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PubMed2000

Pharmacokinetic and pharmacodynamic study of the combination of docetaxel and topotecan in patients with solid tumors.

PURPOSE: The sequence in which chemotherapeutic agents are administered can alter their pharmacokinetics, therapeutic effect, and toxicity. We evaluated the pharmacokinetics and pharmacodynamics of docetaxel and topotecan when coadministered on two different sequences of administration. PATIENTS AND METHODS: On cycle 1, docetaxel was administered as a 1-hour infusion at 60 mg/m(2) without filgrastim and at 60, 70, and 80 mg/m(2) with filgrastim on day 1, and topotecan was administered at 0.75 mg/m(2) as a 0.5-hour infusion on days 1 to 4. On cycle 2, topotecan was administered on days 1 to 4, and docetaxel was administered on day 4. Cycles were repeated every 21 days. Blood samples for high-performance liquid chromatography measurement of docetaxel (CL(DOC)) and topotecan (CL(TPT)) total clearance were obtained on day 1 of cycle 1 and day 4 of cycle 2. CL(DOC) and CL(TPT) were calculated using compartmental methods. RESULTS: Mean +/- SD CL(DOC) in cycles 1 and 2 were 75.9 +/- 79.6 L/h/m(2) and 29.2 +/- 17.3 L/h/m(2), respectively (P: <.046). Mean +/- SD CL(TPT) in cycles 1 and 2 were 8.5 +/- 4.4 L/h/m(2) and 9.3 +/- 3.4 L/h/m(2), respectively (P: >. 05). Mean +/- SD neutrophil nadir in cycles 1 and 2 were 4,857 +/- 6, 738/microL and 2,808 +/- 4,518/microL, respectively (P: =.02). CONCLUSION: Administration of topotecan on days 1 to 4 and docetaxel on day 4 resulted in an approximately 50% decrease in docetaxel clearance and was associated with increased neutropenia.

Adult↗
PubMed2003

Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741.

PURPOSE: Using a 2 x 2 factorial design, we studied the adjuvant chemotherapy of women with axillary node-positive breast cancer to compare sequential doxorubicin (A), paclitaxel (T), and cyclophosphamide (C) with concurrent doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) for disease-free (DFS) and overall survival (OS); to determine whether the dose density of the agents improves DFS and OS; and to compare toxicities. PATIENTS AND METHODS: A total of 2,005 female patients were randomly assigned to receive one of the following regimens: (I) sequential A x 4 (doses) --> T x 4 --> C x 4 with doses every 3 weeks, (II) sequential A x 4 --> T x 4 --> C x 4 every 2 weeks with filgrastim, (III) concurrent AC x 4 --> T x 4 every 3 weeks, or (IV) concurrent AC x 4 --> T x 4 every 2 weeks with filgrastim. RESULTS: A protocol-specified analysis was performed at a median follow-up of 36 months: 315 patients had experienced relapse or died, compared with 515 expected treatment failures. Dose-dense treatment improved the primary end point, DFS (risk ratio [RR] = 0.74; P =.010), and OS (RR = 0.69; P =.013). Four-year DFS was 82% for the dose-dense regimens and 75% for the others. There was no difference in either DFS or OS between the concurrent and sequential schedules. There was no interaction between density and sequence. Severe neutropenia was less frequent in patients who received the dose-dense regimens. CONCLUSION: Dose density improves clinical outcomes significantly, despite the lower than expected number of events at this time. Sequential chemotherapy is as effective as concurrent chemotherapy.

Adult↗
PubMed2005

Temporal and geographic variation in the use of hematopoietic growth factors in older women receiving breast cancer chemotherapy: findings from a large population-based cohort.

PURPOSE: Hematopoietic growth factors have played a major role in preventing infection and shortening the duration of neutropenia in patients receiving cancer chemotherapy. Little information is available on how these growth factors are used in patients with cancer outside the clinical trial setting. We performed descriptive and exploratory analyses on the patterns and correlates of the use of hematopoietic growth factors in community-dwelling elderly patients. PATIENTS AND METHODS: We identified 5,843 women from the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked data cohorts who were diagnosed with breast cancer at age 65 or older in 1992 to 1999 from the 11 SEER areas and received chemotherapy. RESULTS: Overall, 17.3% of the elderly women with breast cancer chemotherapy received filgrastim and 6.8% received epoetin. The use of the growth factors increased significantly over time from 1992 to 1999 (P < .001 for trend). Compared with patients diagnosed in 1992 to 1994, patients diagnosed in 1998 to 1999 were more than five times and 65 times more likely to receive filgrastim and epoetin, respectively, after controlling for other factors such as age and comorbidity. There also was substantial geographic variation in the use of hematopoietic growth factors, ranging from 10.6% in Seattle to 22.9% in Atlanta. Significant predictors of growth factors included patient age, race, tumor stage, and comorbidity. CONCLUSION: There were substantial temporal and geographic variations in the use of hematopoietic growth factors among patients receiving chemotherapy for breast cancer. The nationwide and population-based Medicare claims provide potential for examining the effectiveness, medical costs, and cost effectiveness of hematopoietic growth factors in the community.

