Subcutaneous Trastuzumab Research Articles

Abstract PO3-17-08: SAFETY AND TOLERABILITY OF SUBCUTANEOUS TRASTUZUMAB AS A TREATMENT IN PATIENTS WITH EARLY HER 2 POSITIVE BREAST CANCER : EXPERIENCE OF A CANCER CENTER IN PERU

Abstract BACKGROUND: About 15% to 20% of breast cancers express positivity for human epidermal growth factor receptor 2 (HER2), a more aggressive breast cancer subtype with shorter survival. Trastuzumab, a humanized monoclonal antibody was approved by the U.S. Food and Drug Administration (FDA) for therapeutic use in metastatic breast cancer in 1998 and HER2-positive early breast cancer in 2006. HER2 overexpression is associated with more aggressive tumor growth and worse prognosis compared to HER2-negative tumors. HER2-positive tumors occur more frequently in younger women and node-positive women and are often less responsive to cytotoxic therapies. The primary objective of this study was to evaluate the tolerability of the subcutaneous formulation of trastuzumab in real life at the national institute of neoplastic diseases LIMA-PERU in patients with epidermal growth factor receptor 2 (HER2)-positive early breast cancer; efficacy was a secondary objective. METHOD: Female patients aged 18 years or older diagnosed between 2018-2019 with early epidermal growth factor receptor 2 (HER2)-positive breast cancer who received at least 1 dose of trastuzumab subcutaneously in a neo/adjuvant setting with or without chemotherapy were included. The treatment indication is 600 mg at a fixed dose every 3 weeks for 18 cycles. RESULTS: A total of 70 patients who received treatment with subcutaneous trastuzumab were included in the analysis. The mean age of the population was 52.6 ± 12.4 years, with the majority of patients being older than 50 years (54.29%). The mean number of subcutaneous trastuzumab cycles received was 11.4 ± 4.2. Adverse effects such as arthralgia (47.62%), diarrhea (9.52%), fatigue (9.52%) and injection site reaction (9.52%) occurred in 30% of patients. The mean number of cycles received until the first occurrence of adverse effects was 5.2 ± 2.1. It was observed that 97.14% completed treatment with trastuzumab subcutaneously, and 2.86% had to discontinue treatment. Cardiotoxicity and hypertension were the reasons why patients discontinued treatment. Of the patients included in the study, 63.77% received subcutaneous trastuzumab in the neoadjuvant setting, while the remaining 36.23% received it in the adjuvant setting. Of the patients, 45.71% started treatment with trastuzumab intravenously and received an average of 6 ± 3 cycles before switching to the subcutaneous presentation. After 3 years of follow-up, 7.14% developed disease progression; 57.1% had progression at the cerebral level, 28.6% at the local level and 14.3% at the pulmonary/hepatic level. 98.57% of patients are alive. CONCLUSIONS: In a real-life setting, subcutaneous trastuzumab is a well-tolerated and effective treatment option for patients even in patients who started treatment with the intravenous presentation and made the switch during treatment. Table 1: General clinical characteristics of patients XX XX Citation Format: Iris Otoya, Natalia Valdivieso, Zaida Morante, Carlos Castañeda, Silvia Neciosup, Mónica Calderón, Henry Gómez. SAFETY AND TOLERABILITY OF SUBCUTANEOUS TRASTUZUMAB AS A TREATMENT IN PATIENTS WITH EARLY HER 2 POSITIVE BREAST CANCER : EXPERIENCE OF A CANCER CENTER IN PERU [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-17-08.

