scholarly journals Impact of cardio-oncology strategies in the management of breast cancer patients

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R Karmous ◽  
E Bennour ◽  
I Kammoun ◽  
A Sghaier ◽  
W Chaieb ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Treatment ◽  
Cardiac Dysfunction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Mean Delay ◽  
Anti Cancer ◽  
The Mean

Abstract Background Cardio-oncology has arisen as one of the most rapidly expanding fields of cardiovascular medicine. The accumulated evidence on the possibilities of early diagnosis of cardiotoxicity provided by imaging techniques as well as on the benefits of preventive and therapeutic interventions is also increasing. Objective This study reported our echocardiography lab's initial experience of a cardio-oncology follow-up program. Methods We prospectively studied the outcomes of 107 patients diagnosed with breast cancer who attended our follow-up program between 2017 and 2020. An echocardiographic monitoring were realised according to the chemotherapy protocol. Cancer therapy-related cardiac dysfunction (CTRCD) is defined, according to the european society of cardiology (ESC) guidelines of 2016, as a drop of left ventricular ejection fraction (LVEF) by >10 percentage points from baseline to a value <50%. A new entity named subclinical systolic dysfunction, is defined by a drop of global longitudinal strain (GLS) by >15% from baseline, however, LVEF remains >50%. The diagnosis should be confirmed by a second echocardiogram after 2–3 weeks. Results We enrolled 107 patients diagnosed with breast cancer and receiving anthracycline and/or trastuzumab. 27 patients were excluded for many reasons: 17 patients were lost to follow-up, 10 patients had an inadequate echo-imaging (8 had a follow-up without measurement of GLS and 2 patients were poorly echogenic). Only eighty patients were finally retained. The average age of our patients was 49.9±10.8 years. The mean left ventricular ejection fraction (LVEF) was at 64±4.4%. The incidence of CTRCD was 6%. the mean delay of diagnosis from the onset of chemotherapy was 174 days. It was reversible in 60% of cases after the initiation of a cardioprotective treatment which allowed the anti-cancer treatment pursuit. The incidence of subclinical cardiac dysfunction was 25%. The mean delay between the initiation of anti-cancer treatment and the diagnosis was 314.5 days. A cardioprotective treatment with Bblockers and angiotensin-converting enzyme (ACE) inhibitors was prescribed and all these patients recovered a normal GLS with a mean delay of three months and pursuied their chemotherapy. Conclusion We showed that timely cardiovascular evaluation, intervention and close monitoring in the context of a structured service allowed the majority of patients (99%) to pursue their anti-cancer treatment and to avoid the evolution to CTRCD in patients diagnosed with subclinical cardiac dysfunction. FUNDunding Acknowledgement Type of funding sources: None. Treated subclinical cardiac dysfunction

P3554CMR Fast-SENC intramyocardial LV & RV segmental strain helps manage cardioprotective therapy in patients exhibiting cardiotoxicity during cancer treatment

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Steen ◽  
M Montenbruck ◽  
P Wuelfing ◽  
S Esch ◽  
A K Schwarz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Heart Failure ◽  
Cardiac Function ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
The Impact

