Abstract 16141: Predictors of Death in Patients With Chagas Cardiomyopathy and Pacemaker - Preliminary Results of the PACINCHAGAS Study

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Giselle L Peixoto ◽  
Rodrigo O Madia ◽  
Sérgio F Siqueira ◽  
Mariana M Lensi ◽  
Silvana D Nishioka ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Nyha Class ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Ventricular Ejection Fraction ◽  
Chagas Cardiomyopathy ◽  
The Mean

Introduction: Chagas’ disease causes different clinical expressions in the heart and permanent pacing due to bradycardia is not uncommon. Objective: Predictors of death in patients with Chagas Cardiomyopathy requiring pacemaker (PM) are unknown. This is the aim of this study. Methods: We prospectively evaluated 529 patients included in the Pacinchagas Study - Risk Stratification in Pacemaker Patients with Chagas Cardiomyopathy, which primary objective is to create a risk score to predict death in this population. The patients are submitted to an extent questionnaire which included clinical (NYHA class, symptoms, comorbidities and medications) functional (electrocardiography, Holter and echocardiography) and electronic variables (burden of pacing and arrhythmias). Patients with at least 6 months of follow-up were included in this preliminar analysis. Results: The cohort included 337 (63.7%) females, the mean age was 62.3±11.9 years and 63.1% were in NYHA class I. Indication for PM implantation was atrioventricular block, sick sinus syndrome, atrial fibrillation with slow ventricular response and unknown in 72.0%; 20.4%; 5.1% and 2.5%, respectively. During a mean follow-up of 1.5±0.6 years, 62 (11.7%) patients died. The mean time of PM implantation was not different between the dead and the survivors (11.9±9.0years versus 11.1±8.6years, P=0.503). Twenty-five deaths (40.3%) were sudden, 22 (35.5%) were due to heart failure, 6 (9.7%) were due to other cardiovascular causes, and 7 (11.3%) were due to noncardiovascular causes. The cause of death could not be determined in two patients (3.2%). Cox proportional hazards identified three predictors of death: NYHA class III/IV (Hazard Ratio [HR] 5.661; 95% Confidence Interval [95%IC] 2.617-12.245; P<0.001); left ventricular ejection fraction (LVEF) ≤42% (HR 2.779; 95%IC 1.299-5.945; P=0.008) and chronic kidney disease (HR 2.635; 95%IC 1.167-5.948; P=0.020). Conclusions: This analysis of Pacinchagas study identified in a mean follow-up of one year and half, three predictors of death in PM users with Chagas Cardiomyopathy: NYHA class III/IV, LVEF≤42% and chronic kidney disease.

scholarly journals 85 Diuretics trajectories in dilated cardiomyopathy

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Vincenzo Nuzzi ◽  
Antonio Cannatà ◽  
Paolo Manca ◽  
Caterina Gregorio ◽  
Giulia Barbati ◽  
...  
Keyword(s):  
Dilated Cardiomyopathy ◽  
Nyha Class ◽  
Diuretic Therapy ◽  
Left Ventricular ◽  
Equivalent Dose ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Ventricular Ejection Fraction ◽  
Kaplan Meier

Abstract Aims Diuretics in heart failure (HF) are commended to relieve symptoms at lowest dosage effective. Dilated cardiomyopathy (DCM) is a particular HF setting with several variables that may influence disease trajectory. We aimed to assess the long-term use of diuretics in DCM, the possibility of withdrawal and to explore the prognostic correlations. Methods and results All consecutive DCM patients enrolled from 1990 to 2018 were considered eligible. All the patients had available the information about the furosemide-equivalent dose at baseline and at follow-up evaluation within 24 months. Patients were categorized in stable (diuretic dose variation &lt;50%), increasers (diuretics dose increase ≥50% or initiation of diuretic therapy), and decreasers (diuretics dose decrease ≥50% or never prescribed diuretics in the 24-months observation period). The prognostic role of the diuretics trajectory group was assessed with Kaplan Meier analysis and with a time-dependent multivariable model. The outcome measure was a composite of all-cause death/heart transplantation/HF hospitalization (ACD/HTx/HFH). 908 patients were included [mean age 50 ± 16, 70% male sex, 24% NYHA class III or IV, mean left ventricular ejection fraction (LVEF) 31 ± 9%, 66% treated with diuretics at baseline]. The furosemide-equivalent dose at enrolment had a linear association with the risk of outcome. Compared to other groups, decreaser patients were younger, had less HF symptoms, higher LVEF and more dilated left atrium. Decreasers had a lower prescription rate of diuretics and less frequent indication to renin-angiotensin inhibitors and mineralocorticoid receptors antagonists. Over a median follow-up of 122 (62–195) months decreasers had the lowest incidence of outcome, followed by stable, while increasers had the worst outcome (P &lt; 0.001). After adjustment for other prognosticators, compared to stable patients, decreasers had a reduced risk of ACD/HTx/HFH [HR: 0.497 (95% CI: 0.337–0.731)] while increasers had the highest risk of adverse outcome [HR: 2.027 (95% CI: 1.254–3.276)]. Similarly, amongst patients taking diuretics at baseline, the diuretics withdrawal was in independent outcome predictor. The only multivariable predictors of diuretics withdrawal were younger age and lower furosemide-equivalent dose at enrolment. Conclusions In DCM patients the diuretics dose at baseline is a strong prognosticator. Diuretics dose reduction or its withdrawal provides a prognostic benefit on hard outcome. Diuretics tapering in selected patients should be considered in the short-term follow-up to improve DCM prognosis.

