Anthracycline, taxane, and trastuzumab-based neoadjuvant chemotherapy in HER2-positive early breast cancer: phase II trial

2022 ◽  
pp. 030089162110675
Author(s):  
Benedetta Conte ◽  
Filippo Montemurro ◽  
Alessia Levaggi ◽  
Eva Blondeaux ◽  
Chiara Molinelli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
Phase Ii ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Objective: Neoadjuvant chemotherapy has become the preferred treatment in HER2-positive early breast cancer. Several trials investigated the neoadjuvant efficacy of dual HER2 blockade with anthracycline-free chemotherapy, whereas few data are available on single-agent trastuzumab and anthracycline-based regimens, which represent the standard of care in the adjuvant setting. This phase II, single-arm trial assessed anthracycline-based chemotherapy and trastuzumab as neoadjuvant treatment for high-risk HER2-positive breast cancer. Methods: Forty-three patients with stage II–III HER2-positive breast cancer were treated with 4 courses of neoadjuvant 5-fluorouracil 600 mg/m2, epirubicin 90 mg/m2, cyclophosphamide 600 mg/m2 (FEC ×4) every 21 days, followed by 12 courses of weekly paclitaxel 80 mg/m2 and trastuzumab 2 mg/Kg IV (loading dose 4 mg/kg). Results: Pathologic complete response (pCR) was observed in 22 (51%) of 43 patients. After a median follow-up of 6 years, the 5-year disease-free survival and overall survival were 85.8% (95% confidence interval 75.9%–97%) and 89.6% (80.4%–99.8%), respectively. A temporary decrease in left ventricular ejection fraction was observed in two patients. No cardiac death or congestive heart failure occurred. One patient died due to febrile neutropenia. Conclusions: FEC ×4 followed by paclitaxel and trastuzumab was associated with high pCR rates and favorable long-term outcomes. However, this regimen was associated with relevant hematologic toxicity.

Objective response rate in a phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with trastuzumab (T) in patients (pts) with HER2-positive metastatic breast cancer (MBC) which has progressed during treatment with T

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1004-1004 ◽  
Author(s):  
J. Baselga ◽  
D. Cameron ◽  
D. Miles ◽  
S. Verma ◽  
M. Climent ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Objective Response ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Fixed Dose ◽  
Loading Dose ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

1004 Background: T and P bind to different epitopes on the extra cellular domain of HER2. Unlike T, P binds to the dimerization domain and blocks homo- and hetero-dimerization of HER2 with other HER kinase family members. Xenograft models support the hypothesis that the complementary mechanisms of action could result in augmented efficacy when T and P are combined. Methods: Two-stage design, criteria to proceed to the 2nd stage were: ≥ 2 partial responses (PR) or 1 PR and 12 stable disease (SDs) or 13 SDs. Eligibility included: measurable, centrally-tested HER2 positive breast cancer; up to 3 lines of prior chemotherapy plus T (including adjuvant chemotherapy plus T); disease progression during T as most recent treatment for metastatic disease; baseline left ventricular ejection fraction (LVEF) ≥ 55% and no decrease of LVEF to below 50% during prior T treatment. Consenting Pts received T i.v. weekly or every 3 weeks at 2 mg/kg or 6 mg/kg respectively (with re-loading dose if required) plus 420mg fixed dose of P i.v. every 3 weeks following loading dose 840mg. Study treatment was initiated within 9 weeks of the last dose of T given as most recent therapy. An independent data safety monitoring board has overseen the 1st stage safety data. Results: Recruitment into 1st stage is complete. The main adverse events were diarrhea (71%), fatigue (46%), nausea/vomiting (38%) and rash (25%). Most AE’s were mild to moderate (there was 1 case of Grade 3 diarrhea) and none was treatment-limiting. There were no clinical cardiac events, and central review revealed no case of fall in LVEF of ≥10% and to ≤50%. Response status: 5 confirmed PR (21%); 12 SD (50%). Responses have been observed in lymph node and liver metastases. Recruitment into the 2nd stage of the trial has commenced. Conclusions: The combination of the P and T is active and well tolerated in patients with pre-treated HER2 positive breast cancer which has progressed during treatment with T. No significant financial relationships to disclose.

