title: Phase II trial of pleural photodynamic therapy and surgery for patients with non-small-cell lung cancer with pleural spread.
abstract: OBJECTIVE
  Non-small-cell lung cancer (NSCLC) with pleural spread is incurable, with median survival rates ranging from 6 to 9 months. Surgery alone fails to locally control this disease or extend survival beyond the accepted treatment, palliative chemotherapy.
  
  
  METHODS
  We conducted a phase II trial to evaluate the effects on local control and survival of combining surgery with intraoperative photodynamic therapy (PDT), a light-based cancer treatment, in patients with NSCLC with pleural spread. Patients received porfimer sodium (2 mg/kg), 24 hours before surgery, at which time all gross tumor was resected and followed by illumination of the hemithorax with 630 nm light to a measured dose of 30 J/cm(2). Photosensitizer levels in tumor and surrounding normal tissue were measured.
  
  
  RESULTS
  Twenty-two patients with NSCLC were enrolled; 17 underwent complete debulking and PDT, three underwent partial debulking/PDT, and two patients were unresectable. Local control of pleural disease at 6 months was achieved in 11 of 15 (73.3%; 95% CI, 44.9% to 92.2%) assessable patients. Median overall survival for all 22 patients was 21.7 months (95% CI, 17.7 to 25.8 months). Measured levels of porfimer sodium in tumor were greater than those measured in normal tissues, with ratios ranging from 1.19 to 22.42.
  
  
  CONCLUSIONS
  Our results indicate surgery and PDT can be performed safely with very good local control. The median survival of 21.7 months, calculated from the time of surgery and PDT is encouraging. Further evaluation of this therapy is warranted.
authors.affiliation: Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA 19104-4283, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Friedberg
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Mick
authors.forename: James P
authors.initials: JP
authors.lastname: Stevenson
authors.forename: Timothy
authors.initials: T
authors.lastname: Zhu
authors.forename: Theresa M
authors.initials: TM
authors.lastname: Busch
authors.forename: Daniel
authors.initials: D
authors.lastname: Shin
authors.forename: Debbie
authors.initials: D
authors.lastname: Smith
authors.forename: Melissa
authors.initials: M
authors.lastname: Culligan
authors.forename: Andreea
authors.initials: A
authors.lastname: Dimofte
authors.forename: Eli
authors.initials: E
authors.lastname: Glatstein
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Hahn
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary* / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006414:Hematoporphyrin Photoradiation / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D010997:Pleural Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary* / Q000601:surgery; D016019:Survival Analysis