Rituximab maintenance in follicular lymphoma patients

Table 1 Randomized trials comparing Rituximab-chemotherapy vs chemotherapy alone in follicular lymphoma patients

Reference	Year	Prior treatment	Treatment	No of patients	ORR	OS	PFS
Marcus et al[3,4]	2005, 2008	No	R-CVP vs CVP	321	81% vs 57% (P < 0.001)	83% vs 77% at 4-years (P = 0.029)	27 vs 7 mo ( P < 0.001) 1
Hiddeman et al[5]	2005	No	R-CHOP vs CHOP	428	96% vs 90% (P = 0.001)	95% vs 90% at 2 yrs (P =0.016)	91% vs 79% at 2 yrs ( P < 0.001)1
van Oers et al[6,7]	2006, 2010	Yes	R-CHOP vs CHOP	465	85% vs 72% (P < 0.001)	82% vs 79% at 3 years (P = 0.09)	33 vs 20 mo ( P < 0.001)
Forstpointner et al[10]	2006	Yes	R-FCM vs FCM	125	95% vs 71% (P = 0.01)	Not available2	Not available2
Herold et al[9]	2007, 2010	No	R-MCP vs MCP	358	92% vs 75% (P < 0.001)	86% vs 74% at 5 years (P = 0.02)	86 vs 35 mo ( P < 0.001)
Salles et al[8]	2000	No	R-CHVP-I vs CHVP-I	358	94% vs 85% (P < 0.001)	84% vs 79% at 5-years (P = 0.15)	53% vs 37% at 5 years (P < 0.01)

ORR: Overall response rate; OS: Overall survival; PFS: Progression-free survival;

¹ Time-to-treatment-failure;

² Data not available because of protocol design (double randomization).

Table 2 Randomized trials comparing rituximab maintenance vs observation after single agent rituximab

Reference	Year	Prior treatment	Maintenance schedule	No. of patients	Median F-up	PFS	OS
Haisworth et al[16]	2005	R x 4 (weekly)	R x 4 (weekly) every 6 mo x 4 vs R x 4 weekly at relapse (retreatment)	62	41 mo	31.3 vs 7.4 mo (P = 0.007)	72% vs 68% at 3 years (P = NS)
Ghielmini et al[14] Martinelli et al[19]	2004	R x 4 (weekly)	R every 2 mo x 4 vs observation	185	9.5 years	24 vs 13 mo (P < 0.001)	68% vs 54% (P = 0.081)
	2010

Table 3 Randomized trials comparing rituximab maintenance vs observation after chemotherapy or immunochemotherapy

Reference	Year	Prior treatment	Maintenance schedule	No. of pts	Median F-up	PFS	OS
Hochster et al[17]	2009	CVP (1st line)	R x 4 (weekly) every 6 mo x 4 vs observation	228	3.7 years	Median: 4.3 vs 1.3 years; At 3 years: 64% vs 33% ( P < 0.001)	At 3 years: 91% vs 86% (P = 0.08)
Forstpointner et al[10]	2006	FCM or R-FCM (relapsed disease)	R x 4 (weekly) every 6 mo x 2 vs observation	105	26 mo	Median: Not reached vs 16 mo (P < 0.001)	At 3 years (estimated): 77% vs 57% (P = 0.1)
van Oers et al[6,7]	20062010	CHOP or R-CHOP (relapsed disease)	R every 3 mo x 8 vs observation	334	6 years	Median: 3.7 vs 1.3 years; At 3 years: 59% vs 28% (P < 0.001)	At 5 years: 74% vs 64% (P = 0.07)
Salles et al[18,23]	2010	R-CHOP, R-CVP, R-FCM (1st line)	R every 2 mo x 12 vs observation	1018	25 mo	At 2 years: 79% vs 60% (P < 0.001)	At 2 years: NS

Table 4 Toxicities in trials comparing rituximab maintenance vs observation in follicular lymphoma

Reference	No of. patients	Grade 3-4 AE	Neutropenia (grade 3-4)	Grade 3-4 Infections
Haisworth et al[16]	62	9% vs 4%	2% vs 0%	0
Ghielmini et al[14] Martinelli et al[19]	185	28% vs 20%	18% vs 17%	NA
Hochster et al[17]	228	NA	3% vs 1%	1% vs 1%
Forstpointner et al[10]	105	NA	13% vs 6%	4% vs 3%
van Oers et al[6]	334	NA	10.8% vs 5.4%(P = 0.07)	9% vs 2.4% (P = 0.009)
Salles et al[18,23]	1018	23% vs 16%	4% vs 1%	4% vs 1%