Peg-Filgrastim after High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Hematological Malignancies: A Matched-Pair Analysis.
Authors: Sica Simona , Piccirillo Nicola , De Matteis Silvia , Laurenti Luca , Chiusolo Patrizia , De Vita Serena , Sorà Federica , Putzulu Rossana , Reddiconto Giovanni , Farina Giuliana , d’Onofrio Giuseppe , Leone Giuseppe 
Published: April 2020

G-CSF is used to enhance neutrophil recovery after autologous peripheral blood stem cell transplantation (aPBSCT), even if the optimal timing and dose of G-CSF has not been established. Recently Peg-Filgrastim has been approved for clinical use. The clearance of Peg-Filgrastim is neutrophil-mediated with a sustained duration of action with prolonged serum concentration during neutropenia. In order to verify the efficacy and feasibility of use of Peg-Filgrastim, we administered to 10 patients (A Group, 3F, 7M, median age 46y) submitted to aPBSCT for haematological malignancies (6 NHL, 3 MM, 1 HD) a single 6 mg dose of Peg-Filgrastim subcutaneously on day +1 and we compared the engraftment of these patients to data of a group of 30 patients (B group 9F, 21M, median age 46y, 18 NHL, 6 MM, 2 POEMS syndrome, 1 Plasmacell leukemia, 3 HD) submitted to aPBSCT not receiving G-CSF. Patients were matched for sex, age, disease, disease status at transplant, conditioning regimen, transplant procedure and they received comparable CD34+ cell dose. We evaluated haematological engraftment, and other clinical outcomes, all results are expressed as a median value in the table. Peg-Filgrastim was well tolerated in all but 1 patient reporting bone pain. Neutrophil engrafment was significantly faster (72 hours) in the Peg-Filgrastim group: days +10 and +12 (500 and 1000 cells/μL) vs days +13 and +15.5 of control group; faster neutrophil engraftment was also clear analyzing number of days with absolute neutrophil count (ANC) &lt;100 cells/μL: 4 days vs 6 days. We did not observe statistically significant differences in erythroid and platelet recovery, time to discharge, bloodstream infections, days of fever, days of non prophylactic antibiotic therapy. Otherwise, transfusional requirements were significantly higher in patients receiving Peg-Filgrastim; these results are consistent with observed delay, although not statistically significant, in platelet and erythroid recovery. In conclusion, Peg-Filgrastim is safe, efficacious and improves neutrophil recovery, after aPBSCT; our data suggest a possible detrimental effect on erythroid and platelets recovery but larger trials are needed to confirm it and, particularly, to assess whole clinical benefits of such approach to justify its economical impact.

Results

A Group B Group Statistical analysis Days to ANC &gt; 500/μL 10 (7–11) 13 (7–18) p&lt;0.0001 Days to ANC &gt; 1000/μL 12 (7–15) 15.5 (10–38) p&lt;0.0001 Days of ANC &lt; 100/μL 4 (3–5) 6 (3–12) p=0.0078 Days to Plts &gt; 20 x 10³/μL 11 (8–24) 12 (9–18) p=0.4 Days to Plts &gt; 50 x 10³/μL 24 (12–39) 14 (10–60) p=0.39 Days to Plts &gt; 100 x 10³/μL 40 (14–120) 18 (12–210) p=0.06 Days to Reticulocytes &gt;1% 15 (11–16) 13.5 (10–30) p=0.59 Days to Hgb &gt;10 g/dl 33 (10–84) 21 (10–210) p=0.48 Days of fever 5 (2–10) 5 (2–13) p=0.92 Days of antibiotic therapy 7 (5–20) 9.5 (5–18) p=0.72 Bloodstream infections 4/10 6/30 p=0.2 Number of pRBCu 1 (0–2) 0 (0–2) p=0.02 Number of SDu 1.5 (1–3) 1 (0–2) p=0.022 Days of hospitalization 25 (19–30) 23 (20–34) p=0.89