title: A phase II study of cisplatin plus S-1 with concurrent thoracic radiotherapy for locally advanced non-small-cell lung cancer: the Okayama Lung Cancer Study Group Trial 0501.
abstract: BACKGROUND
  Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective.
  
  
  METHODS
  In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m(2) on days 1, 8, 29 and 36) and S-1 (80mg/m(2) on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate.
  
  
  RESULTS
  A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis.
  
  
  CONCLUSIONS
  This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
authors.affiliation: Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan; Department of General Internal Medicine 4, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.affiliation: Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan. Electronic address: khotta@md.okayama-u.ac.jp.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan; Department of Medical Oncology, International Medical Center Comprehensive Cancer Center, Saitama Medical University, Hidaka, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Segawa
authors.affiliation: Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan; Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Kato
authors.affiliation: Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.affiliation: Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan; Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Oze
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Daizo
authors.initials: D
authors.lastname: Kishino
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aoe
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan; Department of Respiratory Medicine, NHO Iwakuni Medical Center, Iwakuni, Japan.
authors.forename: Shoichi
authors.initials: S
authors.lastname: Kuyama
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Okada
authors.affiliation: Department of Respiratory Medicine, Okayama Red Cross Hospital, Okayama, Japan.
authors.forename: Shinobu
authors.initials: S
authors.lastname: Hosokawa
authors.affiliation: Department of Respiratory Medicine, Ehime Prefectural Hospital, Matsuyama, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Gemba
authors.affiliation: Department of Respiratory Medicine, NHO Minami-Okayama Medical Center, Okayama, Japan; Department of Respiratory Medicine, NHO Okayama Medical Center, Okayama, Japan.
authors.forename: Takuo
authors.initials: T
authors.lastname: Shibayama
authors.affiliation: Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Takemoto
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanazawa
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.affiliation: Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D011879:Radiotherapy Dosage; D019233:Retreatment; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: Chemotherapy; Cisplatin; Phase II trial; Radiation; S-1; Stage III