Long-term cardiac toxicity after adjuvant epirubicin-based chemotherapy in early breast cancer: French Adjuvant Study Group Results

Fumoleau, P.; Roché, Henri; Kerbrat, Pierre; Bonneterre, Jacques; Romestaing, P.; Fargeot, P.; Namer, M.; Monnier, Alain; Montcuquet, P.; Goudier, Marie-Josèphe; Luporsi, É.

doi:10.1093/annonc/mdj034

Cited by 100 publications

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“…The number of cardiac events was identical and the incidence of decrease in LVEF during the follow-up period was 0.8 and 2.1%, respectively, without any development of subsequent cardiac complications or CHF. These results confirmed observations reported from our whole FASG database, which showed that the use of epirubicin-based adjuvant chemotherapy was associated with a low risk of left ventricular dysfunctions ( [Fumoleau et al, 2006). When epirubicin was delivered within recommended doses, a favourable benefit/risk ratio was maintained.…”

Section: Discussionsupporting

confidence: 89%

Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

et al. 2007

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The aim of the study was to compare our reference adjuvant chemotherapy, FEC100 (fluorouracil 500 mg m −2 , epirubicin 100 mg m −2 and cyclophosphamide 500 mg m −2 , six cycles every 21 days), to an epirubicin–vinorelbine (Epi-Vnr) combination for early, poor-prognosis breast cancer patients. Patients (482) were randomised to receive FEC100, or Epi-Vnr (epirubicin 50 mg m −2 day 1 and vinorelbine 25 mg m −2 , days 1 and 8, six cycles every 21 days). The 7-year disease-free survival rates were 59.4 and 58.8%, respectively ( P =0.47). The relative dose intensity of planned epirubicin doses was 89.1% with FEC100 and 88.9% with Epi-Vnr. There were significantly more grades 3–4 neutropenia ( P =0.009) with Epi-Vnr, and significantly more nausea-vomiting ( P <0.0001), stomatitis ( P =0.0007) and alopecia ( P <0.0001) with FEC100. No cases of congestive heart failure were reported, whereas four decreases in left ventricular ejection fraction occurred after FEC100 and five after Epi-Vnr. One case of acute myeloblastic leukaemia was registered in the FEC100 arm. After 7 years of follow-up, there was no difference between treatment arms. Epi-Vnr regimen provided a good efficacy in such poor-prognosis breast cancer patients, and could be an alternative to FEC100, taking into account respective safety profiles of both regimens.

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Section: Discussionsupporting

confidence: 89%

Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

et al. 2007

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“…8 Anthracycline cardiotoxicity comprises both an early toxicity, generally light and reversible, and a late toxicity, dose-dependent and irreversible. 9 Cardiotoxicity severity is also variable and ranges from abnormalities that become apparent only during exercise 2 to severe congestive heart failure (CHF). 4 Swain et al 10 estimated the incidence of Doxorubicin-induced CHF at 5.1%.…”

Section: Discussionmentioning

confidence: 99%

Pre-operative cardiac workup after anthracycline-based neoadjuvant chemotherapy. Is it really necessary?

Shapiro

Barsuk

Segev

et al. 2011

annals

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INTRODUCTION In patients receiving pre-operative anthracyclines for locally advanced breast cancer, early cardiotoxicity is a well-recognised complication that may interfere with surgery. The aim of this study was to assess the safety of breast surgery after neoadjuvant treatment with Doxorubicin. PATIENTS AND METHODS A retrospective study of breast cancer patients treated with Doxorubicin as part of their neoadjuvant protocol. All patients were subsequently operated in our institution. Intra-operative and postoperative haemodynamic, cardiac or respiratory events were collected. RESULTS A total of 83 patients were included. All patients had a normal left ventricular ejection fraction before starting on chemotherapy. Doxorubicin was given in conjunction with Cyclophosphamide and Paclitaxel. The cumulative dose of Doxorubicin was 240 mg/m 2 . All patients completed their chemotherapy less than a year before surgery and were clinically asymptomatic. Of the patients, 2.3% displayed a significant reduction in cardiac function to meet cardiotoxicity criteria, although not clinically apparent. No complications occurred intra-operatively or postoperatively. CONCLUSIONS Breast surgery can be safely performed after breast neoadjuvant chemotherapy with Doxorubicin. The risk of early cardiotoxicity does not mandate a cardiac function assessment after completion of treatment. Work-up should be individualised according to the anthracycline regimen, patient's cardiac risk factors and functional status before surgery.

