title: Ligustrazine as a salvage agent for patients with relapsed or refractory non-Hodgkin's lymphoma.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine Oncology, Shandong Cancer Hospital, Shandong Academy of Medical Sciences, Jinan, Shandong 250117, China. zlysxgy@yahoo.com.cn
authors.forename: Xi-Gui
authors.initials: XG
authors.lastname: Yang
authors.forename: Chao
authors.initials: C
authors.lastname: Jiang
mesh_terms: D020168:ATP Binding Cassette Transporter, Subfamily B, Member 1 / Q000378:metabolism; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D020168:ATP Binding Cassette Transporter, Subfamily B, Member 1; D002121:Calcium Channel Blockers; D011719:Pyrazines; C017953:tetramethylpyrazine