title: Docetaxel consolidation therapy following cisplatin, vinorelbine, and concurrent thoracic radiotherapy in patients with unresectable stage III non-small cell lung cancer.
abstract: BACKGROUND
  To evaluate the feasibility and efficacy of docetaxel consolidation therapy after concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer (NSCLC).
  
  
  METHODS
  The eligibility criteria included unresectable stage III NSCLC, no previous treatment, age between 20 and 74 years, and performance status 0 or 1. Treatment consisted of cisplatin (80 mg/m2 on days 1, 29, and 57), vinorelbine (20 mg/m2 on days 1, 8, 29, 36, 57, and 64), and thoracic radiotherapy (TRT) (60 Gy/30 fractions over 6 weeks starting on day 2), followed by consolidation docetaxel (60 mg/m2 every 3 to 4 weeks for three cycles).
  
  
  RESULTS
  Of 97 patients who were enrolled in this study between 2001 and 2003, 93 (76 males and 17 females with a median age of 60) could be evaluated. Chemoradiotherapy was well tolerated; three cycles of chemotherapy and 60 Gy of TRT were administered in 80 (86%) and 87 (94%) patients, respectively. Grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 62, 11, and 3 patients, respectively. Docetaxel consolidation was administered in 59 (63%) patients, but three cycles were completed in only 34 (37%) patients. The most common reason for discontinuation was pneumonitis, which developed in 14 (24%) of the 59 patients. During consolidation therapy, grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 51, 2, and 4 patients, respectively. A total of four patients died of pneumonitis. We calculated a V20 (the percent volume of the normal lung receiving 20 Gy or more) on a dose-volume histogram in 25 patients. Of these, five patients developed grade 3 or more severe radiation pneumonitis. A median V20 for these five patients was 35% (range, 26-40%), whereas the median V20 for the remaining 20 patients was 30% (range, 17-35%) (p = 0.035 by a Mann-Whitney test). The response rate was 81.7% (95% confidence interval [CI], 72.7-88.0%), with 5 complete and 71 partial responses. The median progression-free survival was 12.8 (CI, 10.2-15.4) months, and median survival was 30.4 (CI, 24.5-36.3) months. The 1-, 2-, and 3-year survival rates were 80.7, 60.2, and 42.6%, respectively.
  
  
  CONCLUSIONS
  This regimen produced promising overall survival in patients with stage III NSCLC, but the vast majority of patients could not continue with the docetaxel consolidation because of toxicity.
authors.affiliation: Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. isekine@ncc.go.jp
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.forename: Minako
authors.initials: M
authors.lastname: Sumi
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mori
authors.forename: Iwao
authors.initials: I
authors.lastname: Tsukiyama
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine