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Lidia Ukarma - One of the best experts on this subject based on the ideXlab platform.
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Effect of Once-Weekly Epoetin Beta on Survival in Patients With Metastatic Breast Cancer Receiving Anthracycline- and/or Taxane-Based Chemotherapy: Results of the Breast Cancer—Anemia and the Value of Erythropoietin (BRAVE) Study
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008Co-Authors: Matti Aapro, Jose I. Mayordomo, Robert C. F. Leonard, Agustí Barnadas, Maurizio Marangolo, Michael Untch, Nikolaos A. Malamos, Dietmar Reichert, Jose Luiz Pedrini, Lidia UkarmaAbstract:Purpose The Breast Cancer—Anemia and the Value of Erythropoietin (BRAVE) study evaluated whether Epoetin Beta would improve survival in patients with metastatic breast cancer (MBC). Patients and Methods BRAVE was an open-label, randomized, multicenter study in patients with MBC treated with anthracycline- and/or taxane-based chemotherapy. Patients (hemoglobin [Hb] < 12.9 g/dL) were randomly assigned (1:1) to Epoetin Beta 30,000 U subcutaneously once weekly or control for 24 weeks. The primary efficacy variable was overall survival. Secondary efficacy outcomes included progression-free survival, transfusion- and severe anemia–free survival, Hb response, safety, and quality of life (QoL). Results After 18 months of follow-up, 62 (27%) of 231 patients survived with Epoetin Beta therapy and 63 (27%) of 232 with control. No difference was detected in overall survival (hazard ratio [HR] = 1.07; 95% CI, 0.87 to 1.33, P = .522) or progression-free survival (HR = 1.07; 95% CI, 0.89 to 1.30, P = .448). There was a ...
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effect of once weekly Epoetin Beta on survival in patients with metastatic breast cancer receiving anthracycline and or taxane based chemotherapy results of the breast cancer anemia and the value of erythropoietin brave study
Journal of Clinical Oncology, 2008Co-Authors: Matti Aapro, Robert C. F. Leonard, Agustí Barnadas, Maurizio Marangolo, Michael Untch, Nikolaos A. Malamos, Dietmar Reichert, Jose Luiz Pedrini, J I Mayordomo, Lidia UkarmaAbstract:Purpose The Breast Cancer—Anemia and the Value of Erythropoietin (BRAVE) study evaluated whether Epoetin Beta would improve survival in patients with metastatic breast cancer (MBC). Patients and Methods BRAVE was an open-label, randomized, multicenter study in patients with MBC treated with anthracycline- and/or taxane-based chemotherapy. Patients (hemoglobin [Hb] < 12.9 g/dL) were randomly assigned (1:1) to Epoetin Beta 30,000 U subcutaneously once weekly or control for 24 weeks. The primary efficacy variable was overall survival. Secondary efficacy outcomes included progression-free survival, transfusion- and severe anemia–free survival, Hb response, safety, and quality of life (QoL). Results After 18 months of follow-up, 62 (27%) of 231 patients survived with Epoetin Beta therapy and 63 (27%) of 232 with control. No difference was detected in overall survival (hazard ratio [HR] = 1.07; 95% CI, 0.87 to 1.33, P = .522) or progression-free survival (HR = 1.07; 95% CI, 0.89 to 1.30, P = .448). There was a ...
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Epoetin Beta in patients with metastatic breast cancer receiving chemotherapy results from the breast cancer anemia and the value of erythropoietin brave study
Journal of Clinical Oncology, 2005Co-Authors: Maurizio Marangolo, Nikolaos A. Malamos, Jose Luiz Pedrini, M Rotarski, I Lang, C Beato, Ramon Colomer, Lidia UkarmaAbstract:8141 Background: Many patients with metastatic breast cancer are treated with anthracycline and/or taxane-based chemotherapy; such therapies produce a high incidence of anemia. The aim of the BRAVE study was to evaluate the impact on survival, efficacy, safety and quality of life (QoL) of once-weekly Epoetin Beta 30 000 IU (NeoRecormon) in patients with metastatic breast cancer receiving anthracycline and/or taxane-based chemotherapy. Methods: Adult patients with metastatic breast cancer, scheduled to receive anthracycline and/or taxane-based chemotherapy and with hemoglobin (Hb) <12.9 g/dl at screening were entered into this open-label, randomized, multicenter, two-arm study. Patients were randomized to receive Epoetin Beta 30 000 IU once weekly or standard care (red blood cell transfusion as required) for 24 weeks. The primary endpoint was overall survival, which will be available 18 months after the last patient last treatment visit. Results: Recruitment for the study was completed in June 2004 and 463...
