Analysis of data collected in the European Society for Blood and Marrow Transplantation (EBMT) Registry on a cohort of lymphoma patients receiving plerixafor

Abstract

Plerixafor + granulocyte-colony stimulating factor (G-CSF) is administered to patients with lymphoma who are poor mobilizers of hematopoietic stem cells (HSCs) in Europe. This international, multicenter, non-interventional registry study (NCT01362972) evaluated long-term follow-up of patients with lymphoma who received plerixafor for HSC mobilization versus other mobilization methods. Propensity score matching was conducted to balance baseline characteristics between comparison groups. The following mobilization regimens were compared: G-CSF + plerixafor (G + P) versus G-CSF alone; G + P versus G-CSF + chemotherapy (G + C); and G-CSF + plerixafor + chemotherapy (G + P + C) versus G + C. The primary outcomes were progression-free survival (PFS), overall survival (OS), and cumulative incidence of relapse (CIR). Overall, 313/3749 (8.3%) eligible patients were mobilized with plerixafor-containing regimens. After propensity score matching, 70 versus 36 patients were matched in the G + P versus G-CSF alone cohort, 124 versus 124 in the G + P versus G + C cohort, and 130 versus 130 in the G + P + C versus G + C cohort. For both PFS and OS, the upper bound of confidence interval for the hazard ratio was >1.3 for all comparisons, implying that non-inferiority was not demonstrated. No major differences in PFS, OS, and CIR were observed between the plerixafor and comparison groups.

Conflict of interest statement

AS has received personal fees from Sanofi, grants and personal fees from BMS and Celgene, personal fees from Janssen, Gilead, Novartis, and Takeda. CC reports receiving fees for data transfer from EBMT during the conduct of the study and grants, and personal fees and nonfinancial support from Sanofi outside the scope of the submitted work. TM received financial supports for advisory board membership for AbbVie, BMS, Janssen-Cilag, Novartis, Pfizer, and Takeda outside the scope of the submitted work. CS reports personal fees from Sanofi. CT received financial supports for advisory board membership for Roche, Takeda, Janssen-Cilag, Bayer, and Celgene outside the scope of the submitted work. IS received personal fees from Sanofi. AD-I received personal fees from the EBMT foundation for data transfer during the conduct of the study. EJ received speaker’s fee and research grant from Sanofi. QL and MC are employees of Sanofi. SM received grants for travel from Gilead, and speaker fees from Roche and is an advisory board member for Bayer, outside the scope of submitted work. PD has received speaker’s honoraria from Gilead, Kite; Consultancy: AbbVie, Gilead, Janssen, and Roche. SvdW, PB, AB, DP, BEW, NR, AJ, CT, and AE declare that they have no conflict of interest.

Figures

Fig. 1

Patient eligibility and treatment. Key: G G-CSF, P plerixafor, C chemotherapy

Fig. 2

Progression-free survival for each of the comparison groups, a G-CSF + plerixafor versus G-CSF alone (comparison 1); b G-CSF + plerixafor versus G-CSF + chemotherapy (comparison 2); and c G-CSF + plerixafor + chemotherapy versus G-CSF + chemotherapy (comparison 3)

Fig. 3

Overall survival for each of the comparison groups, a G-CSF + plerixafor versus G-CSF alone (comparison 1); b G-CSF + plerixafor versus G-CSF + chemotherapy (comparison 2); and c G-CSF + plerixafor + chemotherapy versus G-CSF + chemotherapy (comparison 3)

Fig. 4

Cumulative incidence of relapse for each of the comparison groups, a G-CSF + plerixafor versus G-CSF alone (comparison 1); b G-CSF + plerixafor versus G-CSF + chemotherapy (comparison 2); and c G-CSF + plerixafor + chemotherapy versus G-CSF + chemotherapy (comparison 3)