scholarly journals Myocardial characterization in pre-dialysis chronic kidney disease: a study of prevalence, patterns and outcomes

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Anna M. Price ◽  
Manvir K. Hayer ◽  
Ravi Vijapurapu ◽  
Saad A. Fyyaz ◽  
William E. Moody ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Left Ventricular ◽  
University Hospital ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Ckd Stage ◽  
Multiplicative Risk

Abstract Background Late gadolinium enhancement (LGE) using cardiac magnetic resonance (CMR) characterizes myocardial disease and predicts an adverse cardiovascular (CV) prognosis. Myocardial abnormalities, are present in early chronic kidney disease (CKD). To date there are no data defining prevalence, pattern and clinical implications of LGE-CMR in CKD. Methods Patients with pre-dialysis CKD (stage 2–5) attending specialist renal clinics at University Hospital Birmingham (UK) who underwent gadolinium enhanced CMR (1.5 T) between 2005 and 2017 were included. The patterns and presence (LGEpos) / absence (LGEneg) of LGE were assessed by two blinded observers. Association between LGE and CV outcomes were assessed. Results In total, 159 patients received gadolinium (male 61%, mean age 55 years, mean left ventricular ejection fraction 69%, left ventricular hypertrophy 5%) with a median follow up period of 3.8 years [1.04–11.59]. LGEpos was present in 55 (34%) subjects; the patterns were: right ventricular insertion point n = 28 (51%), mid wall n = 18 (33%), sub-endocardial n = 5 (9%) and sub-epicardial n = 4 (7%). There were no differences in left ventricular structural or functional parameters with LGEpos. There were 12 adverse CV outcomes over follow up; 7 of 55 with LGEpos and 5 of 104 LGEneg. LGEpos was not predicted by age, gender, glomerular filtration rate or electrocardiographic abnormalities. Conclusions In a selected cohort of subjects with moderate CKD but low CV risk, LGE was present in approximately a third of patients. LGE was not associated with adverse CV outcomes. Further studies in high risk CKD cohorts are required to assess the role of LGE with multiplicative risk factors.

scholarly journals Myocardial Characterization in Pre-Dialysis Chronic Kidney Disease: A Study of Prevalence, Patterns and Outcomes

2019 ◽  
Author(s):  
Anna M Price ◽  
Manvir K Hayer ◽  
Ravi Vijapurapu ◽  
Saad A Fyyaz ◽  
William E Moody ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Left Ventricular ◽  
University Hospital ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Ckd Stage ◽  
Multiplicative Risk

Abstract Background Late gadolinium enhancement (LGE) using cardiac magnetic resonance (CMR) characterizes myocardial disease and predicts an adverse cardiovascular (CV) prognosis. Myocardial abnormalities, are present in early chronic kidney disease (CKD). To date there are no data defining prevalence, pattern and clinical implications of LGE-CMR in CKD.Methods Patients with pre-dialysis CKD (stage 2-5) attending specialist renal clinics at University Hospital Birmingham (UK) who underwent gadolinium enhanced CMR (1.5T) between 2005 and 2017 were included. The patterns and presence (LGEpos) / absence (LGEneg) of LGE were assessed by two blinded observers. Association between LGE and CV outcomes were assessed.Results In total, 159 patients received gadolinium (male 61%, mean age 55 years, mean left ventricular ejection fraction 69%, left ventricular hypertrophy 5%) with a median follow up period of 3.8 years [1.04-11.59]. LGEpos was present in 55 (34%) subjects; the patterns were: right ventricular insertion point n=28 (51%), mid wall n=18 (33%), sub-endocardial n=5 (9%) and sub-epicardial n=4 (7%). There were no differences in left ventricular structural or functional parameters with LGEpos. There were 12 adverse CV outcomes over follow up; 7 of 55 with LGEpos and 5 of 104 LGEneg. LGEpos was not predicted by age, gender, glomerular filtration rate or electrocardiographic abnormalities.Conclusions In a selected cohort of subjects with moderate CKD but low CV risk, LGE was present in approximately a third of patients. LGE was not associated with adverse CV outcomes. Further studies in high risk CKD cohorts are required to assess the role of LGE with multiplicative risk factors.