Abstract PO3-11-01: Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer

Abstract Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer Background: Programs to promote the self-administration of systemic anti-cancer therapy (SACT) offer greater convenience and shared decision making for patients with the opportunity to alleviate pressures on cancer services. Aims and Objective: The aims of this study were to quantify the uptake/acceptability of self-administration (SA) of subcutaneous trastuzumab (sc T), to evaluate safety, patients’ perception of the programme and the chair capacity released as a consequence. Methods: Patients receiving T for the treatment of HER2 +ve breast cancer were offered training in SA. The competency-based training programme, under the supervision of a chemotherapy-trained nurse, consisted of a minimum of 3 training sessions. Patients were also provided with printed and electronic material (via an App) on how to self-administer sc T, with 24/7 contact details in the event of an adverse event or device failure. Once trained and deemed competent, sc T was shipped to the patients’ home in a temperature-controlled environment, in a pre-filled syringe. All patients were assessed by telephone one day before and one day after SA using the Common Terminology Criteria for Adverse Events (CTCAE). Analysis of the total number of administrations of sc T, between February 2022 and June 2023 was conducted. A telephone survey using a validated questionnaire Self-Management Assessment scale (SMASc) was also undertaken. Results Of 46 breast cancer patients receiving single agent sc T, 32 agreed to participate in the program and were trained. 2 patients were undergoing training at data analysis. 6 patients declined and 6 were ineligible for the programme on the basis of inclusion criteria. The median age of the 32 patients that participated was 62, (range 27-77). The average distance from their home address to the cancer centre was 11.7 miles (range 3.5-27.9). 25 (78%) patients were Caucasian, 4 (13%) were Asian and 3 (9%) were of African/Caribbean origin. Patients had received an average of 10 sc injections in the hospital environment (median 5, range 1-103) before starting the training sessions. They required an average of 3 training sessions before sign-off (median 3, range 1-4). In the 32 patients studied, a total of 302 SA injections were delivered median 9 (range 1- 24) No Grade 3 or 4 CTCAE toxicities or infusion-related reactions were reported. During the 17-month period, a total of 302 hours of chair time was saved. 25 of the 32 patients responded to SMASc questionnaires utilising the six-point Likert scale. Patients reported average scores of 5.32 (median 6) and 5.56 (median 6) respectively, for questions relating to having information about their condition and sufficient training to self-administer. They felt that they had sufficient support to participate in the programme (average 5.56 median 6). 80% of the patients would recommend this programme and 88% felt they had benefited. Comments from patients themed around the value of the support provided, ease of administration and time saved. Discussion Programs such as these empower patients and carers to take a more active role in managing their condition with consequent reduced hospital attendance. Safety and acceptability for those patients who agreed to the program has been confirmed. Success of this program with sc T has enabled expansion to incorporate self-administration of Phesgo (sc trastuzumab and pertuzumab) with 31% (14/45) of the current P patient cohort enrolled onto the programme within 2 weeks of roll out and the first patients self-administering their treatment from August 2023. With the continued expansion of SACT treatments, we encourage stakeholders to consider self-administration of SACT as an option. Formulation of treatments conducive to patient self-administration is a key component to this. Citation Format: Wendy Ng, Vikash Dodhia, Amy Guppy, Stephanie Sutherland, Marlgozata Wojtas, Karen Harrold, Adisa Aolat, Tome Tapiwa, David Miles. Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-01.

Home-based treatment with subcutaneous trastuzumab: safe and acceptable not only during a pandemic — final analysis of the RWD project ‘FlexCare’

Home-based treatment with subcutaneous trastuzumab: safe and acceptable not only during a pandemic — final analysis of the RWD project ‘FlexCare’

Cardiotoxic Effect of Adjuvant Subcutaneous versus Intravenous Trastuzumab in HER-2 Positive Breast Cancer

Cardiotoxic Effect of Adjuvant Subcutaneous versus Intravenous Trastuzumab in HER-2 Positive Breast Cancer

Evaluation of cost and infusion-related reactions among intravenous trastuzumab, subcutaneous trastuzumab, and trastuzumab biosimilars at an academic medical center.

