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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.
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Background In breast cancer, prognosis is marked by histology and stage at diagnosis. Patients presenting with HER-2 positive or triple negative breast (TNBC) often have a worse prognosis. Early detection of breast cancer is mainly based on yearly screening mammograms, which were disrupted during the lockdown stages of the COVID-19 pandemic. In general, underserved populations, especially the Hispanic population often lack access to preventive care due to lack of funding causing delays in access to timely care. The COVID-19 pandemic caused many patients to miss their annual mammogram screening due to lockdown causing subsequent presentation of more advanced cancer. We, therefore, hypothesized that more patients were diagnosed with advanced cancer after lockdown and worse histology in the Hispanic population compared to the non-Hispanic population of San Antonio, Texas. Methods We identified 3 cohorts retrospectively using chart review: Pre-covid-19 era was defined between 2018 to March 2020. Lockdown is defined as a period between April 2020 to December 2020 followed by the post-vaccine era from January 1st 2021 to 2022. Pearson's Chi-squared and logistic regression tests were used to determine the relationship between time, histology at diagnosis and ethnicity. Results More Hispanic patients were found to present with HER2+ disease (OR: 1.65. p-value .047) compared to non-Hispanic women. When looking at presentation of HER2+ disease in the pre-covid-19 era, there was a 15.11% increase in the presentation of HER2+ disease in the post-vaccine era. When looking at the presentation of TNBC disease in women, there was not a significant correlation seen in the lockdown or post-vaccine period in Hispanic compared non-Hispanic women. Other factors such as funding status were associated with TNBC at presentation independently of ethnicity. In the lockdown era, the number of newly diagnosed breast cancer patients reached an all-time low and during the post-vaccine era, the patient numbers are back to the pre-covid era. Conclusion Ethnicity in part played a role in the number of patients presenting with more aggressive histology such as TNBC and Her 2 positive breast cancer in the post-vaccine era. These findings may be secondary to fact that certain ethnic groups are more likely to miss preventive screenings and the covid 19 pandemic lockdown exacerbated this problem. Diagnosis of advance cancer can further deter patients from seeking care due to socioeconomic factors and possibly increase mortality in these populations. These findings suggest that there seems to be a correlation between race and presentation of more aggressive histology caused by the effects of the pandemic in cancer care affecting minorities.
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Background: The Coronavirus Disease 2019 (COVID-19) pandemic has changed the delivery of cancer care and may have impacted the treatment outcomes. This study described the preliminary outcomes in non-metastatic breast cancer (BC) patients before and during the COVID-19 pandemic. Methods: This retrospective study included adult patients newly diagnosed with non-metastatic BC at two community cancer centers in southeast Texas. Patients diagnosed from 1/2018-10/2018 were included in the control group. Patients diagnosed from 4/2020-1/2021 were included in the COVID-19 group. The key outcomes were progression free survival (PFS), overall survival (OS), breast conserving surgery (BCS) rate, pathological complete response (PCR) rate, and time to treatment initiation (TTI). Results: The study included 74 patients (Table). The proportion of patients with self-detected BC was numerically higher in the COVID-19 group (55%) compared to the control group (36%), although this was not statistically significant (P = 0.09). The median follow-up periods were 38 (IQR: 36-43) months in the control group and 15 (IQR: 13-17) months in the COVID-19 group. No significant difference was observed in PFS (P = 0.74), with 1-year PFS of 93% (95%CI: 80%-98%) in the control group and 100% in the COVID-19 group. No significant difference was observed in OS (p = 0.22), with 1-year OS of 98% (95%CI 85%-100%) in the control group and 100% in the COVID-19 group. No significant difference was observed in TTI between control (51 days) and COVID-19 groups (52 days) (95%CI: -14 to 13;P = 0.91). Among patients who received neoadjuvant systemic therapy and surgery, BCS rates were 29% (5/17) in the control group and 50% (5/10) in the COVID-19 group (P = 0.42). Among patients who had triple negative or HER2 positive BC and received neoadjuvant systemic therapy and surgery, PCR rates were 57% (4/7) in the control group and 33% (1/3) in the COVID-19 group. Conclusions: Although total patient volume decreased during the COVID-19 pandemic, no significant difference was observed in clinical outcomes when comparing patients diagnosed with non-metastatic BC during and prior to the pandemic. Ongoing monitoring with a larger study population and longer followup period will help to elucidate the long-term impact of COVID-19 on BC treatment.