scholarly journals Myocardial Characterization in Pre-Dialysis Chronic Kidney Disease: A Study of Prevalence, Patterns and Outcomes

2019 ◽  
Author(s):  
Anna M Price ◽  
Manvir K Hayer ◽  
Ravi Vijapurapu ◽  
Saad A Fyyaz ◽  
William E Moody ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Left Ventricular ◽  
University Hospital ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Ckd Stage ◽  
Multiplicative Risk

Abstract Background Late gadolinium enhancement (LGE) using cardiac magnetic resonance (CMR) characterizes myocardial disease and predicts an adverse cardiovascular (CV) prognosis. Myocardial abnormalities, are present in early chronic kidney disease (CKD). To date there are no data defining prevalence, pattern and clinical implications of LGE-CMR in CKD.Methods Patients with pre-dialysis CKD (stage 2-5) attending specialist renal clinics at University Hospital Birmingham (UK) who underwent gadolinium enhanced CMR (1.5T) between 2005 and 2017 were included. The patterns and presence (LGEpos) / absence (LGEneg) of LGE were assessed by two blinded observers. Association between LGE and CV outcomes were assessed.Results In total, 159 patients received gadolinium (male 61%, mean age 55 years, mean left ventricular ejection fraction 69%, left ventricular hypertrophy 5%) with a median follow up period of 3.8 years [1.04-11.59]. LGEpos was present in 55 (34%) subjects; the patterns were: right ventricular insertion point n=28 (51%), mid wall n=18 (33%), sub-endocardial n=5 (9%) and sub-epicardial n=4 (7%). There were no differences in left ventricular structural or functional parameters with LGEpos. There were 12 adverse CV outcomes over follow up; 7 of 55 with LGEpos and 5 of 104 LGEneg. LGEpos was not predicted by age, gender, glomerular filtration rate or electrocardiographic abnormalities.Conclusions In a selected cohort of subjects with moderate CKD but low CV risk, LGE was present in approximately a third of patients. LGE was not associated with adverse CV outcomes. Further studies in high risk CKD cohorts are required to assess the role of LGE with multiplicative risk factors.

scholarly journals Myocardial Characterization in Pre-Dialysis Chronic Kidney Disease: A Study of Prevalence, Patterns and Outcomes

2019 ◽  
Author(s):  
Anna M Price ◽  
Manvir K Hayer ◽  
Ravi Vijapurapu ◽  
Saad A Fyyaz ◽  
William E Moody ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Left Ventricular ◽  
University Hospital ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Ckd Stage ◽  
Multiplicative Risk

Abstract Background Late gadolinium enhancement (LGE) using cardiac magnetic resonance (CMR) characterizes myocardial disease and predicts an adverse cardiovascular (CV) prognosis. Myocardial abnormalities, are present in early chronic kidney disease (CKD). To date there are no data defining prevalence, pattern and clinical implications of LGE-CMR in CKD.Methods Patients with pre-dialysis CKD (stage 2-5) attending specialist renal clinics at University Hospital Birmingham (UK) who underwent gadolinium enhanced CMR (1.5T) between 2005 and 2017 were included. The patterns and presence (LGEpos) / absence (LGEneg) of LGE were assessed by two blinded observers. Association between LGE and CV outcomes were assessed.Results In total, 159 patients received gadolinium (male 61%, mean age 55 years, mean left ventricular ejection fraction 69%, left ventricular hypertrophy 5%) with a median follow up period of 3.8 years [1.04-11.59]. LGEpos was present in 55 (34%) subjects; the patterns were: right ventricular insertion point n=28 (51%), mid wall n=18 (33%), sub-endocardial n=5 (9%) and sub-epicardial n=4 (7%). There were no differences in left ventricular structural or functional parameters with LGEpos. There were 12 adverse CV outcomes over follow up; 7 of 55 with LGEpos and 5 of 104 LGEneg. LGEpos was not predicted by age, gender, glomerular filtration rate or electrocardiographic abnormalities.Conclusions In a selected cohort of subjects with moderate CKD but low CV risk, LGE was present in approximately a third of patients. LGE was not associated with adverse CV outcomes. Further studies in high risk CKD cohorts are required to assess the role of LGE with multiplicative risk factors.

scholarly journals Incidence of Cardiotoxicity and Validation of the Heart Failure Association- International Cardio-Oncology Society risk stratification Tool in Patients Treated with Trastuzumab for HER2-Positive Early Breast Cancer.

