Randomized controlled trials evaluating cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in prevention and therapy of peritoneal metastasis: a systematic review.

Clarisse Eveno,Marc Pocard

doi:10.1515/pp-2016-0027

Abstract

Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is increasingly used to prevent or treat peritoneal metastases (PM) in selected indications. The objective of this article was to review published, recruiting or planned randomized controlled trials (RCTs) evaluating CRS and HIPEC versus standard of care. Comparator was systemic chemotherapy and/or CRS alone. Systematic review according to PRISMA guidelines. Electronic searches for published RCT using PubMed (from 1980 to November 2016) and for ongoing RCT in the United States and European clinical databases (until November 2016). Current update on ongoing trials from the 10th PSOGI meeting in November 2016 in Washington DC. Fourteen RCTs on CRS and HIPEC were excluded for various reasons. Thirty-eight trials designed for randomizing 7,303 patients were identified: 11 in colorectal cancer (6 for prevention of PM, n=1,107 patients; 5 for therapy, n=781), 10 in ovarian cancer (5 in frontline therapy, n=438 patients; 5 for treating recurrence, n=1,062) and 17 in gastric cancer (14 for prevention of PM, n=3,659 patients; 3 for therapy, n=256). Results of 9 RCTs have been published: 1 in colorectal cancer (105 patients), 1 in ovarian cancer (130 patients) and 7 in gastric cancer (together 669 patients). Five RCTs have completed recruitment and follow-up is ongoing. There is a clear trend in recent trial design from therapeutic to preventive indications. The number of published RCT evaluating CRS and HIPEC in prevention or therapy of PM is relatively small. There is some evidence that CRS and HIPEC improve survival in recurrent colorectal origin, evidence in ovarian and gastric cancer remains debated. A large number of studies is ongoing that might deliver additional evidence. Trial design and interpretation of results remain difficult because of multiple methodological challenges.

Highlights

Regulations enable the functioning of society with the possible risk of enforcing regulation that is considered burdensome for business and, represents a target in need of removal/reduction. Katsoulacos, Makri and Bageri (2011) see regulations as often being excessive and/or of poor quality and are imposing unnecessary burden on business and, overall, on the economy
The purpose of administrative burden reduction in this area was to minimise the costs for these businesses and, raise their competitiveness in the market
The results shown in Graph 2 suggest that the administrative burden reduction measure was mostly known8 to subjects, a very small portion of them decided to use this option regarding the taxation of their business

Summary

Introduction

Regulations enable the functioning of society with the possible risk of enforcing regulation that is considered burdensome for business and, represents a target in need of removal/reduction. Katsoulacos, Makri and Bageri (2011) see regulations as often being excessive and/or of poor quality and are imposing unnecessary burden on business and, overall, on the economy. Katsoulacos, Makri and Bageri (2011) see regulations as often being excessive and/or of poor quality and are imposing unnecessary burden on business and, overall, on the economy. Businesses may opt to delay their intended business activities if they do not perceive the regulative environment as stimulating (Levie & Autio, 2011). They may have certain hindrances if they experience burdensome obligations that derive from numerous regulatory demands. Such demands can be divided into (1) the necessary and (2) unnecessary ones. This type of unnecessary regulation is referred to as administrative burden..

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