OBJECTIVE
Assessment of the safety profile and adverse events in women with newly diagnosed ovarian cancer and peritoneal carcinomatosis using two-component chemotherapy, including pressurized intraperitoneal aerosol chemotherapy, after surgical cytoreduction.
MATERIAL AND METHODS
The study included 164 patients with morphologically verified peritoneal carcinomatosis. All the women were divided into two groups.
The distribution of patients into groups was carried out during cytoreductive surgery using a digital online randomizer. The first group of the study (the main one) included patients (n=79) who underwent intra-abdominal aerosol chemotherapy under pressure immediately after the completion of the cytoreductive stage of the operation within one surgical intervention and after 1.5 months, as well as courses of polychemotherapy. The second group (n=85) included women who underwent surgical treatment and polychemotherapy. In both observation groups, all adverse events were recorded according to the criteria of the Common Terminology Criteria for Adverse Events (CTCAE).
RESULTS
In the first group of patients during the analyzed time period, a total of 237 courses of PCT and 151 PIPAC sessions were conducted, while we registered 170 (71.7%) cases of adverse events. In the second group, 255 courses of systemic PCT were conducted at the end of the observation. At the same time, 184 (72.1%) episodes of the development of adverse events of a toxicological profile were registered. In none of the women from the first and second observation groups did we record the presence of adverse events of the 4th degree of severity. There were no statistically significant differences between the comparison groups regarding the occurrence of adverse events.
CONCLUSION
At the intermediate stage of a prospective controlled randomized trial, it was possible to establish a favorable safety profile of intraperitoneal aerosol chemotherapy under pressure, used in addition to the standard combined treatment of newly diagnosed ovarian cancer with peritoneal carcinomatosis.
