Phase III randomized trial of surgery with or without intraoperative photodynamic therapy and postoperative immunochemotherapy for malignant pleural mesothelioma
- 154 Downloads
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.
Key WordsMesothelioma Photodynamic therapy Immunochemotherapy Phase III
Unable to display preview. Download preview PDF.
- 1.Pass HI, Pogrebniak HW. Malignant pleural mesothelioma.Curr Prob Surg October 1993Google 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
- 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.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.Google Scholar
- 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.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.Google Scholar