Phase I study of daily cisplatin and concurrent radiotherapy in patients with cervical carcinoma.
OBJECTIVE
Chemoradiation based on cisplatin is the standard treatment for locally advanced cervical carcinoma; however, the optimal scheduling and dosing have still not been established. This study was conducted to determine the maximum-tolerated dose (MTD) of cisplatin for daily administration during pelvic radiotherapy (RT).


METHODS
Fourteen patients with locally advanced cervical carcinoma and 13 who required postoperative RT were registered. A low dose of cisplatin was given daily concurrently with RT. Cisplatin dosing was started at 6.0 mg/m(2)/day, which was incremented by 0.5 mg/m(2)/day. RT was delivered at 2 Gy/day to a total dose of 50 Gy. The MTD was defined as the dose level immediately below that causing dose-limiting toxicity (DLT) in over one-third of treated patients.


RESULTS
Twenty-five patients were treated with a maximum of six escalating dose levels. In 22/25 patients (88%), cisplatin was administered continuously as planned without interruption. The MTD was determined to be 8 mg/m(2) and the DLT was indicated by the onset of neutropenia.


CONCLUSIONS
Daily cisplatin, at 8 mg/m(2)/day, is a well-tolerated radiosensitizer in cervical carcinoma patients.
Mitsuhashi
Akira
A
Department of Reproductive Medicine, Graduate School of Medicine, Chiba University, 1-8-1 Inohana Chuo-ku, Chiba 260-8670, Japan. makira-cib@umin.ac.jp
Uno
Takashi
T
Tanaka
Naotake
N
Suzuka
Kiyomi
K
Tate
Shinichi
S
Yamazawa
Koji
K
Matsui
Hideo
H
Yamamoto
Seiji
S
Ito
Hisao
H
Sekiya
Souei
S
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery
D000970:Antineoplastic Agents; D002945:Cisplatin