ABSTRACT
Objective:To investigate the clinical efficacy and safety of domestic bortezomib in the treatment of patients with multiple myeloma (MM).Methods:The data of 60 MM patients treated with domestic bortezomib as the basic chemotherapy regimen in 5 medical centers of Qilu Hospital of Shandong University, Heze Municipal Hospital, Weifang People's Hospital, Binzhou Medical University Hospital, Zibo Central Hospital in Shandong Province from January 2018 to June 2019 were retrospectively analyzed, 52 of which were newly treated patients and 8 were relapsed and refractory patients. The patients received at least 2 courses of combined chemotherapy based on domestic bortezomib, and the efficacy was assessed and evaluated every 2 courses.Results:Follow-up until June 30, 2019 showed that some patients were unable to return to the hospital for regular treatment. All patients completed at least 2 courses of treatment, with an overall effective rate (ORR) of 76.7% (46/60); 42 patients completed 4 courses of treatment, with an ORR of 78.6% (33/42); 30 patients completed 6 courses of treatment, with an ORR of 86.7% (26/30); there was no significant difference in ORR of 2, 4 and 6 courses ( P > 0.05). The complete remission+very good partial remission rates of 2, 4 and 6 courses were 16.7% (10/60), 47.6% (20/42) and 66.7% (20/30), respectively, and the difference was statistically significant ( P < 0.01). During the treatment, the adverse events mainly included infection, peripheral neuropathy, herpes, digestive tract symptoms, hematologic toxicities and so on, which were light and moderate mostly, and most of them can be reversed. The total incidence of adverse events in patients who completed 2, 4 and 6 courses of treatment were 91.7% (55/60), 66.7% (28/42) and 36.7% (11/30), respectively. Conclusions:The domestic bortezomib-based chemotherapy regimens have good efficacy in the treatment of MM. The incidence of adverse events is similar to that of the original drug, and patients can tolerate the adverse events.
ABSTRACT
<p><b>OBJECTIVE</b>To compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults.</p><p><b>METHODS</b>In this open prospective multicentre study, we randomly assigned patients with relapsed or refractory AML to receive TAE regimen (pirarubicin+cytarabine+etoposide) versus MAE regimen (mitoxantrone + cytarabine + etoposide). The efficacy and toxicity were compared between the two groups.</p><p><b>RESULTS</b>56 patients entered this clinical trial. The complete remission (CR) rate on TAE arm was 79.0% versus 55.6% on MAE arm with the overall response (OR) rates of 86.8% versus 88.9%, respectively. The CR was higher on TAE arm (P=0.035) but with no significant difference between the two groups regarding the overall response (OR) rate. The regimens were well tolerated in both groups. Hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of G-CSF, red blood cells and platelets transfusion on TAE arm. No significant differences were seen between the two groups regarding the overall survival and relapse free survival rates.</p><p><b>CONCLUSION</b>TAE regimen might be an effective salvage therapy in patients with relapsed or refractory AML.</p>