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

ABSTRACT: Background: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. Content: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. Summary: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. Outlook: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.

SUBMITTER: Eveno C

PROVIDER: S-EPMC6386515 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Project description:BackgroundCareful selection of patients with colorectal peritoneal metastases (PM) for cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is crucial. It remains unknown whether the time of onset of colorectal PM (synchronous vs metachronous) influences surgical morbidity and survival outcomes after CRS with HIPEC.MethodsPatients with histologically proven colorectal PM who underwent CRS with HIPEC between February 2006 and December 2017 in two Dutch tertiary referral hospitals were retrospectively included from a prospectively maintained database. The onset of colorectal PM was classified as synchronous (PM diagnosed at the initiational presentation with colorectal cancer) or metachronous (PM diagnosed after initial curative colorectal resection). Major postoperative complications (Clavien-Dindo grade ≥ 3), overall survival (OS), and disease-free survival (DFS) were compared between patients with synchronous colorectal PM and those with metachronous colorectal PM using Kaplan-Meier analyses, proportional hazard analyses, and a multivariate Cox regression analysis.ResultsThe study enrolled 433 patients, of whom 231 (53%) had synchronous colorectal PM and 202 (47%) had metachronous colorectal PM. The major postoperative complication rate and median OS were similar between the patients with synchronous colorectal PM and those with metachronous colorectal PM (26.8% vs 29.7%; p = 0.693 and 34 vs 33 months, respectively; p = 0.819). The median DFS was significantly decreased for the patients with metachronous colorectal PM and those with synchronous colorectal PM (11 vs 15 months; adjusted hazard ratio, 1.63; 95% confidence interval, 1.18-2.26).ConclusionsMetachronous onset of colorectal PM is associated with early recurrence after CRS with HIPEC compared with synchronous colorectal PM, without a difference in OS or major postoperative complications. Time to onset of colorectal PM should be taken into consideration to optimize patient selection for this major procedure.

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

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