부산대학교 도서관

Objective: To identify the maximum tolerated dose (MTD) of docetaxel combined with a fixed dose of cisplatin (75 mg/㎡) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. Methods: In this phase I trial, a time-to-event Bayesian optimal interval design was used. Docetaxel was given at a starting dose of 60 mg/㎡ and was increased in 5 mg/㎡ increments until the MTD was determined or the maximum dose level of 75 mg/㎡ was reached. The dose-limiting toxicity (DLT) rate was set at 25%, with a total sample size of 30 patients. HIPEC was delivered immediately following debulking surgery at a target temperature of 43°C for 90 minutes. Results: From August 2022 to November 2022, 30 patients were enrolled. Among the patients who received a dose of docetaxel ≤65 mg/㎡, no DLT was reported. DLTs were observed in one patient who received 70 mg/㎡ docetaxel (grade 3 anaemia) and in three patients who received 75 mg/㎡ docetaxel (one case of grade 3 anaemia, one case of grade 3 hepatic impairment and one case of grade 4 thrombocytopenia). Patients treated with docetaxel 75 mg/㎡ in combination with cisplatin 75 mg/㎡ had an estimated DLT rate of 25%, which was the closest to the target DLT rate and was therefore chosen as the MTD. Conclusion: Docetaxel, in combination with a fixed dose of cisplatin (75 mg/㎡), can be used safely at intraperitoneal doses of 75 mg/㎡ in ovarian cancer patients who received HIPEC (43°C, 90 minutes) following debulking surgery.