Trastuzumab is a vital treatment option for human epidermal growth factor 2 positive breast cancer. Since 2017, there have been 5 trastuzumab biosimilars approved for use. Despite hypotheses of infusion-related reactions among intravenous trastuzumab, subcutaneous trastuzumab, and trastuzumab biosimilars, there is minimal available literature comparing these agents. This evaluation will compare the rate of infusion-related reactions among these agents, evaluate our institution's utilization, and compare acquisition costs to determine if there is a potential cost savings by utilizing specific agents as our formulary preferred medication. We retrospectively analyzed medical records to identify the incidence of infusion-related reaction after administration of intravenous or subcutaneous trastuzumab or trastuzumab biosimilars. Additionally, we conducted a cost analysis to identify potential cost savings by switching to an alternative institutional preferred agent. Infusion chair time was calculated to identify chair time savings with subcutaneous administration. There were 183 patients included in this study. Seven patients (3.8%) experienced an infusion-related reaction. The most utilized agent within our cohort was intravenous trastuzumab. During our study period, 181 patients received intravenous infusions, which could allow for substantial infusion chair savings by switching to trastuzumab/hyaluronidase, the subcutaneous formulation. Beyond the chair time, direct drug cost savings were also identified when comparing the costs of each of the evaluated medications. Subcutaneous trastuzumab or trastuzumab biosimilars do not pose a greater risk of infusion-related reactions compared to intravenous trastuzumab and may offer more affordable treatment options for breast cancer patients who qualify for trastuzumab therapy.

An Open-Label Study of Subcutaneous CpG Oligodeoxynucleotide (PF03512676) in Combination with Trastuzumab in Patients with Metastatic HER2+ Breast Cancer.

CpG ODN is a Toll-like receptor 9 agonist with immunotherapeutic potential for many cancer types, including aggressive breast cancers. There is strong interest in utilizing CpG ODN as an adjuvant to improve clinical efficacy of current treatments and immunogenicity of breast cancers not traditionally responsive to active immunotherapy, such as those that are human epidermal growth factor receptor 2 (HER2)-positive. This study aimed to study the efficacy and safety of combination CpG ODN plus anti-HER2 antibody trastuzumab treatment in patients with advanced/metastatic breast cancer. This single-arm, open-label phase II clinical trial treated patients (n = 6) with advanced/metastatic HER2-positive breast cancer with weekly subcutaneous CpG ODN and trastuzumab. Patients may have received any number of prior therapies to be enrolled (most enrolled at median 1 prior line of chemotherapy). Peripheral blood was collected at baseline and weeks 2, 6, 12, and 18 for immune analyses. Six patients were enrolled and 50% achieved stable disease (SD) response. Median PFS was 8.3 months. Three of the six patients enrolled opted to stop treatment due to tolerability issues. Multiplex assay for cytokine measurements revealed significantly higher VEGF-D levels at week 2 compared to baseline. Peripheral blood mononuclear cells analyzed by flow cytometry showed a significant increase in monocytic MDSC between weeks 6 and 12. Patients with progressive disease tended to have higher levels of week 6 monocytic MDSC and PD-1+ T cells than patients with SD. NK cell populations did not significantly change throughout treatment. CpG ODN and trastuzumab treatment of metastatic HER2 + breast cancer was safe but was not tolerable for all patients. This combination did induce potentially predictive immune profile changes in treated patients with metastatic HER2 + breast cancer, the significance of which needs to be further explored.

Subcutaneous Trastuzumab: An Observational Study of Safety and Tolerability in Patients With Early HER2-Positive Breast Cancer.

Purpose: In Peru, breast cancer (BC) stands as the most predominant malignancy neoplasm among women. Trastuzumab has marked a significant milestone in the management of this disease. It has been shown to improve prognosis in human epidermal growth factor receptor 2 (HER2)-expressing female patients, but its repercussions and efficacy are yet to be analyzed in a context with limited resources. Methods: The study population is made of woman patients aged 18 years and older diagnosed with HER2-positive BC at Instituto Nacional de Enfermedades Neoplásicas (INEN, Lima, Peru) during 2019-2021 and treated with at least one dose of subcutaneous trastuzumab. We reviewed medical records to register treatment characteristics, adverse events (AEs), disease progression, and survival status. We considered a median follow-up time of 36 and 45 months for progression and survival status. Results: The majority of patients were over 50 years old (54.29%). Tumor size averaged 19.7 ± 16.1 mm. Lymph nodes were present in 44.78% of patients. Most patients received adjuvant chemotherapy (63.8%) as first-line treatment. Descriptive analyses of treatment outcomes revealed a 30% toxicity rate, primarily attributed to arthralgia (47.62%), followed by diarrhea, fatigue, and injection site reactions, with relatively lower discontinuation rates compared to larger scale studies. Differences in demographic, clinical, and treatment characteristics were not statistically significant concerning the emergence of AEs (p > 0.05). Progression appeared in nine patients, and the overall survival (OS) rate stood at 98.6% and 92.8%, respectively, during a median follow-up of 36 and 45 months. Conclusion: The research suggests that subcutaneous trastuzumab is comparable in effectiveness and safety to the intravenous administration. Regional-specific studies may provide valuable insights into demographic factors influencing treatment outcomes in Peru or other countries. Furthermore, it could represent a more accessible alternative, potentially enhancing patient adherence and optimizing healthcare resource logistics.

