Article Figures & Data
Figures
- Figure 1
Flow chart of this phase 1b/2 study.
- Figure 2
Kaplan-Meier survival curves for the phase 2 cohort. (A) Overall survival. (B) Progression-free survival.
- Figure 3
Subgroup analysis of survival outcomes by pathology subtypes. (A) Overall survival. (B) Progression-free survival. AITL, angioimmunoblastic T cell lymphoma; PTCL-NOS, peripheral T cell lymphoma-not otherwise specified; ALCL, anaplastic large cell lymphoma; EATL, enteropathy-associated T-cell lymphoma.
Tables
Characteristics Phase 1b (n = 15), n (%) Phase 2 (n = 113), n (%) Age, years Median 54 54 Range 24–69 20–70 > 60 4 (26.7) 33 (29.2) Male 9 (60.0) 72 (63.7) Ann Arbor staging Stage I 0 (0) 5 (4.4) Stage II 1 (6.7) 19 (16.8) Stage III 4 (26.7) 32 (28.3) Stage IV 10 (66.7) 57 (50.4) B symptoms 10 (66.7) 66 (58.4) IPI 0–1 0 (0) 34 (30.1) 2 6 (40.0) 33 (29.2) 3 4 (26.7) 24 (21.2) 4–5 5 (33.3) 22 (19.5) Pathology subtypes AITL 9 (60.0) 41 (36.3) PTCL-NOS 1 (7.0) 48 (42.5) ALCL, ALK- 4 (26.0) 17 (15.0) EATL 1 (7.0) 7 (6.2) AITL, angioimmunoblastic T cell lymphoma; PTCL-NOS, peripheral T cell lymphoma-not otherwise specified; ALCL, anaplastic large cell lymphoma; EATL, enteropathy-associated T-cell lymphoma; IPI, international prognostic index.
Chidamide dose Patients treated (n) DLT (n) Toxicity Best response 15 mg biw 6 1 Grade 3 pulmonary infection 2CR, 1PR 20 mg biw1 6 1 Grade 4 neutropenia with G-CSF support 2CR 25 mg biw 3 2 Grade 4 neutropenia with G-CSF support 2PR DLT, dose limited toxicity; CR, complete response; PR, partial response; G-CSF, granulocyte colony-stimulating factor.
1Maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D).
Characteristics ORR (%) CR (%) SD (%) PD (%) Not evaluable (%)* Phase 2 (n = 113) 68 (60.2) 46 (40.7) 11 (9.7) 30 (26.5) 4 (3.5) IPI 0–1 (n = 34) 23 (67.6) 18 (52.9) 3 (8.8) 7 (20.6) 1 (2.9) 2 (n = 33) 20 (60.6) 13 (39.4) 6 (18.2) 7 (21.2) 0 (0) 3 (n = 24) 14 (58.3) 7 (29.2) 1 (4.2) 8 (33.3) 1 (4.2) 4–5 (n = 22) 11 (50.0) 8 (36.4) 1 (4.5) 9 (40.9) 2 (9.1) Pathology subtypes AITL (n = 41) 27 (65.9) 17 (41.5) 4 (9.8) 8 (19.5) 2 (4.9) PTCL-NOS (n = 48) 26 (54.2) 20 (41.7) 5 (10.4) 16 (33.3) 1 (2.1) ALCL (ALK-) (n = 17) 13 (76.5) 8 (47.1) 2 (2.8) 2 (2.8) 0 (0) EATL (n = 7) 2 (28.6) 1 (14.3) 0 (0) 4 (57.1) 1 (14.3) *Patients without efficacy assessments due to premature discontinuation by AEs.
ORR, overall response rate; CR, complete response; SD, stable disease; PD, progressive disease; IPI, international prognostic index; AITL, angioimmunoblastic T cell lymphoma; PTCL-NOS, peripheral T cell lymphoma-not otherwise specified; ALCL, anaplastic large cell lymphoma; EATL, enteropathy-associated T-cell lymphoma; AE, adverse event.
AE Phase 1b (n = 15) Phase 2 (n = 113) Any grade Grade ≥ 3 Any grade Grade ≥ 3 n % n % n % n % Leucopenia 14 93.3 9 60.0 93 82.3 78 69.0 Anemia 11 73.3 4 26.7 93 82.3 42 37.2 Neutropenia 11 73.3 10 66.7 86 76.1 78 69.0 Thrombocytopenia 8 53.3 5 33.3 58 51.3 35 31.0 Nausea/vomiting 6 40.0 72 63.7 5 4.4 Fever 4 26.7 2 13.3 42 37.2 12 10.6 Hypokalemia 4 26.7 34 30.1 17 15.0 Hypocalcaemia 8 53.3 1 6.7 25 22.1 3 2.7 Hypoalbuminemia 4 26.7 32 28.3 2 1.8 Upper respiratory tract infection 4 26.7 1 6.7 20 17.7 3 2.7 Pulmonary infection 1 6.7 1 6.7 15 13.3 7 6.2 Fatigue 3 20.0 1 6.7 12 10.6 Hyponatremia 2 13.3 2 13.3 12 10.6 12 10.6 Hyperglycemia 2 13.3 12 10.6 7 6.2 ALT/AST elevation 2 13.3 8 7.1 3 2.7 BUN elevation 1 6.7 8 7.1 3 2.7 Skin rash 1 6.7 7 6.2 Lower limb edema 7 6.2 2 1.8