Abstract Background Cardiotoxicity during cancer treatment has become an acknowledged problem of chemotherapy medications and radiation therapy. Limitations of biomarkers and imaging tests such as echocardiography left ventricular ejection fraction (LVEF) hinder early detection of cardiotoxicity and proactive cardioprotective therapy. Once the heart is unable to compensate for subclinical dysfunction, systemic damage and remodeling occurs increasing the potential for heart failure. Fast-SENC segmental intramyocardial strain (fSENC) is a unique cardiac magnetic resonance imaging (CMR) test that regionally detects subclinical intramyocardial dysfunction in 1 heartbeat. This study evaluates the ability of fSENC to detect subclinical cardiotoxicity and manage cardioprotective therapy in cancer patients. Methods This single center, prospective Prefect Study was used to evaluate cardiotoxicity and the impact of cardioprotective therapy in Breast Cancer and Lymphoma patients (NCT03543228). fSENC was acquired with a 1.5T MRI and processed with the MyoStrain software to quantify intramyocardial strain. Segmental strain was measured in three short axis scans (basal, midventricular & apical) with 16LV/6RV longitudinal segments & three long axis scans (2-, 3-, 4-chamber) with 21LV/5RV circumferential segments. fSENC CMR was performed before chemotherapy, during and after anthracycline/taxan therapy, at 1 year follow-up, and as needed in between designated follow-up periods. Cardioprotective therapy was offered to patients meeting the definition of cardiotoxicity by the ESC Guidelines on Cardiotoxicity and/or ESMO Clinical Practice Guidelines or those observing a substantial decline in cardiac function. Comparisons were made with paired t-Test with a 95% confidence interval. Results Two hundred eight (208) CMRs were performed in fifty-two (52) patients (44 female). Patients had an average (± stdev) age of 53 (15) yrs, BMI of 26 (5) kg/m2; 77% had breast cancer, 23% had Lymphoma. fSENC CMRs required 11 (2) min total exam time. Figure 1 shows bar graphs of the % of normal LV myocardium (e.g. % LV MyoStrain Segments <−17%) at baseline and sequential follow-ups for patients without cardiotoxicity and with cardiotoxicity requiring cardioprotective therapy. Patients observing cardiotoxicity had a statistically significant decline in cardiac function measured by segmental fSENC (p=0.0002) which resolved after cardioprotective therapy. Figure 1 Conclusion Segmental fSENC intramyocardial strain detects subclinical cardiotoxicity during chemotherapy and impact of cardioprotective therapy. The ability to serve as a surrogate safety endpoint for chemotherapy or other pharmacological agents, and aid management of cardiotoxicity by serving as a surrogate efficacy endpoint for cardioprotection agents, dosage, and patient compliance may help physicians detect subclinical cardiac dysfunction, and proactively manage cancer patients to avoid early or late heart failure.

scholarly journals Assessment of Myocardial Work in Cancer Therapy-Related Cardiac Dysfunction and Analysis of CTRCD Prediction by Echocardiography

2021 ◽  
Vol 12 ◽  
Author(s):  
Jingyuan Guan ◽  
Wuyun Bao ◽  
Yao Xu ◽  
Wei Yang ◽  
Mengmeng Li ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Cardiac Dysfunction ◽  
Three Dimensional ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Two Dimensional ◽  
Ventricular Ejection Fraction ◽  
Change Rate

No study has examined myocardial work in subjects with cancer therapy-related cardiac dysfunction (CTRCD). Myocardial work, as a new ultrasonic indicator, reflects the metabolism and oxygen consumption of the left ventricle. The aim of this study was to test the relative value of new indices of myocardial work and global longitudinal strain (GLS) in detecting changes in myocardial function during the treatment of breast cancer by two-dimensional and three-dimensional echocardiography. We enrolled 79 breast cancer patients undergoing different tumor treatment regimens. Follow-up observation was conducted before and after chemotherapy. The effects of breast cancer chemotherapy and targeted therapy on the development of CTRCD [defined as an absolute reduction in left ventricular ejection fraction (LVEF) of &gt;5% to &lt;53%] were detected by two-dimensional and three-dimensional speckle tracking echocardiography. Our findings further indicate that LVEF, myocardial work index (GWI) and myocardial work efficiency (GWE) showed significant changes after the T6 cycle, and GLS showed significant changes after the T4 cycle (p &lt; 0.05). The three-dimensional strain changes after T6 and T8 had no advantages compared with GLS. Body mass index (BMI), the GLS change rate after the second cycle of chemotherapy (G2v) and the 3D-GCS change rate after the second cycle of chemotherapy (C2v) were independent factors that could predict the occurrence of CTRCD during follow-up, among which BMI was the best predictor (area under the curve, 0.922). In conclusion, the current study determined that GLS was superior to GWI in predicting cardiac function in patients with tumors with little variation in blood pressure. BMI, G2v and C2v can be used to predict the occurrence of CTRCD.

