ASH Clinical News May 2015 | Page 41
CLINICAL NEWS
recommendation for each patient,
which would include other tests, such
as molecular genetics.”
Among the 438 patients, 190
underwent HCT, and the remaining
248 patients received conventional
therapies, such as cytoreductive agents
(like hydroxyurea or interferon-alpha),
immunomodulating drugs, and
erythropoiesis-stimulating agents.
Although JAK inhibitors can be
used to treat primary myelofibrosis, the
was: 5.6 for low-risk (95% CI 1.7-19;
p=0.0051); 1.6 for int-1 (95% CI 0.793.2; p=0.19); 0.55 for int-2 (95% CI
0.36-0.83; p=0.005); and 0.37 for highrisk (95% CI 0.21-0.66; p=0.0007).
As seen in TABLE 3 (page 40), DIPSS
risk category changed the survival
benefit of either approach. The number
of patients who survived at 1, 5, and 10
years after undergoing HCT was greater
in patients at higher risk, compared
with higher-risk patients who received
patients in the non-transplant cohort of
this retrospective study did not receive
this therapy, the authors pointed out.
Survival was the study’s primary
outcome, while the DIPSS risk status
was the main criterion for defining
comparison groups, the authors
explained.
According to the investigators’
report, the relative risk (RR) of dying
among patients receiving HCT over
those receiving conventional therapies
conventional therapies. Int-2 and highrisk patients experienced the greatest
survival benefit, with 32 percent of
int-2 patients and 27 percent of highrisk patients surviving to year 10 after
HCT, compared with 11 percent and
1 percent, respectively, in the nontransplant cohort.
However, 10-year survival benefits
were the opposite for low-risk patients
(60 percent for transplant and 92
percent for non-transplant patients).
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
All Adverse Reactionsa
Grade 3/4 Adverse
Reactionsb
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%
Neck pain f
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)
Infections and infestations
Bronchitisc
Nasopharyngitis f
Urinary tract
infection f
80 (15)
54 (10)
76 (14.3) 63 (11.7)
41 (7.6)
8 (1.5)
8 (1.5)
< 1%
Upper respiratory
tract infectionc% f
69 (13.0)
Pneumoniac@
93 (17.5) 87 (16.1) 56 (10.4) 60 (11.3) 57 (10.5) 41 (7.6)
53 (9.8)
31 (5.7)
< 1%
8 (1.5)
< 1%
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