Table 2. Characteristics and outcomes of patients enrolled in randomized studies of peritoneal perfusion at gastrectomy versus gastrectomy alone.
| Authors | Year | Total/HIPEC/other | Stage |
Agent (dose) | Toxicity | Median follow-up | Clinical outcome | |
|---|---|---|---|---|---|---|---|---|
| I-III | IV | |||||||
| Koga et al. (35) | 1988 | 60 | HIPEC: MMC (64-100 mg in 8-12 L) | Anastomotic leak 3.1% HIPEC vs. 7.1% Sx alone; adhesive ileus 3.1% HIPEC vs. 7.1% Sx alone | 30 months | NS* OS 83% HIPEC vs. 67.3% Sx alone | ||
| 26 | 24 | 2 | ||||||
| 0 | ||||||||
| Hamazoe et al. (36) | 1993 | 82 | HIPEC: MMC (10 µg/mL in 8-12 L) | Thrombocytopenia, transaminitis, anastomotic break 4.8% HIPEC vs. 7.5% surgery alone | 6 years | NS 5-year OS 64.2% HIPEC vs. 52.5% Sx alone (P=0.247) | ||
| 42 | 38 | 4 | ||||||
| 0 | ||||||||
| Fujimura et al. (37) | 1994 | 58 | HIPEC: MMC (30 mg/kg) & CDDP (300 mg/kg) in 10 L; NIC: MMC (30 mg/kg) & CDDP (300 mg/kg) in 10 L | Decreased BM, renal dysfunction, intestinal perforation | 31-37 months | 3-year OS 68% HIPEC vs. 51% NIC vs. 23% Sx alone (P<0.001) | ||
| 22 | 17 | 5 | ||||||
| 18 | 13 | 5 | ||||||
| Sautner et al. (38) | 1994 | 67 | 40 | 27 | EPIC: treatment between 10th and 28th postop day | Nausea, vomiting, diarrhea present in 24 patients (73%) | 72.5 months | NS MS 17.3 months HIPEC vs. 16.0 months control (P=0.6) |
| 34 | ||||||||
| 0 | ||||||||
| Ikeguchi et al. (39) | 1995 | 174 | HIPEC: MMC (80-100 mg/m2) in 8-10 L (post-op MMC & UFT) | ND | 6 years | NS* 5-year OS 51% HIPEC vs. 46% Sx alone | ||
| 78 | 78 | 0 | ||||||
| 0 | ||||||||
| Rosen et al. (40) | 1998 | 91 | Perfusion: MMC (50 mg) & CH (375 mg) | Morbidity: 35% perfusion vs 16% Sx alone (P<0.02); mortality (60 days): 11% vs. 2% | 597 days | NS OS 738.9 days HIPEC vs. 515.4 days Sx alone (P=0.44) | ||
| 46 | 46 | 0 | ||||||
| 0 | ||||||||
| Fujimoto et al. (41) | 1999 | 141 | HIPEC: MMC (10 µg/mL) in 3-4 L (post-op chemo) | No difference in rate of duodenal stump leak | ND | 8-year OS 62% HIPEC vs. 49% Sx alone (P=0.0362) | ||
| 71 | 58 | 13 | ||||||
| 0 | ||||||||
| Shimoyama et al. (42) | 1999 | 29 | Perfusion: MMC (10 mg) in 500 mL; regional perfusion: MMC (10 mg) in 500 mL (post op chemo: CDDP, UFT) | No difference in rate of anastomotic leak or pancreatic leak | 47 months | OS improved for perfusion vs. regional perfusion vs. Sx alone (P=0.049) | ||
| 30 | 30 | 0 | ||||||
| 24 | 24 | 0 | ||||||
| Yonemura et al. (43) | 2001 | 139 | HIPC: MMC (30 mg) & CDDP (300 mg) in 8-10 L; NIC: MMC (30 mg) & CDDP (300 mg) in 8-10 L | No difference in rate of leak, pneumonia, renal dysfunction, mortality | 5.5 years | OS* 61% HIPEC vs. 43% NIC & 42% Sx alone (NS btw NIC & surgery alone) | ||
| 48 | 35 | 13 | ||||||
| 44 | 29 | 15 | ||||||
| Miyashiro et al. (44) | 2011 | 268 | ND | ND | Perfusion: CDDP (70 mg/m2) in 1 L (post op chemo: CDDP, 5FU) | Mortality 3 vs. 1 patients; grade 4 AE: 2 vs. 3 patients | 6 years | NS OS 62.0% perfusion vs. 60.9% Sx alone (P=0.482) |
| 135 | ||||||||
*P value not stated. Abbreviations: HIPEC, hyperthermic intraperitoneal chemotherapy; MMC, mitomycin C; Sx, surgery; EPIC, early postoperative intraperitoneal chemotherapy;NS, not significant; OS, overall survival; CDDP, cisplatin; NIC, normothermic intraperitoneal chemotherapy; MS, median survival; UFT, Tegafur/uracil; ND, not declared; CH, activated carbon.