title: [A phase II study of BMS-181339 in patients with ovarian cancer. BMS-181339 Ovarian Cancer Study Group].
abstract: We conducted a multicenter Phase II study of BMS-181339 in patients with ovarian cancer. The facilities participating were 23 in number. The total number of cases registered for the study were 62; 57 of them entered for evaluation in drug efficacy, and 58 cases were evaluable in drug safety. All the cases were previously treated with chemotherapy including platinum-based drugs. The clinical responses of BMS-181339 were as follows: CR, 1 case; PR, 13 cases; MR, 3 cases; NC, 13 cases and PD, 27 cases. The response rate was 24.6% (95% CI: 14.1-37.8%). Histologically, the drug showed its efficacy on serous adenocarcinoma 28.2% (11/39), mucinous adenocarcinoma 20.0% (1/5) and clear cell adenocarcinoma 20.0% (1/5). In regional evaluation, the drug demonstrated its efficacy not only on endopelvic lesions 19.0% (4/21) and abdominal lesions 14.3% (2/14), but also on remote metastatic lesions such as hepatic metastasis 30.8% (4/13) and lung/pleura 33.3% (2/6). The drug also showed its efficacy on the cases 22.9% (8/35) refractory to the platinum-based drugs. Major adverse reactions were fever 63.8% (37/58), alopecia 59.3% (32/54), peripheral nerve disorders 28.1% (16/57) such as numbness of the extremities, nausea/vomiting 24.1% (14/58), arthralgia 20.7% (12/58) and diarrhea 20.7% (12/58) etc.. Abnormal alterations in laboratory test values were an incidence rates of 100% for both leukopenia and neutropenia. However, these symptoms were clinically manageable by transient withdrawal of medication, dose reduction and administration of antibiotics and G-CSF. In addition, decrease in hemoglobin 93.1% (54/58), decrease in platelet counts 31.0% (18/58), elevation in GOT 27.6% (16/58), in GPT 31.0% (18/58) and in LDH 20.7% (12/58) were seen, but no serious organopathy was observed. Thus, we confirmed that BMS-181339 was a clinically useful chemotherapeutic agent in patients with ovarian cancer.
authors.affiliation: Dept. of Obstetrics and Gynecology, Kinki University School of Medicine.
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: M
authors.initials: M
authors.lastname: Ikeda
authors.forename: R
authors.initials: R
authors.lastname: Kudo
authors.forename: I
authors.initials: I
authors.lastname: Nishiya
authors.forename: A
authors.initials: A
authors.lastname: Yajima
authors.forename: K
authors.initials: K
authors.lastname: Tanaka
authors.forename: S
authors.initials: S
authors.lastname: Kodama
authors.forename: S
authors.initials: S
authors.lastname: Nozawa
authors.forename: Y
authors.initials: Y
authors.lastname: Taketani
authors.forename: Y
authors.initials: Y
authors.lastname: Terashima
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; C089957:BMS 181339; D043823:Taxoids; D017239:Paclitaxel