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Epoetin Beta in patients with metastatic breast cancer receiving chemotherapy: Results from the Breast Cancer - Anemia and the Value of Erythropoietin (BRAVE) study
Journal of Clinical Oncology, 2005Co-Authors: Maurizio Marangolo, Nikolaos A. Malamos, Jose Luiz Pedrini, M Rotarski, I Lang, C Beato, Ramon Colomer, Lidia UkarmaAbstract:8141 Background: Many patients with metastatic breast cancer are treated with anthracycline and/or taxane-based chemotherapy; such therapies produce a high incidence of anemia. The aim of the BRAVE study was to evaluate the impact on survival, efficacy, safety and quality of life (QoL) of once-weekly Epoetin Beta 30 000 IU (NeoRecormon) in patients with metastatic breast cancer receiving anthracycline and/or taxane-based chemotherapy. Methods: Adult patients with metastatic breast cancer, scheduled to receive anthracycline and/or taxane-based chemotherapy and with hemoglobin (Hb)
Jacopo Vecchiet - One of the best experts on this subject based on the ideXlab platform.
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use of Epoetin Beta during combination therapy of infection with hepatitis c virus with ribavirin improves a sustained viral response
Journal of Medical Virology, 2010Co-Authors: Katia Falasca, Claudio Ucciferri, Paola Mancino, Valeria Gorgoretti, Eligio Pizzigallo, Jacopo VecchietAbstract:Katia Falasca, Claudio Ucciferri, Paola Mancino, Valeria Gorgoretti, Eligio Pizzigallo,and Jacopo Vecchiet*Infectious Diseases Clinic, Department of Medicine and Science of Ageing. ‘‘G. d’Annunzio’’ University,Chieti-Pescara, ItalyTheaimofthestudywastoevaluatetheeffectsofEpoetin-Beta on anemia and sustained viralresponse in patients with chronic hepatitis Creceiving treatment with pegylated interferonand ribavirin. Forty-two Caucasian patients withchronic hepatitis C infection, treated with pegy-lated interferon a-2a or a-2b plus ribavirin, whoexperienced at least a 2 log decline in HCV-RNAin the first month of therapy and a 2.5g/dlhemoglobin drop from baseline, were recruited.They were divided into two groups: 22 patientsreceived Epoetin-Beta 30,000U administereds.c. q.w. (group A) and 20 patients received areduced ribavirin dose of 600mg daily (group B).Theend-of-treatmentresponsewas95.4%(21/22)in group A and 80% (16/20) (P¼0.2) in group B.Sustained viral response in group A was 81.8%(18/22), statistically higher than in group B (45%,9/20) (P¼0.03). Mean corpuscular volume oferythrocytes was statistically lower in group Athan in group B 4 weeks after starting Epoetin-Betaorreducedribavirindose(P<0.001),end-of-treatment (P<0.001) and after 6 months follow-up(P<0.001).Anegativecorrelationbetweenthelevels of ferritin serum was found in group A atthe baseline and mean corpuscular volumevalue after 1 month of combination antiviraltherapy (r¼ 0.45; P¼0.35), 4 weeks after start-ing Epoetin-Beta (r¼ 0.43; P¼0.04) andafter 6 months follow-up (r¼ 0.45; P¼0.03).Administration of Epoetin-Beta increases sus-tained viral response rates among patientsdeveloping anemia, because the standarddose of ribavirin is maintained, thereby reducingthe side-effects of antiviral treatment. J. Med.Virol. 82:49–56,2010.
