Table 1. Characteristics of randomised and non-randomised comparative studies.
| Author, year, design | Inclusion criteria | n | Interval after resection | Drug, dosage, administration route | Duration and frequency | Methods of i.p. administration |
|---|---|---|---|---|---|---|
| Sugarbaker et al, 1985 RCT | Colorectal cancer N+, T4, obstruction, perforation, age <30 years | 36 | 2 months | i.p. 5FU 1040 mg; | Daily for 5 days every month; 12 cycles | IPC |
| 30 | 2 months | i.v. 5FU 12 mg kg−1 | Daily for 5 days every month; 12 cycles | |||
| Graf et al, 1994 RCT | Colorectal cancer electively operated with curative intent, exclusion of stage I | 50 | 1 day after surgery | i.p. 5FU 500 mg m−2 per day and i.v. LV 60 mg m−2 per day | 4 h daily for 6 consecutive days 1 cycle | IPC |
| 50 | 1 day after surgery | i.p. placebo | 4 h daily for 6 consecutive days 1 cycle | IPC | ||
| Scheithauer et al, 1998 RCT | colon cancer T3/4 and/or N+ | 117 | 1–5 weeks | i.p. LV 200 mg m−2+i.p. 5FU 350 mg m−2 i.v. LV 200 mg m−2 and i.v. 5FU 350 mg m−2 | Day 1 and 3 of each i.v. cycle daily for 4 consecutive days every 4 weeks, total 6 cycles | IPC |
| 119 | 1–5 weeks | p.o. LE 50 mg m−2 and i.v. 5FU 450 mg m−2 | Three times daily for 3 days every 2 weeks; daily for 5 days, 2nd course after 4 weeks, weekly thereafter total 6 cycles | |||
| Vaillant et al, 2000 RCT | Colon cancer T3/4 and/or N+ | 133 | 4–14 days | i.p. 5FU 600 mg m−2 i.v. 1 g 5FU | 3 h daily for 6 consecutive days; 1 cycle Once during surgery | IPC |
| 134 | No chemotherapy | |||||
| Noura et al, 2011 CS | Colorectal cancer positive peritoneal lavage | 31a | Simultaneous with primary tumour resection | i.p. MMC 20 mg T=37 °C; t=1 h i.v. 5FU/LV or p.o. 5FU derivates (n=23) | Once during surgery Schedule not specified | Closed IPEC procedure |
| 22 | i.v. 5FU/LV orp.o. 5FU derivates (n=19) | Schedule not specified | ||||
| Tentes et al, 2011 CS | Colorectal cancer T3/4 | 40 | Simultaneous with primary tumour resection | i.p. MMC 15 mg m−2 T=42.5–43 °C t=90 minor Ox 130 mg m−2 T=42.5–43 °C t=60 min i.v. 5FU/LV in Stage III/IV | Once during surgery 6 cycles | Open HIPEC procedure |
| 67 | 1 day | i.p. 5FU 600 mg m−2 i.v. 5FU/LV in Stage III/IV) | 23 h daily for 5 consecutive days; 1 cycle 6 cycles | IPC | ||
| Sammartino et al, 2012 matched CS | Colon cancer T3/4NxM0, perforation (regardless of tumour stage), signet cell or mucinous tumours | 25 | Simultaneous with primary tumour resection (with appendectomy, omentectomy, resection of the round hepatic ligament, and bilateral ovariectomy) | i.p. Ox 460 mg m−2 T=43 °C t=30 min i.v. 5FU 400 mg m−2+LV 20 mg m−2 i.v. 5FU/Ox (n=13) | Once during surgery not specified | Open HIPEC procedure |
| 50 | i.v. 5FU/Ox (n=23) | Not specified |
Abbreviations: CS=non-randomised comparitive study; 5FU=fluorouracil; (H)IPEC=(hyperthermic) intraperitoneal chemotherapy; i.p.=intraperitoneal; IPC=intraperitoneal catheter; i.v.=intravenous; LE=levamisole; LV=leucovorin; MMC=mitomycine-C; Ox=oxaliplatin; p.o.=oral; RCT=randomised controlled trial; T=temperature of intraperitoneal infusion; t=duration of infusion.
a
Selection based on general patient status and invasiveness of surgery. Intraperitoneal catheter simultaneously placed with primary tumour resection or via a percutaneous approach, with or without a subcutaneous reservoir.