Gemcitabine and treatment of diffuse large B-cell lymphoma in relapsed or refractory elderly patients: A prospective randomized trial in Algeria

• Published in: Journal of cancer research and therapeutics 2010-01, Vol.6 (1), p.41-46
• Main Authors: Aribi, Mourad, Mesli, Naima, Remla, Nesrine, Sari, Badr-Eddine, Taleb, Abdesselam, Touhami, Hadj, Bekadja, Mohamed-Amine, Zouaoui-Benhadji, Zahia, Bouzid, Kamel, Meguenni, Kaoual
• Format: Article
• Language: English
• Subjects: Aged; Aged patients; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Care and treatment; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Cytarabine; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Dexamethasone - administration & dosage; Dexamethasone - adverse effects; Diffuse large B-cell lymphoma, elderly patients, gemcitabine-based therapy, refractory, relapse; Disease; Disease-Free Survival; Dosage and administration; Drug therapy; Etoposide; Female; Gemcitabine; Health aspects; Humans; Kaplan-Meier Estimate; Lymphatic system; Lymphoma, Large B-Cell, Diffuse - drug therapy; Lymphoma, Large B-Cell, Diffuse - mortality; Male; Methylprednisolone; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Non-Hodgkin's lymphomas; Older people; Standard deviation
• ISSN: 0973-1482; 1998-4138
• DOI: 10.4103/0973-1482.63572

Context: 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. Aim: 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. Materials and 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). Conclusion: 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.