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USE OF Epoetin Beta DURING COMBINATION THERAPY OF INFECTION WITH HEPATITIS C VIRUS WITH RIBAVIRIN IMPROVES A SUSTAINED VIRAL RESPONSE
Journal of Medical Virology, 2009Co-Authors: Katia Falasca, Claudio Ucciferri, Paola Mancino, Valeria Gorgoretti, Eligio Pizzigallo, Jacopo VecchietAbstract:The aim of the study was to evaluate the effects of Epoetin-Beta on anaemia and sustained viral response in patients with chronic hepatitis C receiving treatment with pegylated interferon and ribavirin. Forty-two Caucasian patients with chronic hepatitis C infection, treated with pegylated interferon α-2a or α-2b plus ribavirin, who experienced at least a 2 log decline in HCV-RNA in the first month of therapy and a ≥ 2.5 g/dl haemoglobin drop from baseline, were recruited. They were divided into two groups: 22 patients received Epoetin-Beta 30.000U administered s.c. q.w.(group A) and 20 patients received a reduced ribavirin dose of 600 mg daily(group B). The end-of-treatment response was 95.4%(21/22) in group A and 80%(16/20) (p=0.2) in group B. Sustained viral response in group A was 81.8% (18/22), statistically higher than in group B(45%, 9/20) (p=0.03). Mean corpuscular volume of erythrocytes was statistically lower in group A than in group B 4 weeks after starting Epoetin-Beta or reduced ribavirin dose (p
Nagahiro Saijo - One of the best experts on this subject based on the ideXlab platform.
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meta analysis of Epoetin Beta and darbEpoetin alfa treatment for chemotherapy induced anemia and mortality individual patient data from japanese randomized placebo controlled trials
Cancer Science, 2013Co-Authors: Yasuo Ohashi, Yukari Uemura, Rumiko Okamoto, Hironobu Ohmatsu, Yasuhito Fujisaka, Noriyuki Katsumata, Toru Sugiyama, Nagahiro Saijo, Tomomitsu HottaAbstract:Erythropoiesis-stimulating agents (ESA) reduce the need for transfusions and improve the quality of life in patients receiving chemotherapy, but several clinical trials have suggested that ESA might have a negative impact on survival. To evaluate the efficacy and safety of ESA, Epoetin Beta and darbEpoetin alfa, including their impact on overall survival and thromboembolic events, we conducted an individual data-based meta-analysis of three randomized, placebo-controlled trials studying Japanese patients with chemotherapy-induced anemia. All trials were conducted in compliance with Good Clinical Practice. A total of 511 patients with solid tumor or lymphoma (Epoetin Beta or darbEpoetin alfa, n = 273; placebo, n = 238) were included. The ESA significantly reduced the risk of transfusion (relative risk, 0.47; 95% confidence interval, 0.29–0.76). No significant effect of the ESA on overall survival was observed (unadjusted hazard ratio, 1.00; 95% confidence interval, 0.75–1.34). A prespecified subgroup analysis showed no strong interaction between the baseline hemoglobin concentration and the effect of ESA on overall survival. Among the ESA-treated patients, the highest hemoglobin achieved during the treatment period in each patient had no impact on mortality. No increase in thromboembolic events was observed in the ESA-treated patients (0.7% vs 1.7% placebo). The ESA reduced the risk of transfusion without a negative impact on the survival of patients with chemotherapy-induced anemia.
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Meta‐analysis of Epoetin Beta and darbEpoetin alfa treatment for chemotherapy‐induced anemia and mortality: Individual patient data from Japanese randomized, placebo‐controlled trials
Cancer Science, 2013Co-Authors: Yasuo Ohashi, Yukari Uemura, Rumiko Okamoto, Hironobu Ohmatsu, Yasuhito Fujisaka, Noriyuki Katsumata, Toru Sugiyama, Nagahiro Saijo, Tomomitsu HottaAbstract:Erythropoiesis-stimulating agents (ESA) reduce the need for transfusions and improve the quality of life in patients receiving chemotherapy, but several clinical trials have suggested that ESA might have a negative impact on survival. To evaluate the efficacy and safety of ESA, Epoetin Beta and darbEpoetin alfa, including their impact on overall survival and thromboembolic events, we conducted an individual data-based meta-analysis of three randomized, placebo-controlled trials studying Japanese patients with chemotherapy-induced anemia. All trials were conducted in compliance with Good Clinical Practice. A total of 511 patients with solid tumor or lymphoma (Epoetin Beta or darbEpoetin alfa, n = 273; placebo, n = 238) were included. The ESA significantly reduced the risk of transfusion (relative risk, 0.47; 95% confidence interval, 0.29–0.76). No significant effect of the ESA on overall survival was observed (unadjusted hazard ratio, 1.00; 95% confidence interval, 0.75–1.34). A prespecified subgroup analysis showed no strong interaction between the baseline hemoglobin concentration and the effect of ESA on overall survival. Among the ESA-treated patients, the highest hemoglobin achieved during the treatment period in each patient had no impact on mortality. No increase in thromboembolic events was observed in the ESA-treated patients (0.7% vs 1.7% placebo). The ESA reduced the risk of transfusion without a negative impact on the survival of patients with chemotherapy-induced anemia.
