KEY TAKEAWAYS
- The study aimed to investigate the efficacy and safety of Chidamide combined with R-GDP in treating patients with R/R DLBCL.
- Researchers noticed that Chidamide + R-GDP is safe and effective.
Poor prognosis is often associated with increased epigenetic heterogeneity In relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Chidamide, a selective histone deacetylase inhibitor, presents a promising targeted therapy for R/R DLBCL by addressing the abnormal epigenetic changes linked to adverse outcomes.
Guang-Liang Chen and the team aimed to assess the safety and efficacy of Chidamide combined with R-GDP in patients with R/R DLBCL who are not eligible for autologous stem cell transplantation.
They performed an inclusive analysis involving a cohort of 27 patients with R/R DLBCL who were ineligible for autologous stem cell transplantation. An open-label, single-arm study was conducted where Chidamide was administered orally at a dose of 30 mg twice weekly for 1 week during the induction monotherapy phase.
The combination therapy phase involved oral Chidamide at a dose of 20 mg twice weekly for 2 weeks, followed by a 1-week discontinuation period, in conjunction with intravenous R-GDP administered every 21 days.
About 31 patients underwent screening, with a median age of 67 years, and 27 were ultimately included in the study. Of these, 14 individuals completed 6 cycles of Chidamide combined with R-GDP treatment. The overall best objective response rate (ORR) was 79.1% (95% CI: 75.1%-83.3%), comprising a complete response rate of 45.8% (95% CI: 41.6%-49.9%) and a partial response rate of 33.3% (95% CI: 29.3%-37.4%).
Among the 14 patients who completed the full treatment regimen, the best ORR reached 100%, with 71.4% achieving a complete response (n = 10) and 28.6% achieving a partial response (n = 4). The median follow-up period for these patients was 17.0 months, ranging from 3.5 to 55 months.
The progression-free survival (PFS) was 5.9 months, and overall survival (OS) was 48.3 months. Anemia was the most common adverse event (AE), affecting all patients. Thrombocytopenia led to treatment interruption or dose reduction in 13 patients. Other common AE included hypocalcemia, hyponatremia, and hypokalemia. Of these 3 patients experienced grade 3 pneumonitis and 1 had a grade 3 skin rash.
The study concluded that Chidamide combined with R-GDP is a safe and effective treatment option for patients with R/R DLBCL who are not eligible for autologous stem cell transplantation.
The study was funded by the Scientific Research Project of Shanghai Municipal Health Commission (202040040).
Source: https://pubmed.ncbi.nlm.nih.gov/39206577/
Chen GL, Xue K, Zhang Q, et al. (2024). “Chidamide plus R-GDP for relapsed/refractory diffuse large B-cell lymphoma in patients ineligible for autologous transplantation: A prospective, single-arm, phase II study.” Cancer Med. 2024;13(16):e70142. doi:10.1002/cam4.70142
