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Randomized placebo‐controlled trial of granulocyte‐macrophage colony‐stimulating‐factor support for dose‐intensive cyclophosphamide, etoposide, and cisplatin
Author(s) -
Yau Jonathan C.,
Neldhart James A.,
Triozzi Pierre,
Verma Shailendra,
Nemunaitis John,
Quick Donald P.,
Mayernik David G.,
Oette Dagmar H.,
Hayes Ann F.,
Holcenberg John
Publication year - 1996
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/(sici)1096-8652(199604)51:4<289::aid-ajh7>3.0.co;2-s
Subject(s) - etoposide , medicine , randomized controlled trial , cyclophosphamide , granulocyte macrophage colony stimulating factor , oncology , cisplatin , granulocyte , granulocyte colony stimulating factor , placebo , chemotherapy , pathology , cytokine , alternative medicine
This is a double‐blind randomized placebo‐controlled trial to evaluate the efficacy and safety of granulocyte‐macrophage colony‐stimulating‐factor (GM‐CSF) after dose‐intensive cyclophosphamide, etoposide, and cisplatin (DICEP). Fifty‐six patients with lymphoma or breast carcinoma were randomized to receive GM‐CSF 250 μg/m 2 or placebo subcutaneously (SC) every 12 hr after each course of DICEP until recovery of absolute neutrophil count (ANC) of 1.5 × 10 9 /L. Each patient was to receive three courses of DICEP. There were 28 patients in each group. The median duration of ANC below 0.5 × 10 9 /L was 10 versus 12 days for Course 1 ( P = 0.010), 10 versus 12 days for Courses 2 ( P = 0.248), and 16.5 versus 15 days for Course 3 ( P = 0.126); platelet counts below 20 × 10 9 /L was 4 versus 4 days for Course 1 ( P = 0.586), 8.5 versus 7 days for Course 2 ( P = 0.013), and 23.5 versus 10.5 days for Course 3 ( P = 0.104); hospitalization for patients readmitted with cytopenic fever were 4 versus 8 days for Course 1 ( P = 0.035); 7 versus 6 days for Course 2 ( P = 0.692); and 8 versus 12 days for Course 3 ( P = 0.884) in the GM‐CSF and placebo group, respectively. GM‐CSF significantly shortens the duration of neutropenia and readmission only during the first course of DICEP. There was a delay in platelet recovery and an increase in transfusion requirement during subsequent courses in the GM‐CSF group. The result cautions the routine use of lineage specific hematopoietic growth factors in supporting repeated cycles of dose‐intensive chemotherapy. © 1996 Wiley‐Liss, Inc.