Premium
Prospective randomized comparison of morning versus night daily single subcutaneous administration of granulocyte‐macrophage–colony stimulating factor in patients with soft tissue or bone sarcoma
Author(s) -
Dinçol Dilek,
Samur Mustafa,
Pamir Ali,
Şencan Orhan,
Akbulut Hakan,
Yalçın Bülent,
Onur Handan,
Demirkazık Ahmet,
Şenler Filiz Çay,
İçli Fikri
Publication year - 2000
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(20000501)88:9<2033::aid-cncr7>3.0.co;2-r
Subject(s) - medicine , neutropenia , granulocyte colony stimulating factor , chemotherapy , absolute neutrophil count , cytarabine , gastroenterology , granulocyte macrophage colony stimulating factor , surgery , cytokine
BACKGROUND Hematopoietic growth factors (HGFs) have been used to reduce the neutropenic complications of cytotoxic chemotherapy so that higher doses may be given. The authors have previously shown that endogenous serum granulocyte‐colony stimulating factor (G‐CSF) and granulocyte‐macrophage–colony stimulating factor (GM‐CSF) levels at night (p.m.) were significantly higher than those in the morning (a.m.). METHODS Twenty‐four patients with soft tissue or bone sarcoma who were treated with high dose ifosfamide‐based chemotherapy were enrolled in this study. Patients were randomized to either a.m. or p.m. treatment. GM‐CSF was administered at a dose of 5 μg/kg/day at 10 a.m. or 10 p.m., beginning 36–48 hours after the last chemotherapy dose. GM‐CSF therapy was continued until the neutrophil count exceeded 1000/mm 3 for 2 consecutive days. Leukocyte, neutrophil, monocyte, and platelet counts were measured immediately before GM‐CSF administration and exactly 12 hours after the first dose of GM‐CSF, and every 24 hours until 3 days after the cessation of GM‐CSF. RESULTS The mean duration of Grade 3–4 neutropenia was 5.3 ± 0.4 days for the a.m. treatment arm and 6.5 ± 0.3 days for the p.m. treatment arm ( P = 0.017). Although the duration of neutropenia in the a.m. arm was significantly shorter than in the p.m. arm, there were no differences related to the number of febrile neutropenic episodes or the duration of antibiotic administration. Also, there were no differences in the side effects observed in the a.m. and p.m. arms. CONCLUSIONS The finding of 1.2 days' difference in the duration of Grade 3–4 neutropenia warrants further study of chronotherapy with HGFs. Cancer 2000;88:2033–6. © 2000 American Cancer Society.