title: A prospective, multi-institutional phase II study of induction chemoradiotherapy followed by surgery in patients with non-small cell lung cancer involving the chest wall (CJLSG0801).
abstract: The standard therapy for patients with T3N0-1M0 non-small cell lung cancer (NSCLC) involving the chest wall is considered surgical resection and adjuvant therapy. However, the compliance of adjuvant therapy is relatively low, and the prognosis for those patients has been unsatisfactory. Therefore, we conducted a phase II study of induction chemoradiotherapy followed by surgery with the aim of improving the survival.
  
  
  
  This treatment strategy consisted of induction chemotherapy (two cycles of cisplatin at 80mg/m2on Day 1 and vinorelbine at 20mg/m2on Days 1 and 8) concurrent with radiotherapy (40Gy in 20 fractions) followed by surgery. The inclusion criteria were patients with resectable T3N0-1M0 NSCLC involving the chest wall who were 20-70 years of age. The primary end point was the 3-year survival, assuming an expected rate of 67%.
  
  
  
  From January 2009 to November 2012, 51 eligible patients were enrolled. Induction therapy was completed as planned in 49 (96%) patients without treatment-related death, and 25 (51%) had a partial response. Complete resection combined with the involved chest wall was achieved in 46 (92%) patients, and a pathologic complete response was seen in 13 (26%) patients. Five patients experienced major postoperative complications, and 1 patient died of acute exacerbation of interstitial pneumonia. With a median follow-up period of 42 months, the 3- and 5-year overall survivals of all registered patients were 77% and 63%, respectively. There was a significant difference in the survival rate between patients with a pathologic complete response and those with a residual tumor (p=0.039).
  
  
  
  The mature results of this study in a multi-institutional setting showed the treatment strategy to be safe and effective with a high rate of pathologic response for patients with NSCLC involving the chest wall.
authors.affiliation: Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Kawaguchi
authors.affiliation: Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: k-yokoi@med.nagoya-u.ac.jp.
authors.forename: Kohei
authors.initials: K
authors.lastname: Yokoi
authors.affiliation: Division of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, Hamamatsu, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Niwa
authors.affiliation: Division of Thoracic Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Ohde
authors.affiliation: Department of Thoracic Surgery, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan.
authors.forename: Shoichi
authors.initials: S
authors.lastname: Mori
authors.affiliation: Department of Thoracic Surgical Oncology, Japanese Foundation for Cancer Research, Cancer Institute Hospital, Tokyo, Japan.
authors.forename: Sakae
authors.initials: S
authors.lastname: Okumura
authors.affiliation: Department of Thoracic Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shiono
authors.affiliation: Division of Thoracic Surgery, Thoracic Oncology, and Pathology, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ito
authors.affiliation: Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Motoki
authors.initials: M
authors.lastname: Yano
authors.affiliation: Department of Thoracic Surgery, Ogaki Municipal Hospital, Ogaki, Japan.
authors.forename: Kikuo
authors.initials: K
authors.lastname: Shigemitsu
authors.affiliation: Department of Thoracic Surgery, Toyota Kosei Hospital, Toyota, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Hiramatsu
authors.affiliation: Department of General Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Jiro
authors.initials: J
authors.lastname: Okami
authors.affiliation: Departments of Respiratory Medicine and Medical Oncology, Nagoya Medical Center, Nagoya, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Saka
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 / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011446:Prospective Studies; D015996:Survival Rate; D035441:Thoracic Wall / Q000473:pathology*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine
keywords: Chest wall; Clinical trials; Induction therapy; Lung cancer; Lung cancer surgery; Radiation therapy