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Background: Although the COVID-19 pandemic quickly created a spotlight on distance learning, identifying models that can deliver effective educational programs and best serve the needs of oncology clinicians remains a significant challenge. Methods: We conducted an educational program on the evolving standards of care for advanced HER2+ breast cancer hosted on a novel digital platform that offers a personalized social learning experience which prioritizes engagement, peer-to-peer learning, and mentorship within a small group setting. Results: 87 learners within 10 groups of professionallyconnected clinicians participated. Learners progressed through foundational self-study modules, collaborated on asynchronous group challenges, and participated in synchronous live group discussions over six weeks (approximately 4 hours total). Quantitative and qualitative analysis of data extracted from these components highlights the impact of this program (Table). Notably, the learner population was more specialized and engaged than could be expected of a traditional CME program. Feedback suggests strong impact of the live group discussions on learners' intended practice changes. Additionally, analysis of group challenges and live group discussions revealed several key insights into learner thinking about treatment guidelines, including their differing opinions about the role of surgery/radiation in patient care, uncertainty about the mechanisms of action (MOAs) of discussed therapies, and their apprehension about implementing therapies that may impact the heart and lungs. Conclusions: The outcomes from this analysis highlight the utility of this type of social learning platform to create a safe, supportive learning environment that encourages multiple real-time and asynchronous interactions and shared experiences between clinicians who treat patients with advanced HER2+ breast cancer, as well as offering unique and convenient mentoring opportunities for clinicians interested in leading these digital small groups. Program impact.
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Background: Standard of care for HER2+ early/first-line metastatic BC (EBC/MBC) is P + H and concurrent chemotherapy (CT);PH FDC SC offers faster, more convenient admin vs intravenous (IV) P + H. COVID-19 has caused unprecedented strain on healthcare systems and disruption to cancer care;treatment (Tx) at home may: enable pts to continue cancer Tx;reduce exposure to COVID-19;free up hospital resources. This study's main objectives: to enable continuity of care during COVID-19;to assess safety of PH FDC SC given at home. Methods: This is an ongoing single-arm, hybrid, decentralized clinical trial (NCT04395508). Pts with HER2+ EBC/MBC who completed concurrent CT with P + H IV and are receiving/about to receive maintenance P + H IV, PH FDC SC, or H SC are switched to PH FDC SC given at home by a home health nursing provider (HHNP) until disease progression, unacceptable toxicity, pt withdrawal, or physician recommendation (pts with EBC will complete ≤18 cycles). The study endpoint is safety. A subset of pts took part in HARRIET, a substudy of at-home cardiac surveillance with artificial intelligence-guided cardiac ultrasound and optional 6L ECG acquired by an HHNP. Results: Data for 114 pts (1 male) were available at cutoff (Jan 19, 2022): 18 (16%) completed Tx;20 (18%) discontinued;76 (67%) remain on study;79 (69%) had a COVID-19 vaccine while on study. Median age was 49 years;pts were balanced between EBC (n = 55, 48%) and MBC (n = 59, 52%);received a median of 6 (EBC) and 8 (MBC) cycles;and were from metropolitan (n = 109), urban (n = 4), and rural (n = 1) areas. 11 pts tested COVID-19-positive during the Tx phase: 8 continued Tx after appropriate COVID-19 Tx and/or quarantine. Safety is summarized in the table. No new adverse events (AEs) emerged due to home admin. AEs of special interest were grade (gr) 1-2: admin-related reactions (n = 76, 67%), hypersensitivity (n = 5, 4%), cardiac dysfunction (n = 4, 4%), except 1 case of gr ≥3 diarrhea. AEs leading to study Tx discontinuation or interruption/dose reduction occurred in 3 (3%) and 15 (13%) pts. A subset of 7 pts completed at-home cardiac surveillance testing;quantitative assessment of left ventricular ejection fraction was feasible in 3 (43%);5 (71%) preferred at-home surveillance to clinic. Conclusions: In this preliminary analysis, safety of PH FDC SC at home was consistent with the established P + H safety profile, indicating that PH FDC SC at home is a viable option for continuing BC care during and beyond COVID-19.
