Role of bendamustine in the treatment of chronic lymphocytic leukemia

Figures & data

Figure 1 Chemical structure of bendamustine, cyclophosphamide and cladribine.

Table 1 Single-agent clinical trials of bendamustine in CLL

Author	Phase	Regimen	Number of patients	ORR (CR), %	Median time to event (months)
Kath 2001^Citation22	II	<70 yrs: 60 mg/m^2 >70 yrs: 50 mg/m^2 d 1–5, q 28 d	23; 13 previously untreated	65 (26)	NR
Aivado 2002^Citation20	II	100 mg/m^2, d 1–2, q 28 d	23 relapsed/refractory	67 (29)	TTP 6 (4–19)
Bremer 2002^Citation21	II	60 mg/m^2, d 1–5, q 28 d	15 relapsed/refractory	93 (7)	Not reached
Bergmann 2005^Citation23	I/II	70 mg/m^2, d 1–2, q 28 d	16 relapsed/refractory	56 (13)	NR
Lissitchkov 2006^Citation24	I/II	100 mg/m^2, d 1–2, q 28 d	15 relapsed/refractory	60 (27)	NR
Knauf 2008^Citation26	III	B: 100 mg/m^2 d 1–2, q 28 d C: 0.8 mg/kg d 1, 15, q 28 d	319 previously untreated	B: 67 (NR) C: 30 (NR)	PFS (B v C): 21.5 vs 8.3
Niederle 2008^Citation25	II	B: 100 mg/m^2, d 1–2, q 28 d F: 25 mg/m^2, d 1–5, q 28 d	96 relapsed	B: 78 (29) F: 65 (10)	PFS (B vs F): 83 vs 64 weeks

Abbreviations: ORR, overall response rate; CR, complete remission rate; TTP, time to progression; PFS, progression-free survival; OS, overall survival; D, days; NR, not reported; B, bendamustine; C, chlorambucil; F, fludarabine.

Table 2 Grade 3– 4 hematological toxicities occurring in at least 5% of patients in the randomized CLL clinical study

	Bendamustine (%)	Chlorambucil (%)
	(n = 150)	(n = 141)
Leukopenia	28	3
Neutropenia	43	21
Lymphopenia	47	4
Thrombocytopenia	11	10
Anemia	13	9

Table 3 Combination therapy trials of bendamustine in CLL

Author	Phase	Regimen	Number of patients	ORR (CR), %	Median time to event (months)
Koppler 2004^Citation27	I/II	B: 80–240 mg/m^2 over 2–3 days M: 8–10 mg/m^2 d 1	22 relapsed/refractory	86 (27)	TTP: 10 (4–22)
Weide 2004^Citation28	I/II	B: 80 mg/m^2 d 1–2, M: 10 mg/m^2 d 1; cycle 2 d 36 then q 28 d R: 375 mg/m^2 wk 2–5	21 relapsed/refractory	95 (23)	TTP: 17 (1–34+)
Fischer 2008^Citation17	II	B: 70 mg/m^2 d 1–2 R: 375 mg/m^2 for cycle 1 then 500 mg/m^2 for subsequent cycles	81 relapsed/refractory	77.4 (14.5)	NR

Abbreviations: ORR, overall response rate; CR, complete remission rate; TTP, time to progression; PFS, progression free survival; OS, overall survival; D, days; NR, not reported; B, bendamustine; R, rituximab; M, mitoxantrone; C, chlorambucil; F, fludarabine.

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