Age Factors↗
PubMed2006

Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer: results of International Breast Cancer Study Group Trial 15-95.

PURPOSE: To compare adjuvant dose-intensive epirubicin and cyclophosphamide chemotherapy administered with filgrastim and progenitor cell support (DI-EC) with standard-dose anthracycline-based chemotherapy (SD-CT) for patients with early-stage breast cancer and a high risk of relapse, defined as stage II disease with 10 or more positive axillary nodes; or an estrogen receptor-negative or stage III tumor with five or more positive axillary nodes. PATIENTS AND METHODS: Three hundred forty-four patients were randomized after surgery to receive seven cycles of SD-CT over 22 weeks, or three cycles of DI-EC (epirubicin 200 mg/m2 plus cyclophosphamide 4 gm/m2 with filgrastim and progenitor cell support) over 6 weeks. All patients were assigned tamoxifen at the completion of chemotherapy. The primary end point was disease-free survival (DFS). RESULTS: After a median follow-up of 5.8 years (range, 3 to 8.4 years), 188 DFS events had occurred (DI-EC, 86 events; SD-CT, 102 events). The 5-year DFS was 52% for DI-EC and 43% for SD-CT, with hazard ratio of DI-EC compared with SD-CT of 0.77 (95% CI, 0.58 to 1.02; P = .07). The 5-year overall survival was 70% for DI-EC and 61% for SD-CT, with a hazard ratio of 0.79 (95% CI, 0.56 to 1.11; P = .17). There were eight cases (5%) of anthracycline-induced cardiomyopathy (two fatal) among those who received DI-EC. Women with hormone receptor-positive tumors benefited significantly from DI-EC. CONCLUSION: There was a trend in favor of DI-EC with respect to disease-free survival. A larger trial or meta-analysis will be required to reveal the true effect of dose-intensive therapy.

Adult↗
PubMed2002

Pegfilgrastim.

Granulocyte colony stimulating factor (G-CSF) has proven efficacy in the prophylaxis of chemotherapy induced neutropenia and is associated with a reduction in the duration of neutropenia, febrile neutropenia, hospitalisation and intravenous antibiotic use. It is an effective mobiliser of peripheral blood progenitor cells and is used in many countries to mobilise and provide a source of stem cells for autologous and allogeneic bone marrow transplantation. The longevity of G-CSF action is limited by its short half-life, necessitating daily injections. Pegfilgrastim (Neulasta, Amgen, Inc.) is a novel form of filgrastim (G-CSF) with a sustained duration of action. Single dose pegfilgrastim has been shown to be as safe and effective as daily filgrastim in reducing the incidence of chemotherapy induced neutropenia. Pegfilgrastim provides clinical and quality of life benefits for patients as a result of its once per cycle administration. It is licenced in the US for use in the prophylaxis and treatment of chemotherapy induced neutropenia. Clinical trials to evaluate its ability to mobilise peripheral blood progenitor cells are ongoing.

Animals↗
PubMed2005

Pegfilgrastim: a granulocyte colony-stimulating factor with sustained duration of action.

Granulocyte colony-stimulating factors such as filgrastim (Neupogen, Amgen, Inc.) and pegfilgrastim (Neulasta, Amgen, Inc.) are frequently used in clinical practice for the prevention of chemotherapy-induced neutropenia and its potentially life-threatening complications. Due to its unique neutrophil-mediated clearance, pegfilgrastim can be administered once per chemotherapy cycle. Clinical trials have shown that a single, fixed subcutaneous dose of pegfilgrastim 6 mg is comparable in safety and efficacy to daily injections of filgrastim for decreasing the incidence of infection following myelosuppressive chemotherapy in patients with cancer. Postregistrational trials have been conducted to evaluate the use of pegfilgrastim with emerging dose-dense regimens, in myeloid cancers and for mobilisation and engraftment of autologous stem cells. Ongoing clinical trials continue to explore further potential uses for pegfilgrastim.

