Phase I/II study of intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical carcinoma
Version of Record online: 4 JAN 2001
Copyright © 2001 American Cancer Society
Volume 91, Issue 1, pages 74–79, 1 January 2001
How to Cite
Adachi, S., Ogasawara, T., Wakimoto, E., Tsuji, Y., Takemura, T., Koyama, K., Takayasu, Y., Inoue, J.-i. and Nakao, N. (2001), Phase I/II study of intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical carcinoma. Cancer, 91: 74–79. doi: 10.1002/1097-0142(20010101)91:1<74::AID-CNCR10>3.0.CO;2-6
- Issue online: 4 JAN 2001
- Version of Record online: 4 JAN 2001
- Manuscript Revised: 13 SEP 2000
- Manuscript Accepted: 13 SEP 2000
- Manuscript Received: 24 JAN 2000
- uterine cervical carcinoma;
- intraarterial chemotherapy;
Nedaplatin, a platinum analog with less renal toxicity and similar efficacy for cervical carcinoma, recently has been shown to have a synergistic effect on cervical carcinoma lines in combination with cisplatin. To determine the clinical efficacy of this combination in patients with cervical carcinoma, the authors conducted a Phase I/II study of intravenous nedaplatin and intraarterial cisplatin combined with transcatheter arterial embolization (TAE).
Eligibility criteria were as follows: cervical carcinoma (Stages IB2–IV; International Federation of Gynecology and Obstetrics), 16–70 years of age, performance status between 0 and 2, and adequate bone marrow, renal, and hepatic function. Nedaplatin (40–70 mg/m2) was administered intravenously on Day 1 followed by intraarterial administration of cisplatin (70 mg/m2) on Day 3 via both uterine arteries by using the Seldinger method. This then was followed by TAE. This course of treatment was repeated every 3 weeks for 3 cycles.
Patient data were as follows: age 37–68 (median, 55 years) and Stages IB2:4, IIA:3, IIB:2, IIIA:1, IIIB:3, IVA:2 carcinoma. The response to therapy was defined by magnetic resonance imaging as follows: partial response in 60% (9 of 15) of patients, complete response in 40% (6 of 15) of patients, and an overall response rate of 100% (95% confidence interval, 78–100%). Myelosuppression was manageable. Grade 3/4 renal toxicity was observed in 2 patients who received 70 mg/m2 of nedaplatin. Thirteen patients received radical hysterectomy, 1 patient received lymph node sampling, and 11 patients received adjuvant radiotherapy or chemotherapy.
The maximum tolerable dose was 70 mg/m2 nedaplatin, and the dose-limiting toxicity was renal toxicity. The recommended dose was 60 mg/m2 nedaplatin intravenously followed by 70 mg/m2 cisplatin intraarterially. Intravenous nedaplatin followed by intraarterial cisplatin with TAE appears to be very effective for locally advanced cervical carcinoma. Cancer 2001;91:74–9. © 2001 American Cancer Society.