. 2016 Jun 27;17(4):472–488. doi: 10.3348/kjr.2016.17.4.472

Table 3. Summary of Clinical Outcomes of Studies of Y90-SIRT (Glass Microspheres) for Treatment of HCC.

Lead Author, Year	Study Design	n	Treatment	Prognostic Group	RR	Median TTP (Months)	Median Survival, Months (P)
Comparative studies
Moreno-Luna, 2013 (63)	Retrospective, non-randomized	116	TheraSphere vs. TACE				15.0 vs. 14.4 (0.47)
			61	TheraSphere	CR 12%^∥, PR 39%^∥	NR	15.0
				BCLC A	NR	NR	23.9 (0.04)
				BCLC B	NR	NR	16.8 (0.16)
				BCLC C	NR	NR	8.4 (0.47)
			55	TACE	CR 4%^∥, PR 47%^∥	NR	14.4
				BCLC A	NR	NR	18.6
				BCLC B	NR	NR	13
				BCLC C	NR	NR	10.1
Salem, 2011 (45)	Retrospective, non-randomized	245	TheraSphere vs. TACE		49%^* vs. 36%^* (0.104)	13.3 vs. 8.4 (0.046)	20.5 vs. 17.4 (0.23)
			123	TheraSphere	49%^*	13.3	20.5
				BCLC A	47%^* (0.229)	25.1 (0.4)	27.3 (0.74)
				BCLC B	51%^* (0.581)	13.3 (0.047)	17.2 (0.42)
				BCLC C	54%^* (0.097)	13.8 (0.38)	22.1 (0.04)
			122	TACE	36%^*	8.4	17.4
				BCLC A	32%^*	8.8	45.4
				BCLC B	44%^*	9.4	17.5
				BCLC C	17%^*	7.9	9.3
Lance, 2011 (62)	Retrospective, non-randomized	73	TACE vs. SIR-Spheres or TheraSphere				8.0 vs. 10.3 (0.33)
			38	SIR-Spheres or TheraSphere	NR	NR	8.0
			35	TACE	NR	NR	10.3
El Fouly, 2015 (64)	Prospective, non-randomized	86	TheraSphere vs. TACE			13.3 vs. 6.8 (NS)	16.4 vs. 18 (NS)
			44	TheraSphere	CR 7%^∥, PR 68%^∥	13.3	16.4
			44	BCLC B	CR 7%^∥, PR 68%^∥	13.3	16.4
			42	TACE	CR 5%^∥, PR 45%^∥	6.8	18
			42	BCLC B	CR 5%^∥, PR 45%^∥	6.8	18
Carr, 2010 (76)	Retrospective, non-randomized	790	TheraSphere vs. TACE				11.5 vs. 8.5 (< 0.05)
			99	TheraSphere	CR 3%^, PR 33%^	NR	11.5
				+PVT			5 (< 0.05)
				-PVT			16 (NS)
			691	TACE	CR 5%^, PR 55%^	NR	8.5
				+PVT			7
				-PVT			12
Lewandowski, 2009 (56)	Retrospective, non-randomized	86	TheraSphere vs. TACE				41.6 vs. 19.2 (0.008)
			43	TheraSphere	61%^*	33.3	41.6
			43	UNOS T3	61%^*	33.3	41.6
			43	TACE	37%^*	18.2	19.2
			43	UNOS T3	37%^*	18.2	19.2
Woodall, 2009 (77)	Prospective, non-randomized	52	TheraSphere		NR	NR	13.9 vs. 3.2 (0.01)
			20	BCLC A-C	NR	NR	13.9
			20	-PVT	NR	NR	13.9
			15	BCLC C	NR	NR	3.2 (0.26)
			15	+PVT	NR	NR	3.2 (0.26)
			17	No treatment, screen failure	NR	NR	5.2
Goin, 2004 (78)	Retrospective, non-randomized	63	TheraSphere vs. TACE		NR	NR	NR
			34	TheraSphere	NR	NR	25.5
			34	+ Okuda I	NR	NR	25.5
				TheraSphere	NR	NR	10.9
				+ Okuda II	NR	NR	10.9
			29	TACE	NR	NR	11.3
			29	+ Okuda I	NR	NR	11.3
				TACE	NR	NR	11.7
				+ Okuda II	NR	NR	11.7
Non-comparative studies
Dancey, 2000 (79)	Retrospective, non-randomized	20	TheraSphere	Okuda I/II	CP 5%, PR 15%	10.2	12.5
Carr, 2004 (34)	Retrospective, non-randomized	65	TheraSphere		PR 38.4%	NR	21 vs. 10 (NS)
			42	Okuda I	NR	NR	21
			23	Okuda II	NR	NR	10
Geschwind, 2004 (80)	Retrospective, non-randomized	80	TheraSphere		NR	NR	20.6 vs. 12.6 (0.02)
			54	Okuda I	NR	NR	20.6
			26	Okuda II	NR	NR	12.6