Cost-minimization analysis comparing subcutaneous trastuzumab at home with intravenous trastuzumab for HER2-positive breast cancer in Singapore.

Trastuzumab (Herceptin) can be administered intravenously (IV Herceptin) and subcutaneously, with similar efficacy and safety, but with differences in dosage and costs. Previous studies have evaluated the costs of both treatment approaches in the outpatient settings, but no study has compared the costs of IV Herceptin administered in outpatients with subcutaneous Herceptin administered at patients' homes (Homecare SC Herceptin). This study aimed to compare the per-patient costs of Homecare SC Herceptin versus IV Herceptin administered in a healthcare institution's outpatient setting in Singapore. We performed a model-based cost-minimization analysis to estimate and compare the per-patient annual costs associated with each treatment modality from a societal perspective. Direct cost comprised healthcare resources utilization: drug, consumables, manpower, facility and cardiac assessment. Indirect cost was valued using a human capital approach to account for productivity lost by patients. Monte Carlo simulations with 1000 iterations were performed to account for parameter uncertainties. Costs were reported in 2023 Singapore dollars. The annual societal cost per patient receiving IV Herceptin ranged from S$64,194 to S$65,135, while for Homecare SC Herceptin, it ranged from S$25,865 to S$26,807. Homecare SC Herceptin reduced the annual cost burden by 58.8% and 59.7%, per non-metastatic and metastatic breast cancer patient, respectively. The primary cost contributor was drug therapy, comprising more than 90% of the total cost. Even when excluding the cost of drugs, Homecare SC Herceptin remained cheaper by S$1912 annually. The cost reduction is approximately 60% compared to IV Herceptin regardless of disease status, with a 100% probability that the decision to adopt Homecare SC Herceptin leads to cost savings in Singapore. Treatment of breast cancer with Homecare SC Herceptin is a cost-saving option compared to IV Herceptin.

The PHASTER Study: Economic and Organizational Impact of Subcutaneous (SC) Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Treatment of HER2+ Breast Cancer Patients

The PHASTER Study: Economic and Organizational Impact of Subcutaneous (SC) Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Treatment of HER2+ Breast Cancer Patients

Randomized, open-label, phase II, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with locally advanced, inflammatory, or early HER2-positive breast cancer—Immun-HER trial (GOIRC-01-2016)

BackgroundIt is possible to induce immunomodulation in HER2-positive breast cancer (BC) by modifying the route of administration of trastuzumab.MethodsIn this multicenter randomized phase II trial, all enrolled patients (pts) with...

26P Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China

26P Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China

Cost minimization analysis of subcutaneous trastuzumab versus intravenous biosimilar trastuzumab: policy recommendations for breast cancer treatment in Malaysia.

