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PubMedDate not supplied

Maximizing the outcomes in cancer patients receiving chemotherapy through optimal use of colony-stimulating factor.

OBJECTIVE: To discuss clinical data on the utility of 2 colony-stimulating factors (CSFs), filgrastim and pegfilgrastim, in reducing the risk and incidence of neutropenic complications with chemotherapy. DATA SOURCES: This article reviews the data from the clinical studies for both pegfilgrastim and filgrastim. Additionally, data from large, population-based retrospective analyses on the clinical and economic consequences of chemotherapy- induced neutropenia (CIN) are reviewed. CONCLUSIONS: CIN remains an undertreated condition despite the evidence of its danger. Pivotal trials show that CSFs like pegfilgrastim and filgrastim are safe and effective in reducing both the incidence and duration of CIN and febrile neutropenia in patients who have been treated with myelosuppressive chemotherapy. Approximately 11 daily injections of filgrastim per chemotherapy cycle are required to achieve this clinical end point. Pegfilgrastim provides all the clinical benefits of daily filgrastim for managing CIN with a single dose per chemotherapy cycle.

Antineoplastic Agents↗
PubMedDate not supplied

Assessing resource use in oncology patients: a comparison of analyses based on claims data and medical chart review.

BACKGROUND: Provider claims data are used to make medical analyses and decisions, but such databases typically lack important clinical information. OBJECTIVE: To compare the patterns of use of filgrastim in analyses of a claims database and a medical chart review. METHODS: We extracted data from the Medicare 5% sample claims database for the years 1996 through 1998 and from a medical chart review of the Oncology Practice Pattern Survey (OPPS) for the same period to determine the patterns of use of filgrastim in patients with non-Hodgkin.s lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone. The analyses were restricted to the first 3 cycles of the chemotherapy. RESULTS: A total of 414 patients in the Medicare database were treated with 1,360 cycles of chemotherapy. The mean duration of filgrastim use in these patients was 6.6 days. In the OPPS database, 80 patients were treated with 152 cycles of chemotherapy, with a mean duration of filgrastim use of 9.3 days. CONCLUSION: The mean duration of filgrastim use in the OPPS database was greater than that in the Medicare database and was closer to that shown in clinical trials to produce optimal results (approximately 11 days). The actual use of resources may be underestimated in claims databases, owing to their limitations and potential for bias.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2002

Pegfilgrastim.

Pegfilgrastim is a covalent conjugant of filgrastim (a recombinant human granulocyte colony-stimulating factor) and monomethoxypolyethylene glycol. It is administered as a single dose per myelosuppressive chemotherapy cycle to decrease the incidence of infection, as manifest by febrile neutropenia, in patients with nonmyeloid cancer. Pegfilgrastim increases the terminal elimination half-life and decreases the apparent serum clearance of the drug in patients with nonmyeloid cancer. Serum concentrations of pegfilgrastim remain elevated during neutropenia but decline when the neutrophil count increases. In phase III trials in patients with breast cancer and in a phase II trial in patients with non-Hodgkin's lymphoma or Hodgkin's disease, the mean duration of grade 4 neutropenia and the time to absolute neutrophil recovery during cycle 1 of chemotherapy was similar in recipients of single-dose pegfilgrastim or daily filgrastim. In the larger of two phase III trials in patients with breast cancer, the incidence of febrile neutropenia over four cycles of chemotherapy was significantly lower in recipients of single-dose pegfilgrastim than that in recipients of daily injections of filgrastim. Moreover, the mean duration of grade 4 neutropenia in cycles 2 to 4 of chemotherapy was significantly lower in recipients of pegfilgrastim than that in recipients of daily filgrastim. In comparative trials, there were no differences in the incidence and severity of adverse events, including skeletal pain, between single-dose pegfilgrastim and daily filgrastim in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy.

Antineoplastic Agents↗
PubMed2005

Spotlight on pegfilgrastim in chemotherapy-induced neutropenia.

