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Mogamulizumab vs. investigator's choice in ATL
Table 1. Patients’ demographic and clinical characteristics. Characteristic
Age (y)
Median (range) >65 years
<40 years
Gender
Male
Female
Mogamulizumab Investigator’s choice (n=47) (n=24)
55.0 (22-82) 11 (23)
6 (13)
24 (51)
23 (49)
50.5 (24-80) 1 (4)
7 (29)
10 (42)
14 (58)
Race
Black
White
Asian
Other 1(2) 0
Unknown*
Geographical region
North America
Europe
South America and Caribbean
ECOG performance status 0
1 2
ATL subtype at study entry Acute
Lymphoma
Chronic
Disease site Lymph nodes Peripheral blood Bone marrow Skin
Extranodal masses
Spleen
Liver
Other 1(2) 0
32 (68) 6 (13) 2 (4)
15 (63) 5 (21) 1 (4)
3 (13)
14 (58) 7 (29) 3 (13)
11 (46) 6 (25) 7 (29)
12 (50) 9 (38) 3 (13)
1 (4)†
6.6 (1.3-150.6)
6 (13)
25 (53) 14 (30) 8 (17)
12 (26) 16 (34) 19 (40)
21 (45) 19 (40) 7 (15)
0
9.1 (1.3-116.7)
None reported
Median time from initial ATL diagnosis, months (range)
41 (87) 37 (79) 27 (57) 13 (28) 12 (26) 10 (21) 2 (4)
20 (83) 17 (71) 8 (33) 9 (38) 8 (33) 4 (17) 3 (13)
CCR4 expression status
Positive
Negative
Notdone 2 1
Number of prior ATL regimens, median (range)
Prior ATL regimens AZT
CHOP Interferon EPOCH Hyper-CVAD ICE Pralatrexate Autologous SCT Other
2.0 (1-6)
19 (40) 21 (45) 15 (32) 9 (19) 5 (11) 3 (6)
4 (9)
1 (2) 34 (72)
43 (96) 2 (4)
22 (96) 1 (4)
1.5 (1-5)
9 (38) 5 (21) 9 (38) 6 (25) 1 (4) 3 (13) 0
1 (4) 16 (67)
Best response to immediate prior ATL therapy
CR 3(6) 5(21)
PR
SD
PD Unknown
9 (19) 12 (26) 19 (40) 4 (9)
6 (25) 3 (13) 9 (38) 1 (4)
Data are given as n (%) unless otherwise stated. ATL: adult T-cell leukemia/lymphoma; AZT: zidovudine; CCR4: C-C chemokine receptor 4; CHOP: cyclophosphamide, doxoru- bicin, vincristine, and prednisone; CR: complete response; CVAD: cyclophosphamide, vincristine, dexamethasone, and doxorubicin; ECOG: Eastern Cooperative Oncology Group; EPOCH: etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin; ICE: ifosfamide, carboplatin, and etoposide; PD: progressive disease; PR: partial response; SCT: stem cell transplantation; SD: stable disease. *Not reported for those countries that do not allow race/ethnicity data to be collected. †This patient met eligibility criteria with dis- ease in blood and not in lymph nodes according to the investigator but showed lymph node and no blood involvement on independent review.
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