Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report

Abstract

The purpose of this report is to analyze long-term clinical outcomes of patients exposed to plerixafor plus granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization. This was a study of patients with non-Hodgkin lymphoma (NHL; n = 167) and multiple myeloma (MM; n = 163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240 µg/kg plerixafor plus 10 µg/kg G-CSF, or placebo plus 10 µg/kg G-CSF to mobilize and collect CD34⁺ cells for autologous hematopoietic stem cell transplantation. Overall survival (OS) and progression-free survival (PFS) were evaluated over a 5-year period following the first dose of plerixafor or placebo. The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively). In addition, there was no statistically significant difference in the probability of PFS over 5 years between treatment groups in patients with NHL (50%; 95% CI, 44% to 67% for plerixafor versus 43%; 95% CI, 31% to 54% for placebo) or those with MM (17%; 95% CI, 10% to 24% for plerixafor versus 30%; 95% CI, 21% to 40% for placebo). In this long-term follow-up study, the addition of plerixafor to G-CSF for stem cell mobilization did not affect 5-year survival in patients with NHL or patients with MM.

Keywords: Long-term follow-up; Multiple myeloma; Non-Hodgkin lymphoma; Plerixafor; Stem cell mobilization.

Figure 1.

Disposition of patients with NHL included in the 3101 LTF study *‘Does not include 13 patients who received rituximab (patients were part of a Study 3101 substudy) or 9 patients who withdrew prior to receiving plerixafor or placebo. ^†All rescue patients received plerixafor. ^‡Patients censored in the OS analysis at last date where data were available.

Figure 2.

Disposition of patients with MM included in the 3102 LTF study * ‘Does not include the 1 patient who received post-transplant cyto-reductive chemotherapy treatment (patient 25-401) or 8 patients who withdrew prior to receiving plerixafor or placebo. ^†All rescue patients received plerixafor. ^‡Patients censored in the OS analysis at last date where data were available.

Figure 3.

Overall survival in patients with NHL (A) and MM (B) stratified by treatment group

Figure 4.

Progression-free survival in patients with NHL (A) and MM (B) stratified by treatment group A progression-free survival (PFS) event was defined as a report of disease progression, disease relapse, or death due to any cause. Assessment of PFS over 5 years showed no statistically significant difference in patients with non-Hodgkin’s lymphoma (A) (log-rank, P = .343; Wilcoxon, P = .396) or multiple myeloma (MM) (B) between the 2 treatment groups. In patients with MM, a non-significant (log-rank, P = .061; Wilcoxon, P = .138) trend toward shorter PFS in patients treated with plerixafor than in those receiving placebo.