Pegfilgrastim (Neulasta), the sustained-duration form of filgrastim (recombinant human granulocyte colony-stimulating factor [G-CSF]), is created by the addition of a polyethylene glycol (PEG) moiety to filgrastim. Its approved indication in the US is to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.A single subcutaneous injection of pegfilgrastim once per chemotherapy cycle was more effective than placebo as an adjunct to moderately myelosuppressive chemotherapy for breast cancer, no less effective than daily injections of filgrastim as an adjunct to highly myelosuppressive chemotherapy for breast cancer, and as effective as daily filgrastim as an adjunct to chemotherapy for lymphoma (predominantly non-Hodgkin lymphoma [NHL]) and acute myeloid leukemia. Pegfilgrastim has also successfully supported delivery of dose-dense chemotherapy, stem cell mobilization, and stem cell transplantation after high-dose chemotherapy in patients with non-myeloid or myeloid malignancies. By offering a convenient alternative to daily filgrastim, once-per-cycle administration of pegfilgrastim has the potential to simplify the management of chemotherapy-induced neutropenia, further improve patient health-related quality of life, and reduce total treatment costs in breast cancer and NHL, and possibly other cancer settings. Pegfilgrastim should, likewise, permit simplification of G-CSF-based stem cell mobilization and transplantation procedures.

Antineoplastic Agents↗
PubMed2003

[Mobilization of bone marrow stem cells in the management of patients with heart failure. Protocol and first results of ROT FRONT trial].

Mobilization of bone marrow stem cells by granulocyte-colony-stimulating factor (G-CSF) is considered to be an alternative to invasive transplantation of autologous myoblasts or stem cells directly into injured cardiac tissue. We have started a 24 week randomized open study in order to elucidate effects of G-CSF (filgrastim) on clinical, hemodynamic and neurohumoral status of patients with NYHA class II-IV chronic heart failure due to ischemic heart disease with zones of nonviable myocardium and left ventricular ejection fraction <40% as well as to assess safety of addition of G-CSF to standard therapy with ACE inhibitors and beta-blockers. It is planned to include 20 patients into each filgrastim (5 mg/kg/day) and control (0.9% NaCl) groups. Methods to be used: dobutamine stress echocardiography for detection of myocardial viability, magnetic resonance tomography, 6-minute walk test, quality of life questionnaire. By the present time 5 patients were included (4 in filgrastim and 1 in control group) and passed 3-6 months points. A control patient died suddenly on 11th week. All patients in filgrastim group are alive (1 experienced obvious improvement, 2 remained stable, and 1 deteriorated and required urgent hospitalization). None of the patients had signs of appearance of 'regenerated' myocardial zones. The patient with positive clinical dynamics was characterized by young age (48 years), moderately severe heart failure (NYHA class II) and pronounced leukocyte reaction to filgrastim (12 fold increase in white blood cell count with appearance of myelocytes and myeloblasts ). In contrast patients without improvement were older than 60 years, had NYHA class III heart failure and experienced just 6-8 fold increases in leukocyte count. These factors are suggested to be predictors of clinical efficacy of G-CSF in patients with heart failure.

Adolescent↗
PubMed2005

Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients.

OBJECTIVE AND DESIGN: The effect of the granulocyte colony-stimulating factor filgrastim on systemic inflammation was investigated in a prospective, randomized, placebo-controlled, double-blind study in critically ill patients. SUBJECTS: 59 critically ill patients were recruited within 48 h of intubation due to ventilatory insufficiency. TREATMENT: Subcutaneous dosage of placebo or 300 microg filgrastim once daily. METHODS: Serum samples were collected at study entry, and 1 and 3 days after the start (Day1 and Day3, respectively). Levels of soluble E-selectin (sE-selectin) and interleukin (IL)-10 were determined by ELISA, and those of IL-6, and soluble IL-2 receptor (sIL-2R) by Immulite chemiluminescence immunoassay. RESULTS: The median sE-selectin level decreased by day 3 significantly in the control group but not in the filgrastim group. The difference in the change between the study groups was significant (p = 0.049). IL-10 levels decreased significantly in the filgrastim group, tended to decrease in controls (p = 0.052), and the difference in the change tended to be significant (p = 0.058). IL-6 levels decreased in both groups comparably. sIL-2R levels were elevated and stable. CONCLUSIONS: Filgrastim prolongs endothelial activation and possibly inhibits development of immune suppression mediated by IL-10.

Adult↗
PubMed2001

The effects of cefephim, G-CSF, and sucralfate on bacterial translocation in experimentally induced acute pancreatitis.

