title: Gemcitabine and treatment of diffuse large B-cell lymphoma in relapsed or refractory elderly patients: a prospective randomized trial in Algeria.
abstract: BACKGROUND
  Support for non-Hodgkin's lymphoma (NHL) with large cells that is refractory or relapsed after first-line chemotherapy poses a greater therapeutic problem with bone marrow transplant therapy or when old age is a contra-indication for high-dose chemotherapy, especially among developing countries such as Algeria.
  
  
  OBJECTIVE
  To show that the regimen, including gemcitabine, could be more effective in treating elderly patients with diffuse large B-cell lymphoma (DLBCL) in relapse / refractory, without complete remission, when compared with the ESHAP (etoposide, cisplatine, solumedrol, aracytine) regimen.
  
  
  METHODS
  Ninety-six patients in the age group of 60-70 years were volunteers for a prospective randomized single-blind study, carried out for three years. Patients were divided into two groups by the drawing of lots. The first group (GA, n = 48, relapse; n = 27 [56.3%], refractory; n = 21 [43.7%]) received treatment with ESHAP protocol and the second one (GB, n = 48, relapse; n = 28 [58%], refractory; n = 20 [42%]) with GPD (gemcitabine, dexamethasone, cisplatine) protocol.
  
  
  RESULTS
  The overall response rates and mean survival at three years were significantly higher among patients subjected to GPD treatment compared with those subjected to ESHAP treatment (63% vs. 55%, P = 0.01 and 20.5% [95% CI 16.5-24.5] vs. 11.8% [8.9-14.6], respectively). Additionally, three-year progression-free and event-free survival rates were 20.5% (16.3-24) and 19.7% (15.9-23.5), respectively, for the GPD regimen and 10.9% (8.2-13.7) and 11.1% (95% CI 8.5-13.7), respectively, for the ESHAP regimen. Moreover, the GPD regimen was associated with improving overall survival (RR=2.02, 95% CI 1.59-2.56; P = 0.000), event-free survival (2.03, 1.64-2.52; P < 0.001) and progression-free survival (1.86, 1.46-2.37; P < 0.001).
  
  
  CONCLUSIONS
  In cases of contra-indication for high-dose chemotherapy for elderly patients with DLBCL, without complete remission, the Gemcitabine-based therapy protocol represents a more effective and less toxic than that of ESHAP.
authors.affiliation: Division of Molecular Biology, Immunology and Pathology, Toxicomed Laboratory, Faculty of Medical Sciences, Abou-Bekr Belkaïd University, Algeria.
authors.forename: Mourad
authors.initials: M
authors.lastname: Aribi
authors.forename: Naima
authors.initials: N
authors.lastname: Mesli
authors.forename: Nesrine
authors.initials: N
authors.lastname: Remla
authors.forename: Badr-Eddine
authors.initials: BE
authors.lastname: Sari
authors.forename: Abdesselam
authors.initials: A
authors.lastname: Taleb
authors.forename: Hadj
authors.initials: H
authors.lastname: Touhami
authors.forename: Mohamed-Amine
authors.initials: MA
authors.lastname: Bekadja
authors.forename: Zahia
authors.initials: Z
authors.lastname: Zouaoui-Benhadji
authors.forename: Kamel
authors.initials: K
authors.lastname: Bouzid
authors.forename: Kaoual
authors.initials: K
authors.lastname: Meguenni
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005047:Etoposide; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008775:Methylprednisolone; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D000093542:Gemcitabine
chemical_list: D003561:Cytarabine; D003841:Deoxycytidine; D005047:Etoposide; D003907:Dexamethasone; D002945:Cisplatin; D008775:Methylprednisolone; D000093542:Gemcitabine