Thalidomide and Docetaxel Injection: Interaction Details

a) When thalidomide was added to docetaxel in the treatment of prostate cancer, the frequency of venous thromboembolism (VTE) increased significantly compared with the VTE incidence associated with docetaxel alone. Seventy male patients with advanced androgen-independent prostate cancer were involved in a randomized phase II study intended to evaluate the frequency of VTE in such patients. Each patient received one of two drug regimens: intravenous docetaxel 30 mg/m2/week for 3 consecutive weeks followed by 1 week off (n equal to 23), or the combination of continuous oral thalidomide 200 mg every evening plus the same docetaxel regimen (n equal to 47). This 4-week cycle was repeated until there was evidence of excessive toxicity (grade 3 or higher) or disease progression. None of the 23 doxetaxel-only group developed clinically evident VTE; however, none in this group had prior VTE history. Nine patients in the combination group developed VTE, of which six were first-time VTE occurrences. When all patients were analyzed using the Fisher exact test and regardless of VTE history, the frequency of VTE in patients receiving both drugs was significantly greater (19%) than in those receiving docetaxel alone (0%) ( p equal 0.025). Differences became non-significant (p=0.06) when the 3 men with recurrent VTE were excluded from analysis. Clinicians should use caution when adding thalidomide to chemotherapeutic regimens ¹.