Prospective Registry on Mesothelioma Peritonei Treatment (PROMPT): Study Design and Rationale
Year: 2012
Type: article
Abstract: a) Primary Objective: The primary objective of the PROMPT study was to generate high-level prospective evidence to determine the optimal treatment modality for Diffuse Malignant Peritoneal Mesothelioma (DMP), a rare and aggressive neoplasm. Since conducting Randomized Controlled Trials (RCTs) was considered impractical due to the rarity of the disease and ethical limitations, this prospective international registry sought to compare overall survival among different treatment strategies: 1) Cytoreductive Surgery (CRS) + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) + systemic chemotherapy; 2) CRS + systemic chemotherapy; and 3) systemic chemotherapy alone. A key objective was to perform intention-to-treat analysis, including all patients referred to participating centers, regardless of the final treatment received. b) Methodology: An international, multicenter, prospective observational registry was designed. Twenty specialized centers in 13 countries committed to collecting standardized data from all consecutive patients with peritoneal carcinomatosis (PCM) referred between March 2011 and February 2013, with a minimum follow-up of 6 months. • Population: Patients with PCM referred to the participating centers. • Data Collection: An anonymized central database was used with three standardized forms: 1. Registration Data (Part I): Demographic, preoperative (histology, CT staging), and intraoperative (Peritoneal Cancer Index, peritonectomy procedures, Cytoreduction Completion -CRC-) information. 2. Perioperative Data (Part II): Morbidity and mortality at 30, 60, and 90 days. 3. Follow-up Data (Part III): Overall survival, progression-free survival, and relapse. • Statistical Analysis: The primary analysis would be performed on an intention-to-treat basis. To mitigate the limitations of the observational design and minimize selection bias when comparing treatment groups, propensity score matching was planned. c) Most Relevant Results: The document analyzed is a publication outlining the study design and rationale, and therefore does not present the final results of the PROMPT registry. However, to contextualize the need for the study, the most relevant results from the available evidence up to that date (2009-2011), which justify its implementation, are cited: • A previous multi-institutional retrospective registry (Yan et al., 2009) with 405 patients treated with CRS+HIPEC showed a median overall survival of 53 months and 3- and 5-year survival rates of 60% and 47%, respectively, significantly exceeding the historical prognosis (<12 months with conventional treatments). • Grade 3-4 morbidity was 31% (127/405) and perioperative mortality was 2% (9/405). The complete absence of high-level comparative data (RCTs) was highlighted, and the existing evidence was level IV (retrospective series), often reported only in selected patients with optimal CRC, which limited generalizability. d) Final Conclusion: The PROMPT study was conceived as the necessary and feasible initiative to address the lack of RCTs in the treatment of MPMD. By collecting high-quality prospective data and analyzing them using intention-to-treat and propensity score matching, it was anticipated that this registry would provide the best available evidence to evaluate the comparative safety and efficacy of the CRS+HIPEC combination versus other options. Furthermore, it was expected to validate prognostic staging systems and help refine patient selection.
Source: Tumori Journal
Authors: Christopher Cao, Tristan D Yan, David L Morris, Kurt Van Der Speeten, Søren Laurberg, Olivier Glehen, Karl Link, Pompiliu Piso, Antonios-Apostolos K. Tentes, Marcello Deraco, Stein G Larsen, Dragutin Kecmanovic, Luis G Bayón, Juan T Melero, Santiago González-Moreno, Haile Mahteme, Philippe Gertsch, Brendan Moran, Jesus Esquivel, Richard Alexander, Edward A Levine, Paul H Sugarbaker
Institutions: Baird Institute, St George Hospital, Ziekenhuis Oost-Limburg, Aarhus University Hospital, Hospices Civils de Lyon, Hôpital Lyon Sud, Asklepios, University Hospital Regensburg, Oslo University Hospital, Hospital General Universitario Gregorio Marañón, Complejo Hospitalario Torrecárdenas, MD Anderson Cancer Center Madrid, Uppsala University Hospital, University Hospital Zurich, Basingstoke and North Hampshire Hospital, Saint Agnes Hospital, University of Maryland Medical Center, Wake Forest University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4234941140