The preventive effects of granulocyte colony-stimulating factor, cefephim, and sucralfate on bacterial translocation in experimentally induced acute pancreatitis were investigated. Forty male Wistar albino rats were used in this study. For each rat, the pancreatobiliary ductus was ligated and hence acute pancreatitis was induced. In the control group, no further procedure was performed. Meanwhile, cefephim as an antibiotic, filgrastim, which is a colony-stimulating factor, and sucralfate were given to the other groups at the specified doses. To inhibit bacterial translocation by preserving the bowel barrier, sucralfate, which is known to have a cytoprotective effect on the gastrointestinal system, was used in high doses. Cefephim 30 mg/kg per day (intramuscularly) in group II, filgrastim 10 mg/kg per day (subcutaneously) in group III, and sucralfate 50 mg/kg per day by 8-F feeding tube gavage into the stomach in group IV were given. The number of bacteria translocated into the mesenteric lymph nodes, pancreas, liver, and spleen in the control group significantly increased in comparison with the other groups (P < 0.05). The average number of leukocytes (per mm3) in the control group was significantly higher than that of other groups (P < 0.0001). Regarding the average serum amylase levels, the values of all groups clearly decreased in comparison with the control group (P < 0.0001). Although in the cefephim, filgrastim, and sucralfate groups, (+) pancreatitis was generally seen, in the control group (+++) pancreatitis was detected. Bacterial translocation to the mesenteric lymph nodes and pancreas was partially prevented by filgrastim and sucralfate, and was completely prevented by cefephim. We conclude that in the management of acute pancreatitis, the use of the prophylactic antibiotics, sucralfate and filgrastim, may be advantageous.

Acute Disease↗
PubMed2004

A single prior course of BCNU-cisplatin chemotherapy has a significant deleterious effect on mobilization kinetics of otherwise untreated patients.

Extensive prior treatment with cytotoxic agents is associated with impaired mobilization of hematopoietic cells. To assess the effect of a single course of standard-dose chemotherapy (CT), we compared the results of filgrastim-induced mobilization among two sequential groups of grade III-IV malignant glioma patients included in a hematopoietic transplantation program. The first group (21 patients) had never been treated with CT until 2 days after surgery, when they received a course of 100 mg/m2 BCNU (i.v.) and 100 mg intracarotid cisplatin for cytoreduction (not for mobilization). At 1 month after this CT, they were mobilized with 12 microg/kg filgrastim. The second group (22 patients) was mobilized with the same dose of filgrastim directly after the surgery, without having ever received any prior CT. The blood level of CD34+ cells was significantly lower in the CT-treated patients, both on the fourth day of filgrastim (15 vs 36 cells x 10(6)/l; P=0.01) and on the fifth (25 vs 58 cells x 10(6)/l; P=0.003), as it was the number of CD34+ cells collected per apheresis (1.3 vs 3.5 x 10(6)/l; P<0.0005). The toxic effect of a single course of BCNU-cisplatin CT led to significant impairment of the filgrastim-induced mobilization response.

Adult↗
PubMed2006

Actin polymerization in neutrophils from donors of peripheral blood stem cells: divergent effects of glycosylated and nonglycosylated recombinant human granulocyte colony-stimulating factor.

Neutrophil functions can be modified by Recombinant human G-CSF (rhG-CSF) treatment, with divergent effects on phagocytosis, motility, bactericidal activity, and surface molecule expression. Neutrophil morphology is modified by treatment with filgrastim (the nonglycosylated form of rhG-CSF), while it is not affected by lenograstim (the glycosylated type of rhG-CSF). Little information is available about actin polymerization in neutrophils from subjects treated with the two types of rhG-CSF. In the current paper we evaluated two groups of donors of peripheral blood stem cells (PBSC) for allogeneic transplantation. Ten subjects were treated with filgrastim and 10 with lenograstim to mobilize PBSC; 15 blood donors were evaluated as a control group. Actin polymerization (both spontaneous and fMLP-stimulated) was studied by a flow cytometric assay. A microscopic fluorescent assay was also carried out to evaluate F-actin distribution in neutrophils. We found that filgrastim induced an increased F-actin content in resting neutrophils, along with morphologic evidence for increased actin polymerization distributed principally at the cell membrane and frequently polarized in focal areas; in addition, fMLP was not able to induce further actin polymerization. On the contrary, treatment with lenograstim was associated with F-actin content, distribution, and polymerization kinetics indistinguishable from those displayed by control neutrophils. Such experimental results show that filgrastim and lenograstim display divergent effects also on neutrophil actin polymerization and provide further explanation for previous experimental findings.

Actins↗
PubMed1998

Glycosylated and non-glycosylated recombinant human granulocyte colony-stimulating factor (rhG-CSF)--what is the difference?

