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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2024.1
- 수록면
- 1 - 13 (13page)
- DOI
- https://doi.org/10.3802/jgo.2024.35.e1
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초록· 키워드
오류제보하기
Objective: To identif y the maximum tolerated dose (MTD) of docetaxel combined with afixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy(HIPEC) in patients with ovarian cancer.
Methods: In this phase I trial, a time-to-event Bayesian optimal inter val design was used.
Docetaxel was given at a starting dose of 60 mg/m2 and was increased in 5 mg/m2 incrementsuntil the MTD was determined or the maximum dose level of 75 mg/m2 was reached. The dose-limiting toxicity (DLT) rate was set at 25%, with a total sample size of 30 patients. HIPEC wasdelivered immediately following debulking surger y at a target temperature of 43°C for 90 minutes.
Results: From August 2022 to November 2022, 30 patients were enrolled. Among thepatients who received a dose of docetaxel ≤65 mg/m2, no DLT was reported. DLTs wereobser ved in one patient who received 70 mg/m2 docetaxel (grade 3 anaemia) and in threepatients who received 75 mg/m2 docetaxel (one case of grade 3 anaemia, one case of grade3 hepatic impairment and one case of grade 4 thrombocytopenia). Patients treated withdocetaxel 75 mg/m2 in combination with cisplatin 75 mg/m2 had an estimated DLT rate of25%, 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/m2), can be usedsafely at intraperitoneal doses of 75 mg/m2 in ovarian cancer patients who received HIPEC(43°C, 90 minutes) following debulking surger y.
Trial Registration: ClinicalTrials.gov Identifier: NCT05410483
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