Animals↗
PubMed2003

Safety and efficacy of pegfilgrastim in patients receiving myelosuppressive chemotherapy.

The major dose-limiting toxicity associated with myelosuppressive chemotherapy is neutropenia, which can be ameliorated with proactive administration of granulocyte colony-stimulating factor (G-CSF). Pegfilgrastim is a long-acting G-CSF, recently approved by the Food and Drug Administration. The efficacy and safety of pegfilgrastim administered once/chemotherapy cycle have been evaluated in clinical trials involving patients treated with myelosuppressive chemotherapy for breast cancer, lung cancer, non-Hodgkin's lymphoma, and Hodgkin's disease. Two pivotal phase III trials in patients with breast cancer showed that pegfilgrastim is as effective as filgrastim regarding the primary efficacy end point, which was duration of grade 4 (severe) neutropenia in cycle 1 of myelosuppressive chemotherapy. Secondary end points were the frequency of fever with neutropenia (febrile neutropenia), duration of neutropenia in cycles 2-4, depth of the absolute neutrophil count (ANC) nadir, and time to ANC recovery in cycles 1-4. Once/cycle pegfilgrastim 100 microg/kg or 6 mg was as safe and effective as daily filgrastim 5 microg/kg in reducing the frequency and duration of severe neutropenia. A trend toward a greater reduction in the overall frequency of febrile neutropenia with pegfilgrastim was observed. The availability of pegfilgrastim simplifies the use of prophylactic G-CSF, with the potential to increase patient convenience and adherence in management of chemotherapy-induced neutropenia.

Antineoplastic Agents↗
PubMed2003

Pharmacokinetics of pegfilgrastim.

Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) with a long half-life and sustained duration of action. Pegfilgrastim is created with pegylation technology, whereby a 20-kD polyethylene glycol moiety is conjugated to filgrastim (recombinant human G-CSF), resulting in a larger molecule. Consequently, its renal clearance by glomerular filtration is minimized, making neutrophil-mediated clearance the predominant route of elimination. Preclinical animal data have shown that the clearance of pegfilgrastim depends on dosage and absolute neutrophil count, with pegfilgrastim having a longer circulating half-life and more sustained duration of action than filgrastim. The biologic effect of pegfilgrastim is prolonged in a neutropenic setting because few mature neutrophils are available to mediate its elimination. Clinical trials have suggested that neutrophil-mediated clearance of pegfilgrastim may be self-regulating and may therefore be specific to each patient's hematopoietic recovery.

Animals↗
PubMed2006

Pegfilgrastim: current and future perspectives in the treatment of chemotherapy-induced neutropenia.

Myeloid colony-stimulating factors (granulocyte colony-stimulating factor [G-CSF] and granulocyte-macrophage colony-stimulating factor) are commonly used in clinical practice for the prevention of anticancer chemotherapy-induced neutropenia and its potentially life-threatening complications. Pegfilgrastim is a novel recombinant human G-CSF pharmaceutically developed by covalent binding of a polyethylene glycol molecule to the N-terminal sequence of filgrastim. Due to its unique neutrophil-mediated clearance, pegfilgrastim can be administered once per chemotherapy cycle. Clinical trials have demonstrated that a single, fixed, subcutaneous dose of pegfilgrastim is comparable in safety and efficacy to daily injections of filgrastim for decreasing the incidence of infection following myelosuppressive chemotherapy in patients with cancer. Recent trials have been conducted to evaluate the use of pegfilgrastim in different clinical settings, including support of dose-dense regimens, mobilization and transplantation of hematopoietic stem cells.

Antineoplastic Agents↗
PubMed2002

[A case of multiple myeloma with infiltration into skeletal muscle after injections of a granulocyte-colony stimulating-factor].

