Subhash C. Gulati, MD, PhD; Charles L. Bennett, MD, PhD
▪ 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.
Gulati SC, Bennett CL. Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) as Adjunct Therapy in Relapsed Hodgkin Disease. Ann Intern Med. ;116:177–182. doi: 10.7326/0003-4819-116-3-177
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Published: Ann Intern Med. 1992;116(3):177-182.
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