Current clinical practice recommends switching innovator intravenous trastuzumab (IV-TZMi) to subcutaneous trastuzumab (SC-TZM) to save healthcare resources. However, with the availability of biosimilar intravenous trastuzumab (IV-TZMb), there is a need to re-evaluate the recommendation. Hence, this study aims to compare the cost and resource use of SC-TZM and IV-TZMb in a Malaysian public healthcare facility. This activity-based costing study consists of (1) a retrospective medical record abstraction to determine patient details to estimate drug costs and (2) a time-motion study to quantify personnel time, patient time, and consumables used. The total cost of both SC-TZM and IV-TZMb were then compared using a cost-minimization approach, while differences were explored using an independent t-test. A sensitivity analysis was also conducted to determine the impact of uncertainties in the analysis. The mean total cost of SC-TZM and IV-TZMb was USD 13,693 and USD 5,624 per patient respectively. The cost difference was primarily contributed by savings in drug cost of IV-TZMb, a reduction of USD 8,546 (SD = 134), p < 0.001 compared to SC-TZM. Interestingly, SC-TZM had a significantly lower cost than IV-TZMb for both the consumable and personnel cost, a reduction by USD 300 (SD = 17.6); p < 0.001 and USD 176 (SD = 7.3); p < 0.001 respectively. The sensitivity analysis demonstrated that the total cost difference between the formulation was mainly driven by drug costs. The study evidenced that IV-TZMb was a more economically viable option in Malaysian public healthcare currently compared to SC-TZM.

Infective complications in cancer patients treated with subcutaneous versus intravenous trastuzumab and rituximab: An individual patient data meta-analysis.

Investigation of infection risk with subcutaneous versus intravenous trastuzumab and rituximab administration in an individual patient data (IPD) and published data meta-analysis of randomised controlled trials (RCTs). Databases were searched to September 2021. Primary outcomes were serious and high-grade infection. Relative-risk (RR) and 95% confidence intervals (95%CI) were calculated using random-effects models. IPD meta-analysis (6 RCTs, 2971 participants, 2320 infections) demonstrated higher infection incidence with subcutaneous versus intravenous administration, without reaching statistical significance (serious: 12.2% versus 9.3%, RR 1.28, 95%CI 0.93to1.77, P = 0.13; high-grade: 12.2% versus 9.9%, RR 1.32, 95%CI 0.98to1.77, P = 0.07). With exclusion of an outlying study in post-hoc analysis, increased risks were statistically significant (serious: 13.1% versus 8.4%, RR 1.53, 95%CI 1.14to2.06, P = 0.01; high-grade: 13.2% versus 9.3%, RR 1.56, 95%CI 1.16to2.11, P < 0.01). Published data meta-analysis (8 RCTs, 3745 participants, 648 infections) demonstrated higher incidence of serious (HR 1.31, 95%CI 1.02to1.68, P = 0.04) and high-grade (HR 1.52, 95%CI 1.17to1.98, P < 0.01) infection with subcutaneous versus intravenous administration. Results suggest increased infection risk with subcutaneous versus intravenous administration, although IPD findings are sensitive to exclusion of one trial with inconsistent results and identified risk-of-bias. Ongoing trials may confirm findings. Clinical surveillance should be considered when switching to subcutaneous administration. PROSPERO registration CRD42020221866/CRD42020125376.

Subcutaneous versus endovenous trastuzumab: Real world data from a reference cancer center in Peru.

e12527 Background: HER2 receptor amplification/overexpression is identified in approximately 20% of invasive breast neoplasms; it is characterized by biologically aggressive behavior and worse prognosis compared to HER2-negative tumors. Trastuzumab, a humanized monoclonal antibody, was approved for therapeutic use in HER2-positive breast cancer. The objective of this study is to compare the acquisition costs, costs, and preparation and application times of trastuzumab presentations. Methods: Descriptive and retrospective study in female patients aged 18 years and older with a diagnosis of HER 2 positive early breast cancer who received subcutaneous or intravenous trastuzumab during the years 2019-2021. The study setting was the National Institute of Neoplastic Diseases (INEN)- Lima/Peru. We created a simple spreadsheet model to evaluate costs (expressed in soles). The analysis included the calculation of patient time in the chemotherapy chair, preparation time and treatment administration time. Results: The cost of the subcutaneous presentation was S/4212 and S/4348 for the intravenous presentation. The cost of the complete treatment was S/75816 for the subcutaneous presentation and S/82612 for the intravenous presentation. The cost of the supplies used in the preparation of 18 cycles of treatment for the subcutaneous presentation was S/ 20.7 and for the intravenous presentation S/ 399.96; likewise, the cost of the supplies used in the administration of 18 cycles of treatment for subcutaneous trastuzumab was S/ 34.02 and for the intravenous presentation was S/ 1094.4. The cost of using a chemotherapy chair for 18 cycles for subcutaneous presentation was S/36 and for intravenous presentation S/663. The time used in the application of 1 cycle of subcutaneous presentation was 30 minutes for the first application and 15 minutes for subsequent applications; the time used in the application of each cycle for endovenous presentation was 6 hours for the first application and 2 hours for subsequent applications. The administration of 18 cycles for subcutaneous presentation was S/ 732.45 and for intravenous presentation S/ 6168. The trastuzumab formulation for subcutaneous application is a ready-to-use solution, so it did not generate preparation costs. The preparation time for one cycle of intravenous presentation was 15 minutes and meant an investment of S/693.90 for the preparation of 18 cycles (cost of preparation personnel time). Conclusions: The use of subcutaneous trastuzumab generates less costs associated with an overall savings of 16.36%, its use implies less time for preparation and application, as well as a reduction in patient chair time. These time reductions translate into economic savings, a more efficient use of resources and a reduction in waiting time for appointments in the chemotherapy service and a greater capacity of the oncology service to treat a greater number of patients.