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The proceedings contain 5148 papers. The topics discussed include: baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer;fertility preservation decisions and outcomes of young women with breast cancer;adjuvant trastuzumab and vinorelbine (TV) for early-stage HER2+ breast cancer;Outcomes of neoadjuvant (NA) and adjuvant (A) chemotherapy in geriatric patients with stage I-III triple-negative breast cancer (TNBC): a single institution experience;Telehealth delivered Tai Chi intervention for managing aromatase inhibitor-induced arthralgia in breast cancer patients: TaiChi4Joint during the COVID-19 pandemic a pilot study;a prospective real-world study to assess the effectiveness and safety of trastuzumab biosimilar in the adjuvant treatment of HER2-positive breast cancer: preliminary safety results;effectiveness of chemotherapy on prognosis of elderly breast cancer: a retrospective cohort study based on SEER database;and prognostic role of the stromal tumor-infiltrating lymphocytes (TILs) in women with early ER+/HER2+ breast cancer (BC) in whom adjuvant chemotherapy (ChT) was omitted.
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Background: Cardiotoxicity is frequently monitored when anti-HER2 treatment (Tx) is used and is a potential reason for discontinuation. As patients (pts) live longer, improved surveillance via low-interventional management is critical. Advances in digital tools and the impact of COVID-19 are accelerating opportunities for in-home care. We initiated cardiac monitoring at home in a subset of patients from study NCT04395508, which provides continuity of care during the pandemic and home administration of pertuzumab, trastuzumab and hyaluronidase-zzxf (PH FDC SC) for pts with HER2-positive breast cancer. Methods: Pts must be on/will receive maintenance intravenous pertuzumab + trastuzumab/PH FDC SC/subcutaneous trastuzumab post-chemotherapy completion. Up to 36 pts will be enrolled at Memorial Sloan Kettering Cancer Center and selected Mayo Clinic sites. Pts will undergo remote cardiac surveillance by a Home Health Nursing Provider via Caption Artificial Intelligence (AI)-guided ECHO and ECG (KardiaMobile 6L) after a reference in-clinic ECHO and 12-lead ECG. Images and tracing will be assessed centrally. Key objectives are to evaluate feasibility of LVEF assessment at home based on AI-guided cardiac ultrasound images acquired by novice users without prior ECHO experience and to evaluate feasibility, including recording frequency and signal quality, of an AI-guided ECG algorithm at home by the pt with nurse oversight. Results: Enrollment began Aug 2021. Conclusion: For healthcare systems, HARRIET can improve Tx monitoring to avoid premature discontinuation;is a step toward moving away from specialized sites to flexible healthcare delivery and lower cost of care;and can remove logistical, financial and workload barriers of scheduling in-person ECHO readings. For pts, it can optimize care and increase confidence in anti-HER2 Tx and can provide access to specialty care in the comfort of their own home.
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Amplification and/or overexpression of HER2 in breast cancer (BCa) patients is associated with aggressive disease and poor prognosis. Herceptin® (trastuzumab), a monoclonal antibody targeting HER2, has an established role in the treatment of HER2 positive BCa. Addition of trastuzumab to anthracycline-and taxane-based neoadjuvant treatment in women with HER2-positive BCa has resulted in improvements in pathological complete response (pCR, a strong predictor for long-term clinical outcome), event-free survival (EFS) and overall survival (OS). This study is designed to compare efficacy (pCR) and safety between the originator Herceptin and the proposed trastuzumab biosimilar EG12014. The study is conducted during the COVID-19 pandemic (last patient in: March 2020, last patient last visit: planned Jan 2022) in Belarus, Chile, Colombia, Georgia, India, Russia, South Africa, South Korea, Taiwan, and the Ukraine. Methods: Neoadjuvant phase: 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m 2) and cyclophosphamide (600 mg/m2) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) and paclitaxel (175 mg/m2) every 3 weeks Sfor 4 cycles. Subsequently, the patients underwent surgery, and primary endpoint (pCR [ypT0/is ypN0]) was assessed. Adjuvant phase: After surgery, the patients received EG12014 or Herceptin (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) to complete 12 months of overall trastuzumab treatment. COVID-19 infections in the study population were not expected to affect primary endpoint analysis;thus, no sensitivity analysis was performed regarding COVID-19 status (symptomatic/asymptomatic). Differences between