Trastuzumab-Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial

2007 ◽  
Vol 25 (25) ◽  
pp. 3859-3865 ◽  
Author(s):  
Thomas M. Suter ◽  
Marion Procter ◽  
Dirk J. van Veldhuisen ◽  
Michael Muscholl ◽  
Jonas Bergh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Effects ◽  
Cancer Patients ◽  
Cardiac Dysfunction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Ventricular Ejection Fraction ◽  
Neo Adjuvant Chemotherapy

Purpose The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Patients and Methods The Herceptin Adjuvant (HERA) trial is a three-group, multicenter, open-label randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in patients with HER-2–positive breast cancer. Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF ≥ 55%) were eligible. A repeat LVEF assessment was performed in case of cardiac dysfunction. Results Data were available for 1,693 patients randomly assigned to 1 year trastuzumab and 1,693 patients randomly assigned to observation. The incidence of trastuzumab discontinuation due to cardiac disorders was low (4.3%). The incidence of cardiac end points was higher in the trastuzumab group compared with observation (severe congestive heart failure [CHF], 0.60% v 0.00%; symptomatic CHF, 2.15% v 0.12%; confirmed significant LVEF drops, 3.04% v 0.53%). Most patients with cardiac dysfunction recovered in fewer than 6 months. Patients with trastuzumab-associated cardiac dysfunction were treated with higher cumulative doses of doxorubicin (287 mg/m2 v 257 mg/m2) or epirubicin (480 mg/m2 v 422 mg/m2) and had a lower screening LVEF and a higher body mass index. Conclusion Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria.

Abstract P232: Screening Past B-Type Natriuretic Peptide (BNP) Values to Identify Candidates for Treatment of Systolic Dysfunction

2011 ◽  
Vol 4 (suppl_1) ◽  
Author(s):  
Parisa Gholami ◽  
Shoutzu Lin ◽  
Paul Heidenreich
Keyword(s):  
Heart Failure ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Ventricular Ejection ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Significant Difference ◽  
The Mean

Background: BNP testing is now common though it is not clear if the test results are used to improve patient care. A high BNP may be an indicator that the left ventricular ejection fraction (LVEF) is low (<40%) such that the patient will benefit from life-prolonging therapy. Objective: To determine how often clinicians obtained a measure of LVEF (echocardiography, nuclear) following a high BNP value when the left ventricular ejection fraction (LVEF) was not known to be low (<40%). Methods and Results: We reviewed the medical records of 296 consecutive patients (inpatient or outpatient) with a BNP values of at least 200 pg/ml at a single medical center (tertiary hospital with 8 community clinics). A prior diagnosis of heart failure was made in 65%, while 42% had diabetes, 79% had hypertension, 59% had ischemic heart disease and 31% had chronic lung disease. The mean age was 73 ± 12 years, 75% were white, 10% black, 15% other and the mean BNP was 810 ± 814 pg/ml. The LVEF was known to be < 40% in 84 patients (28%, mean BNP value of 1094 ± 969 pg/ml). Of the remaining 212 patients without a known low LVEF, 161 (76%) had a prior LVEF >=40% ( mean BNP value of 673 ± 635 pg/ml), and 51 (24%) had no prior LVEF documented (mean BNP 775 ± 926 pg/ml). Following the high BNP, a measure of LVEF was obtained (including outside studies documented by the primary care provider) within 6 months in only 53% (113 of 212) of those with an LVEF not known to be low. Of those with a follow-up echocardiogram, the LVEF was <40% in 18/113 (16%) and >=40% in 95/113 (84%). There was no significant difference in mean initial BNP values between those with a follow-up LVEF <40% (872 ± 940pg/ml), >=40% (704 ± 737 pg/ml), or not done (661 ± 649 pg/ml, p=0.5). Conclusions: Follow-up measures of LVEF did not occur in almost 50% of patients with a high BNP where the information may have led to institution of life-prolonging therapy. Of those that did have a follow-up study a new diagnosis of depressesd LVEF was noted in 16%. Screening of existing BNP and LVEF data and may be an efficient strategy to identify patients that may benefit from life-prolonging therapy for heart failure.

