Feasibility trial assessing intrapleural photodynamic therapy combined with pleurectomy/decortication then chemotherapy in malignant pleural mesothelioma patients.

摘要

Background: Multimodal treatment associating surgery (pleurectomy/decortication, P/D) then IV adjuvant chemotherapy (platinum/pemetrexed) is an effective therapeutic option for some selected malignant pleural mesothelioma (MPM) patients. Intra-operative pleural photodynamic therapy (iPDT) has emerged as a promising option to improve this multimodal treatment outcome (Friedberg J, Ann Thorac Surg. 2017). The MesoPDT trial (NCT02662504) aimed at assessing the feasibility of such procedure outside the only two US expert centers performing multimodal treatment including iPDT to date. Methods: A single-center pilot clinical trial was designed to assess the feasibility of iPDT protocol in Lille University Hospital. A pool of maximum six patients was expected in order to apply the iPDT protocol, and to assess its applicability and safety outside US center expert. Results: In 2016-2017, four consecutive assessable patients were included and treated per protocol, reaching the study achievement cut-off. iPDT specific procedures have been applied and managed in partnership with US experts. The safety profile was favorable. The main and most specific adverse event was acute lung injury occurring within 72 hours after iPDT, which may lead to reversible respiratory distress, manageable with adequate intensive care. The 4 patients achieved the full scheduled protocol. Conclusion: The iPDT multimodal treatment for MPM is applicable and manageable in a European expert center, involving local skills and dedicated teams. The safety profile of the iPDT in Lille center was favorable, as validated by an external board. Median overall survival was promising (≈28 months), similar to previous US results. Our center is expected to join soon a large phase II randomized, multicentric US trial assessing MPM multimodal treatment (P/D, chemotherapy) ±iPDT (NCT02153229; UPENN, USA).