TY - JOUR
T1 - 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
AU - Gisselbrecht, Christian
AU - Schmitz, Norbert
AU - Mounier, Nicolas
AU - Gill, Devinder Singh
AU - Linch, David C.
AU - Trneny, Marek
AU - Bosly, Andre
AU - Milpied, Noel J.
AU - Radford, John
AU - Ketterer, Nicolas
AU - Shpilberg, Ofer
AU - Duḧrsen, Ulrich
AU - Hagberg, Hans
AU - Ma, David D.
AU - Viardot, Andreas
AU - Lowenthal, Ray
AU - Brier̀e, Josette
AU - Salles, Gilles
AU - Moskowitz, Craig H.
AU - Glass, Bertram
PY - 2012/12/20
Y1 - 2012/12/20
N2 - 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. © 2012 by American Society of Clinical Oncology.
AB - 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. © 2012 by American Society of Clinical Oncology.
U2 - 10.1200/JCO.2012.41.9416
DO - 10.1200/JCO.2012.41.9416
M3 - Article
C2 - 23091101
SN - 1527-7755
VL - 30
SP - 4462
EP - 4469
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 36
ER -
