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Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) as Adjunct Therapy in Relapsed Hodgkin Disease

Subhash C. Gulati, MD, PhD; and Charles L. Bennett, MD, PhD
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This work was presented in part at the American Society of Hematology Conference, Boston, Massachusetts, in December 1990.

Grant Support: In part by a grant from Schering-Plough and Sandoz Corporation. Dr. Bennett is supported by a Career Investigator Award from the Veterans Administration Health Services Research and Development.

Requests for Reprints: Charles L. Bennett, MD, PhD, Veterans Affairs Medical Center, Health Services Research and Development (152), 508 Fulton Street, Durham, NC 27705.

Current Author Addresses: Dr. Gulati: Division of Hematology-Oncology, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021.

Dr. Bennett: Veterans Affairs Medical Center, Health Services Research and Development (152), 508 Fulton Street, Durham, NC 27705.

Ann Intern Med. 1992;116(3):177-182. doi:10.7326/0003-4819-116-3-177
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This excerpt has been provided in the absence of an abstract.

Objective: To determine the clinical and economic effects of granulocyte macrophage colony-stimulating factor (GM-CSF) as adjunct therapy in relapsed or refractory Hodgkin disease.

Design: A randomized, double-blind, phase III clinical trial.

Setting: A tertiary referral center.

Patients: Twenty-four patients (twelve of whom were controls) treated with high-dose chemotherapy and autologous bone marrow transplantation.

Main Results:The 12 patients treated with GM-CSF, when compared with placebo recipients, had shorter periods of neutropenia (median duration of an absolute neutrophil count of less than 1000 cells/mm3, 16 days compared with 27 days; P = 0.02), shorter periods of platelet-transfusion dependency (median duration, 13.5 days compared with 21 days; P = 0.03), and shorter hospitalizations (median hospital stay, 32 days compared with 40.5 days; P = 0.004). Other clinical outcomes, such as frequency and severity of toxicities, development of pneumonia or infection, in-hospital death, and response rate were similar in the two groups. Actuarial long-term disease-free survival was 64% for patients treated with GM-CSF and 58% for patients who received placebo after 32 months of follow-up (P = 0.15). The group treated with GM-CSF had lower total charges after infusion of autologous marrow than the placebo group (median in-hospital charges, $39 800 compared with $62 500; P = 0.005) because of lower post-infusion charges for room and board, antibiotic therapy, transfusions, laboratory tests, and physical therapy visits.

Conclusions: Administration of GM-CSF was associated with acceleration of myeloid and platelet recovery and was cost effective in the treatment of patients with relapsed Hodgkin disease who received intensive chemotherapy.


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