The Relationship Between N-Terminal Pro-Brain Natriuretic Peptide Level and Myocardial Performance Index and Their Prognostic Importances in Patients With Acute Myocardial Infarction in Short Term Follow-up

2020 ◽  
Vol 1 (1) ◽  
pp. 12-17
Author(s):  
Mehmet Küçükosmanoğlu ◽  
Cihan Örem
Keyword(s):  
Heart Failure ◽  
Prognostic Significance ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ejection Time ◽  
Ventricular Ejection Fraction ◽  
Significant Difference ◽  
The Mean ◽  
The Relationship

Introduction: MPI is an echocardiographic parameter that exibit the left ventricular functions globally. NT-proBNP  is an important both diagnostic and prognostic factor in heart failure. In this study, we aimed to investigate the prognostic significance of serum NT-proBNP levels and MPI in patients with STEMI. Method: Totally 104 patients with a diagnosis of STEMI were included in the study. Patients followed for 30-days and questioned for presence of symptoms of heart failure (HF) and cardiac death. Patients were invited for outpatient control after 30-days and were divided into two groups: (HF (+) group) and (HF (-) group). Results: Totally 104 patients with STEMI were hospitalized in the coronary intensive care unit. Of those patients, 17 were female (16%), 87 were male (84%), and the mean age of the patients was 58.9±10.8 years. During the 30-day follow-up, 28 (27%) of 104 patients developed HF. The mean age, hypertension ratio and anterior STEMI rate were significantly higher in the HF (+) group compared to the HF (-) group. Ejection time (ET) and left ventricular ejection fraction (LVEF) were significantly lower and MPI was significantly higher in the HF (+) group. When the values on day first and  sixth were compared, NT-ProBNP levels were decreased in both groups. There was no significant difference between the two groups in terms of the change in MPI values on the first and sixth days. Multiple regression analysis showed that the presence of anterior MI, first day NT-proBNP level and LVEF were independently associated with development of HF and death. Conclusion: In our study, NT-proBNP levels were found to be positively associated with MPI in patients with acute STEMI. It was concluded that the level of NT-proBNP detected especially on the 1st day was more valuable than MPI in determining HF development and prognosis after STEMI.  

P6237Clinical utility of echocardiographic left-ventricular ejection fraction monitoring for cardiotoxicity risk assessment in patients with HER2+ early breast cancer undergoing trastuzumab-based therapy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Posch ◽  
T Glantschnig ◽  
S Firla ◽  
M Smolle ◽  
M Balic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
One Year ◽  
Over Time

