. Author manuscript; available in PMC: 2023 Sep 18.

Published in final edited form as: J Clin Oncol. 2022 Oct 17;41(3):678–700. doi: 10.1200/JCO.22.01690

TABLE 10.

Perioperative Chemotherapy Versus Surgery Alone for Patients With Liver Metastases From Colorectal Cancer²²

Outcome, Time Frame	Study Results	Absolute Effect Estimates		Quality of Evidence	Plain Language Summary
Outcome, Time Frame	Study Results	Surgery Alone	Perioperative Chemotherapy	Quality of Evidence	Plain Language Summary
PFS (ITT, primary outcome), 3 years	HR, 0.79 (95% CI, 0.62 to 1.02) (364 participants in one study)	719 deaths or progressions per 1,000	633 deaths or progressions per 1,000	Moderate^a	Perioperative FOLFOX may have little or no effect on PFS compared with surgery alone
PFS (ITT, primary outcome), 3 years		Difference: 86 fewer per 1,000 (95% CI, 174 fewer to 7 more)		Moderate^a
PFS (resected patients), 3 years	HR, 0.73 (95% CI, 0.55 to 0.97) (303 participants in one study)	668 deaths or progressions per 1,000	553 deaths or progressions per 1,000	Low^a,b	For patients who ultimately undergo resection, perioperative chemotherapy may improve PFS compared with surgery alone
PFS (resected patients), 3 years		Difference: 115 fewer per 1,000 (95% CI, 213 fewer to 11 fewer)		Low^a,b
OS (ITT), 5 years	HR, 0.88 (95% CI, 0.69 to 1.14) (303 participants in one study)	522 deaths⁶⁴ per 1,000	478 deaths per 1,000	Moderate^a	Perioperative chemotherapy may have little or no effect on OS compared with surgery alone
OS (ITT), 5 years		Difference: 44 fewer per 1,000 (95% CI, 123 fewer to 47 more)		Moderate^a
Reversible postoperative complications	RR, 1.58 (95% CI, 1.02 to 2.45) (329 participants in one study)	160 per 1,000	253 per 1,000	Moderate^a,c	Perioperative chemotherapy increases the rate of reversible postoperative complications
Reversible postoperative complications		Difference: 93 more per 1,000 (95% CI, 3 more to 232 more)		Moderate^a,c

Abbreviations: FOLFOX, folinic acid, fluorouracil, and oxaliplatin; HR, hazard ratio; ITT, intention-to-treat; OS, overall survival; PFS, progression-free survival; RR, relative risk.

Downgrade: lack of blinding of participants, personnel, or assessors.

Exploratory subgroup analysis not specified in study protocol; planned before data analysis.

≥ 5% of patients in the perioperative group experienced biliary fistula (8%), hepatic failure (7%), and intra-abdominal infection (7%). ≥ 5% of patients in the surgery alone group experienced hepatic failure (5%).