title: Innate immune therapy with a Bacillus Calmette-Guérin cell wall skeleton after radical surgery for non-small cell lung cancer: a case-control study.
abstract: OBJECTIVE
  We investigated whether adjuvant immunotherapy with Bacillus Calmette-Guérin (BCG) cell wall skeleton (CWS) and surgical resection was better than resection, with or without other adjuvant therapy, for patients with non-small cell lung cancer (NSCLC).
  
  
  METHODS
  The case group comprised 71 patients who underwent radical surgery for NSCLC, followed by BCG-CWS immunotherapy, with follow-up data available. The case-control study was designed with one control selected for each case-group patient. Each control was matched by pathological stage and year of birth (+/-5 years). BCG-CWS 200 microg was inoculated intracutaneously in the upper arm four times per week (sensitization phase); then at 4-week intervals (therapeutic phase).
  
  
  RESULTS
  The case-group patients received 45 +/- 22.6 (average +/- SD) cycles of BCG-CWS inoculation. Overall 5-year and 10-year survival rates were 71% and 61% for the case-group patients, and 63% and 43% for the control-group patients. The survival rate of the case group was better than that of the control group (not significant; P = 0.114). The same trend was seen in the patients with stage III or N+ NSCLC (not significant; P = 0.114, P = 0.168). There were no life-threatening adverse events.
  
  
  CONCLUSIONS
  BCG-CWS immunotherapy seemed to improve survival after resection of NSCLC, especially locally advanced NSCLC. Moreover, this immunotherapy did not compromise quality of life during treatment.
authors.affiliation: Department of Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kodama
authors.forename: Masahiko
authors.initials: M
authors.lastname: Higashiyama
authors.forename: Koji
authors.initials: K
authors.lastname: Takami
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Oda
authors.forename: Jiro
authors.initials: J
authors.lastname: Okami
authors.forename: Jun
authors.initials: J
authors.lastname: Maeda
authors.forename: Takashi
authors.initials: T
authors.lastname: Akazawa
authors.forename: Misako
authors.initials: M
authors.lastname: Matsumoto
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Seya
authors.forename: Mariko
authors.initials: M
authors.lastname: Wada
authors.forename: Kumao
authors.initials: K
authors.lastname: Toyoshima
mesh_terms: D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery*; D016022:Case-Control Studies; D017358:Cell Wall Skeleton / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate
chemical_list: D001500:BCG Vaccine; D017358:Cell Wall Skeleton