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Age-based subgroup analysis of CASTOR and POLLUX
patients with RRMM, a population that is likely to exhibit tolerability and safety concerns with treatment.6,23 A retro- spective, observational study was conducted to assess the efficacy and toxicity of bortezomib-based regimens used in combination with dexamethasone as salvage therapy for elderly patients with RRMM.23 Patients (n=81) who
were aged 65 to 89 years (median, 73 years) and received a median of two prior lines of therapy (range 1-3) were included. A median of six cycles (range 1-11) of Vd were administered, and after a median follow-up of 24 months, the median PFS and OS were 8.7 and 22 months, respec- tively. Partial response or better was achieved in 65.4% of
Table 3. Most common TEAE among patients aged 65 to 74 years and ≥75 years in POLLUX and CASTOR.
TEAE: POLLUXa
Patients with TEAE, n (%)
Hematologic TEAE, n (%)
Neutropenia Anemia Thrombocytopenia
Nonhematologic TEAE, n (%) Diarrhea
Fatigue
Nasopharyngitis
Upper respiratory tract infection Constipation
Nausea
Muscle spasms
Cough
Dyspnea Pneumonia Peripheral edema Asthenia
Back pain Hypokalaemia Pulmonary embolism
TEAE: CASTORa
Patients with TEAE, n (%)
Hematologic TEAE, n (%)
Thrombocytopenia Anemia Neutropenia Lymphopenia
Nonhematologic TEAE, n (%) Peripheral sensory neuropathy Diarrhea
Upper respiratory tract infection Cough
Fatigue Peripheral edema Constipation Pneumonia Bronchitis Dizziness
Bone pain
Any grade (>25%) D-Rd (n=123)
122 (99.2)
77 (62.6) 52 (42.3) 37 (30.1)
61 (49.6) 43 (35.0) 41 (33.3) 40 (32.5) 39 (31.7) 34 (27.6) 33 (26.8) 32 (26.0) 31 (25.2) 29 (23.6) 29 (23.6) 22 (17.9) 21 (17.1) 16 (13.0) 5 (4.1)
Any grade (>25%) D-Vd (n=94)
93 (98.9)
60 (63.8) 29 (30.9) 19 (20.2) 14 (14.9)
49 (52.1) 38 (40.4) 30 (31.9) 29 (30.9) 23 (24.5) 23 (24.5) 22 (23.4) 16 (17.0) 14 (14.9) 9 (9.6)
7 (7.4)
65-74 years Grade 3/4 (>10%)
Any grade (>25%) D-Rd (n=29)
29 (100.0)
14 (48.3) 12 (41.4) 10 (34.5)
11 (37.9) 10 (34.5) 4 (13.8) 11 (37.9) 7 (24.1) 7 (24.1) 8 (27.6) 6 (20.7) 7 (24.1) 9 (31.0) 8 (27.6) 4 (13.8) 8 (27.6) 7 (24.1) 1 (3.4)
Any grade (>25%) D-Vd (n=20)
20 (100.0)
14 (70.0) 5 (25.0) 1 (5.0) 1 (5.0)
13 (65.0) 11 (55.0) 5 (25.0) 10 (50.0) 7 (35.0) 8 (40.0) 4 (20.0) 5 (25.0) 6 (30.0) 5 (25.0) 7 (35.0)
≥75 years Rd
(n=35)
35 (100.0)
14 (40.0) 13 (37.1) 9 (25.7)
12 (34.3) 13 (37.1) 5 (14.3) 9 (25.7) 12 (34.3) 9 (25.7) 6 (17.1) 6 (17.1) 11 (31.4) 6 (17.1) 15 (42.9) 10 (28.6) 7 (20.0) 4 (11.4) 4 (11.4) ≥75 years
Vd (n=35)
35 (100.0)
22 (62.9) 15 (42.9) 2 (5.7) 0
17 (48.6) 13 (37.1) 7 (20.0) 5 (14.3) 14 (40.0) 4 (11.4) 12 (34.3) 6 (17.1) 2 (5.7) 11 (31.4) 2 (5.7)
Grade 3/4 (>10%) D-Rd (n=29)
25 (86.2)
13 (44.8) 3 (10.3) 3 (10.3)
0
1 (3.4) 0
1 (3.4) 0
0
0
1 (3.4) 3 (10.3) 5 (17.2) 0
1 (3.4) 2 (6.9) 4 (13.8) 1 (3.4)
Rd (n=108)
104 (96.3)
49 (45.4) 47 (43.5) 37 (34.3)
D-Rd (n=123)
113 (91.9)
68 (55.3) 23 (18.7) 19 (15.4)
Rd (n=108)
89 (82.4)
43 (39.8) 24 (22.2) 16 (14.8)
1 (0.9) 6 (5.6) 0
2 (1.9) 0
1 (0.9) 2 (1.9) 0
0
7 (6.5) 0
3 (2.8) 3 (2.8) 5 (4.6) 2 (1.9)
Vd (n=86)
60 (69.8)
28 (32.6) 15 (17.4) 3 (3.5) 5 (5.8)
9 (10.5) 1 (1.2) 0
0
1 (1.2) 0
2 (2.3) 6 (7.0) 3 (3.5) 0
2 (2.3)
Rd (n=35)
27 (77.1)
11 (31.4) 7 (20.0) 5 (14.3)
2 (5.7) 1 (2.9) 0
0
1 (2.9) 0
0
0
0
4 (11.4) 2 (5.7) 2 (5.7) 1 (2.9) 1 (2.9) 4 (11.4)
Vd (n=35)
26 (74.3)
13 (37.1) 4 (11.4) 1 (2.9) 0
2 (5.7) 0
0
0
4 (11.4) 0
0
6 (17.1) 0
37 (34.3) 38 (35.2) 25 (23.1) 26 (24.1) 30 (27.8) 17 (15.7) 19 (17.6) 16 (14.8) 11 (10.2) 14 (13.0) 17 (15.7) 19 (17.6) 20 (18.5) 12 (11.1) 3 (2.8)
82 (95.3)
36 (41.9) 31 (36.0) 6 (7.0) 5 (5.8)
30 (34.9) 13 (15.1) 13 (15.1) 13 (15.1) 15 (17.4) 11 (12.8) 14 (16.3) 9 (10.5) 8 (9.3)
9 (10.5)
8 (9.3)
77 (81.9)
49 (52.1) 14 (14.9) 15 (16.0) 12 (12.8)
3 (3.2) 2 (2.1) 2 (2.1) 0
6 (6.4) 1 (1.1) 0
12 (12.8) 3 (3.2) 0
2 (2.1)
00
1 (5.0) 1 (2.9)
8 (6.5)
5 (4.1)
0
2 (1.6)
2 (1.6)
1 (0.8)
1 (0.8)
0
7 (5.7)
19 (15.4)
1 (0.8)
5 (4.1)
1 (0.8)
5 (4.1)
4 (3.3) 65-74 years Grade 3/4 (>10%) D-Vd (n=94)
Grade 3/4 (>10%) D-Vd (n=20)
18 (90.0)
9 (45.0) 2 (10.0) 0
1 (5.0)
2 (10.0) 2 (10.0) 0
0
3 (15.0) 0
0
3 (15.0) 2 (10.0)
Vd (n=86)
TEAE: treatment-emergent adverse event; D-Rd: daratumumab/lenalidomide/dexamethasone; Rd: lenalidomide/dexamethasone; D-Vd: daratumumab/bortezomib/dexametha- sone;Vd: bortezomib/dexamethasone. aThe safety analysis set included all patients who received ≥1 administration of study treatment.
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