NEWS HIGHLIGHTSMedia Articles Related to Ellence (Epirubicin)
Clinical Budgeting And Contracting Excellence Strategies That Empower Investigators And Support Patient Enrollment 7-8 Dec, 2009, Princeton New Jersey
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
Alarming trends captured in clinical study metrics show the glaring discrepancy between the miniscule number of sites that are able to enroll the amount of patients study sponsors are requesting and the amount of sites that cannot. This enrollment inability leads to trial stoppages, lost revenue and most importantly the delay of new treatments used to combat diseases that are available for the population.
British Dental Association Calls For NICE Evaluation Of Decontamination Evidence Base, UK
Source: Dentistry News From Medical News Today [2009.11.18]
The British Dental Association (BDA) has called once again for a full review of the evidence base for the HTM 01-05 guidance document on decontamination in dental surgeries. The BDA has written to the Department of Health (DH) renewing its 2007 call for a National Institute for Health and Clinical Excellence (NICE) review of the evidence, after it emerged that three areas of the guidance have already been amended before the document is even printed.
Indiana University Receives NIH Grant To Improve Health Care In East Africa
Source: IT / Internet / E-mail News From Medical News Today [2009.11.18]
A $1.3 million grant to Indiana University from the National Institutes of Health's Fogarty International Center will establish the East African Center of Excellence in Health Informatics.
2009/068 New NICE Programme To Evaluate Medical Technologies Established
Source: IT / Internet / E-mail News From Medical News Today [2009.11.17]
The National Institute for Health and Clinical Excellence is launching a new programme focusing specifically on the evaluation of innovative medical technologies (including devices and diagnostics). This new programme will both compliment and operate in conjunction with NICE's existing technology appraisal capacity, which will continue to evaluate new pharmaceutical and biotechnology products.
Workplace Stress - Examine The Causes Says UNISON, UK
Source: Anxiety / Stress News From Medical News Today [2009.11.06]
UNISON, the UK's largest public sector union, has accused employers of "burying their heads in the sand," instead of tackling stress, anxiety and depression in the workplace. The latest statistics from the National Institute for Health and Clinical Excellence show that 13.7 million working days are lost each year as a result of work-related illness, costing employers a massive £28.3bn a year.
Published Studies Related to Ellence (Epirubicin)
Randomized trial of cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil with node-positive breast cancer in Japan. [2009.07.03]
BACKGROUND: To compare the cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy and the anthracycline-containing regimen cyclophosphamide, epirubicin, and fluorouracil (CEF) to evaluate the efficacy and safety of the latter... CONCLUSION: Whereas CEF had a good trend compare with CMF, it could not be proven statistically significant. The principal cause of the failure seems to be insufficient power, that is, the dose intensity (EPI: 60 mg/m(2)) set 10 years ago, when the trial began, was low, and the number of trial subjects was small because of the background of the times, which made the accumulation of cases extremely difficult. However, the trial should be considered to be meaningful, as it was the first, formally conducted controlled trial on chemotherapy in Japan.
Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer. [2009.06]
BACKGROUND: This phase III clinical study was designed to investigate whether 6 cycles of epirubicin plus docetaxel (ED) is more effective than 4 cycles of ED as neoadjuvant chemotherapy (NC) in patients with stage II or III breast cancer... CONCLUSION: Six cycles of ED enhanced the rates of pCR and BCS compared with 4 cycles without increasing treatment-related toxicities.
Long-term benefit of high-dose epirubicin in adjuvant chemotherapy for node-positive breast cancer: 15-year efficacy results of the Belgian multicentre study. [2009.02.10]
PURPOSE: The 4-year results of this trial demonstrated that a higher dose of epirubicin with cyclophosphamide (HEC) is superior to a lower dose of epirubicin, 60 mg/m(2) (EC), for event-free survival (EFS; 27% reduction), but is not superior to classical oral cyclophosphamide, methotrexate, and fluorouracil (CMF) in the adjuvant treatment of node-positive breast cancer. Herein we report the 15-year data on efficacy and long-term toxicity of this three-arm Belgian multicenter trial... CONCLUSION: Treatment with HEC demonstrated superior EFS when compared with lower-dose epirubicin. However, we do not recommend the use of HEC regimen in daily clinical practice, mainly because of the higher risk of cardiotoxicity related to the cumulative doses of epirubicin and the lack of superiority of anthracyclines over CMF in our study.
