title: A phase II study of paclitaxel plus cisplatin for advanced non-small-cell lung cancer in Japanese patients.
abstract: We performed a clinical phase II trial of the combination of paclitaxel and cisplatin in patients with locally advanced (stage IIIB) or metastatic non-small-cell lung cancer (NSCLC) using a 3-h infusion of paclitaxel followed by a 1 to 2-h infusion of cisplatin, with a short premedication regimen. Treatment was repeated every 21 days for at least two cycles. The patients received paclitaxel 180 mg/m2 followed by cisplatin 80 mg/m2. Enrolled in the trial were 33 chemotherapy-naive patients with stage IIIB (15%) or stage IV (85%) NSCLC. Their median age was 61 years (range 43-71 years). Of the 33 patients, 10 (30%) were women and 23 (70%) were men, and 82% had adenocarcinoma. With 78 courses of chemotherapy administered, 32 patients were evaluable for toxicity and response. Hematologic toxicities were moderate: Japan Clinical Oncology Group (JCOG) grade 3 or 4 neutropenia occurred in 37% of the cycles (53% of patients). Other toxicities consisted mainly of grade 1 or 2 alopecia and nausea/vomiting, but also included grade 1 or 2 neuropathy (47%), hypotension (grade 1 in 6%, grade 3 in 3%) and allergic reactions (grade 1 or 2 in 16%, grade 3 in 3%). Of 32 patients evaluable for response, a partial response was achieved in 10 (31%; 95% confidence interval 16% to 50%), stable disease was seen in 16 (50%), and disease progression was seen in 2 (6%). The median survival time was 14.8 months and the 1-year survival rate was 56%. These results suggest that the combination of paclitaxel and cisplatin is a well-tolerated and active regimen in Japanese patients with advanced NSCLC. In view of the promising survival outcomes, further evaluation in prospective randomized trials with other regimens is warranted.
authors.affiliation: Department of Respiratory Disease, Saitama Cancer Center, Ina, Saitama, Japan. hiroshi_sakai@cancer-c.pref.saitama.jp
authors.forename: H
authors.initials: H
authors.lastname: Sakai
authors.forename: S
authors.initials: S
authors.lastname: Yoneda
authors.forename: T
authors.initials: T
authors.lastname: Tamura
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: A
authors.initials: A
authors.lastname: Yokoyama
authors.forename: K
authors.initials: K
authors.lastname: Watanabe
authors.forename: N
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin