2 The procedure
2.1.1 Peritoneal carcinomatosis is advanced cancer associated with short survival and poor quality of life.
2.1.2 Current treatments include systemic chemotherapy with the aim of prolonging survival, and/or surgery for short-term palliation of complications such as bowel obstruction.
2.2.1 Cytoreduction surgery aims to remove all macroscopic tumours. Intraoperative intraperitoneal administration of chemotherapy aims to distribute the drug uniformly to all surfaces of the abdomen and pelvis.
2.2.2 With the patient under general anaesthesia, appropriate CRS is carried out, followed by perfusion of the abdomen with heated chemotherapy solution (heating increases penetration and cytotoxic effects). The abdomen is drained prior to closure. A further course of systemic or early postoperative intraperitoneal chemotherapy (EPIC) may be administered.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 A systematic review of 4500 patients with peritoneal carcinomatosis of colorectal origin reported an overall median 5-year survival of 19% (16 studies).
2.3.2 A non-randomised comparative study of 506 patients with peritoneal carcinomatosis of colorectal origin comparing CRS and HIPEC (271 patients) with CRS and EPIC (123 patients) and CRS and HIPEC plus EPIC (112 patients) reported no significant difference in median survival between the groups (19.2 months, 19.2 months and 21.6 months respectively) (p = 0.61).
2.3.3 A case series of 96 patients with peritoneal carcinomatosis of varying primary tumour origin treated by CRS and HIPEC reported a significant improvement in quality of life (using the Short Form-36 questionnaire), with an increase in mean score from 69.5 to 80 at 6-month follow-up (significance not stated).
2.3.4 The Specialist Advisers listed key efficacy outcomes as survival, quality of life, symptom palliation, recurrence rate and return to work and recreational activities.
2.4.1 A meta-analysis of 4 comparative studies included in the systematic review of 4500 patients reported a 3-year survival hazard ratio of 0.55 (95% confidence interval: 0.4–0.75), indicating that patients were more likely to survive if they received CRS plus HIPEC or EPIC (total number of patients not stated).
2.4.2 The systematic review of 4500 patients reported a mortality range of 0–12% (27 studies) (follow-up not stated). A postoperative mortality rate of 4% (20/506) was reported in the non-randomised comparative study of 506 patients. Deaths were attributed to the following causes: septic shock (9), respiratory complications (5), pulmonary embolus (1), stroke (1), peritonitis (1), acute renal failure (1), aplasia (not otherwise described) (1) and unknown causes (1) (timing of events not stated). In an RCT of 105 patients (CRS, HIPEC and systemic chemotherapy group), 3 patients died from abdominal sepsis (2 within 40 days, 1 more than 3 months after the procedure) and 1 patient died of pulmonary embolism more than 3 months after the procedure.
2.4.3 Myocardial necrosis and myocardial infarction were reported in 1 patient each in case series of 207 and 122 patients (varying tumour origin; timing of events not stated).
2.4.4 Acute renal failure was reported in 3% (2/59) (successfully treated by medical therapy) and 1% (1/140) (requiring dialysis in intensive care) of patients in case series of 59 and 140 patients respectively (varying tumour origin). Haemolytic–uraemic syndrome occurred in 1 patient in the case series of 122 patients.
2.4.5 The Specialist Advisers listed possible adverse events as bowel obstruction, bleeding, abdominal pain, eating disturbances, vascular, ureteric and bile duct injury, liver dysfunction and failure, neuropathy and anaphylaxis.