351. Phase II trial of a novel platinum analog, SKI 2053R, in patients with previously untreated extensive-stage small-cell lung cancer.
- Author
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Zang DY, Lee KH, Lee JS, Lee JH, Kim WK, Kim SH, Kim WD, Kim DS, Kim JH, Kim BS, Cho YB, Kim DK, and Kim KH
- Subjects
- Adult, Aged, Antineoplastic Agents chemistry, Carcinoma, Small Cell mortality, Female, Hematologic Diseases chemically induced, Humans, Korea epidemiology, Lung Neoplasms mortality, Male, Malonates chemistry, Middle Aged, Nausea diagnosis, Organoplatinum Compounds chemistry, Survival Rate, Antineoplastic Agents therapeutic use, Carcinoma, Small Cell drug therapy, Lung Neoplasms drug therapy, Malonates therapeutic use, Organoplatinum Compounds therapeutic use
- 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.
- Published
- 1999
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