ABSTRACT
INTRODUCTION: Filgrastim is used for the mobilization of stem cells in healthy donors. Though several biosimilar filgrastim products have been approved, there is limited literature evaluating biosimilar products for stem cell mobilization. Therefore, we conducted this study to compare the effectiveness of the original filgrastim, Neupogen®, to the biosimilar product, Nivestim®, for stem cell mobilization(SCM) in healthy donors. METHODS: This was a retrospective study that included all healthy donors: adults and pediatrics, who received Neupogen® or Nivestim® for stem cell mobilization between 2014 and 2016 at a comprehensive cancer center. Donors received filgrastim at a dose of 5â mcg/kg every 12â h for 4 days to achieve the target CD34 + cell count of 5-10 × 106 CD34 + /kg of recipient body weight. Additional doses of filgrastim were administered and/or the dose increased if target CD34 + was not achieved. The primary endpoint was the number of doses required to achieve the target CD34 + cell count. RESULTS: Over the study period, 89 donors received Neupogen® and 68 received Nivestim®. The median age of donors was 19.5 years (3-64) in the Nivestim® group and 15 years (2-16) in the Neupogen® group. The median number of doses required for SCM was eight doses (6-10) in the Nivestim group and eight (6-16) in the Neupogen® group. CONCLUSION: Biosimilar Nivestim® was as effective as the original, Neupogen®, for stem cell mobilization for healthy adult and pediatric donors. Larger randomized studies are necessary to evaluate the safety and transplant outcomes of the use of Nivestim®.
ABSTRACT
INTRODUCTION: Patients with Fanconi anemia have an increased susceptibility to malignancies associated with human papillomavirus, and thus prevention and early management of human papillomavirus infections in this patient population are crucial. CASE REPORT: A nine-year-old girl with Fanconi anemia developed genital warts about three years after undergoing haplo-identical stem cell transplant. The transplant was complicated by chronic graft-versus-host disease, and the patient had therefore received multiple immunosuppressants. The genital warts were treated with several creams, but minimal improvement was reported. MANAGEMENT AND OUTCOME: Cidofovir was extemporaneously compounded into an unscented 1% moisturizing cream and applied daily at bedtime to the genital warts. By the end of treatment, the warts had been successfully treated, and no adverse events were reported. The patient is still free of any lesions at six months after completing treatment. DISCUSSION: Although reports have been published on the use of cidofovir cream, most were in adults with non-genital warts. Cidofovir cream may be considered as a treatment option for refractory genital warts in pediatric patients. However, further studies are needed to better define the optimal preparation and dosing for such patient population.