scholarly journals P2778Effect of cardiovascular risk factors on left ventricular ejection fraction in HER2 positive breast cancer patients who were treated in adjuvant setting with trastuzumab

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
I Krstic ◽  
M Deljanin-Ilic ◽  
S Vrbic ◽  
D Marinkovic
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cardiovascular Risk ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Adjuvant Setting ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Positive Breast Cancer

Safety and tolerability of subcutaneous trastuzumab and intravenous pertuzumab as adjuvant treatment for HER2 positive breast cancer: a pilot study

2021 ◽  
pp. postgradmedj-2021-140319
Author(s):  
Chi Yan Wong ◽  
Roland Leung ◽  
Gin Wai Kwok ◽  
Josephine Tsang ◽  
Bryan Li ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Secondary Outcome ◽  
Adjuvant Setting ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

BackgroundSubcutaneous (SC) trastuzumab is similar to intravenous trastuzumab in terms of pharmacokinetics, efficacy and tolerability. The use of dual anti-HER2 agents trastuzumab and pertuzumab has become the new standard for node-positive HER2-positive breast cancers at adjuvant setting, but the safety and tolerability of combining SC trastuzumab and intravenous pertuzumab is not well studied.MethodsThis was a prospective single-arm pilot study with locally advanced HER2-positive breast cancer who received adjuvant SC trastuzumab and intravenous pertuzumab after standard anti-HER2 treatment with chemotherapy. Primary outcomes included adverse events (AEs), severe AEs and cardiac AEs. Secondary outcome was invasive disease-free survival (iDFS).ResultsWith a median follow-up of 21.7 months, 20 patients were enrolled. One patient (5%) developed asymptomatic drop in left ventricular ejection fraction from 69% to 53%. Two patients (10%) developed grade 1 injection site reaction related to SC trastuzumab. There were no grade 2 or above AEs. All AEs were transient. No new AEs were observed. The 1-year iDFS was 90% (95% CI 0.656 to 0.974)ConclusionsCombination of SC trastuzumab and intravenous pertuzumab for HER2-positive breast cancer is a safe and well-tolerated option in adjuvant setting.

Safety assessment of trastuzumab diluted in 100 ml of saline in the treatment of HER2-positive breast cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e11555-e11555
Author(s):  
Hajime Abe ◽  
Tsuyoshi Mori ◽  
Yuki Kawai ◽  
Kaori Tomida ◽  
Yoshihiro Kubota ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

e11555 Background: The infusion rate is considered to affect incidence and severity of infusion reaction (IR) caused by infusion of protein formulations. Trastuzumab (TRS) is approved for 90-minute infusion as the initial dose followed by 30-minute infusion with 250 ml saline. We evaluated the safety of TRS intravenously administered over 30minutes with 100 ml saline to reduce burden of patients although safety of infusion with 250 ml saline is established. Methods: Women with HER2 positive breast cancer, ≥18 years and ≥55% left ventricular ejection fraction (LVEF) were registered in the study. Patients received 8mg/kg of TRS 250 ml over 90 minutes diluted in 250 ml saline followed by 6mg/kg of TRS in 100 ml saline over 30 minutes in a three-week cycle. The primary endpoint of this study was the incidence of infusion reactions, and secondary endpoints were as follows: incidence of adverse events and effects on cardiac function. Results: Between June 2011 and June 2012, a total of 31 patients were recruited; 24 for adjuvant therapy and seven with metastases. The median age was 59 years (range, 39 to 82). Hormone receptor was positive in 18 patients (58%). Previous treatment with anthracyclines was reported in seven patients and radiation therapy in fourteen patients. The total number of TRS doses ranged from 5 to 17 with the median of 15. Mild IR occurred in two patients and rash occurred in one patient at the first dose. However, no IR and adverse events were observed after reducing to 100 ml saline. The average LVEF measured every 3 months was between 62.3% and 64.8%. No significant decrease in LVEF was reported with the largest decrease of 8% in one patient at the 12th month on treatment. Conversely, brain natriuretic peptide levels tended to decrease as the number of received doses increased. None of the subgroup analysis (age groups, adjuvant vs. metastatic setting, previous anthracycline treatment, and previous radiotherapy) showed statistical significance. Conclusions: Intravenous infusion of TRS with 100 ml saline over 30 minutes in breast cancer patients is considered safe based on results from the study. The safe treatment with shorter infusion time has benefit for both healthcare professionals and patients. Clinical trial information: UMIN000006710.

