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Clinical Specialist, Pediatric Oncology Department, Hôpital D'Enfants de la Timone, Bd Jean Moulin 13005 Marseille Cedex 5, France, fax 33 (0) 491 386 832, nicolas.andre{at}ap-hm.fr
Clinical Specialist, Pediatric Oncology Department, Hôpital D'Enfants de la Timone
Clinical Specialist, Pediatric Oncology Department, Hôpital D'Enfants de la Timone
Clinical Specialist, Pediatric Oncology Department, Hôpital D'Enfants de la Timone
Published Online, January 8, 2008. www.theannals.com, DOI 10.1345/aph.1K524
From September 2003 to August 2007, there were 60 pediatric patients (26 girls) with a median age of 14 years (range 10-20) and a median weight of 50.5 kg (range 30-82) who were treated for solid tumor with myelosuppressive chemotherapy in our institution received a single subcutaneous injection of pegfilgrastim 100 µg/kg (maximum dose 6 mg) per chemotherapy cycle. Pegfilgrastim was given 48 to 72 hours after completion of the chemotherapy course. Two hundred forty-one administrations of pegfilgrastim were analyzed. Patients received a median dose of 100 µg/kg of pegfilgrastim (range 73-117); the median total number of injections per patient was 4 (range 1-14). After the administration of pegfilgrastim, the median values and extremes of the first increase in absolute neutrophil count (ANC), nadir, and second increase in ANC were 4.24 x 103/µL (range 1-65.4), 0.425 x 103/µL (range 0-9.66), and 6.02 x 103/µL (range 1-80.05), respectively.
Interestingly, none of the patients presented with neutrophil overshoot before or after nadir, with a maximum ANC of 65 x 103/µL and 80 x 103/µL, respectively. The pre- and post-nadir ANC was over 25 x 103/µL in only 20 episodes (8.5%) and 8 episodes (3.5%), respectively. Detailed values of pre- and post-nadir ANC are given in Figure 1.
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Our results, as well as those of other small pediatric studies, are consistent with the fact that, in children, a dose of 100 µg/kg of pegfilgrastim is safe and effective.2-4 While we had previously stated our concerns regarding the potential harm of isolated or repeated high neutrophil counts resulting from pegfilgrastim-induced bone marrow intense stimulations, we did not observe any neutrophil overshoot or related complications when pegfilgrastim was given at the dose of 100 µg/kg. Additionally, as the use of colony-stimulating factor is considered a risk factor for the occurrence of secondary malignancies, no secondary malignancy was observed in the patients we report here.5
Snyder and Stringham1 assumed that the high dose of pegfilgrastim received by their patient appeared to exceed the saturable neutrophil receptor-mediated clearance and could be the cause for the occurrence of the neutrophil overshoot. We do agree with this explanation because, in their case, the child received twice the usual dosage. It is also worth mentioning that pegfilgrastim was given when the bone marrow had begun to recover.2 Nevertheless, the adverse effect reported should be considered the consequence of an overdose and should not call into question the use of pegfilgrastim in children.
Further trials are needed before routine use of pegfilgrastim can be proposed in children, with expansion to pediatric stem cell mobilization or to hasten neutrophil recovery after bone marrow, peripheral stem cell, or cord blood transplantations.
References
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