TABLE 6.
CRS Plus Oxaliplatin-Based HIPEC and Chemotherapy Versus CRS Plus Chemotherapy for Patients With Colorectal Peritoneal Metastases With Less Than 1-mm Residual Tumor8
| Outcome, Time Frame | Study Results | Absolute Effect Estimates | Quality of Evidence | Plain Language Summary | |
|---|---|---|---|---|---|
| CRS + Chemotherapy | CRS + HIPEC + Chemotherapy | ||||
| OS, 12 months | HR, 1.00 (95% CI, 0.63 to 1.58) (265 patients in one study) | 144 deaths per 1,000 | 144 deaths per 1,000 | High | CRS plus HIPEC and chemotherapy may have little or no effect on OS compared with CRS plus chemotherapy |
| Difference: 0 fewer per 1,000 (95% CI, 51 fewer to 74 more) | |||||
| RFS, 12 months | HR, 0.91 (95% CI, 0.71 to 1.15) (265 patients in one study) | 553 recurrences or deaths per 1,000 | 519 recurrences or deaths per 1,000 | High | CRS plus HIPEC and chemotherapy has little or no effect on RFS compared with CRS plus chemotherapy |
| Difference: 34 fewer per 1,000 (95% CI, 118 fewer to 51 more) | |||||
| Grade ≥ 3 AEs, 30 days | RR, 1.32 (95% CI, 0.96 to 1.82) (265 patients in one study) | 320 events per 1,000 | 422 events per 1,000 | High | CRS plus HIPEC and chemotherapy has little or no effect on or may worsen grade ≥ 3 AEs at 30 days compared with CRS plus chemotherapy |
| Difference: 102 more per 1,000 (95% CI, 13 fewer to 262 more) | |||||
| Grade ≥ 3 AEs, 60 days | RR, 1.69 (95% CI, 1.03 to 2.77) (261 patients in one study) | 150 events per 1,000 | 254 events per 1,000 | High | CRS plus HIPEC and chemotherapy probably worsens grade ≥ 3 AEs at 60 days compared with CRS plus chemotherapy |
| Difference: 104 more per 1,000 (95% CI, 5 more to 266 more) | |||||
Abbreviations: AE, adverse event; CRS, cytoreductive surgery; HIPEC, hyperthermic peritoneal chemotherapy; HR, hazard ratio; OS, overall survival; RFS, relapse-free survival (peritoneal or distant relapse or death); RR, relative risk.