title: A randomized phase III trial of combined paclitaxel, carboplatin, and radiation therapy followed by weekly paclitaxel or observation for patients with locally advanced inoperable non-small-cell lung cancer.
abstract: BACKGROUND
  This study was designed to determine the efficacy and safety of additional maintenance chemotherapy after standard induction chemotherapy/radiation therapy (XRT) in stage III non-small-cell lung cancer (NSCLC). The primary objective was to increase 1-year survival.
  
  
  METHODS
  Eligible patients (N = 220) had confirmed stage IIIA or IIIB NSCLC, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients received induction chemotherapy (paclitaxel 200 mg/m(2) + carboplatin AUC = 6/3 weeks) for 2 cycles, followed by paclitaxel 45 mg/m(2) + carboplatin AUC = 2 weekly ×7 and concurrent daily XRT (cumulative dose = 66.6 Gy in 37 fractions) and then observation or maintenance. Before randomization, 101 patients (46%) discontinued treatment due to progressive disease (n = 34), toxicity (n = 33), patient request (n = 13), death (n = 7), or other (n = 14). The remaining 119 patients were randomly assigned to either "observation" or "maintenance" (6 cycles of paclitaxel 70 mg/m(2)/wk [3 weeks on/1 week off]); a median of 5 of 6 planned cycles was delivered in the maintenance arm.
  
  
  RESULTS
  For the observation group vs. the maintenance group, the estimated 1- and 4-year survival rates were 77% vs. 66% and 38% vs. 17% (median, 26.9 months vs. 16.1 months, respectively [P = .07]); the estimated 1- and 4-year performance-free survival (PFS) were 46% vs. 24% and 25% vs. 13% (median, 10.2 months vs. 8.2 months, respectively [P = .04]). Common toxicities were neutropenia, thrombocytopenia, and fatigue.
  
  
  CONCLUSIONS
  Median survival in both groups surpassed the standard, most notably the 26.9-month survival in the observation group. Maintenance chemotherapy, when added to a regimen of both induction and concurrent chemoradiotherapy, did not improve clinical outcomes, with endpoints favoring the standard arm.
authors.affiliation: US Oncology Research, LLC, The Woodlands, TX, USA. craig.reynolds@usoncology.com
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Carter
authors.forename: David
authors.initials: D
authors.lastname: Garfield
authors.forename: James
authors.initials: J
authors.lastname: Hathorn
authors.forename: Richard
authors.initials: R
authors.lastname: Mundis
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
authors.forename: Craig
authors.initials: C
authors.lastname: Reynolds
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D059248:Chemoradiotherapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel