Phase II trial of a novel platinum analog, SKI 2053R, in patients with previously untreated extensive-stage small-cell lung cancer

A phase II trial of a novel platinum analog, SKI 2053R, was performed in pa tients with previously untreated extensive-stage disease (ED) small-cell lu ng cancer (SCLC). SKI 2053B was administered at the dose of 400 mg/m(2) eve ry 3 to 4 weeks as a l-h infusion. After the first cycle, the dose was esca lated 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 (ra nge, 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 respons e were 1.1, 1.5, 1.7, 1.9, 3.4, and 4.6 months. The estimated median surviv al time was 7.4 months (95% CI, 5.1-9.7 months). Grade 3 or 4 toxicities we re 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. Nonhematologi c toxicities included grade 1 to 2 nausea or vomiting (30 of 68 cycles), ne phrotoxicity (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 20 53R.