Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma

被引:0
作者
Goto, Hideki [1 ,2 ]
Sawa, Masashi [3 ]
Fujiwara, Shin-ichiro [4 ]
Ri, Masaki [5 ]
Ishida, Tadao [6 ]
Takeuchi, Masahiro [7 ]
Ishitsuka, Kenji [8 ]
Toyosaki, Masako [9 ]
Sunami, Kazutaka [10 ]
Tsukada, Junichi [11 ]
Sonoki, Takashi [12 ]
Shimogomi, Aiko [13 ]
Ichihashi, Yuki [13 ]
Ouchi, Yoshiumi [13 ]
Miyamoto, Toshihiro [14 ]
Hino, Masayuki [15 ]
Maeda, Yoshinobu [16 ]
Teshima, Takanori [1 ,2 ]
机构
[1] Hokkaido Univ, Grad Sch Med, Dept Hematol, Fac Med, Sapporo, Japan
[2] Hokkaido Univ Hosp, Div Lab & Transfus Med, Sapporo, Japan
[3] Anjo Kosei Hosp, Dept Hematol & Oncol, Anjo, Japan
[4] Jichi Med Univ, Dept Med, Div Hematol, Shimotsuke, Japan
[5] Nagoya City Univ, Grad Sch Med Sci, Dept Hematol & Oncol, Nagoya, Japan
[6] Japanese Red Cross Med Ctr, Dept Hematol, Tokyo, Japan
[7] Chiba Canc Ctr, Div Hematol Oncol, Chiba, Japan
[8] Kagoshima Univ, Dept Hematol & Rheumatol, Kagoshima, Japan
[9] Tokai Univ, Sch Med, Dept Hematol & Oncol, Isehara, Japan
[10] NHO Okayama Med Ctr, Dept Hematol, Okayama, Japan
[11] Univ Occupat & Environm Hlth, Dept Hematol, Kitakyushu, Japan
[12] Wakayama Med Univ, Dept Hematol Oncol, Wakayama, Japan
[13] Kyowa Kirin Co Ltd, Tokyo, Japan
[14] Kanazawa Univ, Inst Med Pharmaceut & Hlth Sci, Fac Med, Dept Hematol, Kanazawa, Japan
[15] Osaka Metropolitan Univ, Grad Sch Med, Dept Hematol, Osaka, Japan
[16] Okayama Univ, Grad Sch Med Dent & Pharmaceut Sci, Dept Hematol & Oncol, Okayama, Japan
来源
SCIENTIFIC REPORTS | 2025年 / 15卷 / 01期
关键词
Multiple myeloma; Pegfilgrastim; Lymphoma; CD34; Mobilization; Peripheral blood stem cell; AUTOLOGOUS HEMATOPOIETIC STEM; COLONY-STIMULATING FACTOR; POOR MOBILIZATION; AMERICAN SOCIETY; TRANSPLANTATION; CHEMOTHERAPY; FILGRASTIM; LEUKAPHERESIS; ENGRAFTMENT; STRATEGIES;
D O I
10.1038/s41598-025-98453-7
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
This phase 2 study evaluated the impact of pegfilgrastim, a single-dose, long-acting granulocyte colony-stimulating factor, on the steady-state mobilization of hematopoietic stem cells into peripheral blood in patients with multiple myeloma (MM) or malignant lymphoma (ML). Efficacy and safety, along with CD34-positive cell mobilization outcomes were assessed in patients with MM, who were randomly assigned to pegfilgrastim (n = 30) or daily filgrastim (n = 31), and ML (pegfilgrastim only, n = 13) cohorts. In the MM cohort, CD34-positive cell counts >= 2 x 106/kg were achieved in 100% of patients in the pegfilgrastim group and 96.7% in the filgrastim group (difference: 3.3%; 80% confidence interval: -0.9-7.5%), demonstrating the non-inferiority of pegfilgrastim to filgrastim. All patients in the ML cohort achieved >= 2 x 106/kg CD34-positive cell counts. The plerixafor administration rates in the MM cohort were 50.0% and 63.3% in the pegfilgrastim and filgrastim groups, respectively, and 91.7% in the ML cohort. There were no major differences in safety measures between the two groups. Although the sample size was small, particularly in the ML cohort, a single dose of pegfilgrastim demonstrated comparable efficacy and safety to daily doses of filgrastim, indicating its potential for clinical use while reducing patient burden.Trial Registration: jRCT2011210029, NCT05007652.
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页数:12
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共 45 条
[1]   A risk-based approach to optimize autologous hematopoietic stem cell (HSC) collection with the use of plerixafor [J].