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Weekly Epoetin Beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy.
Japanese journal of clinical oncology, 2008Co-Authors: Yasuhiro Suzuki, Yasuo Ohashi, Yutaka Tokuda, Yasuhiro Fujiwara, Hironobu Minami, Nagahiro SaijoAbstract:Objective: This study was aimed at investigating the effectiveness and safety of once-weekly Epoetin Beta for anaemic cancer patients receiving chemotherapy. Methods: A total of 104 patients with a haemoglobin level of � 11.0 g/dL were enrolled. Patients received a once-weekly subcutaneous dose of 36 000 IU Epoetin Beta for 12 weeks. If the increase in the haemoglobin level was ,1.0 g/dL after 6 weeks, or a red blood cell transfusion was required between days 15 and 42, the dose of Epoetin Beta was increased to 54 000 IU from the subsequent week. The primary endpoint was the percentage of patients who achieved a haemoglobin increase of � 2.0 g/dL; the haemoglobin response rate. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anaemia (FACT-An) questionnaire. Results: The haemoglobin response rate was 66.3% among the 98 patients (breast cancer: n ¼ 25; malignant lymphoma: n ¼ 21; ovarian cancer: n ¼ 20; lung cancer: n ¼ 15; other cancers: n ¼ 17) assessable for a haemoglobin response. Thirty-nine patients (39.8%) required a dose escalation to 54 000 IU. At the end of the study, QOL assessable patients (n ¼ 96) showed a mean improvement in the FACT-An total fatigue subscale score (FSS) of 0.3 points from baseline. Patients with a haemoglobin response had a mean change in the total FSS of þ3.2, compared with 23.4 for patients without a haemoglobin response. No serious adverse event of Epoetin Beta was observed. Conclusions: Epoetin Beta administered at an initial dose of 36 000 IU once-weekly was well tolerated, with increased haemoglobin levels and improved QOL in anaemic cancer patients receiving myelosuppressive chemotherapy.
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Pharmacokinetics and pharmacodynamics of weekly Epoetin Beta in lung cancer patients.
Japanese journal of clinical oncology, 2006Co-Authors: Yasuhito Fujisaka, Ikuo Sekine, Hiroshi Nokihara, Atsushi Horiike, Hideo Kunitoh, Noboru Yamamoto, Tetsuro Kodama, Tomohide Tamura, Yuichiro Ohe, Nagahiro SaijoAbstract:Background To assess the pharmacokinetic profile and time-course of trough concentrations and hemoglobin levels associated with subcutaneous weekly administration of Epoetin Beta in lung cancer patients with chemotherapy-induced anemia. Methods Epoetin Beta was subcutaneously administered to 15 anemic lung cancer patients once weekly for 8 weeks at doses of 9000, 18,000 and 36,000 IU. Pharmacokinetic parameters (C(max), AUC(inf) and T(1/2)) were determined after the first single dose administration on a model-independent basis, and the relationship between the dose and these parameters was examined for linearity. Results Weekly administration of Epoetin Beta at 9000, 18,000 and 36,000 IU produced C(max) values of 308 +/- 117 (mean +/- standard deviation), 678 +/- 86.7 and 1316 +/- 766 mIU/ml, and AUC(inf) values of 15,300 +/- 9524, 54,574 +/- 16,265 and 88,501 +/- 55,687 hr mIU/ml, respectively, showing dose-proportional increases. Trough concentrations tended to increase in the presence of severe bone marrow suppression induced by chemotherapy or other factors. Extremely high values were seen in three patients, but there was no apparent trend toward an increase with repeated doses. After 8 weeks' administration at 9000, 18,000 and 36,000 IU, hemoglobin levels were changed by -0.37 +/- 1.26, 2.15 +/- 1.36 and 2.82 +/- 2.17 g/dl, respectively. Conclusions Epoetin Beta exhibited linear pharmacokinetics when administered to anemic cancer patients at weekly doses of 9000-36,000 IU and did not cause drug accumulation. Hemoglobin levels increased with weekly doses of 18,000 or 36,000 IU.
