Zang, D Y; Lee, K H; Lee, J S; Lee, J H; Kim, W K; Kim, S H; Kim, W D; Kim, D S; Kim, J H; Kim, B S; Cho, Y B; Kim, D K; Kim, K H
American journal of clinical oncology
1999Oct ; 22 ( 5 ) :495-8.
PMID : 10521066
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Zang, D Y -
Lee, K H -
Lee, J S -
Lee, J H -
Kim, W K -
Kim, S H -
Kim, W D -
Kim, D S -
Kim, J H -
Kim, B S -
Cho, Y B -
Kim, D K -
Kim, K H -
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.
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MESH
Adult, Aged, Antineoplastic Agents/chemistry/*therapeutic use, Carcinoma, Small Cell/*drug therapy/mortality, Female, Hematologic Diseases/chemically induced, Humans, Korea/epidemiology, Lung Neoplasms/*drug therapy/mortality, Male, Malonates/chemistry/*therapeutic use, Middle Aged, Nausea/diagnosis, Organoplatinum Compounds/chemistry/*therapeutic use, Survival Rate
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