title: Phase III randomized trial of surgery with or without intraoperative photodynamic therapy and postoperative immunochemotherapy for malignant pleural mesothelioma.
abstract: BACKGROUND
  Patients with malignant pleural mesothelioma (MPM) usually die of progressive local disease. This report describes the results of a Phase III trial comparing maximum debulking surgery and postoperative cisplatin, interferon alpha-2b, and tamoxifen (CIT) immunochemotherapy with and without intraoperative photodynamic therapy (PDT) to determine (1) whether such a multimodal approach can be performed with minimum morbidity and mortality in malignant pleural mesothelioma (MPM), and (2) whether first-generation (i.e., 630-nm laser light, Photofrin II) intrapleural PDT impacts on local recurrence of survival.
  
  
  METHODS
  From July 1993 to June 1996, 63 patients with localized MPM were randomized to either PDT or no PDT. The tumors of 15 patients could not be debulked to 5 mm. Patients assigned to PDT (n = 25) and no PDT (n = 23) were similar with respect to age, sex, tumor volume, and histology.
  
  
  RESULTS
  The type of resection (11 pleurectomies and 14 pneumonectomies vs. 12 pleurectomies and 11 pneumonectomies), length postoperative stay, and ICU time were comparable (PDT vs. no PDT). There was one operative death (hemorrhage), and each group had two bronchopleural fistulas. Postoperative staging divided patients into the following categories: stage I: PDT, 2, no PDT, 2; stage II: PDT, 2, no PDT, 2; stage III, PDT, 21; no PDT, 17; stage IV, PDT, 0; no PDT, 2. Comparable numbers of CIT cycles were delivered. Median survival for the 15 non-debulked patients was 7.2 months, compared to 14 months for the 48 patients on protocol. There were no differences in median survival (14.4 vs. 14.1 months) or median progression-free time (8.5 vs. 7.7 months), and sites of first recurrence were similar.
  
  
  CONCLUSIONS
  Aggressive multimodal therapy can be delivered for patients with higher stage MPM. First-generation PDT does not prolong survival or increase local control for MPM.
authors.affiliation: Thoracic Oncology Section, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: H I
authors.initials: HI
authors.lastname: Pass
authors.forename: B K
authors.initials: BK
authors.lastname: Temeck
authors.forename: K
authors.initials: K
authors.lastname: Kranda
authors.forename: G
authors.initials: G
authors.lastname: Thomas
authors.forename: A
authors.initials: A
authors.lastname: Russo
authors.forename: P
authors.initials: P
authors.lastname: Smith
authors.forename: W
authors.initials: W
authors.lastname: Friauf
authors.forename: S M
authors.initials: SM
authors.lastname: Steinberg
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D007430:Intraoperative Care; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000601:surgery*; D008875:Middle Aged; D010778:Photochemotherapy; D010997:Pleural Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D011446:Prospective Studies; D011994:Recombinant Proteins; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013629:Tamoxifen; D002945:Cisplatin