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Pharmacokinetics and pharmacodynamics of weekly Epoetin Beta in lung cancer patients with chemotherapy-induced anemia
Journal of Clinical Oncology, 2004Co-Authors: Yasuhito Fujisaka, Ikuo Sekine, Tomoki Tamura, Hiroshi Nokihara, Atsushi Horiike, Hideo Kunitoh, Noboru Yamamoto, Tetsuro Kodama, Nagahiro SaijoAbstract:8206 Background: The dose of Erythropoietin for chemotherapy-induced anemia in cancer patients is considerably higher than the one used for anemia due to renal failure. However, limited number of reports on pharmacokinetics (PK) with higher dose are available. We carried out the PK and pharmacodynamic study of Epoetin Beta (EPOCH) in lung cancer (LC) patients with chemotherapy-induced anemia. Methods: Fifteen LC patients with chemotherapy-induced anemia [hemoglobin (Hb) level of 11 g/dL or less] received EPOCH 9000, 18000 or 36000 IU subcutaneously (SC), weekly for 8 weeks. We estimated the PK parameters following the first administration of EPOCH and also measured the trough level of Erythropoietin and Hb level over 7 weeks. Results: Cmax and AUC rose in proportion to the dose given, and T\batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \({1}/{2}\) \end{document}, Vd, and CL appeared almost stable ...
Javier De Castro - One of the best experts on this subject based on the ideXlab platform.
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Early intervention with Epoetin Beta prevents severe anaemia in lung cancer patients receiving platinum-based chemotherapy: a subgroup analysis of the NeoPrevent study.
Lung cancer (Amsterdam Netherlands), 2007Co-Authors: Javier De Castro, Cristobal Belda-iniesta, Dolores Isla, Manuel Domine, Alfredo Sánchez, Eduard Batiste, Manuel González BarónAbstract:Summary The NeoPrevent study showed that early intervention with Epoetin Beta could prevent severe anaemia in patients with solid tumours receiving platinum-based chemotherapy. An early intervention strategy may be particularly warranted in patients with lung cancer, as anaemia is very common in these patients and can be severe. The purpose of this study was to examine the efficacy and safety of Epoetin Beta in the subpopulation of patients with lung cancer included in the NeoPrevent study. Patients were enrolled if baseline haemoglobin (Hb) levels were ≤13g/dl (men) or ≤12g/dl (women), or fell to these levels during platinum-based chemotherapy. Patients received Epoetin Beta 150IU/kg three times weekly, until 4 weeks after last chemotherapy cycle. The anaemia prevention response was measured as the proportion of patients with an Hb response (Hb increase of >1g/dl) plus the proportion whose Hb was maintained at ±1g/dl of baseline. Quality of life (QoL) was measured using the linear analogue scale assessment. The NeoPrevent study included 255 patients in total, and the results for the 102 patients with lung cancer (non-small-cell lung cancer 64%; small-cell lung cancer 36%) are presented here. The overall anaemia prevention response was 90%, with Hb response in 60% of patients and maintenance of baseline Hb level in 30%. Only 9% of patients required transfusions. QoL improved significantly in patients with Hb response ( p p ≥0.578). Epoetin Beta was effective in preventing severe anaemia in lung cancer patients receiving platinum-based chemotherapy.
