Role of rituximab in first-line treatment of chronic lymphocytic leukemia

Figures & data

Table 1 Single agent rituximab studies in treatment-naïve chronic lymphocytic leukemia

Reference	Doses	N	OR (%)	CR (%)	Median PFS (months)
Thomas et al^Citation18	4	21	90	19	43
Hainsworth et al^Citation19	4	44	51	4	19
	8	28a	58	9

Note:

a Patients who received additional maintenance therapy with rituximab.

Abbreviations: N, evaluable patients; OR, overall response; CR, complete remission; PFS, progression-free survival.

Table 2 Studies exploring chemoimmunotherapy with rituximab in treatment-naïve chronic lymphocytic leukemia

Reference	Phase	N	Regimen(s)	OR (%)	CR (%)	Median survival (months)
Single-arm studies
Keating et al^Citation33 and Tam et al^Citation34	II	300	Fludarabine + Cyclophosphamide + Rituximab (FCR)	95	72	NR
O’Brien et al^Citation36	II	65	Fludarabine + Cyclophosphamide + Rituximab × 3 days (FCR3)	94	65	NR
Foon et al^Citation37	II	50	Fludarabine (↓20%) + Cyclophosphamide (↓40%) + Rituximab × 2 days (FCR-Lite)	100	77	NR
Kay et al^Citation38	II	64	Pentostatin + Cyclophosphamide + Rituximab (PCR)	91	41	PFS:33
Kay et al^Citation39	II	33	Pentostatin + Rituximab (PR)	76	27	TFS:16
Bosch et al^Citation40	II	67	Fludarabine + Cyclophosphamide + Mitoxantrone + Rituximab (FCMR)	93	82	NR
Faderl et al^Citation47	II	30	Fludarabine + Cyclophosphamide + Mitoxantrone + Rituximab (FCMR)	96	83	NR
Fischer et al^Citation52	II	117	Bendamustine + Rituximab (BR)	91	33	NR
Randomized Studies
Byrd et al^Citation27 and Woyach et al^Citation28	II	104	Fludarabine + Rituximab (FR) (Concurrent)	90	47	OS:84; PFS:32
			Fludarabine + Rituximab (FR) (Sequential)	77	28	OS:91; PFS:40
Hallek et al^Citation35	III	817	Fludarabine + Cyclophosphamide + Rituximab (FCR)	95	44	PFS:52; OS:NR
			Fludarabine + Cyclophosphamide (FC)	88	22	PFS:33; OS:NR

Abbreviations: N, evaluable patients; OR, overall response; CR, complete remission; OS, overall survival; PFS, progression-free survival; FFS, failure-free survival; TFS, treatment-free survival; NR, not reported or reached.

Table 3 Studies exploring novel combinations with rituximab in treatment-naïve high-risk or elderly chronic lymphocytic leukemia

Reference	Patient characteristics	N	Regimen(s)	OR (%)	CR (%)	Median survival (months)
Wierda et al^Citation54 and Parikh et al^Citation55	Median age: 59 yrs Median B2M: 5.1 mg/L Rai stage III–IV: 51%	59	Cyclophosphamide + Fludarabine + Alemtuzumab + Rituximab (CFAR)	72	92	NR
Zent et al^Citation62	Median age: 61 yrs Rai stage 0–II: 100% 11q- or 17p-: 57% UM IgVH +ZAP-70+ ±CD38+: 43%	30	Rituximab + Alemtuzumab (RA)	90	37	NR
Hillmen et al^Citation63	Median age: 70.5 yrs Binet C: 52%	47	Chlorambucil + Rituximab (CHl-R)	84	NR	NR
Castro et al^Citation64	Median age: 65 yrs Age > 70: 29% 11q- or 17p-: 14% UM IgVH: 53% ZAP-70+: CD38+: 32%	28	HDMP + Rituximab (HDMP-R)	96	32	PFS:30

Abbreviations: N, evaluable patients; B2M, beta2-microglobulin; UM, unmutated; IgVH, immunoglobulin heavy chain genes; ZAP-70, zeta chain-associated protein kinase 70 kDa; ZAP-70+, ≥ 20% expression; CD38+, ≥ 30% expression; –, indicates deletion; HDMP, high-dose methylprednisolone; OR, overall response; CR, complete remission; PFS, progression-free survival; NR, not reported or reached; yrs, years.

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