Two forms of recombinant human G-CSF (rhG-CSF) are available for clinical use: filgrastim is expressed in E coli and non-glycosylated, whereas lenograstim is derived from Chinese hamster ovary (CHO) cells and glycosylated. The function of the sugar chain, accounting for approximately 4% of the molecular weight of lenograstim (and native G-CSF), is not known. Glycosylation of the G-CSF molecule does not prolong its circulation half life. Lenograstim is more active than filgrastim (and research-use deglycosylated G-CSF) on a weight-by-weight basis in in vitro colony-forming and cell line assays. An international potency standard assigns a specific activity of 100,000 IU/microgram to filgrastim and 127,760 IU/microgram to lenograstim. Correspondingly, two randomised crossover studies in normal subjects, comparing mass equivalent doses of the two rhG-CSFs, have demonstrated a 25-30% higher concentration of blood stem cells (CD34+, CFU-GM) during lenograstim administration. No difference in side effects was observed. Results from a prospective, randomised, non-crossover trial in breast cancer patients suggest that bioequivalent doses of filgrastim and lenograstim have a similar effect on mobilisation of CD34+ cells and immature CD34+ cell subsets, respectively. Although comparisons outside the setting of stem cell mobilisation are lacking, the clinical relevance of the greater specific activity of lenograstim may thus be limited. The difference in potency between microgram identical doses of the two rhG-CSFs makes dosing in biological units (IU) rather than mass units (microgram) more appropriate.

Adjuvants, Immunologic↗
PubMed2003

More efficient mobilisation of peripheral blood stem cells with HiDAC+AMSA+G-CSF than with mini-ICE+G-CSF in patients with AML.

We have compared the efficacy of two PBSC mobilisation regimens, mini-ICE+filgrastim (second consolidation) and HiDAC+AMSA+filgrastim (third consolidation), in two consecutive cohorts of patients with AML CR1 receiving treatment according to a joint protocol. Group A: 18 patients, aged 41 (21-65) years, were mobilised with mini-ICE (idarubicin 8 mg/m(2)+cytarabine 800 mg/m(2)+etoposide 150 mg/m(2) days 1-3) followed by filgrastim 300-480 microg once daily s.c. from day 11 after start of chemotherapy. Only four patients reached >5 CD34+ cells/microl blood (B-CD34+) and were able to undergo leukaphereses. Two out of 18 (11%) reached the defined target of >/=2.0 x 10(6) CD34+ cells/kg after 1-3 leukaphereses. Group B: 20 patients, aged 50 (29-67) years, received HiDAC+AMSA (cytarabine 3 g/m(2) b.i.d. days 1, 3, 5+amsacrine 150 mg/m(2) q.d. days 2, 4) followed by filgrastim at a similar dose starting on day 7. A total of 18 patients reached B-CD34+ >5/microl and underwent PBSC harvesting, starting on day 23 (14-29) and yielding 4.0 (0.9-21) x 10(6) CD34+ cells/kg. Of 20 patients, 17 (85%) reached the defined target of >/=2.0 x 10(6) CD34+ cells/kg after 1-3 leukaphereses. We conclude that HiDAC+AMSA+G-CSF - in contrast to mini-ICE+G-CSF - is an efficient regimen for mobilising PBSC in patients with AML CR1.

Acute Disease↗
PubMed1997

Successful treatment of chronic severe neutropenia with weekly recombinant granulocyte-colony stimulating factor.

Daily treatment for symptomatic chronic neutropenia with recombinant granulocyte-colony stimulating factor (rhG-CSF) filgrastim is costly and sometimes causes neutrophillia. We report the use of weekly filgrastim in a 40-year-old man with life-long symptomatic neutropenia. Baseline neutrophil counts were < 1 x 10(9)/l 60% of the time, and fell below 0.5 x 10(9)/l for 7d periods every 22 d. Following 1 year of weekly filgrastim treatment, the absolute neutrophil count was maintained > 1 x 10(9)/l (averaging 2 x 10(9)/l) and the frequency and severity of symptoms were reduced by 85%. Therefore the benefits of filgrastim for the treatment of at least one form of chronic severe neutropenia can be derived from weekly rather than daily doses.

Adult↗
PubMed2004

Neulasta (pegfilgrastim): a once-per-cycle option for the management of chemotherapy-induced neutropenia.