Abstract Background Monitoring left-ventricular ejection fraction (LVEF) is a routinely-practiced strategy to survey patients with breast cancer (BC) towards cardiotoxic treatment effects. However, whether the LVEF as a single measurement or as a trajectory over time is truly sufficient to identify patients at high risk for cardiotoxicity is currently debated. Purpose To quantify the prognostic impact of LVEF and its change over time for predicting cardiotoxicity in women with HER2+ early BC. Methods We analyzed 1,136 echocardiography reports from 185 HER2+ early BC patients treated with trastuzumab ± chemoimmunoendocrine therapy in the neoadjuvant/adjuvant setting (Table 1). Cardiotoxicity was defined as a 10% decline in LVEF below 50%. Results Median baseline LVEF was 64% (25th-75th percentile: 60–69). Nineteen patients (10%) experienced cardiotoxicity (asymptomatic n=12, symptomatic n=7, during treatment n=19, treatment modification/termination n=14), Median time to cardiotoxicity was 6.7 months, and median LVEF decline in patients with cardiotoxicity was 18%. One-year cardiotoxicity risk was 7.6% in the 35 patients with a baseline LVEF≥60% and 24.5% in the 150 patients with a baseline LVEF<60% (Hazard Ratio (HR)=3.45, 95% CI: 1.35–8.75, Figure 1). During treatment, LVEF declined significantly faster in patients who developed cardiotoxicity than in patients without cardiotoxicity (1.3%/month vs. 0.1%/month, p<0.0001). A higher rate of LVEF decrease predicted for higher cardiotoxicity risk (HR per 0.1%/month higher LVEF decrease/month=2.50, 95% CI: 1.31–4.76, p=0.005), and cardiotoxicity risk increased by a factor of 1.7 per 5% absolute LVEF decline from baseline to first follow-up (HR=1.70, 95% CI: 1.30–2.38, p<0.0001). Thirty-six patients (19%) developed an LVEF decline of at least 5% from baseline to first follow-up (“early LVEF decline”). One-year cardiotoxicity risk was 6.8% in those without early LVEF decline and a baseline LVEF≥60% (n=117), 15.7% in those without an early LVEF decline and a baseline LVEF<60% (n=65), and 66.7% in those with an early LVEF decline and a baseline LVEF<60% (n=3), respectively (log-rank p<0.0001). Table 1. Baseline characteristics Age (years, median [IQR]) 55 [49–65] Estrogen receptor positive (n, %) 124 (67%) Neoadjuvant setting (n, %) 103 (56%) Figure 1. Risk of Cardiotoxicity. Conclusion Both a single LVEF measurement and the rate of LVEF decrease strongly predict cardiotoxicity in early BC patients undergoing HER2-targeted therapy. Routine LVEF monitoring identifies individuals at high risk of cardiotoxicity that may benefit from more sensitive screening techniques such as strain imaging.

P3118CMR Fast-SENC intramyocardial LV & RV segmental strain detects cardiotoxicity during oncology treatment and impact of cardioprotection therapy before echocardiography

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Steen ◽  
M Montenbruck ◽  
P Wuelfing ◽  
S Esch ◽  
A K Schwarz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Global Longitudinal Strain ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Lower Sensitivity ◽  
Pharmacological Agents ◽  
Ventricular Ejection Fraction ◽  
The Impact

Abstract Background The incidence of cardiotoxicity during cancer therapy is underestimated due to limitations of current diagnostic tests. Current biomarkers (BNP, NT-pro-BNP, hs-Troponin, etc.) and imaging calculations (e.g. echocardiography) such as left ventricular ejection fraction (LVEF) are currently included in the guidelines to designate cardiotoxicity during cancer therapy. Unfortunately, these diagnostics identify systemic damage in symptomatic patients after the heart is unable to compensate for regional dysfunction. Fast-SENC segmental intramyocardial strain (fSENC) is a unique cardiac magnetic resonance imaging (CMR) test that regionally detects subclinical intramyocardial dysfunction in 1 heartbeat. Methods This single center, prospective Prefect Study was used to evaluate cardiotoxicity and the impact of cardioprotective therapy in Breast Cancer and Lymphoma patients (NCT03543228). fSENC was acquired with a 1.5T MRI and processed with the software to quantify intramyocardial strain. Segmental strain was measured in three short axis scans (basal, midventricular, apical) with 16 LV/6 RV longitudinal segments & three long axis scans (2-, 3-, 4-chamber) with 21 LV/5 RV circumferential segments. fSENC CMR was performed before chemotherapy, during and after anthracycline/taxane therapy, at 1 year follow-up, and as needed in between designated follow-up periods. Cardioprotective therapy was offered to patients meeting the definition of cardiotoxicity by the ESC Guidelines on Cardiotoxicity and/or ESMO Clinical Practice Guidelines or those observing a substantial decline in cardiac function. Results Two hundred eight (208) CMRs were performed in fifty-two (52) patients (44 female). Patients had an average (± stdev) age of 53 (15) yrs, BMI of 26 (5) kg/m2; 77% had breast cancer, 23% had Lymphoma. fSENC CMRs required 11 (2) min total exam time. The % of normal fSENC (segmental stain <−17%) with a threshold of 65% showed a sensitivity of 87% and specificity of 89% in detecting cardiotoxicity while echocardiography GLS with a threshold of −17% observed a sensitivity of 20% and specificity of 88%. Figure 1 shows receiver operating characteristic curves for fSENC based on the percent of normal myocardium, and echocardiography global longitudinal strain (GLS) respectively. Global fSENC had substantially lower sensitivity than segmental fSENC despite having higher accuracy than the other global metrics. Figure 1 Conclusion Segmental fSENC intramyocardial strain detects subclinical dysfunction due to cardiotoxic response of chemotherapy before other biomarkers and imaging modalities. The ability to detect the subclinical cardiotoxicity of chemotherapy agents, or other pharmacological agents that cause or worsen heart failure, enables proactive prescription of cardioprotective medications to avoid tissue remodeling that precedes systemic cardiac dysfunction and worsening of global measures such as LVEF and current biomarkers.

