Transcript
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Oral cyclophosphamide, bevacizumab, and pembrolizumab, is listed based on an NCCN compendium, based on phase two clinical trials like to comparison arm. So we wanted to test only the efficacy and safety of oral cyclophosphamide and bevacizumab in patients with recurrent ovarian cancer. We did a retrospective analysis study and we enrolled patients with high-grade recurrent ovarian cancer. And treatment regimen consisted of bevacizumab, 15 milligrams per kg every three weeks intravenously, plus oral cyclophosphamide, 50 milligrams daily, orally. And we looked at the response rate in terms of objective response rate, was patients who had partial or complete response, and this was calculated with a 95% confidence interval and adverse events were collected and graded for results. We included a hundred patients in our study and median age was 58. Majority of patients were white, 75%, and ovarian cancer was in 83% of the patients. A high-grade ovarian cancer was 94% and 96% of patients had either stage III-C, or stage IV cancer.
In terms of chemotherapy characteristics, patients were heavily treated before getting this regimen. They received a median of three prior lines of treatment before getting this regimen, and range was one to nine and patients received an average five cycle from this regimen.
Majority of patients were platinum resistant, 86%, and in terms of free response, 36% had partial response and 4% had complete response. 20% had stable disease and 40% had progressive disease. In terms of adverse events, 24% had adverse events, but grade III and IV toxicities were thrombocytopenia and 3% hemorrhagic cystitis in 1%, and nausea and vomiting in 4%, and hypertension in 3%.
In terms of relationship between objective response rate and different variables, there was no relationship between platinum free interval or platinum status observation and having a response to this regimen. In terms of receiving bevacizumab in a prior treatment regimen and having a response to this regimen, patients who did receive bevacizumab in a prior treatment regimen had the response rate of 36%, and patients who did not receive bevacizumab in a prior treatment regimen had a response rate of 42%. However, the B value was not significant.
In conclusion, oral cyclophosphamide plus bevacizumab was well tolerated and effective for patients with recurrent high grade platinum resistant ovarian cancer who had an objective response rate of 40.6% and progression free survival of 4.6 month.