TABLE 5.
CRS Plus HIPEC and Chemotherapy (FU plus folinic acid) Versus Chemotherapy for mCRC Patients With Colorectal Peritoneal Metastases and No Distant Metastases58
Outcome, Time Frame | Study Results | Absolute Effect Estimates | Quality of Evidence | Plain Language Summary | |
---|---|---|---|---|---|
FU Chemotherapy | CRS + HIPEC + FU Chemotherapy | ||||
OS, 24 months | HR, 0.55 (95% CI, 0.32 to 0.95) (105 participants in one study) | 902 deaths per 1,000 | 721 deaths per 1,000 | Moderatea | Risk of death was lower for patients with mCRC and colorectal peritoneal metastases treated with CRS plus HIPEC, compared with chemotherapy alone |
Difference: 181 fewer per 1,000 (95% CI, 378 fewer to 12 fewer) | |||||
Treatment-related mortality | The mortality rate was 8% in the CRS plus HIPEC arm, attributable at least partially to the extent of surgery, which was related to the extent of peritoneal metastases. Extent of disease was reportedly difficult to predict preoperatively | High | Treatment-related mortality risk is increased with CRS plus HIPEC, compared with chemotherapy alone | ||
Grade ≥ 3 AEs and surgical complications | Rate of grade 3–5 adverse events was 65%, and rate of surgical complications (ie, postoperative events needing reintervention) was 35% among patients undergoing CRS plus HIPEC | High | Risk of adverse events and surgical complications are increased with CRS plus HIPEC |
Abbreviations: AE, adverse event; CRS, cytoreductive surgery; FU, fluorouracil; HIPEC, hyperthermic intraperitoneal chemotherapy; HR, hazard ratio; mCRC, metastatic colorectal cancer; OS, overall survival.
Downgrade: the effect on OS may have been due to the impact of CRS alone.