Neutropenia is a significant hematologic complication induced by cytotoxic chemotherapy. The clinical consequences of chemotherapy-induced neutropenia are often severe and can be potentially life-threatening. Patients who develop febrile neutropenia often need to be hospitalized, reducing their quality of life and increasing costs. Neutropenia can also compromise the ability to deliver chemotherapy at the full dose and on schedule. To help prevent the occurrence of neutropenia, patients with a high risk of developing chemotherapy-related infections may be given prophylactic colony-stimulating factors. Filgrastim is a recombinant human granulocyte colony-stimulating factor that has been widely used (in over 3 million patients) for over 12 years in the management of neutropenia. Pegfilgrastim is an approved, long-acting, next generation of granulocyte colony-stimulating factor that has similar clinical benefits to filgrastim but has novel pharmacokinetic properties. Pegfilgrastim shows at least comparable safety and efficacy to filgrastim, with the added benefit of simplified once-per-chemotherapy-cycle dosing. In addition, two randomized, controlled pivotal trials have shown that a single dose of pegfilgrastim given once per cycle led to a lower observed incidence of febrile neutropenia following myelosuppressive chemotherapy, compared with daily injections of filgrastim. Clinical trials are currently expanding the clinical experience with pegfilgrastim in a variety of solid tumors and hematologic malignancies. In addition to prevention of chemotherapy-induced neutropenia in 21- and 28-day regimens, future studies are examining the suitability of pegfilgrastim in dose-dense therapy and other cancer settings.

Antineoplastic Agents↗
PubMed2002

Risk and benefit of treatment of severe chronic neutropenia with granulocyte colony-stimulating factor.

The Severe Chronic Neutropenia International Registry (SCNIR) was established in 1994 following four phase I/II and one phase III clinical trial on the use of filgrastim (recombinant human granulocyte colony-stimulating factor [r-metHuG-CSF]) as a treatment for severe chronic neutropenia (SCN). A primary purpose of the SCNIR is to monitor SCN patients treated with filgrastim for adverse events that might occur over time. As of December 31, 2000, 832 patients with SCN (384 congenital, 160 cyclic, 288 idiopathic) were enrolled. Clinical trial and Registry data show that filgrastim is an effective treatment for SCN; more than 90% of patients treated respond with normalization of blood neutrophil counts. The SCNIR has collected data on bone pain, splenomegaly, hepatomegaly, thrombocytopenia, osteopenia/osteoporosis, vasculitis, glomerulonephritis, growth and development, pregnancy and fertility, leukemic transformation, and mortality. Analysis of data from patients who received filgrastim for up to 11 years did not identify any adverse events associated with increased duration of treatment.

Chronic Disease↗
PubMed2004

Phase I study of Doxil and vinorelbine in patients with advanced malignancies.

INTRODUCTION: This study was designed to define the maximum tolerated dose of pegylated liposomal doxorubicin (Doxil) and multiday vinorelbine (VNB), without and with prophylactic filgrastim, and to identify antineoplastic effect. PATIENTS AND METHODS: Patients with resistant cancers were treated with Doxil 50 mg/m2 every four weeks, and with VNB 15 mg/m2 on the same day. The VNB dose escalations were accomplished in subsequent patient cohorts by adding VNB doses on consecutive days. When the maximum tolerated dose (MTD) of VNB with Doxil was defined, prophylactic filgrastim was added to define a second MTD. RESULTS: Of 29 patients entered, two had early adverse events, and 27 received at least one full cycle with at least one month follow-up. The MTD of VNB, combined with Doxil 50 mg/m2, was 15 mg/m2 on day 1, with neutropenia as the dose-limiting toxicity. With prophylactic filgrastim, the MTD was 15 mg/m2 daily for two days, with neutropenia and stomatitis as dose-limiting toxicities. Palmar plantar erythrodysesthesia occurred frequently, usually after the third cycle. Objective responses were documented in six patients, all of whom received multiday VNB. CONCLUSION: Doxil 50 mg/m2 on day 1 of a 28-day cycle can be safely combined with VNB 15 mg/m2 day 1, or with VNB 15 mg/m2 days 1 and 2 with filgrastim prophylaxis. Antineoplastic activity was observed in this heavily pretreated population. Future studies of Doxil 35-40 mg/m2 with multiday VNB may be worthwhile, especially in metastatic breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Predictors for hematopoietic growth factors use in HIV/HCV-coinfected patients treated with peginterferon alfa 2b and ribavirin.

