title: Phase II trial of a novel platinum analog, SKI 2053R, in patients with previously untreated extensive-stage small-cell lung cancer.
abstract: A phase II trial of a novel platinum analog, SKI 2053R, was performed in patients with previously untreated extensive-stage disease (ED) small-cell lung cancer (SCLC). SKI 2053R was administered at the dose of 400 mg/m2 every 3 to 4 weeks as a 1-h infusion. After the first cycle, the dose was escalated to 440 mg/m2 based on toxicity. Thirty-eight patients (31 male) were enrolled between June 1995 and August 1997. The median age was 61 years (range, 36-70 years). Six of 37 evaluable patients achieved a partial response (16.2%; 95% confidence interval [CI], 4.4-28.0%). The durations of response were 1.1, 1.5, 1.7, 1.9, 3.4, and 4.6 months. The estimated median survival time was 7.4 months (95% CI, 5.1-9.7 months). Grade 3 or 4 toxicities were not observed. Grade 1 to 2 leukopenia, anemia, and thrombocytopenia were seen in 5 of 68 cycles, 16 of 68, and 2 of 68, respectively. Nonhematologic toxicities included grade 1 to 2 nausea or vomiting (30 of 68 cycles), nephrotoxicity (27 of 68), and hepatotoxicity (13 of 68). SKI 2053R showed a modest antitumor activity with limited toxicities in patients with ED SCLC. Further clinical trials are warranted in SCLC with a higher dose of SKI 2053R.
authors.affiliation: Department of Medicine, University of Ulsan, and College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: D Y
authors.initials: DY
authors.lastname: Zang
authors.forename: K H
authors.initials: KH
authors.lastname: Lee
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: W K
authors.initials: WK
authors.lastname: Kim
authors.forename: S H
authors.initials: SH
authors.lastname: Kim
authors.forename: W D
authors.initials: WD
authors.lastname: Kim
authors.forename: D S
authors.initials: DS
authors.lastname: Kim
authors.forename: J H
authors.initials: JH
authors.lastname: Kim
authors.forename: B S
authors.initials: BS
authors.lastname: Kim
authors.forename: Y B
authors.initials: YB
authors.lastname: Cho
authors.forename: D K
authors.initials: DK
authors.lastname: Kim
authors.forename: K H
authors.initials: KH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000737:chemistry / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007723:Korea / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008314:Malonates / Q000737:chemistry / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000175:diagnosis; D009944:Organoplatinum Compounds / Q000737:chemistry / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D008314:Malonates; D009944:Organoplatinum Compounds; C090717:SKI 2053R