Comparison of video-assisted pleurectomy/decortication surgery plus hyperthermic intrathoracic chemotherapy with VATS talc pleurodesis for the treatment of malignant pleural mesothelioma: A pilot study
Marcello Migliore,
Maria Fiore,
Tommaso Filippini,
Rosario Tumino,
Mara Sabbioni,
Corrado Spatola,
Riccardo Polosa,
Paolo Vigneri,
Marco Nardini,
Sergio Castorina,
Francesco Basile,
Margherita Ferrante
Affiliations
Marcello Migliore
Minimally Invasive Thoracic Surgery and New Technologies University Hospital of Catania, Department of General Surgery and Medical Specialties, University of Catania, Catania, Italy; Thoracic Surgery and Lung Transplant, Lung Health Centre, Organ Transplant Center of Excellence (OTCoE), King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia; Corresponding author. Minimally Invasive Thoracic Surgery and New Technologies University Hospital of Catania, Department of General Surgery and Medical Specialties, University of Catania, 95123, Catania, Italy.
Maria Fiore
Department of Medical, Surgical and Advanced Technologies “G.F. Ingrassia”, University of Catania, Catania, Italy
Tommaso Filippini
Environmental, Genetic and Nutritional Epidemiology Research Center (CREAGEN), Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy; School of Public Health, University of California Berkeley, Berkeley, CA, USA
Rosario Tumino
Cancer Registry and Histopathology Department, Provincial Health Authority (ASP 7), Ragusa, Italy
Mara Sabbioni
Italian National Asbestos Organization, Rome, Italy
Corrado Spatola
Radiotherapy Unit, University of Catania, Catania, Italy
Riccardo Polosa
General Medicine, Department of Clinical & Experimental Medicine, University of Catania, Catania, Italy
Paolo Vigneri
Center of Oncology and Hematology, Department of Clinical & Experimental Medicine University of Catania, Catania, Italy
Marco Nardini
Department of Thoracic Surgery, St. James University Hospital, London, UK
Sergio Castorina
General and Thoracic Surgery, Morgagni Policlinic Hospital, Catania, Italy
Francesco Basile
General Surgery, University Hospital of Catania, Department of General Surgery and Medical Specialties, University of Catania, Catania, Italy
Margherita Ferrante
Department of Medical, Surgical and Advanced Technologies “G.F. Ingrassia”, University of Catania, Catania, Italy
Hyperthermic intrathoracic chemotherapy (HITHOC) adjunct to surgery for Malignant Pleural Mesothelioma (MPM) has no definite role. The primary objective of this pilot-trial was to evaluate the feasibility for future large studies. The study design was a prospective randomized three-centric pilot trial. We recruited patients diagnosed with MPM and prospectively assigned them to two groups: Group A: Video Assisted Thoracic Surgery (VATS) talc pleurodesis or Group B: Video-assisted P/D plus HITHOC. From November-2011 to July-2017 24 males and 3 females, with a median age of 68-years were enrolled (recruitment rate 5 patients/year). Preoperative stage was I-II, and 18 had epithelioid type. 14 patients were in the Group A. Operative mortality was 0. Follow-up ranged 6–80 months. The median overall survival time started to diverge at 20 months, being 19 months (95% CI 12–25) in Group A and 28 months (95% CI 0–56) in Group B. Survival rate for the epithelioid type was 15 months (95% CI 0–34) in Group A and 45 months (95% CI 0–107) in the Group B. These findings suggest that video-assisted P/D plus HITHOC may improve survival time in MPM patients undergoing surgical treatment and support the need for a larger multicenter randomized clinical trial.
