Authors' objectives: To assess the efficacy or effectiveness, safety, organisational issues and cost-effectiveness of HIPEC as an adjuvant therapy for PSM.

Authors' results and conclusions: 1-Effectiveness: a. Colorectal Cancer with/without Peritoneal carcinomatosis (metastasis) [CRPM] Two systematic review of non-randomised controlled trials showed that pooled median overall survival (OS) across of all studies for patients received cytoreductive surgery (CRS) and HIPEC was 32 months (range 12.2 – 60.1 months) when comparing with no HIPEC group as a control. However, in another systematic review when patients in colorectal cancer with high risk of peritoneal carcinomatosis (CRPM), demonstrated that 3- or 5- year OS had no survival time benefit compared to those undergoing standard treatment without HIPEC (RR: 1.13; 95% CI: 0.97 to 1.33; p= 0.12; I2=77%). Similarly, 3- or 5-year progression-free survival (PFS), disease free survival (DFS) also did not showed the expected efficacy of preventive HIPEC treatment in improving the survival (RR: 1.10; 95% CI: 0.75 to 1.59; p = 0.63; I2 = 53%); (RR: 0.41; 95% CI: 0.21 to 0.83; p = 0.01; I2 = 58%). In addition to completeness of cytoreduction (CC), increasing peritoneal carcinomatosis index and lymph node involvement, factor related to primary tumour location, adjuvant chemotherapy and perioperative grade III/IV morbidity are also key prognostic factors influencing survival in patients undergoing CRS+HIPEC for isolated CRPM. While CRS+HIPEC as a combined treatment has been demonstrated to be superior to systemic chemotherapy in CRPM, there a very few studies have evaluated the role of CRS alone without HIPEC. Colonic origin of PM showed better outcomes and prognosis (OS and PFS) when compared with rectal origin PM. b. Endometrial Cancer – derived Peritoneal metastasis (EC-PM) Combination treatment (CRS+HIPEC) for patients with EC-PM demonstrated a median OS of 12 to 33 months and a median DFS was 7 to 18 months. CRS and HIPEC are effective when the patient achieved a CC=0 resection in 70% of the patients with EC-PM. c. Ovarian Cancer HIPEC as an adjuvant therapy may improve DFS of patients with ovarian cancer when residual tumours were ≤1 cm or not visible. (DFS: HR= 0.580; 95% CI 0.476 to 0.706) HIPEC treatment also improved the prognosis in both primary and recurrent disease. However, the effect of HIPEC was not observed in patients with primary disease who had residual tumours ≤1 cm or no visible tumours. It may also improve OS of only patients with recurrent disease whose residual tumours were ≤1 cm. (OS: HR= 0.611; 95% CI, 0.376 to 0.99) For women with recurrence ovarian cancer (ROC) and be treated with CRS+HIPEC and chemotherapy, OS showed a significantly improved 1-year OS when compared to without HIPEC (OR 2.42; 95% CI, 1.06 to 5.56; p=0.04; I2 =4%) and maintained significant improvement in OS after 2-, 3- and 5- years respectively. (2-years OS= OR: 3.33; 95% CI, 1.81 to 6.10; p

Authors' recommendations: HIPEC treatment may be introduced and initiated as an adjuvant therapy with cytoreductive surgery (CRS) for the treatment of colorectal carcinomatosis peritoneal metastases (CRC PM) and other gynae-oncological diseases patients in selected centres in Ministry of Health facilities, provided local expertise team is available and refinement of selection criteria of the patients.

Authors' methods: Literature search was conducted by an Information Specialist who searched for published articles pertaining CRS and HIPEC treatment in patients colorectal carcinomatosis peritoneal metastases (CRC PM) and other gynae-oncological diseases. The following electronic databases were searched through the Ovid interface: Ovid MEDLINE® and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions® 1946 to January 2021, EBM Reviews - Health Technology Assessment (4th Quarter 2020), EBM Reviews - Cochrane Database of Systematic Review (2005 to January 2021), EBM Reviews - Cochrane Central Register of Controlled Trials (December 2020), and EBM Reviews - NHS Economic Evaluation Database (1st Quarter 2016). Parallel searches were run in PubMed, US FDA and INAHTA database. No limits were applied to the search. The last search was performed on 31 December 2020. Additional articles were identified from reviewing the references of retrieved articles

Project Status: Completed

Year Published: 2021

URL for published report: http://www.moh.gov.my/index.php/pages/view/1747

Requestor: Ministry of Health

URL for additional information: http://www.moh.gov.my/moh/resources/Penerbitan/Penilaian%20Teknologi%20Kesihatan%20(HTA)/Executive_Summary_HTA_-_HYPERTHERMIC_INTRAPERITONEAL_CHEMOTHERAPY_(HIPEC).pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)