Multiple myelomas often occur in elderly people with complications due to aging. A 54-year-old man was first admitted with cerebral infarction, and multiple myeloma (IgG kappa, stage IIIA) occurred in November 1989 that was followed by partial remission after chemotherapy. The karyotype of the bone marrow cells was 46, XY, and no p53 gene mutations were detected by polymerase chain reaction and single-strand conformation polymorphism analysis. Chemotherapy (melphalan 10 mg, vindesine 3 mg, ranimustine 150 mg, prednisolone 60 mg for 4 days) was performed in February 1999 because of aggravation of the myeloma. After daily subcutaneous injection of 50 micrograms of nartograstim for six days to treat neutropenia, soft tissues around the right eye were swelled gradually without redness, accompanied by elevation of the serum creatine-kinase concentration. The swelling disappeared, and the enzyme level normalized after discontinuation of nartograstim. In July, on the sixth day of daily subcutaneous injection of 75 micrograms of filgrastim after the same chemotherapy, similar swelling of the soft tissues around the left eye became evident, and again this proved reversible. In July 2000, 40 mg of dexamethasone was infused, and after 5-day subcutaneous-injection of 75 micrograms of filgrastim daily, the right subclavicular soft tissue became swollen. He died of myocardial infarction, and autopsy revealed infiltration of myeloma cells into the right subclavicular muscle and bone marrow packed with myeloma cells. This case suggests that myeloma cells can proliferate and infiltrate into soft tissues on exposure to granulocyte-colony stimulating factors.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1999

Granulocyte colony-stimulating factor: its potential role in infectious disease.

Studies on the role of endogenous granulocyte colony-stimulating factor (G-CSF) in host defense indicate that, in addition to its anti-infectious role, this cytokine has an immunomodulatory function and also augments antibiotic efficacy. Pre-clinical and clinical trials with Filgrastim, recombinant-methionyl human G-CSF, in neutropenic and non-neutropenic infections demonstrate a reduction in morbidity and mortality. This is attributed to Filgrastim's ability to control infectious complications and permit continuation of immunosuppressive therapies.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Prevention of bacterial infections in patients with advanced HIV infection.

In a study of 258 moderately neutropenic HIV-infected patients, Filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) treatment significantly reduced the incidence of severe neutropenia and bacterial infections. Filgrastim-treated patients also had 54% fewer severe bacterial infections and 45% fewer days in hospital for any bacterial infections. No unexpected or new adverse events were observed and there were no differences in plasma HIV-1 RNA levels between the groups.

Acquired Immunodeficiency Syndrome↗
PubMed2000

[G-CSF administration following autologous peripheral blood stem cell transplantation--the effect of G-CSF level on neutrophil recovery].

We studied the usefulness of rhG-CSF (filgrastim) administration in patients who received autologous peripheral blood stem cell transplantation (PBSCT) combined with super-high dose chemotherapy. Twenty patients received 0-8.3 micrograms/kg/day filgrastim after PBSCT. There was a significant relationship between G-CSF dose and the neutrophil recovery rate, and the highest levels of serum G-CSF tended to correlate with neutrophil recovery rate. The highest G-CSF level after 75 micrograms injection in normal volunteers is reported to be 1,500 pg/ml. On the other hand, as one patient in our series exhibited extremely high endogenous G-CSF of 11,500 pg/ml, measurements of G-CSF might reduce the over-administration of rhG-CSF.

Adolescent↗
PubMed2000

[Concurrent chemoradiotherapy for T4 and/or M1 LYM squamous cell carcinoma of the esophagus].

A phase II study was conducted to investigate the efficacy and feasibility of chemoradiotherapy for locally advanced carcinoma of the esophagus. Fifty-four patients with clinical T4 and/or M1 LYM squamous cell carcinoma of the esophagus were enrolled. Patients received protracted infusions of fluorouracil 400 mg/m2/24 hours on days 1 to 5 and 8 to 12, 2-hour infusions of cisplatin 40 mg/m2 on days 1 and 8, and concurrent radiotherapy at a dose of 30 Gy in 15 fractions over 3 weeks. Filgrastim was prophylactically administered to 35 patients. This schedule was repeated twice every 5 weeks, for a total radiation dose of 60 Gy followed by two courses of fluorouracil (800 mg/m2/24 hours for 5 days) and cisplatin (80 mg/m2 on day 1). There were 36 patients with T4 disease and 33 with M1 LYM. Forty-nine patients (91%) completed the chemoradiotherapy segment. The 18 patients (33%) who achieved a complete response included nine (25%) of the 36 with T4 disease and nine (50%) of the 18 with non-T4 disease. Major toxicities were leukopenia and esophagitis; there were four (7%) treatment-related deaths. Prophylactic filgrastim reduced the incidence of grade 3 or worse leukopenia without improving dose-intensity or response. With a median follow-up duration of 43 months, median survival time was 9 months. The 3-year survival rate was 23%. Despite its significant toxicity, this combined modality seemed to have curative potential even in cases of locally advanced carcinoma of the esophagus.

