title: [A dose escalation study of concurrent chemoradiation therapy with nedaplatin for cervical cancer].
abstract: Doses of nedaplatin (CDGP) were established for concurrent chemoradiation therapy (CCRT) for cervical cancer, and a collaborative dose escalation study involving 8 hospitals was conducted to investigate the safety and efficacy of this therapy. Radiotherapy was performed according to the standard treatment described in the Regulations of Cervical Carcinoma Treatment. CDGP at 80 mg/m2 as Level 1 or at 90 mg/m2 as Level 2 was administered on Days 1 and 29 of treatment. Dose-limiting toxicity (DLT) was observed in 1 of 6.patients receiving 80 mg/m2 of CDGP and in all 2 patients receiving 90 mg/m2 of CDGP; therefore, Level 2 was regarded as the maximum tolerated dose (MTD), and Level 1 as the recommended dose. DLT signs consisted of delayed improvement in the leukocyte count in 2 patients and anorexia in 1 patient, suggesting that delayed improvement in the leukocyte count is the main DLT of this combination therapy. The main side effects were digestive disorders such as nausea and anorexia and bone marrow suppression, such as leukopenia, neutropenia, and thrombopenia. Side effects in the Level 1 group were more mild than in the Level 2 group. The efficacy was PR or better in all patients. The CR rates were 60% (6/10) in the Level 1 group and 50% (1/2) in the Level 2 group; there was no marked difference between the two groups. These results suggest that CCRT involving administration of CDGP at 80 mg/m2 on Days 1 and 29 is safe and effective.
authors.affiliation: Dept of Obstetris and Gynecology, Kagoshima City Hospital.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hatae
authors.forename: Takeshi
authors.initials: T
authors.lastname: Takahashi
authors.forename: Shoji
authors.initials: S
authors.lastname: Kodama
authors.forename: Hiroki
authors.initials: H
authors.lastname: Nakayama
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kuzuya
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Saji
authors.forename: Shoji
authors.initials: S
authors.lastname: Kamiura
authors.forename: Yo
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Nishimura
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kono
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ariyosh
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Imajo
authors.forename: Kazuo
authors.initials: K
authors.lastname: Hasegawa
authors.forename: Kiichiro
authors.initials: K
authors.lastname: Noda
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D014840:Vomiting, Anticipatory / Q000209:etiology
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C053989:nedaplatin