title: A phase I trial of concurrent chemoradiotherapy with non-split administration of docetaxel and cisplatin for dry stage III non-small-cell lung cancer (JCOG9901DI).
abstract: OBJECTIVE
  This study aimed to establish the maximum tolerated dose of concurrent chemoradiotherapy (cCRT) with conventional administration of the docetaxel (D) plus cisplatin (P) (conv-DP) regimen.
  
  
  METHODS
  Patients (aged ≤70 years) with unresectable dry stage III non-small-cell lung cancer (NSCLC) and having performance status 0 or 1 and adequate organ function were eligible. They received radiotherapy (60 Gy in 30 fractions) once daily starting on day 2. Concurrent P (day 1; 60 mg/m(2) at Levels 1-3, 80 mg/m(2) at Level 4) and D (day 1; 30 mg/m(2) at Level 1, 40 mg/m(2) at Level 2, 50 mg/m(2) at Levels 3-4) were administered every 4 weeks for 2-4 courses.
  
  
  RESULTS
  Eighteen patients were enrolled (stage IIIA/IIIB, 5/13 patients). Three cases of dose-limiting toxicity were observed in this study, although another 3 cases were added at Levels 2 and 3. Radiotherapy was completed in 15 patients. Seventeen patients received more than 2 courses of chemotherapy. Neither Grade 3/4 esophagitis nor severe hematological events were observed at Levels 1-4. However, dose escalation to Level 5 (P [80 mg/m(2)], D [60 mg/m(2)]) was stopped because the Level 5 dose was the recommended dose (RD) of chemotherapy alone for stage IIIB/IV NSCLC in Japan. Therefore, the RD was determined as D50/P80 mg/m(2) in this cCRT. The objective response rate was 89%, and the median survival time was 23.6 months.
  
  
  CONCLUSIONS
  cCRT with non-split DP was a tolerable and effective regimen, and RD was 50/80 mg/m(2) every 4 weeks.
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-Ku, Yokohama, Kanagawa, 240-8555, Japan. na00-hida@city.yokohama.jp
authors.forename: Naoya
authors.initials: N
authors.lastname: Hida
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Yuuki
authors.initials: Y
authors.lastname: Misumi
authors.forename: Akira
authors.initials: A
authors.lastname: Sato
authors.forename: Mari
authors.initials: M
authors.lastname: Ishii
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Kashizaki
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Shimokawa
authors.forename: Teppei
authors.initials: T
authors.lastname: Shimizu
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016371:Cranial Irradiation; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin