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Phase I/II study of intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical carcinoma
Author(s) -
Adachi Susumu,
Ogasawara Toshitada,
Wakimoto Eiko,
Tsuji Yoshiyuki,
Takemura Tadashi,
Koyama Koji,
Takayasu Yukio,
Inoue Jyunnichi,
Nakao Norio
Publication year - 2001
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20010101)91:1<74::aid-cncr10>3.0.co;2-6
Subject(s) - medicine , nedaplatin , cisplatin , urology , performance status , phases of clinical research , carcinoma , surgery , chemotherapy
BACKGROUND 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). METHODS 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/m 2 ) was administered intravenously on Day 1 followed by intraarterial administration of cisplatin (70 mg/m 2 ) 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. RESULTS 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/m 2 of nedaplatin. Thirteen patients received radical hysterectomy, 1 patient received lymph node sampling, and 11 patients received adjuvant radiotherapy or chemotherapy. CONCLUSIONS The maximum tolerable dose was 70 mg/m 2 nedaplatin, and the dose‐limiting toxicity was renal toxicity. The recommended dose was 60 mg/m 2 nedaplatin intravenously followed by 70 mg/m 2 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.