title: [Late phase II clinical study of KW-2307 in advanced/recurrent breast cancer patients (II)].
abstract: A late phase II clinical study (II) of a novel vinca alkaloid derivative KW-2307 (vinorelbine ditartrate) in advanced/recurrent breast cancer patients was performed at 22 institutions throughout Japan. An intravenous dose of KW-2307, 20 mg/m2, was administered once a week. Of the 60 patients enrolled in the study, 58 were eligible and 56 were evaluable. The response rate was 33.9% (19/56; 95% confidence interval: 21.8 to 47.8%) with one CR and 18 PRs. The response rate was as high as 37.0% (17/46; 95% confidence interval: 23.2 to 52.5%) when KW-2307 was used as a first-line chemotherapy for advanced/recurrent disease. The most common adverse event was myelosuppression including leukopenia in 96.4% (54/56) and neutropenia in 94.3% (50/53). Other events observed were increased GOT in 51.8% (29/56), increased GPT in 55.4% (31/56), LDH increased in 50.0% (27/54), serum total protein decrease in 39.3% (22/56), anorexia in 41.1% (23/56), nausea and vomiting in 66.1% (37/56), constipation in 30.4% (17/56), alopecia in 33.9% (19/56) and general fatigue in 46.4% (26/56). None of them were serious. This study demonstrated that KW-2307 was an effective and safe treatment for advanced/recurrent breast cancer patients.
authors.affiliation: Dept. of Surgery, Tokyo Metropolitan Komagome Hospital.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Noboru
authors.initials: N
authors.lastname: Horikoshi
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Hiroki
authors.initials: H
authors.lastname: Koyama
authors.forename: Nobuteru
authors.initials: N
authors.lastname: Kikkawa
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Toge
authors.forename: Shoshu
authors.initials: S
authors.lastname: Mitsuyama
authors.forename: Tadaoki
authors.initials: T
authors.lastname: Morimoto
authors.forename: Koji
authors.initials: K
authors.lastname: Enomoto
authors.forename: Tomio
authors.initials: T
authors.lastname: Wada
authors.forename: Izo
authors.initials: I
authors.lastname: Kimishima
authors.forename: Hisanobu
authors.initials: H
authors.lastname: Niitani
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine