Abstract
BackgroundMalignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa. The standard frontline treatment of MPM is cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) unless the peritoneal disease is considered unresectable. For unresectable patients the standard frontline treatment is a combination of cisplatin and pemetrexed but the prognosis remains ominous with only 13 months of overall survival (OS).MethodsThe proposed study is a multicenter randomized non-comparative study evaluating the association of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) and systemic chemotherapy vs. systemic chemotherapy alone as first-line treatment of MPM. Patients will be randomized with a 2:1 ratio using a minimization technique. Sixty-six patients have to be enrolled. Stratification will be performed according to histology (epithelioid vs. sarcomatoid and biphasic), presence of extraperitoneal disease and center. Primary objective is OS and secondary objectives include progression-free survival (PFS), safety, compliance, feasibility, conversion to resectability, histological response to treatment and quality of life.ConclusionsWe expect to show that intensification of the first line treatment with PIPAC for initially unresectable MPM patients increases OS.Trial registrationProspective study. Clinicaltrials.gov: NCT03574493 EudraCT: 2019–001515-23.
Highlights
Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa [1]
It has been shown that cytoreductive surgery (CRS) associated to hyperthermic intraperitoneal chemotherapy (HIPEC) improves prognosis resulting in a median overall survival (OS) of 29.5 to 53 months and a 5 years OS rate ranging between 39 and 63% [7,8,9]
This study showed a benefit in median survival of 5 months and an increase in the response rate of 10% [11]
Summary
Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa [1]. It has been shown that cytoreductive surgery (CRS) associated to hyperthermic intraperitoneal chemotherapy (HIPEC) improves prognosis resulting in a median overall survival (OS) of 29.5 to 53 months and a 5 years OS rate ranging between 39 and 63% [7,8,9]. Peritoneal mesothelioma has benefitted from very few systemic chemotherapy studies but was the setting of choice for testing intraperitoneal administration of chemotherapy either as early postoperative intraperitoneal chemotherapy [17] or as neoadjuvant intraperitoneal chemotherapy [18]. Both studies offered promising results suggesting a particular sensitivity of MPM to intraperitoneal administration. The aim of this trial is to test an intensification of the neoadjuvant treatment in these patients using modern intraperitoneal drug delivery methods (PIPAC)
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