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Randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating-factor support for dose-intensive cyclophosphamide, etoposide, and cisplatin

✍ Scribed by 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


Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
670 KB
Volume
51
Category
Article
ISSN
0361-8609

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✦ Synopsis


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 clspiatln (DEEP). Fifty-six patients with lymphoma or breast carcinoma were randomized to receive GM-CSF 250 pglm2 or placebo subcutaneously (SC) every 12 hr after each course of DEEP until recovety of absolute neutrophii count (ANC) of 1.5 x 10Β°/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 x 10% was 10 versus 12 days for Course 1 (P = O.OlO), 10 versus 12 days for Course 2 (P = 0.248), and 16.5 versus 15 days for Course 3 (P = 0.126); platelet counts below 20 x 10B/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 flrst 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 hematopoletic growth factors In supportlng repeated cycles of dose-intenslve chemotherapy.


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## Abstract ## Backgrounds and objectives The optimal strategy for the management of elderly patients with acute myeloid leukaemia (AML) is still controversial. We previously reported the effectiveness of low dose cytarabine (Ara‐C) and etoposide (VP‐16) (AV therapy) for those elderly AML patients