ABSTRACT
Background and purpose: Malignant tumors often relapsed or metastasized after first-line chemotherapy and needed second-line or above treatment. We conducted this study to deifne the maximum-tolerated dose (MTD) of lobaplatin with ifxed docetaxel for Chinese patients in previously treated solid tumors. Methods:Escalating doses of lobaplatin with fixed docetaxel were administered in a modified Fibonacci sequence. The initial doses were lobapla-tin 30 mg/m2 and docetaxel 60 mg/m2, respectively. Escalating doses was 5 mg/m2. The regimen was repeated every 21 days. If no dose-limiting toxicity (DLT) was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be one dose level below the level at which DLT appeared. Results:Seventeen patients received fifty-eight cycles chemotherapy at lobaplatin of levelⅠ(30mg/m2), levelⅡ(35 mg/m2)and levelⅢ(40 mg/m2). Cases of complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) for the whole group were 0, 1, 10 and 3, respectively. Response rate (RR, CR+PR) and disease control rate (DCR, CR+PR+SD) were 7.1%(1/14) and 78.6%(11/14), respectively. The most common toxicity was leukopenia. Three DLTs occurred in 3 patients in the whole group, including 2 DLTs in dose levelⅢ. We declared thus levelⅡwas MTD. Conclusion:MTD of lobaplatin in our re-search was 35 mg/m2 combined with fixed dose of docetaxel. This combination regimen was well tolerated.