2021 ◽  
Author(s):  
Nicolò Matteo Luca Battisti ◽  
Maria Sol Andres ◽  
Karla A Lee ◽  
Tharshini Ramalingam ◽  
Tamsin Nash ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Heart Failure ◽  
Early Breast Cancer ◽  
Nyha Class ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Very High

Abstract PurposeTrastuzumab improves survival in patients with HER2+ early breast cancer. However, cardiotoxicity remains a concern, particularly in the curative setting, and there are limited data on its incidence outside of clinical trials. We retrospectively evaluated the cardiotoxicity rates (left ventricular ejection fraction [LVEF] decline, congestive heart failure [CHF], cardiac death or trastuzumab discontinuation) and assessed the performance of a proposed model to predict cardiotoxicity in routine clinical practice.MethodsPatients receiving curative trastuzumab between 2011-2018 were identified. Demographics, treatments, assessments and toxicities were recorded. Fisher’s exact test, chi-squared and logistic regression were used.Results931 patients were included in the analysis. Median age was 54 years (range 24-83) and Charlson comorbidity index 0 (0-6), with 195 patients (20.9%) aged 65 or older. 228 (24.5%) were smokers. Anthracyclines were given in 608 (65.3%). Median number of trastuzumab doses was 18 (1-18). The HFA-ICOS cardiovascular risk was low in 401 patients (43.1%), medium in 454 (48.8%), high in 70 (7.5%) and very high in 6 (0.6%).Overall, 155 (16.6%) patients experienced cardiotoxicity: LVEF decline≥10% in 141 (15.1%), falling below 50% in 55 (5.9%), CHF NYHA class II in 42 (4.5%) and class III-IV in 5 (0.5%) and discontinuation due to cardiac reasons in 35 (3.8%). No deaths were observed.Cardiotoxicity rates increased with HFA-ICOS score (14.0% low, 16.7% medium, 30.3% high/very high; p=0.002). ConclusionsCardiotoxicity was relatively common (16.6%), but symptomatic heart failure on trastuzumab was rare in our cohort. The HFA-ICOS score identifies patients at high risk of cardiotoxicity

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.  

Phase III trial of non-pegylated liposomal doxorubicin (M) in combination with trastuzumab (T) and paclitaxel (P) in HER2+ metastatic breast cancer (MBC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 517-517 ◽  
Author(s):  
Lorena De La Pena ◽  
Javier Cortes ◽  
Alexey Manikhas ◽  
Laslo Roman ◽  
Vladimir Semiglazov ◽  
...  
Keyword(s):  
Nyha Class ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Left Ventricular ◽  
Phase Iii ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Ventricular Ejection Fraction ◽  
Phase Iii Trial

517 Background: M in combination with T has shown promising activity and cardiac safety in MBC patients (pts). We conducted a randomized Phase III trial of first-line M plus T and P (MTP) versus T plus P (TP) in HER2+ MBC pts. Methods: Pts with HER2+ (by FISH) MBC ≥ 18 years and ECOG 0-1, who had received no prior chemotherapy for metastatic disease, were eligible. Left ventricular ejection fraction should be within normal institutional limits. Prior (neo-) adjuvant anthracyclines, T or P were permitted, if completed >1 year before the start of the study. Pts received M 50 mg/m2 q3w for 6 cycles, T 4 mg/kg loading dose followed by 2 mg/kg qw, and P 80 mg/m2qw, or T+P at the same doses until progression or toxicity. Primary outcome was progression-free survival (PFS). Enrollment of 332 pts would provide 80% power with a 5% significance to detect an improvement in PFS with MTP, assuming a median PFS of 8 months in TP and a hazard ratio (HR) of 0.70. Results: 363 pts enrolled (MTP 181, TP 183), 360 received treatment. The two groups were well balanced for demographics, pretreatment characteristics and extent of disease. One third of the pts had prior exposure to anthracyclines, but almost none to trastuzumab (1% and 2% in MTP and TP arms, respectively). Six cycles of M could be given to 72% of the pts. With a median follow-up of 31 months, median PFS was 16.1 and 14.5 months with MTP and TP, respectively (HR 0.84, P=0.174). In pts with ER and PR-negative tumors, PFS was 20.7 and 14.0 months, respectively (HR, 0.68; 95% CI 0.47–0.99). Median overall survival (OS) was 33.6 and 28.9 months, respectively (HR, 0.79, P=0.083). In ER and PR-negative tumors, OS was 38.2 and 27.9 months, respectively (HR, 0.63; 95% CI 0.42–0.93). The incidence of NYHA Class III/IV congestive heart failure was 3% with MTP and there were 2 cardiac deaths with TP. The frequency of adverse events was higher with MTP, especially myelosuppression, stomatitis and gastrointestinal intolerance. Conclusions: The trial failed to demonstrate a significant clinical improvement with the addition of M to TP. The clinical benefit observed in an exploratory analysis in the ER and PR-negative population deserves consideration for further clinical trials. Clinical trial information: NCT00294996.

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