Randomised, Placebo-Controlled, Trial Comparing Low Dose Versus Standard Dose Lenograstim (L) Following Myeloablative Chemotherapy (HDT) and Peripheral Blood Progenitor Cell Rescue (PBPCR) for Lymphoma

7624 Background: This trial was performed to determine whether low-dose or standard dose L would influence recovery of haematopoiesis following HDT and PBPCR. Methods: 61 patients (pts) with non-Hodgkin lymphoma (40) or Hodgkin’s disease (21) undergoing HDT were randomised. Pts had normal peripheral blood counts prior to HDT (Hb ≥100g/L, total white cell count ≥ 3.0, neutrophils (N) ≥ 1.0 and platelets ≥ 50, and had a minimum 2.5 million CD34+ cells/kg PBPC previously collected following mobilisation with Cyclophosphamide 3g/m2 and G-CSF. All received HDT with BCNU 300mg/m2 d-7, Etoposide 200mg/m2 od d-5-d-2, Cytosine arabinoside 200mg/m2 bd d-5-d-2 and Melphalan 140mg/m2 d-1 before return of PBPC on D0. Pts were allocated standard dose L 263mcg daily (20 pts), low dose L 105mcg daily (21 pts) or placebo injections (20 pts). These commenced on day +5 following PBPCR and continued until N≥0.5. Pts received standard supportive care including prophylactic Fluconazole and Acyclovir, but not routine antibacterial prophylaxis, until haemopoietic recovery. Results: L at any dose resulted in a significantly shorter median time to N recovery ≥0.1 (10.0 vs 11.0 days, P=0.02) and ≥0.5 (11.0 vs 14.0 days, p=0.0003) compared to placebo. The only significant difference between standard- and low-dose L was in hospital stay (21.0 vs 22.0 days, p=0.04), however L at any dose showed a significant reduction over placebo (22.0 vs 23.0 days, p=0.01). Conclusions: Short course low dose L is as effective as standard dose in reducing neutrophil engraftment time following HDT and PBSCR. L at any dose reduces hospital stay when compared to placebo. This approach should be considered for those patients in whom growth factor support is indicated. Long-term follow-up data will be presented. [Table: see text] No significant financial relationships to disclose.