Impact of the Addition of Rituximab to Initial CHOP Chemotherapy Compared with CHOP Alone in Patients with Relapsed Diffuse Large B-Cell Lymphoma Who Underwent Autologous Stem Cell Transplantation.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5124-5124
Author(s):  
Yi-Bin Chen ◽  
Ephraim P. Hochberg ◽  
Yang Feng ◽  
Gabriela Motyckova ◽  
Donna Neuberg ◽  
...  

Abstract Standard therapy for chemosensitive relapsed diffuse large B-cell lymphoma (DLBCL) is high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) based on the results of the Parma study (NEJM1995;333:1540–5). However, the addition of rituximab to initial chemotherapy has improved progression-free and overall survival compared with CHOP alone. Patients who relapse after R-CHOP may have disease which is less sensitive to second line therapy or, alternatively, the benefit of ASCT may be independent of the impact of rituxuimab, and, therefore, the true benefit of ASCT in current patients with relapsed DLBCL is unclear. We performed a retrospective cohort analysis of patients who received ASCT for DLBCL during the period of 1997–2006. Our goal was to evaluate the benefit of ASCT for patients with relapsed DLBCL who received R-CHOP as initial chemotherapy compared to those who were treated with CHOP alone. A total of 145 patients at first relapse with chemotherapy sensitive disease who underwent ASCT were identified. 111 received a CHOP-like regimen, and 34 received R-CHOP as their initial chemotherapy regimen. All patients received salvage chemotherapy prior to ASCT. 86.5% of CHOP patients and 88.2% of R-CHOP patients achieved a CR/CRu with their initial chemotherapy (p=0.99). At initial diagnosis, Ann Arbor stage and ECOG performance status (PS) between the two groups were also similar. The two groups of patients had significant differences in the following characteristics: median age at ASCT (51 for CHOP vs 57 for R-CHOP, p=0.002), Ann Arbor stage of disease at relapse (22.5% localized disease for CHOP vs 55.9% localized disease for R-CHOP, p=0.001), and percentage of patients who underwent nuclear imaging to evaluate response to salvage chemotherapy (37.8% in CHOP vs 79.4% in R-CHOP, p<0.0001). The majority of patients in both groups received either CBV or Bu/Cy conditioning chemotherapy at ASCT. 2-year relapse-free survival (RFS) was 57% in the CHOP group versus 35% in the R-CHOP/ASCT group (p=0.10). 2-year OS was 75% (CHOP) and 67% (R-CHOP/ASCT), respectively (p=0.09). Longer follow-up is essential and further analysis examining the potential impact of rituximab containing salvage therapy in rituximab naïve patients is needed. In conclusion, although this is a retrospective comparison, the trend toward inferior RFS and OS in the patients who initially received R-CHOP suggests that the benefit of ASCT in patients who subsequently relapse after R-CHOP may be inferior compared to patients who received CHOP alone. Figure Figure

2012 ◽  
Vol 30 (36) ◽  
pp. 4462-4469 ◽  
Author(s):  
Christian Gisselbrecht ◽  
Norbert Schmitz ◽  
Nicolas Mounier ◽  
Devinder Singh Gill ◽  
David C. Linch ◽  
...  

Purpose The standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known. Patients and Methods In total, 477 patients with CD20+ DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation. Results After ASCT, 122 patients received rituximab, and 120 patients were observed only. The median follow-up time was 44 months. The 4-year event-free survival (EFS) rates after ASCT were 52% and 53% for the rituximab and observation groups, respectively (P = .7). Treatment with rituximab was associated with a 15% attributable risk of serious adverse events after day 100, with more deaths (six deaths v three deaths in the observation arm). Several factors affected EFS after ASCT (P < .05), including relapsed disease within 12 months (EFS: 46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (EFS: 37% v 61% for saaIPI < 1), and prior treatment with rituximab (EFS: 47% v 59% for no prior rituximab). A significant difference in EFS between women (63%) and men (46%) was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor (P < .001), as was male sex (P = .01). Conclusion In relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT.


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