The analysis of rubitecan in phase I tolerance trial

Objective: To investigate the efficacy of rubitecan for patients with malignant tumor and to observe patients’tolerance to rubitecan. Methods: The laboratory examinations (including blood and urine rou-tine examination, coagulation test, blood biochemical test and electrocardiogram) were performed in patients treated with rubitecan orally once or continuously. Imaging for efficacy evaluation was carried out after continuous treatment of one cycle. Results: Thirty patients were enrolled into the single experiment and 20 patients were enrolled into the consecutive experiment. The major adverse effects were Ⅰ~Ⅱ hematological toxicity, proteinuria, nausea, vomiting, and electrocardiographic changes. The efficacy could be assessed in 13 patients. PR was obtained in 1 patient and SD was obtained in 8 patients. The disease control rate (DCR) was 69.2%. Conclusion: Oral administration of rubitecan is effective for patients with advanced and drug-resistent malignant tumor and can be well tolerated.