HIV/hepatitis C virus (HCV)-coinfected individuals have accelerated liver disease, increased drug toxicities, and modest responses to peginterferon and ribavirin. Hematologic toxicities necessitating dose reduction or discontinuation are limiting factors to HCV treatment in the coinfected patient. This study aimed to identify predictors for the need of filgrastim and darbepoetin to manage hematologic toxicities so as to maintain patients on full doses of study drugs for the duration of study. The primary study was a single-center, open-label, prospective study to evaluate the safety, efficacy, and viral kinetics of 48-week peginterferon alfa 2b and ribavirin in HIV/HCV-coinfected patients. Complete blood count was monitored at baseline, days 3, 7, 10, 14, and then weekly for the first month, fortnightly until week 8, then monthly from week 12 to 48. Filgrastim was initiated when absolute neutrophil count (ANC) fell below 750 cells/mm(3) and darbepoetin was used when hemoglobin dropped to less than 10 g/dL. All patients experienced decrease in ANC and hemoglobin. Twenty of 30 (66.6%) of patients required hematopoeitic growth factors, 15 (50%) received filgrastim, and 12 (40%) received darbepoetin. Seven (23.3%) required both. Baseline ANC of less than 2250 cells per millimeter and negative rate of change of hemoglobin on day 3 of therapy were excellent predictors for filgrastim and darbepoetin use, respectively. Supplemental growth factors were associated with substantial increase in overall cost for HCV treatment. Larger clinical trials will be needed to address the cost effectiveness of supplemental growth factor use in the HIV/HCV-coinfected patients.

Adult↗
PubMed2002

Clinical applications of colony-stimulating factors: a historical perspective.

The development of the therapeutic roles of filgrastim and sargramostim over the past decade is reviewed. Filgrastim, a recombinant granulocyte colony-stimulating factor (G-CSF), and sargramostim, a recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF), have been available in the United States for over a decade to treat various types of neutropenia. In addition, data are available to support their use in a variety of clinical settings. Because of the high cost of these agents, clinical guidelines for their appropriate use have been developed. With respect to the comparability of filgrastim and sargramostim, the American Society of Clinical Oncology recommends that additional data be generated since current data are insufficient to adequately address this question in each clinical setting. A limited number of randomized, comparative trials have directly compared filgrastim with sargramostim. Outcomes data from these trials are reviewed. Further, there is evidence to suggest that, at least for GM-CSF, tolerability is dependent on the degree of protein glycosylation. A nonglycosylated protein, molgramostim, available in Europe appears to be associated with greater toxicity in clinical trials, although randomized comparative trials are lacking. The therapeutic equivalence of CSFs requires further study. While data show that the efficacy and tolerability of CSFs are similar in certain settings, there has been no definitive, randomized, large-scale clinical trial conducted to address this issue. Pharmacists should continue to evaluate clinical data to determine not only which CSF to use but also when a CSF should be used.

Antineoplastic Agents↗
PubMed2004

The role of diagnosis in patients failing peripheral blood progenitor cell mobilization.

BACKGROUND: Failure to mobilize PBPCs for auto-logous transplantation has mostly been attributed to previous therapy and poses therapeutic problems. STUDY DESIGN AND METHODS: The role of underlying disease was analyzed in 17 of 73 (23%) patients with PBPC mobilization failure, and secondary mobilization with high-dose filgrastim was attempted. RESULTS: Of 16 patients with acute leukemia, 13 (81%) mobilized poorly. In contrast, of 57 patients with non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, and solid tumor, 53 (93%, p < 0.001) showed good PBPC mobilization. Relapsed disease did not predispose to poor mobilization. As secondary mobilization attempt, 7 patients received 25 micro g per kg per day filgrastim without chemotherapy leading to a 3.7 +/- 2.8-fold (SD) increase in the maximum number of circulating CD34+ cells (p = 0.104). PBPC apheresis yielded 3.3 (+/-0.5) x 10(6) CD34+ cells per kg of body weight in 5 patients. Four poor mobilizers received 50 micro g per kg per day filgrastim as second or third mobilization attempt. Circulating CD34+ cells in these patients increased by 1.5 (+/-0.7) compared with the primary G-CSF application. CONCLUSION: Selective PBPC mobilization failure was seen in patients with acute leukemia whereas remarkably good mobilization was seen in other malignancies. Increasing the filgrastim dose to 25 micro g per kg per day may allow PBPC collection in patients failing PBPC mobilization.

Adult↗