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Treatment of Neutropenia-Related Fungal Infections with Granulocyte Leukemia (1997) 11, 1621–1630 1997 Stockton Press All rights reserved 0887-6924/97 $12.00 Treatment of neutropenia-related fungal infections with granulocyte colony- stimulating factor-elicited white blood cell transfusions: a pilot study MC Dignani1, EJ Anaissie2, JP Hester3, S O’Brien4, SE Vartivarian5, JH Rex6, H Kantarjian4, DB Jendiroba4, B Lichtiger7, BS Andersson4 and EJ Freireich4 2Section of Infectious Diseases, Department of Medical Specialties, 4Department of Hematology, 7Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA; 1Infectious Diseases, Fundaleu, Buenos Aires, Argentina; 3Haemapheresis Consultants, Houston, Texas; 6Department of Internal Medicine, Center for Infectious Diseases, 5The University of Texas Medical School, Houston, Texas, USA Neutropenia-related fungal infections can be life-threatening and efficacy of rG-CSF-elicited WBC transfusions in patients despite antifungal therapy. We evaluated the role of recombi- with neutropenia-related fungal infections that were refractory nant granulocyte colony-stimulating factor (rG-CSF)-elicited white blood cell (WBC) transfusions in patients with neutro- to therapy with amphotericin B. penia-related fungal infections. Adult patients with hematologic malignancies, absolute neutrophil counts (ANC) ,500/ml and fungal infections refractory to amphotericin B, received daily Materials and methods transfusions of rG-CSF-elicited and irradiated WBC trans- fusions from related donors. Donors received 5 mg/kg/day of rG-CSF subcutaneously. Donors achieved a mean ANC of Study design 29.4 3 103 per microliter. The mean yield of neutrophils per transfusion was 41 3 109 (range, 10–116). Fifteen patients This pilot study was conducted at The University of Texas MD received a median of eight transfusions (range, 3–16). Fourteen Anderson Cancer Center between May 1993 and May 1994. patients had received rG-CSF for a median of 12 days. The Informed consents were obtained from donors and recipients. median ANC baseline was 20/ml. Eleven patients had favorable responses and eight of them remained free of infection 3 weeks after therapy. Favorable responses occurred among patients with better Zubrod performance status (median, 3 vs 4) and Patients shorter duration of both profound neutropenia (median, 15 vs 25 days) and active infection (median, 8 vs 17 days). The mean Adult patients were enrolled in the study if they had a hemato- 1- and 24-h post-transfusion ANCs were 594/ml (range, 98– , m 1472/ml) and 396/ml (range, 50–1475/ml), respectively. Adverse logic malignancy, neutropenia (ANC 500/ l), and an invas- 1 reactions were observed in nine of 35 donors and in the recipi- ive fungal infection as previously defined. Infections were ents of six of 130 transfusions. rG-CSF-elicited WBC trans- documented by culture, biopsy specimen, or both. Mold fusions may be a safe and promising approach for treating infections were confirmed if the biopsy specimen showed neutropenia-related fungal infections. acute branching septated hyphae but the culture evaluation Keywords: granulocyte transfusion; granulocyte colony-stimulating yielded negative results. factor (G-CSF); fungal infections; leukemia; pneumonia Pretreatment evaluation included history and physical examination, Zubrod scale performance status and hemato- logic evaluation, liver and kidney function tests, and appropri- Introduction ate roentgenographic, histopathologic, and culture evalu- ations of infected sites. Patients were examined and the Neutropenia-related fungal infections can be life-threatening 1 above-mentioned laboratory parameters were monitored daily in cancer patients despite antifungal therapy. The role of during therapy, at the end of therapy, and 3 weeks after the white blood cell (WBC) transfusions in the treatment of neu- end of therapy. Patients were also evaluated at least 3 months tropenia-related infections has been examined and remains 2–13 after the end of therapy. controversial. Patients were evaluable for response if they received three The low number of donor cells collected probably accounts or more transfusions. Response was evaluated by two investi- for the marginal efficacy of WBC transfusions in some studies. gators (MCD and EJA). Patients were considered to have a fav- A dose–response was established in some experimental14 and 8,11,15 orable response if they had improvement or stabilization of clinical studies. the clinical and laboratory parameters on the last day of WBC Dexamethasone has been the preferred agent for donor transfusion therapy. stimulation. However, administration of recombinant granulo- Response at 3 weeks and 3 months was defined as pre- cyte colony-stimulating factor (rG-CSF) safely increases the viously