116P Time and motion randomised study of a subcutaneous (SC) pertuzumab and trastuzumab fixed-dose combination (PH FDC) for the treatment of HER2-positive early breast cancer (HER2 EBC): PHaTiMa

In oncologic monotherapy, SC compared to intravenous (IV) route brings advantages like patients’ (Pts) and healthcare professionals (HCP) preference and improved healthcare efficiency, thanks to reductions of both time and use of resources. During adjuvant dual blockade for HER2 EBC, trained observers measured time used in various treatment activities for 3 cycles (2nd to 4th) of pertuzumab (Perjeta or P) IV and trastuzumab (Herceptin® or H) IV or SC (Group A: P-IV+H-IV; Group B: P-IV+H-SC) and later for subsequent 3 cycles (5th to 7th) of PH FDC SC (Phesgo). The objectives were to assess time saved by Pts and HCP and what resources were used with PH FDC SC versus P-IV+H-IV or P-IV+H-SC. In 10 Spanish centres, 34 women were randomised (n=17 in Groups A and B). Per cycle, PH FDC SC saved 71% and 63% of Pts time in treatment room (-119 and -87 min, both p<0.0001) and 75% and 69% in chair (-121 and -90 min, both p<0.0001) compared with P-IV+H-IV and P-IV+H-SC, respectively. Active HCP time was reduced by 49% and 48% (-22.9 and -23.0 min, both p<0.0001), including preparation (-6.05 min p<0.0001 and -2.05 min p=0.1112) and administration (-16.9 min p=0.0006 and -20.8 min p<0.0001). Active times were reduced both for pharmacists (-2.10 min p=0.0185 and -1.46 min p=0.0488) and nurses (-18.3 min p=0.0004 and -20.0 min p<0.0001). PH FDC SC reduced use of consumables and avoided drug waste. Safety data up to cycle 7 (in 2025 ends 3-year follow-up) reported 20 Pts with 38 adverse events related to study treatments (only 2 Grade 3: diarrhoea and a serious [SAE] drug hypersensitivity). PH FDC SC significantly saved Pts and HCP times and reduced use of healthcare resources. In dual therapies, the advantages of the SC route are added to those of fixed dose combination, versus administering drugs separately. Preliminary safety data indicated that the study treatments were overall well tolerated. Together with previous findings showing comparable efficacy and safety profiles and Pts preference of PH FDC SC versus P-IV+H-IV in (neo)adjuvant settings, these results encourage the use of PH FDC SC for dual blockade treatments.

