title: Randomized phase II trial of uracil/tegafur and cisplatin versus vinorelbine and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-small-cell lung cancer: NJLCG 0601.
abstract: BACKGROUND
  The optimal chemotherapy with thoracic radiotherapy (TRT) for locally advanced non-small-cell lung cancer (NSCLC) remains to be established. This randomized phase II study of concurrent chemoradiotherapy was conducted to compare uracil/tegafur (UFT) and cisplatin with vinorelbine and cisplatin for stage III NSCLC.
  
  
  METHODS
  Patients with unresectable stage III NSCLC were randomized to receive UP (400 mg/m(2) UFT on days 1-14 and 29-42 and 80 mg/m(2) cisplatin on days 8 and 36) or NP (20 mg/m(2) vinorelbine on days 1, 8, 29, and 36 and 80 mg/m(2) cisplatin on days 1 and 29). TRT began on day 1 (total 60 Gy in 30 fractions).
  
  
  RESULTS
  Of 70 enrolled patients, 66 were evaluable for efficacy and safety. The overall response rates were 80% (95% CI: 67-93%) and 71% (95% CI: 55-87%) for the UP arm and the NP arm. With a median follow-up of 20.2 months, the progression-free survival and median survival time were 8.8 and 26.9 months in the UP arm, and 6.8 and 21.7 months in the NP arm. The 2-/3-year survival rates were 51.0/34.3% and 46.9/33.4% for the UP arm and the NP arm, respectively. Grade 3/4 neutropenia occurred in 20% and 58% of patients in the UP and NP arms, respectively.
  
  
  CONCLUSIONS
  Combined with concurrent TRT, the UP arm achieved better efficacy and safety compared with the NP arm, suggesting it to be a promising candidate as a standard regimen for locally advanced NSCLC. Further evaluation of the UP arm is warranted.
authors: Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirosemachi, Aoba-ku, Sendai 980-0873, Japan. swara357@cat-v.ne.jp
authors: Shunichi
authors: S
authors: Sugawara
authors: Makoto
authors: M
authors: Maemondo
authors: Motoko
authors: M
authors: Tachihara
authors: Akira
authors: A
authors: Inoue
authors: Osamu
authors: O
authors: Ishimoto
authors: Tomohiro
authors: T
authors: Sakakibara
authors: Kazuhiro
authors: K
authors: Usui
authors: Hiroshi
authors: H
authors: Watanabe
authors: Nobumichi
authors: N
authors: Matsubara
authors: Kana
authors: K
authors: Watanabe
authors: Kenya
authors: K
authors: Kanazawa
authors: Takashi
authors: T
authors: Ishida
authors: Yasuo
authors: Y
authors: Saijo
authors: Toshihiro
authors: T
authors: Nukiwa
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; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D055815:Young Adult
chemical_list: D005641:Tegafur; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine