Skip to main content
SpringerLink
Log in

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

  • Original Articles
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Pass HI, Pogrebniak HW. Malignant pleural mesothelioma.Curr Prob Surg October 1993

  2. Rusch VW, Saltz L, Venkatraman E, et al. A phase II trial of pleurectomy/decortication followed by intrapleural and system chemotherapy for malignant pleural mesothelioma.J Clin Oncol 1994;12:1156–63.

    CAS  PubMed  Google Scholar 

  3. Hilaris BS, Nori D, Kwong E, et al. Pleurectomy and intraoperative brachytherapy and postoperative radiation in the treatment of malignant pleural mesothelioma.Int J Radiat Oncol Biol Phys 1984;10:352–30.

    Google Scholar 

  4. Rusch VW, Venkatraman E. The importance of surgical staging in the treatment of malignant pleural mesothelioma.J Thorac Cardiovasc Surg 1996;111:815–25.

    CAS  PubMed  Google Scholar 

  5. Sugarbaker DJ, Lynch TJ, Strauss GM, et al. Node status has prognostic significance in the multimodality therapy of diffuse, malignant mesothelioma.J Clin Oncol 1993;11:1172–8.

    CAS  PubMed  Google Scholar 

  6. Takita H, Mang TS, Loewen GM, et al. Surgery and intracavitary photodynamic therapy for malignant pleural mesothelioma.Proceedings of the 5th International PDT Association, 1994:65. Abstract 68.

  7. Lofgren L, Larsson M, Thaning L, Hallgren S. Transthoracic endoscopic photodynamic treatment for malignant mesothelioma.Lancet 1991;337:359.

    Article  CAS  PubMed  Google Scholar 

  8. Ris HB, Altermatt HJ, Inderbitizi R, et al. Photodynamic therapy with chlorins for diffuse malignant mesothelioma: Initial clinical results.Br J Cancer 1991;64:1116–20.

    CAS  PubMed  Google Scholar 

  9. Knight SR, Clarke CP, Daniel FJ, et al. Photodynamic therapy for malignant pleural mesothelioma.Proceedings of the 5th International PDT Association, 1994:66. Abstract 70.

  10. Warloe T, Heyerdahl H, Peng Q, et al. Photodynamic therapy of pleural mesothelioma.Proceedings of the 5th International PDT Association, 1994:65. Abstract 69.

  11. Pass HI, DeLaney TF, Tochner Z, et al. Intrapleural photodynamic therapy: Results of Phase I Trial.Ann Surg Oncol 1994;1:28–37.

    CAS  PubMed  Google Scholar 

  12. Pass HW, Temeck BK, Kranda K, Steinberg SM Pass HI. A Phase II trial investigating primary immunochemotherapy for malignant pleural mesothelioma and the feasibility of adjuvant immunochemotherapy after maximal cytoreduction.Ann Surg Oncol 1995;2:214–20.

    CAS  PubMed  Google Scholar 

  13. International Mesothelioma Interest Group. A proposed new international TNM staging system for malignant pleural mesothelioma.Chest 1995;108:1122–8.

    Google Scholar 

  14. Kaplan EL, Meier P. Non-parametric estimation from incomplete observation.J Am Stat Assoc 1958;53:457–81.

    Google Scholar 

  15. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration.Cancer Chem Rep 1966;50:163–70.

    CAS  Google Scholar 

Download references

Author information

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
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Barbara K. Temeck MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Karen Kranda RN
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Gunther Thomas PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Angelo Russo MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Paul Smith BS
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Walt Friauf BS
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Seth M. Steinberg PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Issue Date:

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

Key Words

Search

Navigation