Abstract P6-08-13: Home-based treatment with subcutaneous (SC) trastuzumab - only a pandemic solution? Real world evidence (RWE) analysis

Abstract Background The pandemic has accelerated the introduction of more flexible and cost-effective treatment forms. The efficacy of trastuzumab in the intravenous (IV) and SC forms is similar both in early and advanced HER2-positive breast cancer (BC) patients. Compared to IV administration, SC enables reduction of treatment costs and time, and saves equipment and human resources. SC formulation is more convenient for both patients and healthcare providers and may be implemented as a home-based therapy. Recently, systemic anticancer treatment (including chemotherapy) has been increasingly performed at home, improving patient comfort and reducing the burden on the healthcare system. Poland has already implemented home-based treatment with some biologic compounds; however, they have not included trastuzumab in BC patients. Objectives This RWE analysis aims to evaluate the organizational and therapeutic procedures related to the home-based treatment with SC trastuzumab and the attitudes of patients and healthcare providers to this approach. Material and methods The study enrolled early HER2(+) BC patients treated with trastuzumab during the COVID-19 pandemic. Monitoring and treatment duration were consistent with SmPC and reimbursement regulations in Poland. The first 3-6 doses of SC trastuzumab (alone or in combination with CHT) were administered at a cancer center in outpatient and inpatient settings. Subsequent doses were administered at home by 3 qualified breast nurses. Post-injection follow-up was used for educational purposes. Data were analyzed with descriptive statistics. The study was reviewed and approved by the local Bioethics Committee. Results The analysis included 20 patients treated in two comprehensive cancer centers in Poland with a median age of 59 years (range, 36-72 years). Seven patients (35%) were professionally active. The average distance from the place of residence to the cancer center was 24 km (range, 2-65 km). A total of 232 doses were administered (mean 11.6 doses per patient; range 6-14), 133 doses at home and 99 at the cancer center. The overall tolerance of trastuzumab was good and consistent with the known safety profile described in Summary of Product Characteristics. Only 1 patient (5%) discontinued treatment prematurely due to decreased LVEF; another 19 patients completed treatment as planned. For 19 patients (95%), the benefits of SC treatment included time savings, the ability to continue working, and avoiding crowded places and infection risk. 2 patients (10%) considered the nurse’s visit privacy disturbing, while 18 (90%) would recommend home-based drug administration. The average duration of a nurse’s stay at home was 60 minutes (range 30 to 130 minutes). No logistical or technical problems were reported, except for occasional patient lateness. Nurses positively assessed the treatment provided in the nursing office, which was a source of additional knowledge, and experience. The overall impression of home-based therapy was positive for both patients and nurses. The limitation of the study is the declarative nature of the data. Conclusions Home-based treatment with SC trastuzumab should be pursued due to its safety, ease of organization, positive perception by patients and nurses, and reducing healthcare system resources. It can be particularly valuable for disabled patients who have difficulty reaching the hospital and professionally active patients. Specialized, trained nurses can self-sufficiently carry out part of the prolonged trastuzumab treatment, reducing physician involvement. Citation Format: Barbara Radecka, Hudała-Klecha Joanna, Dariusz Sawka, Jolanta Sarga, Bożena Noworolska, Jolanta Sawicka, Elżbieta Duda, Natalia Obruśnik, Patryk Zając. Home-based treatment with subcutaneous (SC) trastuzumab - only a pandemic solution? Real world evidence (RWE) analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-08-13.

Quality of care in the course of subcutaneous versus intravenous trastuzumab administration in patients with breast cancer: an integrated time–motion study with mixed-methods research

ObjectivesThis study aimed to compare the time required and concerns raised by various perspectives of participants regarding administering subcutaneous and intravenous trastuzumab for patients with breast cancer (BC).DesignThis observational time–motion...

Cost-minimisation analysis of intravenous versus subcutaneous trastuzumab regimen for breast cancer management in Hong Kong.

