Dose-Intensive Epirubicin-Based Chemotherapy Is Superior to an Intensive Intravenous Cyclophosphamide, Methotrexate, and Fluorouracil Regimen in Metastatic Breast Cancer: A Randomized Multinational Study

Ackland, Stephen P.; Antón, Antonio; Breitbach, George Peter; E, Colajori; Tursi, Jennifer; Delfino, Carlos; Efremidis, Anna; Ezzat, Adnan; Fittipaldo, A.; Kolarić, K; Lopez, Massimo; Viaro, Donatella

doi:10.1200/jco.2001.19.4.943

Cited by 51 publications

(28 citation statements)

References 40 publications

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“…Likewise, FEC is known to typically achieve median time to disease progression and median survival of 8.9 and 20.1 months, respectively, with an overall response rate of 57% [14]. Response rates achieved for monotherapy with capecitabine in patients pretreated with anthracyclines or taxanes range from 15 to 26%, with a median survival of approximately 1 year for patients showing disease progression following initial treatment [15,16,17].…”

Section: Discussionmentioning

confidence: 99%

Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

et al. 2005

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Objective: Patients with metastatic breast cancer (MBC) generally have a poor prognosis. Many of these patients have a good performance status. A new all-oral regimen (XIC) was evaluated in a phase II trial. The impact of the regimen on the safety and efficacy of the drug, as well as quality of life (QOL) of the patients was assessed. Patients andMethods:From September 2000 to September 2001, informed consent was obtained from 20 heavily pretreated women with MBC. They were placed on a 6-week cycle regimen comprising capecitabine (X; 2,000 mg/m²/day in two divided doses for 2 weeks then 1 week rest), idarubicin (I; 10 mg/m²/day, days 1, 3 and 5) and cyclophosphamide (C; 100 mg/m²/day for 2 weeks then 1 week rest). Results: Toxicities were generally tolerable. One patient had grade III neutropenia, which was reversible on cessation of treatment. One patient (5%) had a complete response and 4 patients (20%) achieved partial responses, yielding an overall response rate of 25%. Eight patients (40%) had stable disease. Median time to disease progression and median survival time were 13.4 and 23.7 months, respectively. Global and physical EORTC QLQ-30 scores showed no significant decrease in QOL. Conclusion: This is a small-scale study. XIC was generally well tolerated and favoured by the patients. This moderately active and convenient ‘all-oral’ regimen deserves clinical trials at a wider scale.

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Section: Discussionmentioning

confidence: 99%

Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

et al. 2005

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“…The use of anthracyclines in chemotherapy regimens is now standard practice in treating breast cancers [1]. Anthracyclines act by directly intercalating with DNA and causing free radical release, therefore inhibiting tumour cell proliferation [1].…”

Section: Introductionmentioning

confidence: 99%

“…Anthracyclines act by directly intercalating with DNA and causing free radical release, therefore inhibiting tumour cell proliferation [1]. The most commonly used anthracyclines in combination breast cancer chemotherapy are doxorubicin and epirubicin [2], and due to the success in achieving greater survival rates, they have now set a new benchmark for breast cancer chemotherapy [3,4].…”

Section: Introductionmentioning

confidence: 99%

Combination chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil causes trabecular bone loss, bone marrow cell depletion and marrow adiposity in female rats

et al. 2015

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The introduction of anthracyclines to adjuvant chemotherapy has increased survival rates among breast cancer patients. Cyclophosphamide, epirubicin and 5-fluorouracil (CEF) combination therapy is now one of the preferred regimens for treating node-positive breast cancer due to better survival with less toxicity involved. Despite the increasing use of CEF, its potential in causing adverse skeletal effects remains unclear. Using a mature female rat model mimicking the clinical setting, this study examined the effects of CEF treatment on bone and bone marrow in long bones. Following six cycles of CEF treatment (weekly intravenous injections of cyclophosphamide at 10 mg/kg, epirubicin at 2.5 mg/kg and 5-flurouracil at 10 mg/kg), a significant reduction in trabecular bone volume was observed at the metaphysis, which was associated with a reduced serum level of bone formation marker alkaline phosphatase (ALP), increased trends of osteoclast density and osteoclast area at the metaphysis, as well as an increased size of osteoclasts being formed from the bone marrow cells ex vivo. Moreover, a severe reduction of bone marrow cellularity was observed following CEF treatment, which was accompanied by an increase in marrow adipose tissue volume. This increase in marrow adiposity was associated with an expansion in adipocyte size but not in marrow adipocyte density. Overall, this study indicates that six cycles of CEF chemotherapy may induce some bone loss and severe bone marrow damage. Mechanisms for CEF-induced bone/bone marrow pathologies and potential preventive strategies warrant further investigation.

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“…It was refused marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2008 due to its marginal benefit with significant peripheral neuropathy [30]. Ixabepilone as monotherapy and in combination with [31,32]. There are also other combination regimens with gemcitabine, cisplatin, vinorelbine, epirubicin, or etoposide with high response rates often in heavily pretreated patients, but without superior survival when compared to less toxic regimens or even single agents.…”

Section: Discussionmentioning

confidence: 99%

A multicenter phase II trial of docetaxel and capecitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer

Karachaliou

Ziras

Syrigos

et al. 2012

Cancer Chemother Pharmacol

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Dose-Intensive Epirubicin-Based Chemotherapy Is Superior to an Intensive Intravenous Cyclophosphamide, Methotrexate, and Fluorouracil Regimen in Metastatic Breast Cancer: A Randomized Multinational Study

Abstract: This CEF regimen safely provides significantly better tumor control than CMF, manifest as a higher response rate, and longer TTP and TTF, but not survival, when used as first-line chemotherapy for metastatic breast cancer.

Cited by 51 publications

References 40 publications

Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

Combination chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil causes trabecular bone loss, bone marrow cell depletion and marrow adiposity in female rats

A multicenter phase II trial of docetaxel and capecitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer

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