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Phase III randomized trial of surgery with or without intraoperative photodynamic therapy and postoperative immunochemotherapy for malignant pleural mesothelioma

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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 α-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 or 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; 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.

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Authors and Affiliations

  1. From the Thoracic Oncology Section, National Institutes of Health, Bethesda, Maryland, USA

    Harvey I. Pass MD, Barbara K. Temeck MD & Karen Kranda RN

  2. Radiation Biology Section, National Institutes of Health, Bethesda, Maryland, USA

    Gunther Thomas PhD & Angelo Russo MD, PhD

  3. Biostatistics and Data Management Section, National Institutes of Health, Bethesda, Maryland, USA

    Seth M. Steinberg PhD

  4. National Cancer Institute, Biomedical Engineering and Instrumentation Program, National Center for Research Resources, National Institutes of Health, Bethesda, Maryland, USA

    Paul Smith BS & Walt Friauf BS

Authors
  1. Harvey I. Pass MD
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  2. Barbara K. Temeck MD
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  3. Karen Kranda RN
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  4. Gunther Thomas PhD
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  5. Angelo Russo MD, PhD
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  6. Paul Smith BS
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  7. Walt Friauf BS
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  8. Seth M. Steinberg PhD
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Pass, H.I., Temeck, B.K., Kranda, K. et al. Phase III randomized trial of surgery with or without intraoperative photodynamic therapy and postoperative immunochemotherapy for malignant pleural mesothelioma. Annals of Surgical Oncology 4, 628–633 (1997). https://doi.org/10.1007/BF02303746

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  • DOI: https://doi.org/10.1007/BF02303746

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