Purpose: Previous research has proposed that the hypomethylating agent
decitabine can sensitize ovarian cancer cells to chemical agents. In this open-label,
phase I/II clinical study, we analyzed the toxicity and efficacy of low dose decitabine
combined with taxol and platinum chemotherapy in treatment of refractory and recurrent
ovarian cancer. Methods: Decitabine was administered intravenously at 7 mg/m2 for 30 minutes over five consecutive
days and followed by reduced dose taxol and platinum chemotherapy treatment (TC) every 28 days for at least four cycles.
Adverse events (AEs) were graded according to the Common Terminology Criteria for AEs (NCI-CTCAE), and efficacy
was assessed using the Response Evaluation Criteria in Solid Tumors assessment (RECIST). Results: Twenty-one
patients diagnosed with relapsed/refractory ovarian cancer were initially enrolled in this study, and 17 patients were able
to be evaluated. The combination of low dose decitabine and TC was well-tolerated. The most common adverse effects
were nausea (77.8%) and neutropenia (66.7%), and adverse events greater than Grade 4 were not observed. The clinical
benefit rate (CBR) was 70.6% (12/17), and the partial response (PR) and stable disease (SD) rates were 17.6% (3/17) and
52.9% (9/17), respectively. A significant decrease in serum CA125 levels was observed in many of the responsive cases
even after completing the first treatment cycle. Conclusion: Low dose decitabine combined with taxol and platinum was
well-tolerated and suitable for treating refractory/refractory ovarian cancer. The change in CA125 levels might be a potential
predictor for patient clinical response. The efficacy of low dose decitabine for treatment of ovarian cancer requires
more volunteers for further investigation.
Keywords: CA 125, low dose decitabine, phase I/II, relapsed/refractory ovarian cancer.
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