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Optimising the response to Epoetin Beta for the treatment of cancer-related anaemia
Current Medical Research and Opinion, 2006Co-Authors: Pierre Soubeyran, Javier De CastroAbstract:ABSTRACTEpoetin Beta is effective in treating anaemia associated with solid and haematological malignancies, improving haematopoietic response and quality of life, and reducing the need for transfusions, regardless of chemotherapy type. A rapid haemoglobin response to Epoetin Beta typically occurs within 3–4 weeks of initiating treatment. However, some patients remain untreated or do not respond to treatment. Anaemia therapy can be optimised by improving compliance. Epoetin Beta given once weekly is as effective as three times weekly dosing in treating anaemia associated with several types of cancer. Reduced frequency of dosing can improve patient compliance, and reduce costs of healthcare and lost productivity of patients and carers. The response to Epoetin Beta can also be improved in many cases by the addition of adjuvant intravenous iron to erythropoietic therapy, especially in patients with functional iron deficiency. New means of predicting and monitoring patients who require adjuvant iron have been...
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Early intervention with Epoetin Beta prevents severe anaemia in patients with solid tumours receiving platinum-based chemotherapy: results of the NeoPrevent study.
Cancer chemotherapy and pharmacology, 2006Co-Authors: Javier De Castro, Dolores Isla, Alfredo Sánchez, Amalio Ordóñez, Antonio Arrivi, Jose Luis Manzano, Manuel González BarónAbstract:Background Anaemia is common during platinum-based chemotherapy. This study aimed to evaluate the efficacy and safety of Epoetin Beta in the prevention of severe anaemia in patients with solid tumours receiving concomitant platinum therapy.
D Mitsibounas - One of the best experts on this subject based on the ideXlab platform.
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once weekly Epoetin Beta therapy in patients with solid tumours and chemotherapy induced anaemia a randomized double blind dose finding study
European Journal of Cancer Care, 2008Co-Authors: P Heras, K Kritikos, A Hatzopoulos, D MitsibounasAbstract:Anaemia is common in patients receiving chemotherapy, causing symptoms that have a major impact on quality of life (QoL). Epoetin Beta rapidly increases haemoglobin (Hb) levels and improves QoL in anaemic patients with a variety of tumours. This was a randomized, double-blind, parallel-group, dose-finding study assessing the efficacy and safety of once-weekly Epoetin Beta in patients with solid tumours receiving chemotherapy. Adult patients with anaemia (Hb < 11 g/dL) were randomized to receive Epoetin Beta 30 000 IU or 20 000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Haemoglobin levels, transfusion need and QoL [Functional Assesment of Cancer Therapy-fatigue (FACT-F) subscale score] were assessed at regular intervals. Fifty patients were randomized; 30 patients received Epoetin Beta 30 000 IU once weekly and 20 received 20 000 IU once weekly. Mean (± SD) increase in Hb from baseline to week 12 was 1.75 ± 2.15 g/dL in the 30 000 IU group (P = 0.008 vs. baseline) and 1.04 ± 1.75 g/dL in the 20 000 IU group (non-significant). Haemoglobin response (increase in Hb ≥2 g/dL from baseline) was observed in 78.3% of patients receiving Epoetin Beta 30 000 IU and 66.7% receiving Epoetin Beta 20 000 IU. Improvements in FACT-F subscale score were significantly (P < 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both Epoetin Beta regiments were well tolerated and there were no dose-dependant adverse events. Epoetin Beta 30 000 IU once weekly is an effective and well-tolerated treatment of anaemia in patients with solid tumours.
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Once-weekly Epoetin Beta therapy in patients with solid tumours and chemotherapy-induced anaemia: a randomized, double-blind, dose-finding study.
European journal of cancer care, 2008Co-Authors: P Heras, K Kritikos, A Hatzopoulos, D MitsibounasAbstract:Anaemia is common in patients receiving chemotherapy, causing symptoms that have a major impact on quality of life (QoL). Epoetin Beta rapidly increases haemoglobin (Hb) levels and improves QoL in anaemic patients with a variety of tumours. This was a randomized, double-blind, parallel-group, dose-finding study assessing the efficacy and safety of once-weekly Epoetin Beta in patients with solid tumours receiving chemotherapy. Adult patients with anaemia (Hb