A Phase II Study of Continuous Infusion Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor as an Adjunct to Autologous Bone Marrow Transplantation for Patients With Non-Hodgkin’s Lymphoma in First Remission

• Published in: Blood 1994-05, Vol.83 (9), p.2707-2714
• Main Authors: O’Day, Steven J., Rabinowe, Susan N., Neuberg, Donna, Freedman, Arnold S., Soiffer, Robert J., Spector, Neil A., Robertson, Michael J., Anderson, Kenneth, Whelan, Mary, Pesek, Kelly, Ritz, Jerome, Nadler, Lee M.
• Format: Article
• Language: English
• Subjects: Adult; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bone Marrow Transplantation; Bone marrow, stem cells transplantation. Graft versus host reaction; Cyclophosphamide - therapeutic use; Doxorubicin - therapeutic use; Female; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects; Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use; Humans; Infections; Length of Stay; Lymphoma, Non-Hodgkin - therapy; Male; Medical sciences; Middle Aged; Neutrophils - pathology; Prednisone - therapeutic use; Prospective Studies; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Remission Induction; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Vincristine - therapeutic use
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V83.9.2707.2707

Recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) clearly hastens myeloid recovery in patients with relapsed hematologic malignancies undergoing autologous bone marrow transplantation (ABMT). In efforts to further improve neutrophil engraftment and shorten hospital stay in ABMT patients, rhGM-CSF was administered by a potentially more potent route (continuous infusion) to non-Hodgkin’s lymphoma (NHL) patients with better BM reserve (first remission). Time to myeloid engraftment was compared with that of NHL patients treated in first remission at our institution on a similar ABMT protocol but without growth factor support (controls). Median neutrophil engraftment (absolute neutrophil count, 500 cells/μL) in first remission patients treated with rhGM-CSF was 14 days, compared with 22 days in controls (P = .0001). Hospital stays were also significantly reduced for rhGM-CSF patients (P = .0003). Platelet engraftment did not differ between the two groups. Persistent fever and generalized serositis were the primary toxicities. rhGM-CSF, delivered by this route, was efficacious but more toxic than 2-hour rhGM-CSF infusions previously reported by other investigators. Future alterations in both dose and schedule may retain comparable efficacy yet diminish toxicity.