Goin, 2005 (81)	Combined prospective 121 and retrospective, non-randomized	121	TheraSphere		NR	NR	15.5 vs. 3.6 (< 0.0001)
			88	Low risk	NR	NR	15.5
			33	High risk	NR	NR	3.6
Kulik, 2006 (55)	Retrospective, non-randomized	35	TheraSphere	UNOS T3	50%^*	NR	26.3
Goin, 2005 (82)	Retrospective, non-randomized	88	TheraSphere		NR	NR	(< 0.001)
			26	CLIP 0	NR	NR	26.7
			41	CLIP 1?2	NR	NR	11.6
			13	CLIP > 2	NR	NR	7.1
Salem, 2004 (23)	Retrospective, non-randomized	15	TheraSphere	+Branch PVT	NR	NR	7.1
Pressiani, 2013 (69)	Prospective, non-randomized	297	Sorafenib		NR	4.1	9.1
			234	BCLC B/C	NR	4.2	10.0 (< 0.001)
			234	CPA	NR	4.2	10.0 (< 0.001)
			63	BCLC B/C	NR	3.8	3.8
			63	CPB	NR	3.8	3.8
Bruix, 2012 (68)	Subgroup Study of Prospective Phase III	299	Sorafenib vs. Placebo			6.9 vs. 4.9	14.5 vs. 9.7
			54	BCLC B	NR	6.9	14.5
			245	BCLC C	NR	4.9	9.7
Llovet, 2008 (66)	Prospective Phase III	602	Sorafenib vs. Placebo			5.5 vs. 2.8 (< 0.001)	10.7 vs. 7.9 (< 0.001)
			299	Sorafenib	PR 2%^‡	5.5	10.7
			299	BCLC B + C	PR 2%^‡	5.5	10.7
			303	Placebo	PR 1%^‡	2.8	7.9
			303	BCLC B + C	PR 1%^‡	2.8	7.9
Cheng, 2009 (67)	Prospective Phase III	226	Sorafenib vs. Placebo			2.8 vs. 1.4 (0.005)	6.5 vs. 4.2 (0.014)
			150	Sorafenib	PR 5%^‡	2.8	6.5
			150	BCLC C, CPA	PR 5%^‡	2.8	6.5
			76	Placebo	PR 1%^‡	1.4	4.2
			76	BCLC C, CPA	PR 1%^‡	1.4	4.2
Mazzaferro, 2013 (47)	Prospective Phase II	52	TheraSphere		OR 40.4%^*	11	15
			17	-PVT
				BCLC B	OR 8%^*	13	18
				CPA	OR 6%^*	13	18
			35	+PVT
				BCLC C	OR 13%^*	7	13
				CPA	OR 10%^*	6	16
				CPB	OR 3%^*	NR	6
Salem, 2010 (46)	Prospective, non-randomized	291	TheraSphere		42%^*	7.9	NR
				BCLC A	21%^*	25.1	26.9
				BCLC B	42%^*	13.3	13.3
				BCLC C, -EHD	40%^*	6.0	7.3
				BCLC C, +EHD	11%^*	3.1	5.4
Hilgard, 2010 (43)	Retrospective, non-randomized	108	TheraSphere		CR 3%^‡¶, PR 20%^‡¶	10.0	16.4
			2	BCLC A	NR	NR	NR
			51	BCLC B	NR	NR	16.4
			55	BCLC C	NR	NR	NR
				CPA	NR	NR	17.2
				CPB	NR	NR	6
				-PVT	NR	NR	16.4
				+PVT	NR	NR	10.0
Kulik, 2008 (24)	Prospective Phase II	108	TheraSphere		PR 42.4%^*, RR 70%^†	NR	(0.0052)
			71	BCLC C, -PVT	NR	NR	15.4
			25	BCLC C, +Branch PVT	NR	NR	10.0
			12	BCLC C, +Main PVT	NR	NR	4.4
Salem, 2005 (11)	Prospective Phase II	43	TheraSphere		PR 47%	NR	24.4 vs. 12.5 (< 0.001)
			21	Okuda I	NR	NR	24.4
			22	Okuda II	NR	NR	12.5

^*WHO criteria, ^†EASL criteria, ^‡RECIST criteria, ^∥mRECIST criteria (30), ^¶76 out of 108 responses + necrosis after 30 days of treatment.

BCLC = Barcelona Clinic Liver Cancer staging system, CLIP = Cancer of the Liver Italian Program scoring system, CP = Child-Pugh score, CR = complete response, -EHD/+EHD = without or with extrahepatic disease, HCC = hepatocellular carcinoma, NR = not recorded, NS = not statistically significant, OR = objective response, PR = partial response, PVT = portal vein thrombosis, RR = response rate, SIRT = selective internal radiation therapy, TACE = transarterial chemoembolization, TTP = time to progression, UNOS = United Network for Organ Sharing, Y90 = yttrium-90