title: [Early phase II study of BMS-181339 (paclitaxel) in patients with non-small cell lung cancer. BMS-181339 Non-Small Cell Lung Cancer Study Group].
abstract: We conducted a multi-institutional (11 facilities), early phase II study of BMS-181339 (paclitaxel), a novel anti-cancer drug, for non-small cell lung cancer (NSCLC). The 150 mg/m2 dose of paclitaxel was given by intravenous infusion over 24 hours every three weeks. When fifteen patients were accumulated, the interim review revealed that three of 15 eligible patients had a partial response for a response rate of 20%. The most common toxic effects were grade 3 or 4 leukopenia seen in 73.3% (11/15), and grade 4 neutropenia in 93.3% (14/15). One patient with neutropenia had suspected septic shock, which could be managed by G-CSF and antibiotics. No serious hypersensitivity reaction was seen with premedication of anti-allergic drugs, although mild allergic reactions such as skin rash and flush, were observed in 20.0% (3/15). Other adverse reactions, including alopecia, fever, arthralgia, myalgia and peripheral neuropathy, were mild in most cases. We conclude that it is relevant to proceed to a late phase II study for NSCLC.
authors.affiliation: Pulmonary Medicine Clinic, Saitama Cancer Center.
authors.forename: S
authors.initials: S
authors.lastname: Yoneda
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: H
authors.initials: H
authors.lastname: Niitani
authors.forename: Y
authors.initials: Y
authors.lastname: Kurita
authors.forename: Y
authors.initials: Y
authors.lastname: Ariyoshi
authors.forename: H
authors.initials: H
authors.lastname: Ikegami
authors.forename: K
authors.initials: K
authors.lastname: Furuse
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
authors.forename: I
authors.initials: I
authors.lastname: Kimura
authors.forename: N
authors.initials: N
authors.lastname: Hara
authors.forename: N
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012074:Remission Induction; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; C089957:BMS 181339; D043823:Taxoids; D017239:Paclitaxel