Page 269 - 2021_04-Haematologica-web

Letters to the Editor
patients receiving prophylactic antibiotic treatment (Online Supplementary Table S3). In the Isa-Pd arm, the TEAE with the greatest differences in incidences in patients ≥75 versus <65 years were infusion reaction (28.1% versus 42.6%) and acute kidney injury (15.6% versus 1.9% [10.7% versus 5.9% in the Pd arm], possibly
because elderly patients have less renal buffer). Hematologic laboratory abnormalities were assessed dur- ing the study (Table 2) and were recorded as TEAE only if they were serious or led to a modification or discontin- uation of study treatment. Grade 3-4 neutropenia was more common with Isa-Pd than with Pd, regardless of
Table 2. Most common treatment-emergent adverse events and hematologic laboratory abnormalities while on treatment by patient age
group and treatment arm in the safety population.
≥75 years (n=60)
65–74 years (n=119)
<65 years (n=122)
Isa-Pd
(n=32) (n=28) (n=66) (n=53)
Pd
28 (100)
19 (67.9)
1 (3.6)
2 (7.1)
15 (53.6) 13 (46.4) 3 (10.7)
17 (60.7)
7 (25.0) 7 (25.0)
13 (46.4) 6 (21.4) 1 (3.6)
20 (71.4)
3 (10.7)
0
21 (75.0)
10 (35.7)
0
2 (7.1)
15 (53.6) 13 (46.4) 3 (10.7)
0
0
0
2 (7.1) 1 (3.6) 0
0
2 (7.1) 0
4 (14.3) 16 (57.1) 4 (14.3)
18 (64.3) 12 (42.9) 8 (28.6)
Isa-Pd
Pd
52 (98.1)
30 (56.6)
8 (15.1)
7 (13.2)
25 (47.2) 18 (34.0) 7 (13.2)
23 (43.4)
10 (18.9)
7 (13.2)
29 (54.7) 4 (7.5) 7 (13.2)
30 (56.6)
1 (1.9)
1 (1.9)
40 (75.5)
14 (26.4)
1 (1.9)
7 (13.2)
22 (41.5) 17 (32.1) 7 (13.2)
2 (3.8)
1 (1.9) 0
3 (5.7) 0
1 (1.9)
0
1 (1.9) 0
5 (9.4) 32 (60.4) 8 (15.1)
38 (71.7) 11 (20.8) 13 (24.5)
Isa-Pd (n=54)
53 (98.1)
40 (74.1)
11 (20.4)
9 (16.7)
29 (53.7) 24 (44.4) 4 (7.4)
29 (53.7)
13 (24.1) 9 (16.7)
29 (53.7) 9 (16.7) 5 (9.3)
28 (51.9)
1 (1.9)
23 (42.6)
46 (85.2)
20 (37.0)
3 (5.6)
7 (13.0)
29 (53.7) 24 (44.4) 4 (7.4)
4 (7.4)
1 (1.9)
0
7 (13.0) 2 (3.7) 1 (1.9)
1 (1.9) 1 (1.9) 1 (1.9) 6 (11.1) 31 (57.4) 4 (7.4)
48 (88.9) 14 (25.9) 16 (29.6)
Pd (n=68)
66 (97.1)
47 (69.1)
17 (25.0) 17 (25.0)
25 (36.8) 19 (27.9) 8 (11.8)
34 (50.0)
12 (17.6) 12 (17.6)
32 (47.1) 12 (17.6) 5 (7.4)
39 (57.4) 4 (5.9) 1 (1.5) 44 (64.7) 21 (30.9) 0
14 (20.6)
22 (41.5) 18 (26.5) 8 (11.8)
1 (1.5)
0
0
3 (4.4) 1 (1.5) 0
0
3 (4.4) 0
4 (5.9) 32 (47.1) 7 (10.3)
47 (69.1) 18 (26.5) 15 (22.1)
Any TEAE*, n (%)
Infections
Upper respiratory tract infection
Pneumonia
Blood and lymphatic system disorders Neutropenia
Thrombocytopenia
Gastrointestinal disorders
Diarrhea
Constipation
Musculoskeletal disorders Back pain
Arthralgia
Others
32 (100)
26 (81.3)
10 (31.3)
4 (12.5)
22 (68.8) 17 (53.1) 6 (18.8)
19 (59.4)
12 (37.5) 4 (12.5)
19 (59.4) 6 (18.8) 4 (12.5)
19 (59.4)
5 (15.6)
9 (28.1)
30 (93.8)
15 (46.9)
1 (3.1)
4 (12.5)
22 (68.8) 16 (50.0) 5 (15.6)
3 (9.4)
1 (3.1) 0
2 (6.3) 0
2 (6.3)
2 (6.3) 2 (6.3) 1 (3.1) 2 (6.3) 22 (68.8) 5 (15.6)
28 (87.5) 14 (43.8) 11 (34.4)
66 (100)
57 (86.4)
22 (33.3) 18 (27.3)
38 (57.6) 30 (45.5) 9 (13.6)
33 (50.0)
14 (21.2) 11 (16.7)
38 (57.6) 10 (15.2) 7 (10.6)
35 (53.0)
1 (1.5)
24 (36.4)
56 (84.8)
30 (45.5)
1 (1.5)
14 (21.2)
36 (54.5) 30 (45.5) 9 (13.6)
2 (3.0)
1 (1.5)
0
3 (4.5) 1 (1.5) 1 (1.5)
3 (4.5) 1 (1.5) 2 (3.0) 3 (4.5) 41 (62.1) 2 (3.0)
53 (80.3) 20 (30.3) 20 (30.3)
Fatigue
Acute kidney injury Infusion reaction
Grade ≥3 TEAE†, n (%) Infections
Upper respiratory tract infection
Pneumonia
Blood and lymphatic system disorders Neutropenia
Thrombocytopenia
Gastrointestinal disorders
Diarrhea
Constipation
Musculoskeletal disorders Back pain
Arthralgia
Others
Fatigue
Acute kidney injury Infusion reaction
Grade 5 (fatal) TEAE
Serious TEAE
TEAE leading to definitive discontinuation Hematologic laboratory abnormalities‡ (grade 3-4)
Neutropenia Anemia Thrombocytopenia
*System Organ Class with treatment-emergent adverse events (TEAE) with an incidence of ≥15%. †System Organ Class with grade ≥3 TEAE with an incidence of ≥10%. ‡Derived from clinical laboratory analysis,including complete blood count,neutrophil count,platelet count,and hemoglobin values.Clinical laboratory abnormalities were recorded as TEAE only if they were serious or led to modification or discontinuation of the study treatment. Isa: isatuximab: Pd: pomalidine and dexamethasone; TEAE: treatment-emergent adverse event.
haematologica | 2021; 106(4)
1185