关键词: 剂量递增, 洛铂, 多西紫杉醇, 二线化疗, 恶性肿瘤

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 define the maximum-tolerated dose (MTD) of lobaplatin with fixed 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 lobaplatin 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 level Ⅰ (30mg/m²), level Ⅱ (35 mg/m²)and level Ⅲ(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 level Ⅲ. We declared thus level Ⅱ was MTD. Conclusion: MTD of lobaplatin in our research was 35 mg/m² combined with fixed dose of docetaxel. This combination regimen was well tolerated.

Key words: Dose escalation, Lobaplatin, Docetaxel, Second-line chemotherapy, Malignant tumor