Abhyankar, S. ;
DeJarnette, S. ;
Aljitawi, O. ;
Ganguly, S. ;
Merkel, D. ;
McGuirk, J. .
BONE MARROW TRANSPLANTATION, 2012, 47 (04) :483-487
[2]   CD34+hematopoietic progenitor cell dose as a predictor of engraftment and survival in multiple myeloma patients undergoing autologous stem cell transplantation [J].
Aladag, Elifcan ;
Demiroglu, Haluk ;
Buyukasik, Yahya ;
Turgut, Mehmet ;
Aksu, Salih ;
Sayinalp, Nilgun ;
Haznedaroglu, Ibrahim Celalettin ;
Ozcebe, Osman Ilhami ;
Goker, Hakan .
TURKISH JOURNAL OF MEDICAL SCIENCES, 2020, 50 (08) :1851-1856
[3]   Hematopoietic stem cell transplantation for patients with AML in first complete remission [J].
Cornelissen, Jan J. ;
Blaise, Didier .
BLOOD, 2016, 127 (01) :62-70
[4]   Mobilization and Transplantation Patterns of Autologous Hematopoietic Stem Cells in Multiple Myeloma and Non-Hodgkin Lymphoma [J].
Costa, Luciano J. ;
Kumar, Shaji ;
Stowell, Stephanie A. ;
Dermer, Shari J. .
CANCER CONTROL, 2015, 22 (01) :87-94
[5]   Pegfilgrastim [J].
Curran, MP ;
Goa, KL .
DRUGS, 2002, 62 (08) :1207-1213
[6]   Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Colony-Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin's Lymphoma [J].
DiPersio, John F. ;
Micallef, Ivana N. ;
Stiff, Patrick J. ;
Bolwell, Brian J. ;
Maziarz, Richard T. ;
Jacobsen, Eric ;
Nademanee, Auayporn ;
McCarty, John ;
Bridger, Gary ;
Calandra, Gary .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (28) :4767-4773
[7]   Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma [J].
DiPersio, John F. ;
Stadtmauer, Edward A. ;
Nademanee, Auayporn ;
Micallef, Ivana N. M. ;
Stiff, Patrick J. ;
Kaufman, Jonathan L. ;
Maziarz, Richard T. ;
Hosing, Chitra ;
Frueehauf, Stefan ;
Horwitz, Mitchell ;
Cooper, Dennis ;
Bridger, Gary ;
Calandra, Gary .
BLOOD, 2009, 113 (23) :5720-5726
[8]   Peripheral Blood Progenitor Cell Mobilization for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation [J].
Duong, Hien K. ;
Savani, Bipin N. ;
Copelan, Ed ;
Devine, Steven ;
Costa, Luciano J. ;
Wingard, John R. ;
Shaughnessy, Paul ;
Majhail, Navneet ;
Perales, Miguel-Angel ;
Cutler, Corey S. ;
Bensinger, William ;
Litzow, Mark R. ;
Mohty, Mohamad ;
Champlin, Richard E. ;
Leather, Helen ;
Giralt, Sergio ;
Carpenter, Paul A. .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2014, 20 (09) :1262-1273
[9]   Optimizing Autologous Stem Cell Mobilization Strategies to Improve Patient Outcomes: Consensus Guidelines and Recommendations [J].
Giralt, Sergio ;
Costa, Luciano ;
Schriber, Jeffrey ;
DiPersio, John ;
Maziarz, Richard ;
McCarty, John ;
Shaughnessy, Paul ;
Snyder, Edward ;
Bensinger, William ;
Copelan, Edward ;
Hosing, Chitra ;
Negrin, Robert ;
Petersen, Finn Bo ;
Rondelli, Damiano ;
Soiffer, Robert ;
Leather, Helen ;
Pazzalia, Amy ;
Devine, Steven .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2014, 20 (03) :295-308
[10]   Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study [J].
Goto, Hideki ;
Sugita, Junichi ;
Hasegawa, Yuta ;
Hayasaka, Koji ;
Sunagoya, Kana ;
Hatase, Rie ;
Nishida, Mutsumi ;
Ichihashi, Yuki ;
Odera, Mitsuhiko ;
Senjo, Hajime ;
Yokoyama, Shota ;
Ara, Takahide ;
Shiratori, Souichi ;
Endo, Tomoyuki ;
Hino, Masayuki ;
Maeda, Yoshinobu ;
Sawa, Masashi ;
Sato, Norihiro ;
Teshima, Takanori .
TRANSPLANTATION, 2024, 108 (04) :996-1003