PMID- 10714552
OWN - NLM
STAT- MEDLINE
DCOM- 20000421
LR  - 20111117
IS  - 1079-9907 (Print)
IS  - 1079-9907 (Linking)
VI  - 20
IP  - 2
DP  - 2000 Feb
TI  - Randomized trial of sequential administration of G-CSF and GM-CSF vs. G-CSF alone 
      following peripheral blood progenitor cell autograft in solid tumors.
PG  - 171-7
AB  - A trial was conducted to investigate whether the sequential administration of 
      recombinant human granulocyte colony-stimulating factor (G-CSF) and recombinant 
      human granulocyte-macrophage colony-stimulating factor (GM-CSF) could accelerate 
      reconstitution of hematopoiesis, compared with G-CSF alone following high-dose 
      chemotherapy (HDCT). A group of 34 consecutive patients with solid tumors 
      undergoing HDCT and autologous peripheral blood progenitor cell (PBPC) 
      transplantation was studied. Conditioning regimen included carboplatin, 
      etoposide, mitoxantrone, and melphalan for breast cancer and cyclophosphamide or 
      ifosfamide, carboplatin, and etoposide for the other tumors. HDCT was delivered 
      from day -3 to day -1. PBPC were infused on day 0, and on the same day growth 
      factors were administered subcutaneously (s.c.) 5 microg/kg each. Seventeen 
      patients were randomized to receive G-CSF from day 0 to day 13 after HDCT (arm 
      A), and 17 patients received G-CSF from day 0 to day 6 and GM-CSF from day 7 to 
      day 13 (arm B). Patients were stratified, and their characteristics were 
      homogeneous in both arms for age, performance status, and number of previous 
      chemotherapy courses and CD34+ infused. The median time to absolute neutrophil 
      count (ANC) >500/microl was 10 days in arm A and 9 days in arm B (p = 0.96). Days 
      to platelet (PLT) count >20,000 were not different in the two treatment arms (p = 
      0.1), but patients randomized to arm A had a lower platelet count compared with 
      patients in arm B. One month after PBPC transplantation, a statistically 
      significant difference in PLT count was observed (arm A median 150x10(3)/microl 
      (90-310), arm B median 254x10(3)/microl (117-387),p = 0.0013). The days patients 
      had fever >38 degrees C were 39 in arm A and 26 in arm B (p = 0.18). The 
      difference in the length of hospital stay was not statistically significant 
      between the groups (Mann-Whitney sum rank test). After a median follow-up of 30 
      months, 21 patients were alive and 20 were disease free. These data show that the 
      two growth factors are associated with different patterns of hematopoietic 
      recovery, and larger randomized trials in groups of more homogeneous patients 
      will be needed to define the effects and benefits of combination growth factor 
      therapies.
FAU - Recchia, F
AU  - Recchia F
AD  - Division of Oncology, Civil Hospital-Avezzano, Italy. fran.re@ermes.it
FAU - Accorsi, P
AU  - Accorsi P
FAU - Bonfini, T
AU  - Bonfini T
FAU - De Filippis, S
AU  - De Filippis S
FAU - Grimaldi, M
AU  - Grimaldi M
FAU - Corrao, G
AU  - Corrao G
FAU - Rosselli, M
AU  - Rosselli M
FAU - Amiconi, G
AU  - Amiconi G
FAU - Iacone, A
AU  - Iacone A
FAU - Rea, S
AU  - Rea S
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Interferon Cytokine Res
JT  - Journal of interferon & cytokine research : the official journal of the 
      International Society for Interferon and Cytokine Research
JID - 9507088
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Recombinant Proteins)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 83869-56-1 (Granulocyte-Macrophage Colony-Stimulating Factor)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antineoplastic Agents/administration & dosage
MH  - Combined Modality Therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Granulocyte Colony-Stimulating Factor/*administration & dosage
MH  - Granulocyte-Macrophage Colony-Stimulating Factor/*administration & dosage
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Leukocyte Count
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/blood/*drug therapy/*therapy
MH  - Platelet Count
MH  - Recombinant Proteins
MH  - Transplantation Conditioning
EDAT- 2000/03/14 09:00
MHDA- 2000/04/29 09:00
CRDT- 2000/03/14 09:00
PHST- 2000/03/14 09:00 [pubmed]
PHST- 2000/04/29 09:00 [medline]
PHST- 2000/03/14 09:00 [entrez]
AID - 10.1089/107999000312577 [doi]
PST - ppublish
SO  - J Interferon Cytokine Res. 2000 Feb;20(2):171-7. doi: 10.1089/107999000312577.