Background
Phase 3 multicenter trial (9 Chinese centers), N=128 untreated PTCL. Allocation by participating center (not individually randomized). AC-CHOP n=84 vs CHOP n=44.
Results
Interventions and follow up: Arm A: CHOP + azacitidine 200 mg d1–2, 100 mg d3 + chidamide 20 mg twice weekly
Arm B: CHOP
Primary endpoint: efficacy (ORR/PFS; see paper)
mFollow up: NR in abstract
Results: ORR: 60.7% vs 54.6%, NS.
CR: 47.6% vs 36.4%, NS.
PFS: median 10.2 vs 8.4 mo, P=.093.
OS: median 46.2 vs 24.1 mo, P=.023.
Biomarkers: DNMT3A mut → lower response; IDH2/TP53 mut → inferior survival.
Arm B: CHOP
Primary endpoint: efficacy (ORR/PFS; see paper)
mFollow up: NR in abstract
Results: ORR: 60.7% vs 54.6%, NS.
CR: 47.6% vs 36.4%, NS.
PFS: median 10.2 vs 8.4 mo, P=.093.
OS: median 46.2 vs 24.1 mo, P=.023.
Biomarkers: DNMT3A mut → lower response; IDH2/TP53 mut → inferior survival.
Adverse events
Overall: comparable between arms
Most common: hematologic toxicity, infection
Grade ≥3 rates: NR in abstract
Most common: hematologic toxicity, infection
Grade ≥3 rates: NR in abstract
Conclusions
Adding azacitidine + chidamide to CHOP did not significantly improve ORR or PFS. OS gain should be interpreted cautiously.
Key Limitations
Center-based allocation (not randomized), unbalanced arms (84 vs 44), imbalanced post-protocol therapy, PFS not significant, OS secondary and likely confounded. Hypothesis-generating only.
Clinical Context
CHOP remains the standard backbone for most PTCL. Chidamide is approved in China for relapsed/refractory PTCL; not a frontline standard elsewhere. Does not change practice; compare with ECHELON-2 and HOVON/other CHOP-plus trials.
