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A randomized clinical trial comparing granulocyte–colony‐stimulating factor administration sites for mobilization of peripheral blood stem cells for patients with hematologic malignancies undergoing autologous stem cell transplantation
Author(s) -
Renfroe Heather,
Arnold Mike,
Vaughn Louette,
Harvey R. Donald,
Hamilton Ellie,
Lonial Sagar,
Khoury H. Jean,
Kaufman Jonathan L.,
Lechowicz Mary Jo,
Flowers Christopher R.,
Waller Edmund K.
Publication year - 2011
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2010.03052.x
Subject(s) - medicine , apheresis , granulocyte colony stimulating factor , multiple myeloma , autologous stem cell transplantation , clinical endpoint , surgery , transplantation , randomization , melphalan , cd34 , stem cell , gastroenterology , randomized controlled trial , chemotherapy , biology , platelet , genetics
BACKGROUND: A study was undertaken to investigate whether granulocyte–colony‐stimulating factor (G‐CSF) injection in lower adipose tissue–containing sites (arms and legs) would result in a lower exposure and reduced stem cell collection efficiency compared with injection into abdominal skin. STUDY DESIGN AND METHODS: We completed a prospective randomized study to determine the efficacy and tolerability of different injection sites for patients with multiple myeloma or lymphoma undergoing stem cell mobilization and apheresis. Primary endpoints were the number of CD34+ cells collected and the number of days of apheresis. Forty patients were randomly assigned to receive cytokine injections in their abdomen (Group A) or extremities (Group B). Randomization was stratified based on diagnosis (myeloma, n = 29 vs. lymphoma, n = 11), age, and mobilization strategy and balanced across demographic factors and body mass index. RESULTS: Thirty‐five subjects were evaluable for the primary endpoint: 18 in Group A and 17 in Group B. One evaluable subject in each group failed to collect a minimum dose of at least 2.0 × 10 6 CD34+ cells/kg. The mean numbers of CD34+ cells (±SD) collected were not different between Groups A and B (9.15 × 10 6 ± 4.7 × 10 6 /kg vs. 9.85 × 10 6 ± 5 × 10 6 /kg, respectively; p = NS) after a median of 2 days of apheresis. Adverse events were not different between the two groups. CONCLUSION: The site of G‐CSF administration does not affect the number of CD34+ cells collected by apheresis or the duration of apheresis needed to reach the target cell dose.