reported1 and was based on a combination of clinical number of circulating neutrophils in patients with neutro- and laboratory findings. penia16 and results in a significantly higher neutrophil yield per collection and a higher absolute neutrophil count (ANC) (1) Complete response: This indicated the disappearance of in the recipients than the administration of dexamethasone or all clinical and laboratory signs and symptoms of infection no treatment at all.17 including radiologic examination, and negative cultures We conducted this prospective study to evaluate the safety from previously infected sites when possible. The persist- ence of minimal scarring, as determined by a radiologist not participating in the study, was considered as a com- plete response if no recrudescence of disease was noted Correspondence: Dr EJ Anaissie, Department of Hematology/ Oncology, The University of Arkansas for Medical Sciences, Little (ie all clinical and laboratory parameters of infection have Rock, AR 72205, USA remained negative for at least 3 months after discontinu- Received 28 October 1996; accepted 26 June 1997 ation of therapy or until patient’s death, whichever came G-CSF-stimulated leukocyte transfusions MC Dignani et al 1622 first, and/or if complete autopsy examination failed to Collection rates varied from 1.5 to 3 ml per min. All WBC show persistent infection). concentrates were irradiated with 3000 rad except for four (2) Complete response with residuae indicated continuous concentrates collected from a bone marrow donor. In this improvement and clinical evolution compatible with the patient, the intent of the WBC transfusion was to both treat natural history of mold infection and no recrudescence of infection and induce myeloid engraftment (patient 13). disease described above. (a) Pulmonary: defervescence of fever, resolution of clini- cal signs and symptoms of infection, no new lesions White-blood cell transfusions or increase in existing lesions, negative respiratory tract cultures, but with persistent pulmonary cavity. The WBC concentrates were infused within 2 h of collection (b) Sinusitis: defervescence of fever, resolution of clinical over 60–90 min and at least 4 h after the amphotericin B signs and symptoms of infections, negative cultures. infusion. Recipients were premedicated with hydrocortisone The persistence of residual non-specific findings by (100 mg) and diphenhydramine intravenously (25 mg) and sinus X-rays or CT scan did not exclude response if no acetaminophen (650 mg) orally. WBCs were transfused daily recrudescence of disease, as described above, was when possible, and the transfusions were continued until no seen. more donors were available or until patients recovered from (3) Partial response: Partial response indicated clinical myelosuppression (ANC >1000/ml for 2 successive days with- improvement, and regression of more than 50% in the size out transfusion), died, had no response to therapy, or were of objective parameters of fungal infection. cleared of infection. (4) Stable disease: Indicated stabilization in the clinical signs Complete blood and platelet counts of the concentrates and symptoms of infection, no change in the size of the were obtained with a Coulter automated STKS hematology objective measurements or regression of less than 50% in system (Coulter Corporation, Miami, FL, USA), and a differen- the size of these measurements. tial count was done manually. (5) Failure: Indicated progressive infection (clinical and/or ANCs were obtained for all patients at baseline and at 1 laboratory). and 24 h after the WBC transfusions. Occasionally, WBC (6) Relapse: Documented infection with the same organism transfusions were withheld for 24 h because of suspected at any site occurring at any time after discontinuation of bone marrow recovery or because we could not perform leu- study drug. Same organism implies same antibiogram. kapheresis on Sundays. In those cases, the ANC was obtained A favorable response indicated complete or partial resolution 48 h after transfusion. of the infection. Donor and recipient toxic effects Donors Toxic effects were assessed daily in all recipients and donors. Only related donors were enrolled in the study, except in two Recipients were monitored for adverse reactions during the cases in which spouses were allowed to donate pending the 2 h of WBC infusion and for 6 h after the infusion. The severity arrival of related donors. Human lymphocyte antigen (HLA) of the reactions was classified as: (1) mild: transient, resolved and blood typing were done on all donors, but no attempt without medication; (2) moderate: resolved with medication; was made to select donors on the basis of antigen or blood and (3) severe: potentially life-threatening and requiring dis- type compatibility.
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