Phase I/II study of intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical carcinoma

BACKGROUND. Nedaplatin, a platinum analog with less renal toxicity and simi lar efficacy for cervical carcinoma, recently has been shown to have a syne rgistic effect on cervical carcinoma lines in combination with cisplatin. T o determine the clinical efficacy of this combination in patients with cerv ical carcinoma, the authors conducted a Phase I/II study of intravenous ned aplatin and intraarterial cisplatin combined with transcatheter arterial em bolization (TAE). METHODS. Eligibility criteria were as follows: cervical carcinoma (Stages I B2-IV; International Federation of Gynecology and Obstetrics), 16-70 years of age, per formance status between 0 and 2, and adequate bone marrow, rena l and hepatic function. Nedaplatin (40-70 mg/m(2)) was administered intrave nously on Day 1 followed by intraarterial administration of cisplatin (70 m g/m(2)) on Day 3 via both uterine arteries by using the Seldinger method. T his then was followed by TAE. This course of treatment was repeated every 3 weeks for 3 cycles, RESULTS. Patient data were as follows: age 37-68 (median, 55 years) and Sta ges IB2:4, IIA:3, IIB:2, IIIA:1 IIIB:3, IVA:2 carcinoma. The response to th erapy was defined by magnetic resonance imaging as follows: partial respons e in 60% (9 of 15) of patients, complete response in 40% (6 of 15) of patie nts, and an overall response rate of 100% (95% confidence interval, 78-100% ). Myelosuppression was manageable. Grade 3/4 renal toxicity was observed i n 2 patients who received 70 mg/m(2)? of nedaplatin. Thirteen patients rece ived radical hysterectomy, 1 patient received lymph node sampling, and 11 p atients received adjuvant radiotherapy or chemotherapy. CONCLUSIONS. The maximum tolerable close M:as 70 mg/m(2) nedaplatin, and th e dose-limiting toxicity was renal toxicity, The recommended dose was GO mg /m(2) nedaplatin intravenously followed by 70 mg/m(2) cisplatin intraarteri ally. Intravenous nedaplatin followed by intraarterial cisplatin with TAE a ppears to be very effective for locally advanced cervical carcinoma.