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“…2 This process is particularly true for reporting side effects associated with administration of systemic chemotherapy. [3][4][5][6][7][8][9][10][11][12][13][14][15] However, clinical trials generally have rigid eligibility criteria, often excluding elderly patients, pregnant women, patients with multiple coexisting diseases, and those taking medications suspected of interacting with the study drug. 16,17 Therefore, study participants (motivated volunteers) in clinical trials often represent a much more homogeneous patient population in terms of gender, age, race/ethnicity, and comorbidity, and they are not representative of the population at large, particularly the elderly population who are often substantially underrepresented in clinical trials.…”

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confidence: 99%

“…31,32 Several reports have been published on chemotherapy-associated cardiac complications, particularly anthracycline-containing agents that are known to be associated with a range of cardiotoxic syndromes. [11][12][13] Cardiotoxicity may occur either immediately at the time of drug administration or months to years after treatment. Two studies recently examined the incidence of congestive heart failure associated with chemotherapy for breast cancer and found a 14% to 35% increase in risks for those receiving chemotherapy.…”

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confidence: 99%

Cardiac toxicity associated with anthracycline‐containing chemotherapy in older women with breast cancer

Xia

Liu

et al. 2009

Cancer

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Objective To identify the autoantigen recognized by the autoantibody that is associated with clinically amyopathic dermatomyositis (C‐ADM) and rapidly progressive interstitial lung disease (ILD). Methods An anti–CADM‐140 antibody–positive prototype serum sample was used to screen a HeLa cell–derived complementary DNA (cDNA) library. Selected cDNA clones were further evaluated by immunoprecipitation of their in vitro–transcribed and in vitro–translated products using anti–CADM‐140 antibody–positive and anti‐CADM‐140 antibody–negative sera. The lysates of COS‐7 cells transfected with the putative antigen were similarly tested. An enzyme‐linked immunosorbent assay (ELISA) to detect the anti–CADM‐140 antibody was established using a recombinant CADM‐140 antigen, and its specificity and sensitivity for C‐ADM and rapidly progressive ILD were assessed in 294 patients with various connective tissue diseases. Results By cDNA library screening and immunoprecipitation of in vitro–transcribed and in vitro–translated products, we obtained a cDNA clone encoding melanoma differentiation–associated gene 5 (MDA‐5). The anti–CADM‐140 antibodies in patients' sera specifically reacted with MDA‐5 protein expressed in cells transfected with full‐length MDA‐5 cDNA, confirming the identity of MDA‐5 as the CADM‐140 autoantigen. The ELISA, using recombinant MDA‐5 protein as the antigen, showed an analytical sensitivity of 85% and analytical specificity of 100%, in comparison with the “gold standard” immunoprecipitation assay, and was useful for identifying patients with C‐ADM and/or rapidly progressive ILD. Conclusion Given that RNA helicase encoded by MDA‐5 is a critical molecule involved in the innate immune defense against viruses, viral infection may play an important role in the pathogenesis of C‐ADM and rapidly progressive ILD. Moreover, our ELISA using recombinant MDA‐5 protein makes detection of the anti–CADM‐140 antibody routinely available.

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Long-term cardiac toxicity after adjuvant epirubicin-based chemotherapy in early breast cancer: French Adjuvant Study Group Results

Abstract: After a long-term follow-up, epirubicin-related LVD risk was acceptable (1.36%) with one toxic death (0.04%). In 78% of cases, LVD were transient or well controlled.

Cited by 100 publications

References 20 publications

Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

Pre-operative cardiac workup after anthracycline-based neoadjuvant chemotherapy. Is it really necessary?

Cardiac toxicity associated with anthracycline‐containing chemotherapy in older women with breast cancer

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