Low-dose decitabine-based chemoimmunotherapy for patients with refractory advanced solid tumors: a phase I/II report

Area of Science:

• Oncology
• Cancer Therapeutics
• Epigenetics

Background:

• Aberrant DNA methylation drives tumor initiation and progression.
• Decitabine, a hypomethylating agent, shows clinical benefits but high-dose toxicity.
• Low-dose decitabine offers reduced toxicity and targeted DNA hypomethylation.

Purpose of the Study:

• To evaluate the efficacy and safety of low-dose decitabine-based chemoimmunotherapy in refractory advanced solid tumors.
• To explore the potential of this regimen as a novel treatment option.
• To identify correlations between previous treatment response and clinical outcomes.

Main Methods:

• A clinical trial (NCT01799083) administered a low-dose decitabine-based chemoimmunotherapy regimen.
• Adverse events were monitored and graded.
• Clinical activity, including clinical benefit rate and progression-free survival (PFS), was assessed.
• Correlation between PFS to previous treatment and clinical response was analyzed.

Main Results:

• The regimen demonstrated a favorable adverse event profile, with most events being grades 1-2.
• An optimistic clinical activity was observed, with a clinical benefit rate of up to 60%.
• Median PFS was prolonged compared to previous treatments.
• A significant correlation was found between PFS to previous treatment and clinical response.

Conclusions:

• Low-dose decitabine-based chemoimmunotherapy is a promising protocol for refractory advanced solid tumors.
• This approach may enhance treatment specificity and efficiency.
• The regimen offers a potentially safer and more effective alternative for patients with limited options.