ASH Clinical News April 2016 | Page 47
CLINICAL NEWS
David Grimwade, a co-author of the study told ASH
Clinical News.
Adam Ivey, MSc, from the Molecular Oncology
Unit and Cancer Genetics Laboratory in the Department of Medical and Molecular Genetics at Guy’s
Hospital in London, and colleagues evaluated outcomes according to molecular profiles and sequential
monitoring of MRD in a large series of patients with
NPM1-mutated AML who had undergone intensive
treatment in the National Cancer Research Institute
bined with monitoring of minimal residual disease
(MRD) by reverse-transcriptase quantitative polymerase chain reaction assays, help determine whether
patients would benefit from AlloHCT, according to
the authors of a recent report published in The New
England Journal of Medicine.
“We wanted to see which method was more powerful – the up-front profiling technique or the MRD
testing – and, in terms of predicting patient outcome,
the MRD testing was much more powerful,” Prof.
AML17 trial. Patients were enrolled between April 6,
2009, and December 31, 2014.
“People decide whether or not to do a transplant
based largely on the characteristics of the AML at diagnosis – relying on genetic markers and cytogenetics,”
Prof. Grimwade said. For the large portion of AML patients who are considered “standard risk” according to
cytogenetics, he continued, meaning “they do not have
low- or high-risk cytogenetics. … They account for
a good half of younger adults with AML, and people
T:7”
Table 4: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions
in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms*
All Adverse Reactionsa
Table 4: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions
in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms*
Grade 3/4 Adverse
Reactionsb
Grade 3/4 Adverse
Reactionsb
All Adverse Reactionsa
Rd
Rd
System organ class Continuous Rd18
MPT Continuous Rd18
MPT
Preferred term
(N = 532) (N = 540) (N = 541) (N = 532) (N = 540) (N = 541)
Rd
Rd
System organ class Continuous Rd18
MPT Continuous Rd18
MPT
Preferred term
(N = 532) (N = 540) (N = 541) (N = 532) (N = 540) (N = 541)
Musculoskeletal and connective tissue disorders
Psychiatric disorders
Back painc
170 ( 32) 145 (26.9) 116 (21.4)
37 (7)
34 (6.3)
28 (5.2)
Muscle spasms f
109 (20.5) 102 (18.9) 61 (11.3)
< 1%
< 1%
< 1%
Arthralgia f
101 (19.0) 71 (13.1) 66 (12.2)
9 (1.7)
8 (1.5)
8 (1.5)
Bone pain f
87 (16.4) 77 (14.3) 62 (11.5) 16 (3.0)
15 (2.8)
14 (2.6)
Pain in extremity f 79 (14.8) 66 (12.2) 61 (11.3)
8 (1.5)
8 (1.5)
7 (1.3)
Musculoskeletal
pain f
67 (12.6) 59 (10.9)
36 (6.7)
< 1%
< 1%
< 1%
Musculoskeletal
chest pain f
60 (11.3)
51 (9.4)
39 (7.2)
6 (1.1)
< 1%
< 1%
Muscular
weakness f
43 (8.1)
35 (6.5)
29 (5.4)
< 1%
8 (1.5)
< 1%
40 (7.5)
19 (3.5)
10 (1.8)
< 1%
< 1%
< 1%
90 (16.9) 59 (10.9)
43 (7.9)
9 (1.7)
6 (1.1)
3 (0.6)
33 (6.1)
0 (0.0)
0 (0.0)
0 (0.0)
Neck pain
f
Infections and infestations
Bronchitisc
Nasopharyngitis f
