. 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 8.

First-Line FOLFOX Plus SIRT Versus FOLFOX for Unselected Patients With Liver-Only or Liver-Dominant Metastases and Limited Extrahepatic Metastases¹⁹

Outcome	Study Results	Absolute Effect Estimates		Quality of Evidence	Plain Language Summary
Outcome	Study Results	FOLFOX	First-Line FOLFOX + SIRT	Quality of Evidence	Plain Language Summary
OS	HR, 1.04 (95% CI, 0.90 to 1.19) (1,103 participants in three studies)	749 deaths per 1,000	763 deaths per 1,000	Low^a,b	FOLFOX plus SIRT probably has little or no effect on OS compared with FOLFOX alone
OS		Difference: 14 more per 1,000 (95% CI, 37 fewer to 58 more)		Low^a,b
PFS	HR, 0.90 (95% CI, 0.79 to 1.02) (1,103 participants in three studies)	851 deaths or progressions per 1,000	82 deaths or progressions per 1, 000	Low^a,b	FOLFOX plus SIRT probably has little or no effect on PFS, compared with FOLFOX alone
PFS		Difference: 31 fewer per 1,000 (95% CI, 73 fewer to 6 more)		Low^a,b
Grade ≥ 3 AEs	OR, 1.42 (95% CI, 1.09 to 1.85) (1,078 participants in three studies)	670 events per 1,000	742 events per 1,000	Moderate^a	FOLFOX plus SIRT worsens grade ≥ 3 adverse events during treatment, compared with FOLFOX alone
Grade ≥ 3 AEs		Difference: 72 more per 1,000 (95% CI, 19 more to 120 more)		Moderate^a

Abbreviations: AE, adverse event; FOLFOX, folinic acid, fluorouracil, and oxaliplatin; HR, hazard ratio; OR, odds ratio; OS, overall survival; PFS, progression-free survival; SIRT, selective internal radiation therapy.

Downgrade: indirectness (38% with extrahepatic metastases).

Downgrade: imprecision.