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In Western populations, 10–15% of all non-Hodgkin lymphomas are peripheral T-cell lymphomas (PTCLs). Patients with PTCLs have poor long-term survival and often relapse after firstline treatment. Currently, four histone deacetylase inhibitors (HDACis) have been approved globally for patients with relapsed or refractory (R/R) PTCL.1 Belinostat, a hydroxamic acid-based HDACi, was the second HDACi to receive U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of R/R PTCL. Approval was based on the BELIEF study (NCT00865969), where monotherapy with belinostat produced complete and durable responses with a manageable safety profile in patients with R/R PTCL.1
In the BELIEF study, a higher overall response rate was seen among patients with R/R angioimmunoblastic T-cell lymphoma (AITL). Therefore, Ahmed Sawas and colleagues carried out an unplanned analysis of the AITL patient subgroup. These results have recently been published in a letter to the editor of the journal Leukemia & Lymphoma.1
Table 1. Selected baseline patient characteristics1
AITL, angioimmunoblastic T-cell lymphoma; CHOP, cyclophosphamide + doxorubicin + vincristine + prednisone; ECOG, Eastern Cooperative Oncology Group |
||
Characteristic |
Overall (n = 120) |
AITL (n = 22) |
Sex, male/female, % |
51.7/48.3 |
36.4/63.6 |
Age (years), % |
|
|
< 65 |
50.8 |
31.8 |
≥ 65 |
49.2 |
68.2 |
Median (range) |
64.0 (29–81) |
69.5 (48–78) |
ECOG performance status, % |
|
|
0–1 |
77.5 |
72.8 |
2 |
21.7 |
27.3 |
3 |
0.8 |
0.0 |
Median time from initial diagnosis, months (range) |
12.0 (2.6–266.4) |
13.9 (4.8–93.4) |
Bone marrow involvement, % |
|
|
No |
54.2 |
45.5 |
Yes |
29.2 |
36.4 |
Intermediate/not assessed |
16.7 |
18.1 |
Ann Arbor stage at study entry, % |
|
|
I |
4.2 |
0.0 |
II |
9.1 |
9.0 |
III |
35.0 |
40.9 |
IV |
50.0 |
50.0 |
Prior systemic therapy |
|
|
Median systemic therapies (range) |
2.0 (1–8) |
1.5 (1–5) |
Multi-agent regimens, % |
|
|
CHOP or CHOP-like |
96.7 |
95.5 |
Platinum-containing |
31.7 |
31.8 |
Other |
36.7 |
36.4 |
Single-agent regimens, % |
|
|
Pralatrexate |
8.3 |
0.0 |
Other |
20.0 |
9.1 |
Radiation, % |
— |
22.7 |
Stem cell transplantation, % |
— |
18.2 |
Baseline platelet count (≥ 50,000/µL), % |
|
|
< 100,000 µL |
16.7 |
22.7 |
≥ 100,000 µL |
83.3 |
77.3 |
Table 2. ORR by pretreatment characteristics1
CR, complete response; ECOG, Eastern Cooperative Oncology Group; NE, not evaluable; ORR, overall response rate; PD, progression of disease; PR, partial response; SD, stable disease |
||
Pretreatment characteristic |
Overall ORR, % (n = 120) |
AITL ORR, % (n = 22) |
Baseline bone marrow involvement |
|
|
Yes |
30.8 |
50.0 |
No |
22.9 |
50.0 |
Indeterminate |
25.0 |
100.0 |
NE |
8.3 |
0.0 |
Baseline platelet count (≥50,000/µL) |
|
|
< 100,000 µL |
28.0 |
40.0 |
≥ 100,000 µL |
15.0 |
47.1 |
Response to last systemic therapy |
|
|
CR |
48.2 |
71.4 |
PR |
28.6 |
40.0 |
SD |
25.0 |
16.7 |
PD |
8.1 |
33.3 |
NE |
27.2 |
100.0 |
ECOG performance status |
|
|
0 |
29.3 |
50.0 |
1 |
15.4 |
16.7 |
2 |
42.3 |
66.7 |
3 |
— |
— |
In this subset analysis, the ORR to belinostat was higher in patients with AITL compared with the entire population. This finding is consistent with previous reports of other HDACis. Belinostat induced durable responses in patients with R/R AITL, with 37% of responders having an ongoing response after a median follow-up of 2 years. The authors suggest that AITL may represent a subtype of PTCL with a unique vulnerability to HDACis. The safety data also suggest that belinostat is better tolerated in patients with AITL.
Limitations of this study include the small cohort size and that the analysis was unplanned.
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