Trastuzumab-related cardiotoxicity in patients with non-limiting cardiac comorbidity.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12043-e12043
Author(s):  
Rossella Martinello ◽  
Paolo Becco ◽  
Patrizia Vici ◽  
Mario Airoldi ◽  
Lucia Del Mastro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Adjuvant Trastuzumab ◽  
Ventricular Ejection Fraction ◽  
Cardiac Comorbidity

e12043 Background: Significant and symptomatic cardiac comorbidity (CC) is a contraindication to adjuvant trastuzumab (T) in breast cancer patients (pts). However, some pts with asymptomatic, non-limiting CC and normal baseline left ventricular ejection fraction (LVEF) receive T in the clinical practice. We sought to describe the tolerability of T in these pts. Methods: Retrospective analysis of pts with baseline asymptomatic non-limiting CC receiving adjuvant T with chemotherapy (CT) at 6 Institutions between Jul 2006 and Jan 2016. Results: Thirty-seven patients HER2-positive, operable BC at high risk of relapse BC were studied. Median age was 64y (range 36-82, 80% post-menopausal), median baseline LVEF was 61% (range 50-85%) and median BMI 26 (18-42, obesity 22%). Thirteen patients (35%) received T with adjuvant anthracycline and taxane-based, 19 (51%) taxane-based and 3 (8%) other adjuvant CT regimens (13 pts sequential, 22 pts concomitant with CT) and 2 (5%) with endocrine therapy. Prior non-limiting CC was ischemic heart disease (35%), valvular disease (30%), atrial fibrillation (19%), conduction disorders (13%), aortic aneurism (3%), and other (19%). Nine (29%) pts experienced TRC: congestive heart failure (1 pt, 3%), LVEF reduction (6 pts, 16%) and rhythm disturbances (1 pt, 3%). TRC occurred in pts with ongoing multiple cardiovascular risk factors (i.e. obesity and hypertension). Seven pts discontinued T because of TRC (19%), 5 permanently (14%) and 2 temporarily (5%). These latter pts, were able to resume and complete T after TRC resolution. At the end of adjuvant treatment, all pts showed LVEF within normal limits, except one of those who experienced a TRC (last FU value 46 %). Conclusions: This is the first analysis of TRC in pts receiving adjuvant T in the presence prior non-limiting CC. Despite the small size, our analysis shows that T is feasible in these pts and most of the TRC events were reversible at T withdrawal. Caution is needed in pts with significant ongoing cardiovascular risk factors, but when adjuvant T is deemed beneficial on breast cancer outcomes, non-limiting CC should not preclude treatment.

Prevalence of trastuzumab-induced cardiotoxicity in Uruguayan HER2-positive breast cancer patients treated in a real life setting during a 10 year period.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12537-e12537
Author(s):  
Natalia Camejo ◽  
Cecilia Castillo ◽  
Nora Artagaveytia ◽  
Crisitian Etcheverría ◽  
Jessica Ferradaz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiac Toxicity ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Chi Square ◽  
Ventricular Ejection Fraction ◽  
Her 2 ◽  
Positive Breast Cancer

e12537 Background: To estimate the prevalence of Trastuzumab (TTZ) induced cardiotoxicity in Uruguayan women diagnosed with early HER – 2 positive breast cancer (BC) over a period of ten years, treated under the financial coverage of the National Resource Fund (FNR). Methods: A prospective descriptive observational study based on the analysis of an anonymized database provided by the FNR of Uruguayan HER-2 positive early BC patients treated with TTZ between 2006 and 2016. Variables analyzed included: age, menopausal status, stage, presence of cardiovascular risk factors, use or not of anthracyclines, left ventricular ejection fraction prior and during treatment, and temporary or permanent suspension of treatment. Statistical analysis was performed using SPSS Statistics version 25. The variables were assessed through the use of measures of central tendency, dispersion, contingency tables and proportions. To analyze the relationship between the different variables, the Chi-Square test of independence was performed. Results: The analysis included 1401 patients diagnosed with HER-2 + stage I to III breast cancer who received adjuvant TTZ. The mean age at diagnosis was 52.45 years. The prevalence of cardiotoxicity in evaluable patients (1065 pts) was 20.3%. The proportion of patients who had symptomatic heart failure was 3% (32 pts) and in those who discontinued treatment for asymptomatic cardiac toxicity managed to resume trastuzumab prevalence was 92.6 %. About 9,7 % (21 pts) of patients had drop of left ventricular ejection fraction (LVEF) below 50%, whilst 10% drop of LVEF below their baseline levels were found in 75% of patients (162 pts) There is significant difference in the risk of cardiotoxicity according to the type of chemotherapy (anthracycline containing vs non-anthracycline based) (Chi-square = 3.9, p-value < 0.005). There was no evidence of a relationship between cardiovascular risk factors and the development of cardiotoxicity as well there was no evidence between sequential or concurrent use of TTZ with chemotherapy. Conclusions: The prevalence of cardiotoxicity in this study was similar to that reported internationally. The majority of patients did not develop cardiac toxicity and those who presented it did so asymptomatically and reversibly.

