Phase II Trial of 131-Iodine Tositumomab with High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed Diffuse Large B Cell Lymphoma

Abstract Abstract 5013 Introduction Primary mediastinal large B-cell lymphoma (PMBCL) was formally established as a distinct subtype of diffuse large B-cell lymphoma (DLBCL). Some studies indicated that patients with PMBCL have an aggressive clinical course with short median survival but more recent studies reported a relatively good response rate and survival. Therefore, controversies still exist regarding the response to therapy and prognosis of patients with PMBCL. Patients and methods Between July 1993 and July 2008, a total of 26 patients with PMBCL were identified at Asan Medical Center, Seoul Korea. We retrospectively reviewed the clinic-pathologic features and clinical outcomes of them in comparison with 597 patients diagnosed with non-mediastinal DLBCL during the same period. Result Out of the 26 patients, 17 (65.4%) were females and 9 (34.6%) males, while out of the 597 patients, 257 (43.0%) were females and 340 (57.0%) males (p=0.025). The median age of the PMBCL patients was 31.5 years old (range 15-78 years old), while that of the DLBCL patients was 56.0 years old (range 15-85 years old). Out of the 26 patients, 14 (53.8%) had a Ann Arbor stage III or IV disease, 7 (26.9%) had B symptoms, and by the IPI, 11 were in low, 9 in low intermediate, 2 in high-intermediate and 4 in high risk group. Out of 24 patients treated with front-line therapy CHOP or R-CHOP, 17 (70.8%) reached a CR, while 1 PR patient reached a CR after being treated with high-dose chemotherapy followed by autologous stem cell transplantation. Five refractory patients were treated with high-dose chemotherapy followed by autologous stem cell transplantation, but among them only one reached a CR and 4 died of disease progression. With a median follow-up of 41.5 months (range 1-92 months), 5-year survival rates of PMBCL and non-mediastinal DLBCL patients were 69% and 65.7%, respectively (p=0.982, Log Rank). Conclusion There was no difference between PMLBL and non-mediastinal DLBCL in terms of clinical features and outcomes. Disclosures No relevant conflicts of interest to declare.

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Rituximab Maintenance Therapy After Autologous Stem-Cell Transplantation in Patients With Relapsed CD20+ Diffuse Large B-Cell Lymphoma: Final Analysis of the Collaborative Trial in Relapsed Aggressive Lymphoma

Journal of Clinical Oncology ◽

10.1200/jco.2012.41.9416 ◽

2012 ◽

Vol 30 (36) ◽

pp. 4462-4469 ◽

Cited By ~ 158

Author(s):

Christian Gisselbrecht ◽

Norbert Schmitz ◽

Nicolas Mounier ◽

Devinder Singh Gill ◽

David C. Linch ◽

...

Keyword(s):

Stem Cell ◽

Stem Cell Transplantation ◽

B Cell ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Salvage Chemotherapy ◽

High Dose ◽

Large B Cell Lymphoma ◽

Relapsed Disease ◽

Large B Cell

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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