Table 1 Comparison of series

From: Still no certainty about the role of upfront bortezomib among patients with AL amyloidosis

 

Palladini

Venner

 

BMDex

MDex

P-value

CVD

CTD

P-value

N

87

87

—

69

69

—

Year of diagnosisa

2005–2012

—

<0.001

2008–2012

—

NP

Age, years

69.1

—

—

60

64

0.09

Mayo 2004 stage a

 I, %

15

—

—

12

12

—

 II, %

45

—

—

30

30

—

 III, %

40

—

—

58

58

—

dFLC ⩾18,a %

51

—

—

65

74

NS

NT-proBNP ⩾8500,a %

22

—

—

26

22

NS

Systolic BP <100 mm Hg, %

31

—

—

NP

NP

NP

Cardiac, %

851

—

—

81

77

NS

Renal, %

631

—

—

75

81

NS

GFR 30, %

71

—

—

NP

NP

NP

Follow-up, months

26

26

NP

13

26

NP

Therapy switch,b %

21

40

NP

1

20

<0.005

Early death

 At 6 months, %

~27

~27

NS

32

27

NS

 At 12 months, %

34

38

NS

35

33

NS

ORR, %

69

51

0.01

71

80

NS

 CR, %

42

19

0.002

40

25

<0.05

 Preswitch CR, %

NP

NP

NP

41

19

0.002

1-year OS, %

~60

~60

NS

65

67

NS

TTNT or death, months

39

22

NS

NP

NP

NP

Median DOR, months

NP

NP

—

28

14

0.04

Landmark 6 months

 1-year OS, %

~85–90

~75–80

0.03

96

92

NS

 DOR, months

NP

NP

—

NR

19.2

0.03

Organ response

 Cardiac response,c %

16

13

NS

21

8

NP

 Kidney response,c %

16

27

NS

25

29

NP

 Liver response,c %

NP

NP

—

38

20

NP

  1. Abbreviations: BMDex, bortezomib, melphalan and dexamethasone; BP, blood pressure; CVD, cyclophosphamide, bortezomib and dexamethasone; dFLC, difference free light chain; DOR, duration of response; MDex, melphalan and dexamethasone; NP, not provided; NR, not reached; NS, not significant; ORR, overall response rate; TTNT, time to next treatment.
  2. aMatching criteria.
  3. bCriteria for switching therapy: for the Palladini study, no hematologic response after two cycles or an ‘unsatisfactory response’ after six cycles; for Venner study, absence of a 90% reduction in dFLC after three cycles.
  4. cOrgan response calculated by dividing numbers of patients with organ involved at baseline divided by number of responders.
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