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 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.

scholarly journals P197 Assesment of cardiac function during trastuzumab therapy in HER2 positive breast cancer patients

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
I Krstic ◽  
M Deljanin Ilic ◽  
I Pejcic ◽  
S Vrbic ◽  
D Marinkovic
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Left Ventricular ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Trastuzumab Therapy ◽  
Before And After ◽  
Echocardiographic Parameters ◽  
Positive Breast Cancer

Abstract Background Although trastuzumab has benefits in treatment of HER2 positive breast cancer, it also carries the risk of cardiotoxicity. It is very important to evaluate the cardiac status before and after therapy with trastuzumab, as well as monitoring of electrocardiografic and echocardiographic parameters. The aim of this study was to assess of cardiac function during trastuzumab therapy in HER2 positive breast cancer patients. Method Ninety six HER2 positive female breast cancer patients (mean age, 59.57 ± 9.6 years) were enrolled in the study. At the time, they were on sequential therapy with anthracyclines (IV to VI cycles) within the FAC regimen (fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) on day 22, and after that trastuzumab therapy (6 mg/kg of body weight on day 21, for the period of one year). In all patients (pts) blood pressure (BP), heart rate (HR), electrocardiografic and echocardiographic parameters (left ventricular ejection fraction–LVEF(%); fractional shortening–FS(%); end-diastolic diameter–EDD(mm); left ventricular mass – LVM (g)) were assesed at the beginning and after the therapy with trastuzumab. Results There was no significant changes in arterial BP before and after trastuzumab in examined pts (systolic BP119.90 ± 16.04 mmHg vs 121.30 ± 13.06 mmHg; diastolic BP 75.89 ±7.25 mmHg vs 76.30 ± 7.65 mmHg) ns and HR (68.78 ± 7.69/min vs 67.92 ± 7.90/min) ns. All pts at the beginning and after the last therapy with trastuzumab on the electrocardiogram (ECG) were in sinus rhythm, one pts has LBBB and one RBBB. During therapy ectopic beats were registred in 11 pts, SVES in 7 (7.29%), VES in 4(4.16%). In the most of this patients with PSR in the middle of treatment period with trastuzumab sinus tachycardia was recorded as well. At the end of trastuzumab therapy in examined group LVEF was decreased by 1.73% (from 65.49 ± 5.82% to 63.76 ± 6.43%; p = 0.007), FS by 0.86% (from 36.18 ± 5.10% to 35.32 ± 4.91%; p = 0.123) ns, EDD increased by 1.26 mm (from 47.53 ± 4.48 mm to 48.80 ± 5.19 mm; p = 0.005) and LVM increased by 173.68 g (from 161.55 ± 43.76 g to171.15 ± 47.88 g; p = 0.031). Cardiotoxicity is registred in 4 (4.17%) patients, according to the criteria of EACVI and ASE. Results Tratsuzumab has not significant effect on BP and ECG changes.The rate of cardiotoxicity after trastuzumab therapy was low and was expressed through reduction of left ventricle ejection fraction, the increase in the end-diastolic diameter and the left ventricular mass.

scholarly journals Trastuzumab Mechanism of Action; 20 Years of Research to Unravel a Dilemma

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3540
Author(s):  
Hamid Maadi ◽  
Mohammad Hasan Soheilifar ◽  
Won-Shik Choi ◽  
Abdolvahab Moshtaghian ◽  
Zhixiang Wang
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Cancer Patients ◽  
Mechanism Of Action ◽  
Mechanisms Of Action ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Insight Into ◽  
Positive Breast Cancer

Trastuzumab as a first HER2-targeted therapy for the treatment of HER2-positive breast cancer patients was introduced in 1998. Although trastuzumab has opened a new avenue to treat patients with HER2-positive breast cancer and other types of cancer, some patients are not responsive or become resistant to this treatment. So far, several mechanisms have been suggested for the mode of action of trastuzumab; however, the findings regarding these mechanisms are controversial. In this review, we aimed to provide a detailed insight into the various mechanisms of action of trastuzumab.

Survival Outcomes In Human Epidermal Growth Factor Receptor 2 (HER 2) Positive Breast Cancer Patients At Kenyatta National Hospital

2021 ◽  
Author(s):  
Gloria Tuwei ◽  
Amsalu Degu
Keyword(s):  
Breast Cancer ◽  
Survival Rate ◽  
Cancer Patients ◽  
Survival Outcomes ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Predictors Of Mortality ◽  
Her2 Positive Breast Cancer ◽  
The Mean ◽  
Positive Breast Cancer

Abstract Background: For several years, HER2-positive breast cancer was associated with poor outcomes and higher mortality rates than other breast cancer subtypes. Nevertheless, the advent of Trastuzumab has significantly changed the treatment paradigm of HER2-positive breast cancer. However, it is not an affordable treatment option in sub-Saharan African countries. Besides, there was a lack of comprehensive data about the survival outcomes of HER2-positive breast cancer patients in our setting. Hence, the present study aimed to determine the survival outcomes among HER2-positive breast cancer patients at the Oncology Department of Kenyatta National Hospital.Methods: A hospital-based retrospective cohort design was used to evaluate the survival outcomes, and associated factors among patients with HER2-positive breast cancer admitted between 2015 and 2019 at Kenyatta National Hospital. A total of 50 eligible HER2-positive breast cancer patients were included in the study. In the pre-designed data abstraction tool, the data were collected by reviewing the medical records of the patients. The data were entered and analyzed using the Statistical Package for the Social Sciences version 27 software. The mean survival time was estimated using Kaplan Meier survival analysis. Cox regression analysis was employed to estimate the predictors of mortality among HER2-positive breast cancer patients.Results: The study showed that the overall survival rate was 30%, with a significant decrease in the percentage survival rate across the five years. More than half of the study participants (26, 52%) showed cancer progression during the last follow-up period. The present study showed that the mean cancer-specific survival rate among the study patients was 26.74±18.395 months. The study showed that the mean survival time of patients aged below 60 years (32.513 months), without co-morbidities (34.40 months), and the early stage of the disease (50.639 months) was higher than their counterparts. Multivariate cox-regression analysis revealed that advanced stage (AHR=13.1, 95% CI=2.6-66.6, P=0.002 and distant metastasis (AHR=15.0, 95% CI=3.6-62.8, P≤0.001) were the significant predictors of mortality among HER2 positive breast cancer patients.Conclusions: The overall survival rate of HER 2 positive breast cancer was 30%. Advanced stage and distant metastasis were the significant predictors of mortality among HER2-positive breast cancer patients.

scholarly journals 227P Cardiotoxicity in HER2 positive breast cancer patients treated with trastuzumab

2020 ◽  
Vol 31 ◽  
pp. S332
Author(s):  
M. Lopez ◽  
C. Minguito Carazo ◽  
I. Delgado Sillero ◽  
M. Rojas Piedra ◽  
B. Távara Silva ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer
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