Cardiac safety of pegylated liposomal doxorubicin (PLD) in combination with trastuzumab (T) in patients with metastatic breast cancer (MBC): Results from a multicenter phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1106-1106 ◽  
Author(s):  
E. Stickeler ◽  
D. O. Watermann ◽  
J. Woll ◽  
M. Foeldi ◽  
G. Gitsch
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Metastatic Breast ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Cardiac Safety ◽  
Ventricular Ejection Fraction ◽  
Cardiac Side Effects

1106 Background: Combination therapy of doxorubicin and trastuzumab is highly effective for Her2 positive MBC but characterized by frequent cardiac toxicity (CT). PLD can significantly reduce CT compared to conventional doxorubicin. Patients and Methods: 15 patients were enrolled in a phase II trial to evaluate cardiac safety of T (4 mg/Kg loading dose day 2, followed by weekly 2 mg/Kg) in combination with PLD (40 mg/m2 IV bolus day 1, q 28 d). 75% of pts. presented with more than 1 metastatic site and 40% for second line treatment. PLD was administered for 6 or 9 cycles, respectively, T until disease progression. To assess CT, all pts were evaluated with electrocardiogram (ECG) and echocardiograms (E) for Left Ventricular Ejection Fraction (LVEF) at baseline, every cycle during PLD and T, and every three months during T therapy alone. CT was defined as appearance of signs/ symptoms of congestive heart failure and/or an absolute decrease in LVEF > 10 units (below 50%) or decrease in LVEF > 15 units (above 50%). Results: Four pts. received 6 cycles, 4 pts. received 9 cycles of PLD, 4 pts discontinued treatment due to PD, 3 pts. due to toxicity. After a median follow up time of 15.4 months, 6 pts. (42.9%) demonstrated a clinical benefit and median OS was 16.2 months. Non cardiac side effects were mild with only 3 CTC Grade 3 events of 247 treatment cycles (1.2%). Three pts. developed minor ECG changes without pathological significance and 5 pts. had minor changes in their E with slight diastolic (n=3) or systolic (n=2) dysfunction. During follow-up, 3 pts. were diagnosed with pathological E findings, including 1 slight decrease of LVEF, one diffuse hypokinesia and one strong decrease in LVEF.The median LVEF in the study cohort was 66.1% at baseline, 62.7% after 6 cycles of therapy, 64.4% at the first follow up and did not change significantly until the 5 th examination. Conclusions: This study supports the combination of PLD and H in pts. with HER2 overexpressing metastatic breast cancer as a safe and feasible therapy. Due to the promising clinical response rates in this prognostically unfavorable group, this combination should be evaluated in larger studies as a potential regimen for adjuvant treatment of breast cancer. No significant financial relationships to disclose.

