title: Phase II study of twice-daily high-dose thoracic radiotherapy alternating with cisplatin and vindesine for unresectable stage III non-small-cell lung cancer: Japan Clinical Oncology Group Study 9306.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non--small-cell lung cancer (NSCLC).
  
  
  METHODS
  Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m(2) on day 1 and vindesine 3 mg/m(2) on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3.
  
  
  RESULTS
  The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT > or = 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients.
  
  
  CONCLUSIONS
  Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.
authors.affiliation: Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan. isekine@gan2.ncc.go.jp
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogino
authors.forename: Akira
authors.initials: A
authors.lastname: Yokoyama
authors.forename: Mari
authors.initials: M
authors.lastname: Saito
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mori
authors.forename: Iwao
authors.initials: I
authors.lastname: Tsukiyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.forename: Kimio
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate; D014751:Vindesine / Q000008:administration & dosage*
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D002945:Cisplatin; D014751:Vindesine