the 2 arms regarding delays in study treatments and procedures due to COVID-19 were assessed. Results (at interim data base lock, blinded as study is ongoing): Study population: the mean age was 50 years, the majority were white Europeans with tumor stage II, estrogen receptor positive and progesterone receptor negative. The median time from date of first diagnosis was 0.5 months. Primary endpoint pCR (ypT0/is ypN0) was reached with relative risk ratio (RR) for the full analysis set: 0.992 (90% CI 0.880 to 1.118) between the 2 treatment arms. Secondary pCR endpoints (defined as ypT0 ypN0 and ypT0/is) were also reached, with RR between the treatment arms: 0.917 and 0.992, respectively. Objective clinical response prior to surgery was similar for the 2 treatment arms: 83.8% and 83.6%, respectively. EFS, OS, safety endpoints (e.g., adverse events [most frequently reported: alopecia], serious adverse events, and deaths), and toxicity assessments, supported similarity between EG12014 and Herceptin. Sixty-two patients (7.7%) were infected with COVID-19;the infections were equally distributed between the 2 treatment arms. COVID-19 did not cause any discontinuations or deaths in the study. Among all reported COVID-19 events, 13 (21%) were asymptomatic, 11 (18%) were graded as 3 (severe), and 1 (1.6%) was graded as grade 4 (life threatening). Conclusion: EG12014 has shown equivalent efficacy to Herceptin in regard to clinical response (pCR) and has also demonstrated a similar safety profile. The impact of the COVID-19 pandemic has been comparable between the two treatment arms. The influence of the pandemic on this clinical study has been relatively low considering timing and the participating countries.
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The increasing use of pre-operative systemic therapy has resulted in more limited information about axillary lymph node status, both from the impact of systemic therapy itself as well as from less extensive axillary surgery. Decisions about the use of adjuvant endocrine therapy have not been majorly affected, but information on the presence and number of involved lymph nodes can have a significant influence on the use of adjuvant chemotherapy and HER-2 targeted therapies. In addition, lymph node information can also impact decisions around radiation therapy, making multidisciplinary discussions highly relevant when planning therapy. Patients with hormone receptor positive breast cancer may be treated with pre-operative endocrine therapy. This strategy was often used in early stage breast cancer during the COVID pandemic due to delays in surgery. Although an effective approach, pre-operative endocrine therapy may impact nodal status at surgery, information which is important when deciding on the use of OncotypeDX testing in premenopausal women. Similarly, in postmenopausal women, the presence and number of lymph nodes involved is a critical factor in determining the appropriateness of OncotypeDx testing. This nodal information may be lost in the setting of pre-operative therapy and would alter decisions regarding adjuvant chemotherapy. For patients with HER2 positive breast cancer, the presence of nodal disease remains critical for adjuvant decision making. In the situation of small (up to 3 cm) node negative cancers, up front surgery is preferred, because pathologic confirmation of the tumor size and node negative status may make patients eligible for a de-escalated approach of adjuvant paclitaxel and trastuzumab. Patients with more advanced HER2 positive disease are good candidates for preoperative chemotherapy and HER2 targeted therapy. If they have residual disease at surgery, they can be offered trastuzumab emtansine, which was shown in the KATHERINE trial to improve outcomes. In both situations, accurate information about the presence of disease in the axillary lymph nodes determines the most effective treatment approach. Finally, accurate information about nodal status is also relevant to decisions in patients with triple negative breast cancer. Patients who are treated with pre-operative chemotherapy and have residual disease in either the breast or axillary lymph nodes may be offered adjuvant capecitabine, based on the CREATE-X study, which indicated improved survival outcomes in those patients with residual disease who received adjuvant capecitabine. As in HER2 positive breast cancer, the presence of residual disease (including in the lymph nodes) after preoperative therapy will influence the adjuvant therapy recommendation. Thus, when considering de-escalation approaches in axillary management, the impact on systemic therapy decision making must be carefully considered, as these additional adjuvant therapies may improve survival for patients. Conflict of Interest: No significant relationships.