Assessment of trastuzumab-related cardiac dysfunction in the Herceptin Adjuvant (HERA) Trial with 3.6 years median follow- up

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 540-540
Author(s):  
M. J. Procter ◽  
T. Suter ◽  
E. de Azamuja ◽  
S. Muehlbauer ◽  
U. Dafni ◽  
...  
Keyword(s):  
Treatment Period ◽  
Cardiac Dysfunction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Term Outcome ◽  
Ventricular Ejection Fraction ◽  
Long Term Outcome ◽  
Group Randomized Trial ◽  
Neo Adjuvant Chemotherapy

540 Background: The Herceptin Adjuvant (HERA) Trial is a three-group randomized trial that compared 1 year or 2 years trastuzumab with observation. We investigated cardiac dysfunction in HERA patients randomized to observation or 1 year trastuzumab and report results at a median follow-up of 3.6 years. Methods: Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF > 55%) were eligible. Cardiac function was monitored throughout the trial. A repeat LVEF assessment was required in case of cardiac dysfunction. Results: There were 1,698 patients randomized to observation and 1,703 randomized to 1 year trastuzumab. The incidence of discontinuation of trastuzumab due to cardiac disorders was low (5.1%). The incidence of cardiac endpoints was low (severe CHF 0.77% in the trastuzumab group). The incidence of cardiac endpoints was higher in the trastuzumab group compared to observation (severe CHF 0.77% vs 0.00%; confirmed significant LVEF drops 3.57% vs 0.64%). In the trastuzumab group, there were no occurrences of severe CHF after the end of the scheduled treatment period of 1 year. Among the patients in the trastuzumab group with confirmed significant LVEF drop, the first occurrence was within the scheduled treatment period of 1 year for 55 out of 60 patients (91.7%). In the trastuzumab group, 59 of 73 patients (80.8%) with a cardiac endpoint reached acute recovery and of these 59 patients 52 (88.1%) were consider to have a favourable long term outcome. Conclusions: The incidence of cardiac endpoints remains low even with longer term follow-up. The cumulative incidence of any type of cardiac endpoint increases during the scheduled treatment period of 1 year, but appears to remain approximately constant after the scheduled treatment period of 1 year is completed. [Table: see text]

Trastuzumab-Related Cardiotoxicity: Calling Into Question the Concept of Reversibility

2007 ◽  
Vol 25 (23) ◽  
pp. 3525-3533 ◽  
Author(s):  
Melinda L. Telli ◽  
Sharon A. Hunt ◽  
Robert W. Carlson ◽  
Alice E. Guardino
Keyword(s):  
Breast Cancer ◽  
Left Ventricular ◽  
Stopping Rules ◽  
Left Ventricular Ejection ◽  
Adjuvant Trastuzumab ◽  
Ventricular Ejection Fraction ◽  
International Research Group ◽  
Number Of Patients ◽  
B 31

Purpose To assess the spectrum and reversibility of the cardiotoxicity observed in the adjuvant trastuzumab trials. Design The design and efficacy of the major adjuvant trastuzumab trials was assessed, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group N9831, Herceptin Adjuvant, Breast Cancer International Research Group 006, and Finland Herceptin trials. The cardiotoxicity data were evaluated with a focus on the follow-up cardiac evaluations of women who were diagnosed with cardiotoxicity. Proposed mechanisms of trastuzumab-related cardiotoxicity were considered. The natural history of congestive heart failure (CHF) was reviewed with the goal of placing the trastuzumab experience in context. Results Up to 4% of patients enrolled onto the adjuvant trastuzumab trials experienced severe CHF during treatment. In these trials, early stopping rules that identified an unacceptable level of cardiotoxicity were never reached. Despite this, a large number of patients on these trials experienced some form of cardiotoxicity that ultimately required discontinuation of trastuzumab. Approximately 14% of patients in the NSABP B-31 trial discontinued trastuzumab because of asymptomatic decreases in left ventricular ejection fraction (LVEF). Results of follow-up cardiac evaluations of patients diagnosed with any degree of cardiotoxicity in the NSABP B-31 trial document that a clinically significant proportion of patients have sustained decrements in their LVEF to less than 50%. Conclusion Adjuvant trastuzumab provides substantial benefits to patients with human epidermal growth factor receptor 2–positive breast cancer, however, competing immediate and long-term cardiovascular risks are a great concern. Continued cardiac follow-up of these women is of critical importance.

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