scholarly journals An Exploration of Heart Failure Risk in Breast Cancer Patients Receiving Anthracyclines with or without Trastuzumab in Thailand: A Retrospective Study

2021 ◽  
Vol 11 (3) ◽  
pp. 484-493
Author(s):  
Jukapun Yoodee ◽  
Aumkhae Sookprasert ◽  
Phitjira Sanguanboonyaphong ◽  
Suthan Chanthawong ◽  
Manit Seateaw ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Ventricular Ejection Fraction ◽  
Factors Associated ◽  
Palliative Intent ◽  
Increased Risk

Anthracycline-based regimens with or without anti-human epidermal growth factor receptor (HER) 2 agents such as trastuzumab are effective in breast cancer treatment. Nevertheless, heart failure (HF) has become a significant side effect of these regimens. This study aimed to investigate the incidence and factors associated with HF in breast cancer patients treated with anthracyclines with or without trastuzumab. A retrospective cohort study was performed in patients with breast cancer who were treated with anthracyclines with or without trastuzumab between 1 January 2014 and 31 December 2018. The primary outcome was the incidence of HF. The secondary outcome was the risk factors associated with HF by using the univariable and multivariable cox-proportional hazard model. A total of 475 breast cancer patients were enrolled with a median follow-up time of 2.88 years (interquartile range (IQR), 1.59–3.93). The incidence of HF was 3.2%, corresponding to an incidence rate of 11.1 per 1000 person-years. The increased risk of HF was seen in patients receiving a combination of anthracycline and trastuzumab therapy, patients treated with radiotherapy or palliative-intent chemotherapy, and baseline left ventricular ejection fraction <65%, respectively. There were no statistically significant differences in other risk factors for HF, such as age, cardiovascular comorbidities, and cumulative doxorubicin dose. In conclusion, the incidence of HF was consistently high in patients receiving combination anthracyclines trastuzumab regimens. A reduced baseline left ventricular ejection fraction, radiotherapy, and palliative-intent chemotherapy were associated with an increased risk of HF. Intensive cardiac monitoring in breast cancer patients with an increased risk of HF should be advised to prevent undesired cardiac outcomes.

scholarly journals Safety and Clinical Evaluation of Dual Inhibition with Pertuzumab and Trastuzumab Biosimilar SB3 in HER2-Positive Breast Cancer Patients

Breast Care ◽  
2021 ◽  
pp. 1-7
Author(s):  
Christoph Suppan ◽  
Daniel Steiner ◽  
Eva Valentina Klocker ◽  
Florian Posch ◽  
Elisabeth Henzinger ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Safety And Efficacy ◽  
Her2 Positive Breast Cancer ◽  
Tumor Stages ◽  
Positive Breast Cancer