Adult↗
PubMed2000

[Haematopoietic stem cell mobilization in patients with multiple myeloma--comparison of 3 variations of the stimulating regime].

In the literature various regimes are described for successful collection of haematopoietic stem cells in patients with multiple myeloma. Most frequently cyclophosphamide is used, 5 g/m2 combined with different doses of haematopoietic growth factors. In our group the yields and tolerance of three stimulating regimes are compared: 1. cyclophosphamide 5 g/m2 and filgrastim (G-CSF) 5 micrograms/kg 2. cyclophosphamide 5 mg/m2 and filgrastim 10 micrograms/kg 3. cyclophosphamide 5 g/m2 and figrastim 5 micrograms/kg along with erythropoitin 50 IU/kg. Cyclophsphamide is administered always on the first day and the haematopoietic growth factors then from the third day till the end of collection of haematopoitic cells. In patients with multiple myeloma where only four cycles of VAD chemotherapy preceded and where radiotherapy of the axial skeleton was not used, optimal collection of haematopoietic stem cells was achieved after administration of cyclohosphamide 5 g/m2 with subsequent administration of 5 micrograms/kg G-CSF. By increasing the dose of G-CSF to 10 micrograms/kg or adding 50 IU/kg erthropoietin did not lead to a significant improvement of the tolerance and yield of this procedure.

Cyclophosphamide↗
PubMedDate not supplied

[Ticlopidine-induced aplastic anemia. A case report and review of the literature].

Ticlopidine, an inhibitor of platelet aggregation, is widely used for peripheral arterial disease. The use of this drug has been associated with neutropenie and other adverse hematologic effects. Aplastic anemie is a rate complication that carries high mortality. We describe the case of a 91 years old woman with ticlopedine-induced aplastic anemia. The patient was treated with filgrastim brood spectrum antibiotics and other general supportive care measures. Despite initial improvement the old woman died 7 weeks after admission for septic shock. A review of medical literature revealed 24 similar cases. Filgrastim has been used previous by with variable success.

Aged↗
PubMed2003

Optimizing the management of chemotherapy-induced neutropenia.

Chemotherapy-induced neutropenia (CIN), the most common dose-limiting toxicity of cancer chemotherapy, is associated with numerous clinical, personal, and economic consequences. The principal strategies for managing CIN are reducing the dose intensity of the chemotherapy, using antibiotics, and using colony-stimulating factors (CSFs). Reducing or delaying the chemotherapy dose is effective, but this can compromise treatment outcomes. Antibiotics can be lifesaving, but they are associated with numerous adverse effects and the emergence of resistant pathogens. The granulocyte CSF (G-CSF) filgrastim can reduce the incidence, duration, and severity of CIN, as well as the risk of infection, in patients treated with myelosuppressive chemotherapy. The availability of pegfilgrastim, a sustained-duration G-CSF that has benefits comparable to those of filgrastim with a single injection per chemotherapy cycle, has simplified CSF therapy.

Antineoplastic Agents↗
PubMed2006

[Two cases of malignant lymphoma with high fever and C-reactive protein (CRP) elevation after treatment with granulocyte colony-stimulating factor (G-CSF)].

We present two cases of malignant lymphoma that developed a high fever that eventually reached an extremely high 38.9 degrees C. The C-reactive protein( CRP) elevation also climbed to a very high 12.2 mg/dl after treatment with granulocyte colony-stimulating factor (G-CSF). In the one case, after stem cells were mobilized with CHASER therapy (cyclophosphamide, cytarabine, etoposide, dexamethasone and rituximab) followed by G-CSF (filgrastim 600 microg/day) subcutaneous daily, the serum CRP level rose to a maximum of 5.6 mg/dl, with a maximum fever elevation of 38.9 degrees C. In the other case, after the subject was given CHASE therapy followed by subcutaneous treatment with G-CSF (filgrastim 75 microg/day) daily, the maximum serum CRP level was 12.2 mg/dl along with a maximum fever of 38.9 degrees C. Although no infection was found in either case, multiple antibacterial agents were ineffective;after discontinuation of G-CSF, fever dissipated and the serum CRP level became negative. G-CSF induces the proliferation and differentiation of neutrophils and also causes the mobilization of mature neutrophils from hematopoietic tissues. With the increasing propensity to G-CSF, we must keep in mind the possibility of such adverse reactions so as to serve the overall best interests of the patient.

Adult↗