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 subclinical cardiotoxicity in patients with early stage HER2-positive breast cancer: A retrospective single-center cohort study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10123-10123
Author(s):  
Olexiy Aseyev ◽  
Moira Rushton-Marovac ◽  
Freya L. Crawley ◽  
Christopher Johnson ◽  
Susan Faye Dent
Keyword(s):  
Breast Cancer ◽  
Regression Analysis ◽  
Early Stage ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Increased Risk ◽  
Positive Breast Cancer

10123 Background: Trastuzumab-based therapy (TT) is standard treatment for HER2-positive breast cancer (HBC). Subclinical cardiotoxicity (SCTx), defined as asymptomatic decline in left ventricular ejection fraction (LVEF) > 10% to < 50%, has been reported in up to 30 % of HBC patients (pts) receiving TT. Objectives included: determine prevalence of SCTx; associated risk factors (RF); and completion rates of TT in pts with HBC referred to a cardio-oncology clinic (COC). Methods: HBC patients receiving TT referred to the Ottawa Hospital COC were included. Demographics, TNM staging, performance status, stage, cardio-vascular (CV) RF (history of heart disease, hypertension, smoking, dyslipidemia, and diabetes), cardiac medications (CM) (ACE-inhibitors, beta-blockers), baseline LVEF, previous cancer therapy, baseline anthracycline exposure, previous radiation therapy (RT) (including mediastinal RT) were collected. LVEF was evaluated by ECHO or MUGA. Rate of successful completion of TT among pts with SCTx was determined. Risk ratio (RR) and logistic regression analysis was performed. Results: 240/408 BC pts referred to the COC (2008-2016) had HBC and 163/240 (68%) were referred with SCTx while on TT. 139/163 (85 %) pts with SCTx recovered after COC assessment: 77/163 (47%) pts were prescribed CMs. A significantly higher proportion of recovery was observed in pts who did not require CM (0.92 vs 0.78, p = 0.012; RR = 0.85, 95%CI:0.74-0.91). A total of 129/163 (79%) pts who experienced SCTx finished a full course of TT. Regression analysis found baseline LVEF, diabetes, and diastolic blood pressure as significant RFs for SCTx. There were no independent predictors for recovery after asymptomatic drop in LVEF while on TT. Diabetes (OR:2.97, 95%CI:1.3-6.8) and left chest wall RT (OR:2.4, 95%CI:1.1-5.6) significantly increased risk of permanent TT interruption in pts with asymptomatic drop in LVEF. Conclusions: The majority of HBC pts who experience SCTx can safely complete a full course of TT; many without use of CMs. While CV RFs were associated with increased risk of SCTx, this did not impact CV recovery after asymptomatic drops in LVEF.

scholarly journals 2D-echocardiography vs cardiac MRI strain: a prospective cohort study in patients with HER2-positive breast cancer undergoing trastuzumab

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Nathalie I. Bouwer ◽  
Crista Liesting ◽  
Marcel J. M. Kofflard ◽  
Jasper J. Brugts ◽  
Marc C. J. Kock ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Global Longitudinal Strain ◽  
Radial Strain ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Trastuzumab Treatment ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Background We aimed to study the predictive value of early two-dimensional echocardiography (2DE) speckle tracking (ST) for left ventricular ejection fraction (LVEF) changes during trastuzumab treatment for HER2-positive breast cancer. Methods HER2-positive breast cancer patients receiving trastuzumab, with or without anthracycline, underwent 2DE-ST at baseline and after 3 and 6 months (m) trastuzumab. Cardiac magnetic resonance (CMR) imaging (with ST) was performed at baseline and 6 m. We studied the correlation between 2DE-ST- and CMR-derived global longitudinal strain (GLS) and global radial strain (GRS) measured at the same time. Additionally, we associated baseline and 3 m 2DE-ST measurements with later CMR-LVEF, and with cardiotoxicity, defined as CMR-LVEF < 45% and/or absolute decline > 10% during trastuzumab. Results Forty-seven patients were included. Median baseline LVEF was 60.4%. GLS measurements based on 2DE-ST and CMR showed weak correlation (Pearson’s r = 0.33; p = 0.041); GRS measurements were uncorrelated (r = 0.09; p = 0.979). 2DE-LVEF at baseline and 3 m, and 2DE-ST-GLS at 3 m were predictive of CMR-LVEF at 6 m. In contrast, the change in 2DE-ST-GLS at 3 m was predictive of the change in CMR-LVEF at 6 m, whereas the change in 2DE-LVEF was not. Importantly, the 11 patients who developed cardiotoxicity (28%) had larger 2DE-ST-GLS change at 3 m than those who did not (median 5.2%-points versus 1.7%-points; odds ratio for 1% difference change 1.81, 95% confidence interval 1.11–2.93; p = 0.016; explained variance 0.34). Conclusions Correlations between 2DE-ST and CMR-derived measurements are weak. Nevertheless, ST-measurements appeared useful to improve the performance of 2DE in predicting LVEF changes after 6 m of trastuzumab treatment.