EPO in combination with G-CSF improves mobilization effectiveness after chemotherapy with ifosfamide, epirubicin and etoposide and reduces costs during mobilization and transplantation of autologous hematopoietic progenitor cells. [2009.02]
A successful stem cell harvest is a prerequisite for peripheral blood SCT. We investigated the number of CD34(+) cells mobilized, the number of leukaphereses needed and the expenses of treatment for 28 patients with multiple myeloma randomly assigned to receive either G-CSF alone or G-CSF+EPO for stem cell mobilization after chemotherapy with ifosfamide, epirubicin and etoposide...
Gemcitabine plus conventional-dose epirubicin versus gemcitabine plus cisplatin as first-line chemotherapy for stage IIIB/IV non-small cell lung carcinoma--a randomized phase II trial. [2008.12]
BACKGROUND: Epirubicin was effective for the treatment of non-small cell lung carcinoma (NSCLC). This study compared the efficacy and safety of gemcitabine plus conventional-dose epirubicin (GE) with gemcitabine-cisplatin (GC) as first-line chemotherapy for stage IIIB/IV NSCLC and evaluated the predictive value of nuclear expression of excision repair cross-complementing group 1 (ERCC1) and topoisomerase IIalpha (TopoIIalpha) on treatment outcome... CONCLUSION: GE regimen is effective and well-tolerated for NSCLC patients. Expression of both ERCC1 and TopoIIalpha may be associated with poor response to chemotherapy.
Clinical Trials Related to Ellence (Epirubicin)
Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer [Terminated]
The purpose of this study is to compare two combinations of drugs, epirubicin given with a
taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to
see if one of the combinations is better at preventing or delaying the time for breast cancer
recurrence and death after 3 years. The study will also evaluate the side effects of both
treatment combinations.
Study of Docetaxel in Breast Cancer Patients [Completed]
Primary objectives:
- To compare the disease free survival (DFS) in patients treated with the sequential
epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that
in patients treated with the same treatment plus docetaxel given sequentially after
epidoxorubicin
Secondary objectives:
- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and
CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with
sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen
- To evaluate the overall survival in each arm
- To evaluate the tolerability of a sequential intensified
epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen
versus a standard sequential epidoxorubicin/CMF regimen (arm A)
Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and
cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast
cancer.
Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE) [Active, not recruiting]
The present clinical trial will investigate the efficacy of a sequential interval-shortened
and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative
sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast
cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of
life is to be investigated in both treatment arms.
Arm A: Sequential treatment in standard doses with Epirubicin (90 mg/m2)/cyclophosphamide
(600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×.
Pegfilgratim should be used as secondary preventive after febrile neutropenia in the standard
arm of the study, or in exceptional cases also after severe febrile neutropenia necessitating
postponement of the treatment by more than one week ± Darbepoetin alfa 1 × 4. 5 µg/kg of body
weight every two weeks with the start of the first epirubicin dose (day 1) until 14 days
after the last dose of paclitaxel Daily oral intake of 200 mg iron unless there complications
occur with taking iron
Arm B: sequential dose-intensified, interval-shortened treatment with Epirubicin (150 mg/m2)
d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF (600/40/600 mg/m2) d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg after epirubicin and/or paclitaxel:
subcutaneous injection on day 2. After CMF pegfilgrastim should be used as a secondary
preventive measure
± Darbepoetin alfa 1 × 4. 5 µg/kg of body weight every two weeks with the start of the first
dose of epirubicin (day 1) until 14 days after the last dose of CMF Daily oral dose of 200 mg
iron unless complications occur in taking iron.
Primary goal: Determining the relapse-free survival time and overall survival after
dose-intensified sequential preoperative chemotherapy including anthracycline and taxan
and/or after preoperative chemotherapy including anthracycline followed by taxan in a
standard dose
Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer [Terminated]
The epirubicin/docetaxel combination is one of the most active and best tolerated
taxane/anthracycline combinations. In this phase II trial, we will further evaluate the
feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when
administered as first-line treatment for metastatic breast cancer.
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