Ligustrazine as a salvage agent for patients with relapsed or refractory non-Hodgkin's lymphoma

Background The prognosis is poor for patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) The main reason for poor prognosis is multidrug resistance (MDR), for which the main phenotype is overexpression of P-glycoprotein (P-gp) This study explored the efficacy of ligustrazine as a salvage agent in patients with relapsed or refractory NHL, and the relationship to P-gp expression Methods Sixty patients were randomized to a reversal agent group, receiving ligustrazine plus chemotherapy, and a control group, receiving chemotherapy alone Flow cytometry was performed to evaluate P-gp expression Results In the 56 patients we were able to evaluate, there was no statistically significant difference in progression-free survival (PFS) in the two groups (P=0 0651), but the reversal agent group had a higher overall response rate (ORR) than did the control group (P=0 048) Forty-one of 56 patients had P-gp(+) tumor cells Among these patients, six of eighteen patients in the reversal agent group and in the control group had complete remission or complete remission/unconfirmed (CR+CRu) reflecting a significant advantage in the reversal agent group (P=0 048) Patients with P-gp(+) tumor cells in the reversal agent group had a higher overall response rate (ORR) than did the control group (11/18 vs 6/23, P=0 024) Kaplan-Meier Survival curve and log-rank test demonstrated that patients with P-gp(+) tumor cells in the reversal agent group had longer progression-free survival than did the control group (P=0 0464) A small number of patients who received ligustrazine had a decrease in blood pressure Conclusion Ligustrazine as a salvage agent in combination with chemotherapy can elevate response rate, prolong PFS with manageable toxicity, and correlate with P-gp expression in relapsed or refractory NHL Chin Med J 2010,123(22) 3206-3211