title: Phase I study of a carboplatin-cisplatin-etoposide combination chemotherapy in advanced non-small-cell lung cancer.
abstract: Cisplatin (CDDP)-containing chemotherapy has become the mainstay of clinical trials in unresectable non-small-cell lung cancer (NSCLC), but the role of chemotherapy in the routine management of NSCLC remains controversial. We conducted a phase I study with the combination carboplatin (CBDCA), CDDP, and etoposide (Etop) in unresectable NSCLC. CBDCA, at a starting dose of 80 mg/m2, on day 1, was combined with a fixed dose of CDDP (80 mg/m2, day 1) and Etop (80 mg/m2, days 1-3). Escalation was performed after four patients entered at each dose level. If no World Health Organization (WHO) grade 4 toxicity developed after the first cycle in more than half of the patients or WHO grade 3/4 toxicity in more than two thirds, the dose was escalated. The maximum tolerated dose was established at 300 mg/m2 for CBDCA. Thrombocytopenia and leukopenia were the dose-limiting toxicities. No grade 3/4 nonhematologic toxicities were seen. The recommended dose of CBDCA to be combined with CDDP (80 mg/m2, day 1) and Etop (80 mg/m2, days 1-3) is 280 mg/m2. This trial suggests that our combination chemotherapy may be effective in patients with advanced NSCLC. A multicenter phase II study based on these findings is now under way.
authors.affiliation: Department of Internal Medicine, National Nishi-Gunma Hospital, Shibukawa, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Nakano
authors.forename: S
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: Y
authors.initials: Y
authors.lastname: Takei
authors.forename: K
authors.initials: K
authors.lastname: Minato
authors.forename: S
authors.initials: S
authors.lastname: Watanabe
authors.forename: T
authors.initials: T
authors.lastname: Makimoto
authors.forename: I
authors.initials: I
authors.lastname: Naruse
authors.forename: T
authors.initials: T
authors.lastname: Nomoto
authors.forename: S
authors.initials: S
authors.lastname: Ishihara
authors.forename: A
authors.initials: A
authors.lastname: Takise
authors.forename: K
authors.initials: K
authors.lastname: Ezawa
authors.forename: N
authors.initials: N
authors.lastname: Fueki
authors.forename: H
authors.initials: H
authors.lastname: Hoshino
authors.forename: R
authors.initials: R
authors.lastname: Saito
authors.forename: M
authors.initials: M
authors.lastname: Mori
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D005047:Etoposide; D016190:Carboplatin; D002945:Cisplatin