. 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 11.

Hepatectomy Plus Postoperative FOLFOX Versus Hepatectomy Alone in Patients With Liver-Only Colorectal Cancer Metastases²³

Outcome, Time Frame	Study Results	Absolute Effect Estimates		Quality of Evidence	Plain Language Summary
Outcome, Time Frame	Study Results	Hepatectomy	Hepatectomy + Postoperative FOLFOX	Quality of Evidence	Plain Language Summary
DFS (primary outcome), 3-year	HR, 0.67 (95% CI, 0.50 to 0.92) (300 participants in one study)	574 recurrences, secondary cancers or deaths per 1,000	435 recurrences, secondary cancers or deaths per 1,000	Moderate^a	Hepatectomy plus postoperative FOLFOX probably improves DFS
DFS (primary outcome), 3-year		Difference: 139 fewer per 1,000 (95% CI, 227 fewer to 30 fewer)		Moderate^a	Hepatectomy plus postoperative FOLFOX probably improves DFS
OS, 3-year	HR, 1.25 (95% CI, 0.78 to 2.00) (300 participants in one study)	82 deaths per 1,000	101 deaths per 1,000	Low^a,b	We are unsure of the effect of hepatectomy plus postoperative FOLFOX on OS. The addition of FOLFOX to hepatectomy may worsen OS
OS, 3-year		Difference: 19 more per 1,000 (95% CI, 17 fewer to 75 more)		Low^a,b
AEs	—			High	Hepatectomy plus postoperative FOLFOX worsens adverse events, compared with hepatectomy alone

Abbreviations: AE, adverse event; DFS, disease-free survival; HR, hazard ratio; FOLFOX, folinic acid, fluorouracil, and oxaliplatin; OS, overall survival.

Downgrade: inconsistency of results between OS and DFS; open-label trial; trial terminated early according to protocol.

Insufficient follow-up of this end point noted by Kanemitsu et al.