<b><i>Background:</i></b> The addition of trastuzumab to standard chemotherapy has improved survival in patients with HER2-positive breast cancer in neoadjuvant, adjuvant, and metastatic settings. In higher tumor stages, the addition of pertuzumab is now a standard of care and associated with a favorable toxicity profile. We evaluated the safety and efficacy of the trastuzumab biosimilar SB3 in combination with pertuzumab in HER2-positive breast cancer patients. <b><i>Methods:</i></b> Seventy-eight patients with HER2-positive breast cancer treated at the Division of Oncology at the Medical University of Graz were included. Summary measures are reported as medians (25th to 75th percentile) for continuous variables and as absolute frequencies (%) for count data. <b><i>Results:</i></b> Thirty-five patients received a median of 4 (3–7) cycles of trastuzumab biosimilar SB3 plus pertuzumab. All patients had a normal baseline left ventricular ejection fraction (LVEF; &#x3e;50%) prior to the initiation of SB3 plus pertuzumab treatment with a median LVEF of 60% (60–65). Twenty-one patients had a median absolute LVEF decline of 1% (–5 to 0). Two patients (5.7%) had a LVEF reduction ≤50%, but none ≥10%. There were no unexpected adverse events. Twenty-two of 35 patients (63%) were treated with trastuzumab biosimilar SB3 and pertuzumab in the neoadjuvant setting and 11 patients (50%) achieved a pathological complete response. The safety and the efficacy in this setting was comparable to the trastuzumab plus pertuzumab combination in neoadjuvantly treated matched samples. <b><i>Conclusion:</i></b> In this series of HER2-positive breast cancer patients, the combination of SB3 plus pertuzumab was consistent with the known safety and efficacy profile of trastuzumab and pertuzumab combination.

Safety analysis from PACS 04—A phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+ patients: Preliminary results

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 632-632 ◽  
Author(s):  
M. Spielmann ◽  
H. Roché ◽  
T. Delozier ◽  
G. Romieu ◽  
H. Bourgeois ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Safety Data ◽  
Left Ventricular ◽  
Phase Iii ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Phase Iii Trial ◽  
Post Surgery

632 Background: Following the BCIRG 001, PACS 01 and HERA trials, this randomised, multicentre, open-label, Phase III trial was designed to demonstrate the benefit of concomitant docetaxel and epirubicin versus anthracyclines, and evaluate the use of sequential trastuzumab. Methods: Patients (pts) with localised, resectable, unilateral breast cancer who met the following criteria were eligible: age <65 years, ≥1 positive node, M0, adequate heart and organ functions. Pts were randomised to receive either 6 cycles of 5-fluorouracil-epirubicin-cyclophosphamide (FEC100: F and C, 500 mg/m2, E 100 mg/m2) (Arm A) or epirubicin-docetaxel (ET75: E 75 mg/m2, T 75 mg/m2) (Arm B). Primary prophylaxis with G-CSF was not planned. Radiotherapy was mandatory after conservative surgery and tamoxifen was required in pts with hormone receptor-positive tumours. Pts with HER2-positive disease were then further randomised to observation only or to 1 year of trastuzumab monotherapy (6 mg/kg iv every 3 weeks). In HER2-positive pts receiving trastuzumab, left ventricular ejection fraction (LVEF) was determined at Cycles 2, 4, 8, 13, 18 and after 2 years. Otherwise, LVEF was determined at baseline and at 1 year post-surgery. Results: Of the 3010 pts recruited (2622 evaluable for safety to date), 1518 received FEC100 and 1492 received ET75 after the first randomisation. Haematologic toxicity was the most frequent toxicity in both arms. Grade 3–4 toxicities were similar for Arms A and B, except febrile neutropenia (10.3% and 31.4%, respectively) and nausea/vomiting (13.2% and 7.5%, respectively). Grade 2 clinical cardiac toxicity (decreased LVEF) was observed in 4 pts in Arm A and 5 in Arm B, with median LVEF scores of 63% in both arms at the end of chemotherapy. HER2-positive pts (n=500) were then randomised to either receive trastuzumab (n=259) or observation only (n=241). Conclusions: These preliminary safety data indicate that FEC100 and ET75 were both well tolerated, with acceptable cardiac safety values. The trial is ongoing and further analysis regarding the use of trastuzumab in this setting will be presented. [Table: see text]

Anthracycline-based preoperative chemotherapy plus lapatinib and trastuzumab or both in HER2-positive breast cancer: Preliminary cardiac safety report of the CHER LOB trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 573-573
Author(s):  
V. Guarneri ◽  
A. Frassoldati ◽  
A. Bottini ◽  
K. Cagossi ◽  
L. Cavanna ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Preoperative Chemotherapy ◽  
Treatment Plan ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Cardiac Safety ◽  
Ventricular Ejection Fraction ◽  
Her 2 ◽  
Positive Breast Cancer

