Comparison of VATS Pleurectomy/Decortication Surgery plus Hyperthermic Intrathoracic Chemotherapy with VATS talc pleurodesis for the treatment of Malignant Pleural Mesothelioma: a randomized pilot study

Abstract

AbstractIntroductionNo previous study provides compelling evidence to convince surgeons to opt for one procedure over another for the treatment of Malignant Pleural Mesothelioma (MPM). Hyperthermic intrathoracic chemotherapy (HITHOC) adjunct to surgery for MPM has no definite role. The primary objective of this randomized pilot trial was to evaluate the feasibility for future large studies.MethodThe study design was a prospective randomized three-centric pilot trial (ISRCTN12709516). 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 VATS P/D plus HITHOC. The main outcome measures were description of study feasibility. We collected socio-demographic and clinical patient information. Data of Kaplan-Meier survival analysis and Cox regression analysis are presented.ResultsFrom 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 from 6 to 80 months. The median overall survival time started to diverge at 20 months. In Group A, it was 19 months (95% CI:12-25) and in Group B, it was 28 months (95% CI:0-56). Survival rate for the epithelioid type was 15 months (0-34) in groups A. and 45 months (0-107) in the Group B with an HR 0.77 (95% CI:0.28-2.2).ConclusionThese findings suggest that VATS 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.Strengths and limitations of this studythis pilot study represents an important step forward of the treatment of malignant pleural mesotheliomaThe study demonstrates the feasibility for a multicenter randomized trial to compare VATS P/D plus HITHOC with VATS talc pleurodesis in the management of MPMAlthough survival for the epitheliod type is 45 months, the inclusion of small number of patients is a limitation.Although neoadjuvant, adjuvant chemo-radio or immunotherapy have been administered to the patients, we have no specific information about doses for every single patient.A potential source of bias could be that the house staff of the Centre A has not been formally educated about the study while in the Centre B house staff was informed about the pilot trial.