In 2017, breast cancer was the most common cancer and third leading cause of cancer death among women in Hong Kong. Approximately 20% of patients were human epidermal growth factor receptor-2 (HER2)-positive. This study was conducted to investigate cost differences between intravenous and subcutaneous trastuzumab regimens in Hong Kong using medical resources utilisation data from other countries. A cost-minimisation model was developed to compare the cost of total care, including direct medical cost and full-time equivalent (FTE) hours. The drug acquisition cost was obtained from the manufacturer, whereas the costs for hospitalisation and clinic visits were acquired from the Hong Kong Gazette. Time (in FTE hours) was determined by literature review. All costs were expressed in US dollars (US$1 = HK$7.8). Costs were not discounted because of the short time horizon. One-way deterministic sensitivity analysis was performed to identify the effects of changes in drug acquisition cost, changes in FTE hours (based on confidence intervals reported), and changes in body weight (±20%). Literature review indicated that 0.18 FTE hour of nursing time (7.9 hours) and 0.14 FTE hour of pharmacist time (6.2 hours) could be saved each week if the subcutaneous formulation was used. Using data in 2017, after 18 cycles of treatment with subcutaneous trastuzumab, the drug acquisition and healthcare professional time costs were reduced by US$9451.28 and US$566.16, respectively, yielding an annual savings of over US$8 million. The subcutaneous formulation of trastuzumab is a potential cost-saving therapy for HER2-positive breast cancer patients in Hong Kong. The drug acquisition cost was the parameter with the greatest effect on the total cost of treatment.

An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction.

This study was designed to investigate treatment satisfaction in patients and Health Care Professionals (HCP) and to evaluate the safety and tolerability of subcutaneous (SC) trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC). Two-hundred and twenty-three patients with eBC were screened, of whom 173 patients met the eligibility criteria and received at least one dose of SC trastuzumab. The primary efficacy endpoint was to assess patient satisfaction via a questionnaire. The majority of patients (n = 166, 97.6%) reported satisfaction with the SC route. Patients and HCPs stated that SC trastuzumab was easy to use (93.5% and 62.5%, respectively) compared to the intravenous (IV) route and all HCPs (n = 16) expressed satisfaction with the SC route. Progression, disease recurrence or death was reported in 24 patients (13.8%) by two years of follow up. Four-year disease-free survival (DFS) and overall survival (OS) rates were 84.2% (±3.1) and 90.5% (±4.7), respectively. A total of 1299 adverse events (AEs) were recorded over 4-years follow-up, nearly 97% of which were judged non-serious. The most common AEs were arthralgia (n = 54, 4.2%), flu-like symptoms (n = 41, 3.2%) and nausea (n = 39, 3.0%). Fifty-four cardiac events, including left ventricular dysfunction, left ventricular failure and cardiotoxicity, were reported. Ejection fraction (EF) decrease [median decrease 3.5% (0.12-19.0)] was reported in 5.4% of cases. SC trastuzumab treatment was interrupted due to decreased EF in two cases. SC trastuzumab was widely acceptable to both patients and HCPs. The safety and tolerability of SC trastuzumab was consistent with the known safety profile of SC and IV administration.

Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba

PURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the effectiveness/safety of neoadjuvant therapy with subcutaneous (SC) trastuzumab- pertuzumab chemotherapy (real world) to extend the evidence, which comes mainly from clinical trials (selected population; intravenous [IV] trastuzumab).MATERIALS AND METHODS: A prospective, longitudinal, observational study in a Cuban hospital. Population: women aged ≥18 years with histologically confirmed HER2+ early-stage BC (2017–2021) eligible for neoadjuvant treatment (IV pertuzumab, SC trastuzumab, taxane-based chemotherapy). The aim was to determine the pathological complete response (pCR) rate to this scheme, its safety, and the impact of patient's characteristics on the outcomes.RESULTS: Eighty-seven women were included: n=29 (DPT [docetaxel-IV pertuzumab- SC trastuzumab 600 mg; 4 cycles]); n=58 (ddAC-DPT [dose-dense anthracycline-based scheme+DPT]; 8 cycles). The median age was 57 years (range 30–83), ECOG 0: 97%. Time from diagnosis to treatment (median) was 28 days. The overall pCR rate was 62.1% (55.2%, DPT; 66.5%, ddAC-DPT; p =0.351); HR+, 47.7% vs. HR-, 76.7% (p=0.006). There were no statistically significant differences based on nodal status, stage, or Ki-67 levels. Overall, 94.2% of patients experienced ≥1 adverse event related to treatment, all of them grade 1-3 and more common with ddAC-DPT. The main cause of treatment delays (n=19; ddAC-DPT, 16; DPT, 3) was treatment-related toxicities.CONCLUSION: Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile.