who achieved a complete response, partial response, or stable disease received two 21-day cycles of consolidation chemotherapy consisting of paclitaxel 200 mg/m2 IV for 3 hours and carboplatin at a dose based on an AUC of 6 mg/mL x min.
  
  
  RESULTS
  Thirty-four patients were eligible. Their median age was 62 years (range, 39 to 73 years), 59% were female, 41% were male, 94% had a performance status of 0 or 1, 38% had stage IIIA NSCLC, and 62% had stage IIIB NSCLC. Common grade III and IV toxicities during the induction chemoradiation phase included esophagitis (38%) and neutropenia (12%). The most common adverse reaction during consolidation chemotherapy was grade III neutropenia in five patients (15%). The overall response rate was 71%, which was achieved in the induction phase. The median follow-up was 20 months, the median survival was 17 months, and 2-year actuarial survival rate was 40% (95% confidence interval, 20% to 65%).
  
  
  CONCLUSIONS
  This regimen is tolerable and results are promising. We recommend further evaluation of this regimen in a phase III trial.
authors.affiliation: University of California, Davis Cancer Center, and Veterans Affairs Northern California Health Care System, Sacramento 95817, USA. derick.lau@ucdavis.edu
authors.forename: D
authors.initials: D
authors.lastname: Lau
authors.forename: B
authors.initials: B
authors.lastname: Leigh
authors.forename: D
authors.initials: D
authors.lastname: Gandara
authors.forename: M
authors.initials: M
authors.lastname: Edelman
authors.forename: R
authors.initials: R
authors.lastname: Morgan
authors.forename: V
authors.initials: V
authors.lastname: Israel
authors.forename: P
authors.initials: P
authors.lastname: Lara
authors.forename: R
authors.initials: R
authors.lastname: Wilder
authors.forename: J
authors.initials: J
authors.lastname: Ryu
authors.forename: J
authors.initials: J
authors.lastname: Doroshow
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage; D016019:Survival Analysis
chemical_list: D011838:Radiation-Sensitizing Agents; D016190:Carboplatin; D017239:Paclitaxel