RT Journal Article
SR Electronic
T1 Phase I study of chemoradiation with nedaplatin and ifosfamide in patients with advanced squamous cell carcinoma of the uterine cervix
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 1300
OP 1304
DO 10.1111/j.1525-1438.2008.01199.x
VO 18
IS 6
A1 J. Kodama
A1 M. Takemoto
A1 N. Seki
A1 K. Nakamura
A1 A. Hongo
A1 S. Moriya
A1 S. Kanazawa
A1 Y. Hiramatsu
YR 2008
UL http://ijgc.bmj.com/content/18/6/1300.abstract
AB Cisplatin and ifosfamide are considered among the most active drugs in both neoadjuvant and salvage treatments for patients with cervical cancer. Nedaplatin is an analog of cisplatin and it exhibits lesser nephrotoxicity, neurotoxicity, and gastrointestinal toxicity than cisplatin. This study aimed to determine the recommended dosage of nedaplatin plus ifosfamide chemoradiotherapy for advanced squamous cell carcinoma (SCC) of the uterine cervix. Beginning with a dose of 65 mg/m2, nedaplatin (day 1) combined with ifosfamide 1 g/m2 (days 1–5) was designed to be administered for three cycles (minimum: two cycles); its dose was gradually escalated up to 80 mg/m2. Dose-limiting toxicity (DLT) was defined as a more than 7-day delay in the planned radiation therapy and/or planned chemotherapy (prior to the completion of two cycles) due to toxicity. Chemotherapy was not interrupted prior to the completion of two cycles in any patients. Of the 12 patients, 11 received three cycles of chemotherapy. DLT did not occur in any patient. We confirmed a clinical complete response (CR) in ten and partial response (PR) in two patients. The median follow-up period was 39 months (range: 18–57 months). Ten patients (83%) were alive and disease free, one patient was alive with disease, and only one patient died due to the disease. Nedaplatin and ifosfamide combination chemotherapy is a feasible and active chemoradiation strategy for patients with advanced SCC of the uterine cervix. With the ifosfamide dose fixed to 1 g/m2, the recommended nedaplatin dosage was determined to be 80 mg/m2 to be administered for three cycles.