Phase I study of daily cisplatin and concurrent radiotherapy in patients with cervical carcinoma.

Abstract:

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. CONCLUSION:Daily cisplatin, at 8 mg/m(2)/day, is a well-tolerated radiosensitizer in cervical carcinoma patients.

journal_name

Gynecol Oncol

journal_title

Gynecologic oncology

authors

Mitsuhashi A,Uno T,Tanaka N,Suzuka K,Tate S,Yamazawa K,Matsui H,Yamamoto S,Ito H,Sekiya S

doi

10.1016/j.ygyno.2004.09.038

subject

Has Abstract

pub_date

2005-01-01 00:00:00

pages

194-7

issue

1

eissn

0090-8258

issn

1095-6859

pii

S0090-8258(04)00778-4

journal_volume

96

pub_type

临床试验,杂志文章
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