QIM19-132: Trastuzumab Induced Cardiotoxicity: Are We Monitoring and Managing Appropriately?

2019 ◽  
Vol 17 (3.5) ◽  
pp. QIM19-132
Author(s):  
Heather Katz ◽  
Hassaan Jafri ◽  
Emilia Cindy Leigh ◽  
Layana Biglow ◽  
Madhulika Urella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Package Insert ◽  
Left Ventricular ◽  
Stage I ◽  
Left Ventricular Ejection ◽  
Comprehensive Cancer Center ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Background: Per the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer (available at NCCN.org), left ventricular ejection fraction (LVEF) should be evaluated prior to and during treatment with trastuzumab. Optimal frequency of assessment is unknown. The FDA label recommends monitoring prior to and every 3 months during therapy. Trastuzumab should be held for 4–8 weeks when LVEF decreases ≥16% from pretreatment values or LVEF is below normal limits and decreases ≥10% from pretreatment values. Trastuzumab should be permanently discontinued for persistent (>8 weeks) LVEF decline or if trastuzumab is stopped >3 times for cardiomyopathy (trastuzumab package insert). Methods: A retrospective chart review was performed analyzing 98 charts of patients with stage I–III HER2-positive breast cancer who were seen at the Edwards Comprehensive Cancer Center (ECCC) in Huntington, WV from January 1, 2012–December 30, 2017. Patients who received trastuzumab at ECCC (59) were further reviewed to see if cardiac function was assessed prior to treatment, at 3 month intervals, and if trastuzumab was held or discontinued permanently if indicated. Results: Analysis of 98 patient charts with stage I–III HER2-positive breast cancer was performed. 59 patients (60.2%) received trastuzumab under supervision of medical oncology at ECCC and continued in the study. LVEF was evaluated in all patients (100%) prior to treatment. LVEF was evaluated every 3 months in 36 (61%) patients while 23 (38.9%) occurred at longer time intervals. Preserved EF was seen in 41 (69.4%) patients. 18 (30.5%) patients had a decrease in LVEF by the defined criteria. Trastuzumab was not held appropriately in 4 of those patients (22.2%). 10 of 18 patients that had a drop in LVEF had persistent LVEF decline or had stopped treatment >3 times for cardiomyopathy. Trastuzumab was permanently discontinued appropriately in 4 of the 10 patients (40%). Conclusions: Better compliance is needed to monitor LVEF at 3-month intervals while on trastuzumab. Improvement to recognize when to hold trastuzumab to prevent cardiotoxicity is needed. Better documentation, easier accessibility to previous EF results, and a multidisciplinary team (breast navigator, cardiologist, oncologist, and pharmacist) will likely improve adherence to current recommendations for cardiac assessment and to determine if Trastuzumab should be held or stopped.

scholarly journals 2D-echocardiography vs cardiac MRI strain using deep learning: a prospective cohort study in patients with HER2-positive breast cancer undergoing trastuzumab

