Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness

Abstract

IntroductionThere is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery.Primary objectivesTo compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis.Secondary objectivesTo compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost–utility analysis.Methods and analysisWe will perform a systematic review of literature by updating the searches from MEDLINE, Embase, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost–utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting.Ethics and disseminationThis project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal.PROSPERO registration numberCRD42019130504.

In vitro 3D microfluidic peritoneal metastatic colorectal cancer model for testing different oxaliplatin-based HIPEC regimens

“…(460 mg/m 2 for 60 min), and Stewart et al. (200 mg/m 2 for 120 min) using the 3D CRC-PM mimicking system [ 19 ], [ 20 ], [ 21 ]. Following these treatments, cell viability at the 48th h post-perfusion was 61.6 %, 54.6 %, and 24.9 %, respectively, under normothermic conditions.…”

“…CRS removes macroscopic tumors from the peritoneum and is supplemented by HIPEC to eliminate microscopic tumor residuals, enhancing treatment efficacy [ 20 ]. Despite this, HIPEC protocols vary in drug type, concentration, administration temperature, and duration [ 21 ]. Our goal is to develop a preclinical tool that mimics the CRCPM system and precisely predicts HIPEC administration parameters.…”

Cytoreductive surgery plus hyperthermic intraoperative peritoneal chemotherapy for people with peritoneal metastases from colorectal, ovarian or gastric origin: A systematic review of randomized controlled trials

“…We used GRADE guidance to assess the certainty of evidence and determine the strength of recommendations. 42 For detailed methods of performing the systematic review, please see our published protocol 43 and Supporting Information S1 (accepted for publication in NIHR Journals).…”

“…For detailed methods of performing the systematic review, please see our published protocol 43 and Supporting Information (accepted for publication in NIHR Journals).…”

Lobaplatin-based prophylactic hyperthermic intraperitoneal chemotherapy for T4 gastric cancer patients: A retrospective clinical study

“…In recent years, HIPEC has been used as one form of treatment for patients with advanced gastrointestinal cancers ( 8 , 9 ). Compared with conventional intravenous chemotherapy, HIPEC has significant advantages ( 10 ).…”