. 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 9.

SIRT Versus Chemotherapy for Patients With Unresectable Liver Metastases Who Have Progressed on First-Line Chemotherapy²⁰

Outcome, Time Frame	Study Results	Absolute Effect Estimates		Quality of Evidence	Plain Language Summary
Outcome, Time Frame	Study Results	Chemotherapy	SIRT + Chemotherapy	Quality of Evidence	Plain Language Summary
PFS (coprimary outcome), 12 months	HR, 0.69 (95% CI, 0.54 to 0.88) (428 participants in one study)	868 deaths or progressions per 1,000	753 deaths or progressions per 1,000	Moderate^a	SIRT plus chemotherapy may improve PFS compared with chemotherapy alone
PFS (coprimary outcome), 12 months		Difference: 115 fewer per 1,000 (95% CI, 203 fewer to 36 fewer)		Moderate^a
Hepatic PFS (coprimary outcome), 12 months	HR, 0.59 (95% CI, 0.46 to 0.77) (428 participants in one study)	868 deaths or progressions per 1,000	697 deaths or progressions per 1,000	Moderate^a	SIRT plus chemotherapy may improve hepatic PFS compared with chemotherapy alone
Hepatic PFS (coprimary outcome), 12 months		Difference: 171 fewer per 1,000 (95% CI, 262 fewer to 78 fewer)		Moderate^a
OS, 12 months	HR, 1.07 (95% CI, 0.86 to 1.32) (428 participants in one study)	376 deaths per 1,000	396 deaths per 1,000	Moderate^a	SIRT plus chemotherapy probably has little or no effect on OS compared with chemotherapy alone
OS, 12 months		Difference: 20 more per 1,000 (95% CI, 43 fewer to 87 more)		Moderate^a
ORR	RR, 1.61 (95% CI, 1.17 to 2.21) (428 participants in one study)	211 responses per 1,000	340 responses per 1,000	Moderate^a	SIRT plus chemotherapy increases the ORR compared with chemotherapy alone
ORR		Difference: 129 more per 1,000 (95% CI, 36 more to 255 more)		Moderate^a
Grade 3 or 4 AEs, 12 months	RR, 1.39 (95% CI, 1.17 to 1.64) (394 participants in one study)	493 events per 1,000	685 events per 1,000	High	SIRT plus chemotherapy increases the rate of grade 3 or 4 AEs compared with chemotherapy alone
Grade 3 or 4 AEs, 12 months		Difference: 192 more per 1,000 (95% CI, 84 more to 316 more)		High

Abbreviations: AE, adverse event; HR, hazard ratio; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RR, relative risk; SIRT, selective internal radiation therapy.

Downgrade: 13% did not receive planned SIRT. Open-label trial (independent central review) inconsistency.