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
NI Bouwer ◽  
C Liesting ◽  
MJM Kofflard ◽  
JJ Brugts ◽  
MCJ Kock ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cardiac Magnetic Resonance ◽  
Magnetic Resonance ◽  
Left Ventricular ◽  
Mean Difference ◽  
Left Ventricular Ejection ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Funding Acknowledgements Type of funding sources: Private hospital(s). Main funding source(s): Promotiefonds Albert Schweitzer Hospital Background Subclinical cardiotoxicity due to trastuzumab could be recognized by repeated measurements of global longitudinal/radial strain (GLS/GRS) which could be performed with cardiac magnetic resonance (CMR) or two-dimensional speckle tracking echocardiography (2DE-ST). Although CMR is the gold standard for cardiac function evaluation, it is not used for cardiac monitoring. 2DE-ST might be a reasonable alternative.  Purpose To study the predictive value of early 2DE-ST for left ventricular ejection fraction (LVEF) changes during trastuzumab for HER2-positive breast cancer. Methods HER2-positive breast cancer patients receiving trastuzumab, with or without anthracycline, underwent 2DE-ST at baseline and after 3 and 6 months (m) trastuzumab. Cardiac magnetic resonance (CMR) imaging (with ST) was performed at baseline and 6m. We studied the correlation between 2DE-ST- and CMR-derived GLS and GRS. We then associated baseline and 3m 2DE-ST with later CMR-LVEF, and with cardiotoxicity, defined as CMR-LVEF &lt;45% and/or absolute decline &gt;10% during trastuzumab. Results 47 patients were included. GLS measurements based on 2DE-ST and CMR showed weak correlation (Pearson’s r = 0.33; P = 0.041); GRS measurements were uncorrelated (r = 0.09; P = 0.979). 2DE-LVEF at baseline and 3m, and 2DE-STE-GLS at 3m were predictive of CMR-LVEF at 6m (Table 1). In contrast, the change in 2DE-ST-GLS at 3m was predictive of the change in CMR-LVEF at 6m, whereas the change in 2DE-LVEF was not. Importantly, the 11 patients (28%) who developed cardiotoxicity had larger 2DE-ST-GLS change at 3m than those who did not (median 5.2% versus 1.7%; odds ratio 1.81, 95% confidence interval 1.11–2.93; P = 0.016). Conclusion Although correlations between 2DE-ST and CMR are weak, ST-measurements appeared useful to improve the performance of 2DE in predicting LVEF changes after 6m of trastuzumab. Table 1 2DE CMR-LVEF after 6m TZT Mean difference (95% CI) Change in CMR-LVEF after 6m TZT Mean difference (95% CI) Cardiotoxicity OR (95% CI) Before TZT LVEF, % 0.85 (0.42, 1.27)* 0.32 (-0.16, 0.80) 0.88 (0.75, 1.02) ST-GLS, % -0.42 (-1.31, 0.46) -0.28 (-1.14, 0.58) 1.13 (0.87, 1.46) 3 Months TZT LVEF, % 0.59 (0.30, 0.88)* 0.29 (-0.04, 0.61) 0.85 (0.74, 0.98)* ST-GLS, % -1.14 (-2.07, -0.19)* -0.62 (-1.54, 0.30) 1.36 (0.94, 1.84) Change at 3 months TZT LVEF, % 0.30 (-0.11, -0.71) 0.21 (-0.19, 0.61) 0.90 (0.80, 1.01) ST-GLS, % -1.17 (-2.14, -0.20)* -1.10 (-2.02, -0.18)* 1.81 (1.11, 2.93)* * P-value &lt;0.05

scholarly journals Influence of Ile655Val polymorphism on trastuzumab-induced cardiotoxicity in early-stage HER2 positive breast cancer

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ljubica Vazdar ◽  
Ivo Darko Gabrić ◽  
Ivan Kruljac ◽  
Hrvoje Pintarić ◽  
Robert Šeparović ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Genotype Distribution ◽  
Her2 Positive ◽  
Adjuvant Trastuzumab ◽  
Ventricular Ejection Fraction ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

AbstractTrastuzumab has improved the prognosis of HER2 positive breast cancer, but cardiotoxicity remains a concern. We aimed to identify risk factors for trastuzumab-induced cardiotoxicity, with an emphasis on the HER2 Ile655Val single nucleotide polymorphism. This single-center case–control study included 1056 patients with early-stage HER2 positive breast cancer that received adjuvant trastuzumab. Cardiotoxicity was defined as a decline in left ventricular ejection fraction (LVEF) > 15% in patients without previous cardiomyopathy, or > 10% in patients with baseline LVEF of < 50%. Patient characteristics and cardiac parameters were compared in 78 (7.38%) cases and 99 randomly assigned controls, and the polymorphism was genotyped using real-time polymerase chain reaction. Cardiotoxicity was independently associated with advanced age (P = 0.024), lower body mass index (P = 0.023), left breast involvement (P = 0.001), N3 status (P = 0.004), diabetes (P = 0.016), and a family history of coronary artery disease (P = 0.019). Genotype distribution was as follows: A/A (Ile/Ile) was found in 111 (62.7%) patients, A/G (Ile/Val) in 60 (33.9%) patients, and G/G (Val/Val) in 6 (3.4%) patients. The genotype was not associated with cardiotoxicity or the severity of heart failure, reversibility, and recovery time. We found no association between the HER2 Ile655Val polymorphism and trastuzumab-induced cardiotoxicity; therefore, we do not recommend routine cardiotoxicity-risk stratification using this polymorphism.

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.

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