title: Phase II trial of preoperative chemoradiotherapy followed by surgical resection in patients with superior sulcus non-small-cell lung cancers: report of Japan Clinical Oncology Group trial 9806.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of preoperative chemoradiotherapy followed by surgical resection for superior sulcus tumors (SSTs).
  
  
  METHODS
  Patients with pathologically documented non-small-cell lung cancer with invasion of the first rib or more superior chest wall were enrolled as eligible; those with distant metastasis, pleural dissemination, and/or mediastinal node involvement were excluded. Patients received two cycles of chemotherapy every 4 weeks as follows; mitomycin 8 mg/m(2) on day 1, vindesine 3 mg/m(2) on days 1 and 8, and cisplatin 80 mg/m(2) on day 1. Radiotherapy directed at the tumor and the ipsilateral supraclavicular nodes was started on day 2 of each course, at the total dose of 45 Gy in 25 fractions, with a 1-week split. Thoracotomy was undertaken 2 to 4 weeks after completion of the chemoradiotherapy. Those with unresectable disease received boost radiotherapy.
  
  
  RESULTS
  From May 1999 to November 2002, 76 patients were enrolled, of whom 20 had T4 disease; 75 patients were fully assessable. Chemoradiotherapy was generally well tolerated. Fifty-seven patients (76%) underwent surgical resection, and pathologic complete resection was achieved in 51 patients (68%). There were 12 patients with pathologic complete response. Major postoperative morbidity, including chylothorax, empyema, pneumonitis, adult respiratory distress syndrome, and bleeding, was observed in eight patients. There were three treatment-related deaths, including two deaths owing to postsurgical complications and one death owing to sepsis during chemoradiotherapy. The disease-free and overall survival rates at 3 years were 49% and 61%, respectively; at 5 years, they were 45% and 56%, respectively.
  
  
  CONCLUSIONS
  This trimodality approach is safe and effective for the treatment of patients with SSTs.
authors.affiliation: Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. hkkunito@ncc.go.jp
authors.forename: Hideo
authors.initials: H
authors.lastname: Kunitoh
authors.forename: Harubumi
authors.initials: H
authors.lastname: Kato
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Hisao
authors.initials: H
authors.lastname: Asamura
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichonose
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Kanji
authors.initials: K
authors.lastname: Nagai
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mitsudomi
authors.forename: Akihide
authors.initials: A
authors.lastname: Matsumura
authors.forename: Ken
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tada
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000627:therapeutic use; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011292:Premedication; D011829:Radiation Dosage; D013902:Radiography, Thoracic; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate; D013908:Thoracotomy; D014747:Vinblastine / Q000627:therapeutic use
chemical_list: D008937:Mitomycins; D014747:Vinblastine; D002945:Cisplatin