80 (15)
54 (10)
Urinary tract
infection f
76 (14.3) 63 (11.7)
41 (7.6)
8 (1.5)
8 (1.5)
< 1%
Upper respiratory
tract infectionc% f
69 (13.0)
31 (5.7)
< 1%
8 (1.5)
< 1%
Pneumoniac@
93 (17.5) 87 (16.1) 56 (10.4) 60 (11.3) 57 (10.5) 41 (7.6)
53 (9.8)
Respiratory tract
infection%
35 (6.6)
25 (4.6)
21 ( 3.9)
7 ( 1.3)
4 ( 0.7)
1 ( 0.2)
Influenza f
33 (6.2)
23 (4.3)
15 (2.8)
< 1%
< 1%
0 (0.0)
Gastroenteritis f
32 (6.0)
17 (3.1)
13 (2.4)
0 (0.0)
< 1%
< 1%
29 (5.5)
14 (2.6)
16 (3.0)
10 (1.9)
3 (0.6)
3 (0.6)
Rhinitis f
29 ( 5.5)
24 ( 4.4) 14 ( 2.6)
0 (0.0)
0 (0.0)
0 (0.0)
Cellulitisc
< 5%
< 5%
< 5%
8 (1.5)
3 ( 0.6)
2 ( 0.4)
Sepsisc@
33 (6.2)
26-(4.8)
18 (3.3)
26 (4.9)
20 (3.7)
13 (2.4)
Nervous system disorders
Headache f
75 (14.1)
52 (9.6)
56 (10.4)
< 1%
< 1%
< 1%
Dysgeusia f
39 (7.3)
45 (8.3)
22 (4.1)
< 1%
0 (0.0)
< 1%
Blood and lymphatic system disordersd
Anemia
233 (43.8) 193 (35.7) 229 (42.3) 97 (18.2) 85 (15.7) 102 (18.9)
Neutropenia
186 (35.0) 178 (33) 328 (60.6) 148 (27.8) 143 (26.5) 243 (44.9)
Thrombocytopenia 104 (19.5) 100 (18.5) 135 (25.0) 44 (8.3)
43 (8.0)
60 (11.1)
Febrile neutropenia
7 (1.3)
17 (3.1)
15 (2.8)
6 (1.1)
16 (3.0)
14 (2.6)
Pancytopenia
5 (0.9)
6 (1.1)
7 (1.3)
1 (0.2)
3 (0.6)
5 (0.9)
Respiratory, thoracic and mediastinal disorders
Cough f
121 (22.7) 94 (17.4) 68 (12.6)
Dyspneac,e
117 (22.0) 89 (16.5) 113 (20.9) 30 (5.6)
< 1%
< 1%
< 1%
22 (4.1)
18 (3.3)
Epistaxis f
32 (6.0)
31 (5.7)
17 (3.1)
< 1%
< 1%
0 (0.0)
Oropharyngeal
pain f
30 (5.6)
22 (4.1)
14 (2.6)
0 (0.0)
0 (0.0)
0 (0.0)
Dyspnea
exertional e
27 (5.1)
29 (5.4)
< 5%
6 (1.1)
2 (0.4)
0 (0.0)
Metabolism and nutrition disorders
Decreased
appetite
123 (23.1) 115 (21.3) 72 (13.3) 14 (2.6)
7 (1.3)
5 (0.9)
Hypokalemia%
91 ( 17.1) 62 (11.5)
20 (3.7)
11 (2.0)
38 ( 7)
35 (6.6)
Hyperglycemia
62 (11.7)
52 (9.6)
19 (3.5)
28 (5.3)
23 (4.3)
9 (1.7)
Hypocalcemia
57 (10.7) 56 (10.4)
31 (5.7)
23 (4.3)
19 (3.5)
8 (1.5)
Dehydration%
25 ( 4.7)
29 ( 5.4)
17 ( 3.1)
8 (1.5)
13 (2.4)
9 (1.7)
Gout e
< 5%
< 5%
< 5%
8 (1.5)
0 (0.0)
0 (0.0)
Diabetes mellitus% e
< 5%
< 5%
< 5%
8 (1.5)
4 (0.7)
2 (0.4)
Hypophosphatemia e
< 5%
< 5%
< 5%
7 (1.3)
3 (0.6)
1 (0.2)
Hyponatremia% e
< 5%
< 5%
< 5%
7 (1.3)
13 (2.4)
6 (1.1)
139 (26.1) 151 (28.0) 105 (19.4) 39 (7.3)
38 (7.0)
33 (6.1)
Skin and subcutaneous tissue disorders
Rash
Pruritus f
47 (8.8)
49 (9.1)
24 (4.4)
< 1%
< 1%
< 1%
(continued)
147 (27.6) 127 (23.5) 53 (9.8)
4 (0.8)
6 (1.1)
0 (0.0)
Depression
58 (10.9)
10 (1.9)
4 (0.7)
1 (0.2)
46 (8.5)
30 (5.5)
Vascular disorders
Deep vein
thrombosisc%
55 (10.3)
39 (7.2)
22 (4.1)
30 (5.6)
20 (3.7)
15 (2.8)
Hypotensionc%
51 (9.6)
35 (6.5)
36 (6.7)
11 (2.1)
8 (1.5)
6 (1.1)
Injury, Poisoning, and Procedural Complications
Fall f
43 (8.1)
25 (4.6)
25 (4.6)
< 1%
6 (1.1)
6 (1.1)
Contusion f
33 (6.2)
24 (4.4)
15 (2.8)
< 1%
< 1%
0 (0.0)
73 (13.7)
31 (5.7)
5 (0.9)
31 (5.8)
14 (2.6)
3 (0.6)
< 5%
< 5%
< 5%
7 (1.3)
0 (0.0)
0 (0.0)
48 (8.9)
11 (2.1)
4 (0.7)
4 (0.7)
Eye disorders
Cata &7@