Chidamide in the treatment of peripheral T-cell lymphoma

Figures & data

Table 1 Types of histone deacetylase inhibitors and their current approval status in the treatment of mature T-cell lymphomas

Type	Examples	Regulatory approval for T-cell lymphoma
Hydroxamic acids	Vorinostat	Yes (US FDA)
	Belinostat	Yes (US FDA)
	Panobinostat	No
Short-chain aliphatic acids	Phenylbutyrate	No
	Valproic acid	No
Cyclic tetrapeptides	Romidepsin	Yes (US FDA)
Benzamides	Chidamide	Yes (China FDA)

Abbreviation: FDA, Food and Drug Administration.

Table 2 Adverse events of chidamide in >5% of patients in clinical trials

Adverse events	Total number	Percentage	Grade 3 number	Percentage	Grade 4 number	Percentage
Phase I (N=31)a
Fatigue	11	35	0	0	0	0
Thrombocytopenia	8	26	2	6	0	0
Anorexia	8	26	2	6	0	0
Leukopenia	7	23	3	10	0	0
Anemia	6	19	0	0	0	0
Nausea	5	16	0	0	0	0
Diarrhea	5	16	1	3	0	0
Dizziness	4	13	0	0	0	0
Vomiting	2	6	1	3	0	0
Flatulence	2	6	0	0	0	0
Hemoptysis	2	6	0	0	0	0
Insomnia	2	6	0	0	0	0
Headache	2	6	0	0	0	0
Phase II (N=83)b
Thrombocytopenia	42	51	13	16	5	6
Leukopenia	33	40	10	12	1	1
Neutropenia	18	22	7	8	2	2
Prolonged QTc interval	11	13	1	13	0	0
Fatigue	8	10	0	0	0	0
Anemia	7	8	3	4	1	1
Decreased appetite	7	8	2	2	0	0
Fever	7	8	0	0	0	0
Nausea	7	8	0	0	0	0
Diarrhea	7	8	0	0	0	0
Pericardial effusion	6	7	0	0	0	0
Increased ALT	6	7	1	1	0	0
Increase GGT	5	6	1	1	0	0
Increased CPK	5	6	0	0	0	0
Lung infection	5	6	1	1	0	0

Notes:

a In patients with solid tumors and different lymphomas. Data from a previous study.²⁶

b In patients with T-cell lymphomas. Reproduced and adapted, with permission, from Y Shi et al. Results From A Multicenter, Open-Label, Pivotal Phase II Study Of Chidamide In Relapsed Or Refractory Peripheral T-Cell Lymphoma. Annals of Oncology. 2015;26 (8):1766–1771.²⁷ Published by Oxford University Press on behalf of the European Society for Medical Oncology online at: http://annonc.oxfordjournals.org/content/26/8/1766.abstract. Published under a Standard License only. For permissions please email: [e-mail].

Abbreviations: N, number of patients; ALT, alanine aminotransferase; GGT, gamma-glutamyl transferase; CPK, creatine phosphokinase.

Table 3 Response of mature T-cell lymphomas to chidamide in clinical trials

Pathology	Number of cases	ORR number	Percentage	CR/CR unconfirmed number	Percentage
Phase Ia
CTCL	NA	1	NA	0	0
SPTCL	NA	1	NA	0	0
PTCL-NOS	NA	1	NA	0	0
ALCL	NA	1	NA	0	0
Phase II
AITL	10	5	50	4	40
ALCL
ALK+	6	2	33	0	0
ALK−	11	5	45	4	36
PTCL-NOS	27	6	22	2	7
ENKL	16	3	19	1	6
Others	9	1	11	0	0

Notes: Data from Dong et al²⁶ (Phase I trial) and Shi et al²⁷ (Phase II trial).

a A total of six cases of mature T-cell lymphomas were included in this trial.

Abbreviations: ORR, overall response rate; CR, complete remission; CTCL, cutaneous T-cell lymphoma; SPTCL, subcutaneous panniculitis-like T-cell lymphoma; PTCL-NOS, peripheral T-cell lymphoma, not otherwise specified; ALCL, anaplastic large cell lymphoma; AITL, angioimmunoblastic T-cell lymphoma; ALK, anaplastic lymphoma kinase; ENKL, extranodal NK/T-cell lymphoma; NA, not available.

DongMNingZQXingPYPhase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomasCancer Chemother Pharmacol20126961413142222362161

 PubMed Web of Science ®Google Scholar

ShiYDongMHongXResults from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphomaAnn Oncol20152681766177126105599

 PubMed Web of Science ®Google Scholar