RT Journal Article T1 The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer-Hyperthermia versus Normothermia: A Randomized Controlled Trial. A1 Casado-Adam, Angela A1 Rodriguez-Ortiz, Lidia A1 Rufian-Peña, Sebastian A1 Muñoz-Casares, Cristobal A1 Caro-Cuenca, Teresa A1 Ortega-Salas, Rosa A1 Fernandez-Peralbo, Maria Auxiliadora A1 Luque-de-Castro, Maria Dolores A1 Sanchez-Hidalgo, Juan M A1 Hervas-Martinez, Cesar A1 Romero-Ruiz, Antonio A1 Briceño, Javier A1 Arjona-Sanchez, Alvaro K1 Intraperitoneal chemotherapy K1 Ovarian cancer K1 Peritoneal carcinomatosis AB The treatment of ovarian carcinomatosis with cytoreductive surgery and HIPEC is still controversial. The effect and pharmacokinetics of the chemotherapeutics used (especially taxanes) are currently under consideration. A phase II, simple blind and randomized controlled trial (NTC02739698) was performed. The trial included 32 patients with primary or recurrent ovarian carcinomatosis undergoing cytoreductive surgery (CRS) and intraoperative intraperitoneal chemotherapy with paclitaxel (PTX): 16 in hyperthermic (42-43 °C) and 16 in normothermic (37 °C) conditions. Tissue, serum and plasma samples were taken in every patient before and after intraperitoneal chemotherapy to measure the concentration of PTX. To analyze the immunohistochemical profile of p53, p27, p21, ki67, PCNA and caspase-3 and the pathological response, a scale of intensity and percentage of expression and a grouped Miller and Payne system were used, respectively. Perioperative characteristics and morbi-mortality were also analyzed. The main characteristics of patients, surgical morbidity, hemotoxicity and nephrotoxicity were similar in both groups. The concentration of paclitaxel in the tissue was higher than that observed in plasma and serum, although no statistically significant differences were found between the two groups. No statistically significant association regarding pathological response and apoptosis (caspase-3) between both groups was proved. There were no statistically significant differences between the normothermic and the hyperthermic group for pathological response and apoptosis. The use of intraperitoneal PTX has proven adequate pharmacokinetics with reduction of cell cycle and proliferation markers globally without finding statistically significant differences between its administration under hyperthermia versus normothermia conditions. PB MDPI SN 2077-0383 YR 2022 FD 2022-09-28 LK http://hdl.handle.net/10668/21353 UL http://hdl.handle.net/10668/21353 LA en NO Casado-Adam A, Rodriguez-Ortiz L, Rufian-Peña S, Muñoz-Casares C, Caro-Cuenca T, Ortega-Salas R, et al. The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer-Hyperthermia versus Normothermia: A Randomized Controlled Trial. J Clin Med. 2022 Sep 29;11(19):5785 DS RISalud RD Apr 9, 2025