573 Background: The combination of anthracyclines and anti-HER-2 agents is highly active in HER-2 positive breast cancer, but its use is limited by an enhanced risk of cardiac toxicity. We are running a randomized phase II trial of combined preoperative chemotherapy (CT) with anthracycline plus trastuzumab, lapatinib, or both in HER-2 positive stage II-IIIA breast cancer patients. Aims of the study are the percentage of pathological complete response (pCR = breast + axillary nodes) and cardiac safety. We report the updated cardiac safety and activity data following the IDMC recommendation to continue study accrual. Methods: CT consists of sequential paclitaxel (P) 80 mg/m2 weekly for 12 weeks followed by 4 courses of FE75C administered every 3 weeks. Arm A is CT + trastuzumab 2 mg/kg weekly; arm B is CT + lapatinib 1500 mg po daily; arm C is CT + trastuzumab 2 mg/kg weekly + lapatinib 1,000 mg po daily. Both trastuzumab and lapatinib are started concomitantly with the first P administration, and are administered throughout the duration of CT. Left ventricular ejection fraction (LVEF) is evaluated at baseline, before the start of FE75C, and at the completion of treatment. The planned sample size is 120 patients, and has been calculated according to the two steps Simon's design. Results: 53 out of the 120 planned patients have been randomized: 16 in arm A, 17 in arm B, and 20 in arm C. Median age is 48 years (range 27–66). The mean LVEF was 63% (range 54–77%) at baseline, 61% (50–78%) at the completion of weekly P + trastuzumab, lapatinib, or trastuzumab + lapatinib, and 60.3% (54–74%) at the completion of the whole treatment plan. Thirty patients underwent surgery: 19 patients (63%) received breast conserving surgery; 13 patients (43%) achieved a pCR. Conclusions Following the updated interim analysis, the combination of T, L or both with an anthracycline-containing regimen is feasible, with very interesting level of activity. The next planned analysis will be performed when 60 patients will be evaluable and will be presented at the Meeting. [Table: see text]

Cardiotoxicity risks of adjuvant trastuzumab in Asian breast cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 561-561
Author(s):  
V. Shih ◽  
A. Chan ◽  
J. Chiang ◽  
C. Teo ◽  
J. Chen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Chi Square ◽  
Adjuvant Trastuzumab ◽  
Ventricular Ejection Fraction ◽  
Chi Square Test

561 Background: Adjuvant trastuzumab (T)-based chemotherapy has been shown to reduce relapse and improve survival in breast cancer patients but has been associated with increased risks of cardiotoxicity. Our study aims to define the incidence and severity of cardiotoxicity amongst Asian breast cancer patients. Methods: This is a retrospective review of patients who have received adjuvant T from June 2005 to 2007. Cardiotoxicity was defined as a drop in left ventricular ejection fraction (LVEF) to less than 50% and/or reduction of > 10% of baseline. Cardiovascular (CVS) risk factors were defined as having a family history or presence of CAD, hypertension, diabetes mellitus, hyperlipidemia and smoking. We used pair sampled t-test to evaluate the mean LVEF change and Chi-square test to evaluate the association of cardiotoxicity and demographics. Results: There were 179 female patients. Cardiotoxicity was reported in 70 (39.1%), of whom 59 had asymptomatic decline in LVEF and 11 experienced CHF. Mean LVEF, comparing various time points (3, 6, 9 and 12 months) against baseline showed statistically significant decline (p<0.05). T was withheld (n=33) due to asymptomatic decline in LVEF (n=24), symptomatic heart failure (n=4) and both (n=5). Twenty-one with resolution of CHF (n=7) or LVEF recovery (n=14) were rechallenged. Cardiotoxicity recurred in 9 - asymptomatic decline in LVEF (n=8) and recurrent CHF (n=1). There were no cardiac-related deaths. Neither patient demographics nor CVS risk factors predicted for cardiotoxicity. Conclusions: This is one of the largest series reported in Asians receiving T. As previously reported, T-induced cardiotoxicity resulted in mostly asymptomatic reversible decline in LVEF. Our incidence of cardiotoxicity appeared higher (39.1%) in Asians and more importantly, almost half of the patients experienced cardiotoxicity upon rechallenge. It would be prudent to explore whether there is any difference in susceptibility to T-induced cardiotoxicity between the different races. [Table: see text] No significant financial relationships to disclose.

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