title: [Phase II study of combination therapy with paclitaxel and carboplatin against postoperative small residual disease in patients with stage I c-IV ovarian cancer--KCOG 989 trial].
abstract: The tolerability and feasibility of combination therapy with paclitaxel (TXL) and carboplatin (CBDCA) against small residual disease following first-line optimal debulking of stage I c-IV ovarian cancer were evaluated in a multicenter dose-finding study. Eligibility criteria included histologically diagnosed stage I c-IV epithelial ovarian cancer with a postoperative residual lesion < or = 10 mm in diameter, no prior chemotherapy, and written informed consent of the patient and his/her family members to the chemotherapy. Twenty-two patients were enrolled and 20 of them were eligible. The patients were to receive 5 courses of TXL (175 mg/m2) and CBDCA (AUC 5) every 3 weeks. Hematological toxicities occurred in the form of grade 3 leukopenia during 25.7% of all courses, grade 3 neutropenia during 32.0% of all courses, and grade 4 neutropenia during 56.0% of all courses. No courses were associated with grade 4 leukopenia. G-CSF support was needed during 48 of 109 courses (44%) and caused normalization of the leukocyte count from a nadir of 1,921 +/- 434/mm3 after a mean time of 6 +/- 3.1 days, compared with 6 +/- 3.6 days needed for recovery from a nadir of 2, 357 +/- 360/mm3 without G-CSF support. This indicates similarly rapid recovery from severe leukopenia with the use of G-CSF. All eligible patients completed at least 5 courses of the chemotherapy. Some courses were given at a reduced dose or delayed due to toxicity but these dosage modifications were thought to be acceptable for both TXL and CBDCA. Five courses of TXL combined with CBDCA were tolerated well in this patient population.
authors.affiliation: Obstetrics and Gynecology, Kyoto First Redcross Hospital.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Nakata
authors.forename: Toshio
authors.initials: T
authors.lastname: Yamada
authors.forename: Ryoji
authors.initials: R
authors.lastname: Itoh
authors.forename: Kiyoko
authors.initials: K
authors.lastname: Koishi
authors.forename: Katsutada
authors.initials: K
authors.lastname: Hiraoka
authors.forename: Keizo
authors.initials: K
authors.lastname: Yamagami
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Itani
authors.forename: Shinji
authors.initials: S
authors.lastname: Toyoda
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Itoh
authors.forename: Toshio
authors.initials: T
authors.lastname: Kimura
authors.forename: Kenichi
authors.initials: K
authors.lastname: Hosokawa
authors.forename: Hideo
authors.initials: H
authors.lastname: Honjo
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujita
authors.forename: Hisato
authors.initials: H
authors.lastname: Koshiba
authors.forename: Yuko
authors.initials: Y
authors.lastname: Hara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsuchiya
authors.forename: Susumu
authors.initials: S
authors.lastname: Adachi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D018365:Neoplasm, Residual / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D016190:Carboplatin; D017239:Paclitaxel