Introduction: Most breast cancers are diagnosed after an image-guided biopsy. When performed under stereotactic guidance, biopsy markers (clips) are almost always placed. In comparison, clip placement after ultrasound (US) guided biopsy is variable. Neoadjuvant chemotherapy (NAT) may be administered before surgery to shrink large tumors so breast conservation therapy (BCT) instead of mastectomy can be done. After NAT, tumors may no longer be clinically palpable or visible on imaging. The clip localizes tumors so that the site can be identified and less extensive and more precise surgery can be performed. If no clip is placed at the time of biopsy, NAT is delayed and mastectomy may be required in a patient who would have otherwise qualified for BCT. Most often, a second US procedure for clip placement will be required and sometimes a second biopsy prior to NAT. International and national guidelines state that clips should be placed when the radiologist suspects the patient is a candidate for NAT. The aim of this project was to decrease the number of patients presenting to the NAT clinic at BC Cancer Vancouver Center without a clip in situ to less than 5% by the end of 2020. Methods: Ethical risk assessed using the ARECCI screening tool were minimal. Initial data included all patients who presented for NAT at BC Cancer VCC from January 2018 to January 2019 and final data was from January 2021 to March 2021 (delayed due to Covid-19 pandemic). All lower mainland health authority sites (LMMI) were surveyed in regards to whether they perform US guided breast biopsies. An online survey about specific radiologist practices was sent out to radiologists at all LMMI sites, as well as in community imaging clinics (CICs) and other health authorities in the province. Patient interviews have been conducted through BC Cancer Patient Engagement. A fee code specific to CICs in the lower mainland, which perform over 60% of the US guided breast biopsies, to encourage and support appropriate clip use was proposed to the British Columbia ministry of health and was implemented in July 2019. Education was targeted at other community sites where surgeons were engaged to explain the impact on clinical outcomes when clips are not used. An online webinar about clip placement was developed in conjunction with a local surgeon and was hosted by the Canadian Society of Breast Imaging. Results: 19 LMMI sites perform US breast biopsies. 25% of radiologists surveyed stated anticipation of NAT as a reason for clip placement and 21% were aware of the national guidelines for clip placement. Initial data included 121 patients who presented for NAT clinic in our time frame and 77 were included in our analysis (received NAT and clip status was known). Final data included 33 patients who presented to the NAT clinic and 30 were include in our analysis. Before intervention, 49% of patients considered for NAT had a clip placed at the initial biopsy. Of 50 patients who did not have a clip at initial biopsy, 21 (42%) required a clip prior to NAT. There was a 5.5 day difference in time to NAT after biopsy for patients who had clips placed initially at the time of biopsy (34.7 days) and patients who did not (40.2 days). There was no difference in mastectomy rates. After intervention, 80% of patients considered for NAT had a clip placed at the initial biopsy. Though it is difficult to quantify the clinical impact a 5.5 day delay to start of therapy may have, patient interviews indicate significant anxiety associated with the time between diagnosis and treatment. Conclusion: Targeted education on clip use with engagement of surgeons to explain the clinical implications, and development of a fee code to encourage and support appropriate use of clip placement, reduced the number of patients presenting for NAT without a clip in place. Future projects include exploring the financial costs or savings of increasing clip use. Citation Format: Charlotte J. Yong-Hing, Chisato Ito, Lauren Corke, Christine Simmons, Bethina Abrahams. Clip placement after ultrasound guided biopsy in the setting of neoadjuvant chemotherapy [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-03-02.
Background: When the first wave of COVID-19 hit globally in early 2020, concerns were raised about access to surgical interventions for cancer patients. It was considered that neoadjuvant therapy (NAT) although conventionally given to locally advanced breast cancer may need to also be provided to earlier-stage disease. In addition, due to the temporary closure of breast cancer screening programs during the pandemic, concerns were raised about patients presenting with later-stage disease at initial diagnosis. This project aims to assess the impact of COVID-19 on the volume of neoadjuvant referrals at a large cancer centre, as well as any stage migration, impact on treatment timelines and impact on outcomes for breast cancer patients compared to the pre-pandemic population. Methods: The BC Cancer Vancouver centre has a neoadjuvant breast cancer program to ensure high quality of care is maintained. This program’s prospective database of breast cancer patients referred for and treated with NAT between the years 2012-2021 was queried to assess data on neoadjuvant referrals, clinical stage, receptor status, treatment timelines, and outcomes between January 1, 2019 - December 31, 2020. Data from the years 2019 and 2020 were compared to evaluate the impact of COVID-19 on NAT. Summary data available from earlier years were also utilized as reference. Results: The COVID-19 pandemic resulted in a 51% increase in the number of patients referred to the neoadjuvant program, with 102 patients referred for NAT in 2019, whereas 154 patients were referred in 2020. This proportional increase in referrals is higher than any other year since the database inception. Of note, during 2020 there were no COVID related closures for cancer surgeries in the province. The proportion of patients referred who received NAT remained similar between 2019 and 2020 (69.1% vs 70.8% in 2020). The trend in referrals by month varied between the two years. In 2019, the majority of patients were referred between April to July with the lowest proportion of referrals in October to December. In 2020, the opposite occurred with the lowest proportion of referrals transpiring between January - June, and the greatest proportion in October to December. The proportion of patients who presented with de-novo metastatic disease was consistent between the two years (7.8% in 2019 vs 9.7% in 2020). Despite the closure of all screening mammography programs between March-June of 2020, the clinical stage and receptor status are equivalent between 2019 and 2020. With regards to treatment timelines, there was a 3 day increase in the median time between referral date and medical oncology consultation in 2020 compared to 2019. No other treatment timeline delays were found between 2019 and 2020. With regards to outcomes, 34.9% of patients achieved pCR in 2019, but only 24.1% achieved pCR in 2020, despite similar stage and receptor subtypes. Conclusion: During the COVID-19 pandemic in 2020, a higher volume of patients were referred for NAT than had ever before been referred, despite the fact that there were no closures of operating rooms in our province for COVID-19. From a quality of care perspective there was a delay in referral to consultation for medical oncology, but no delay on referral to treatment, treatment to surgery, or surgery to radiation. However, and a significantly lower pCR rates was seen in 2020 compared to 2019. The 10% decrease in pCR rates may have resulted from increased complexity in breast cancer cases. This trend may continue, as the impact of COVID-19 on breast cancer outcomes will likely take many years to fully appreciate. Attention should be paid to encouraging women to return to regular breast screening programs to decrease the number of patients needing neoadjuvant therapy. Citation Format: Lauren Corke, Omar Hajjaj, Kaylie Willemsma, Stephen Chia, Christine Simmons. Impact of COVID-19 on patients undergoing neoadjuvant therapy: A pre/post pandemic analysis and assessment of quality of care delivered [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-11-08.
Background Continued HER2 suppression in metastatic breast cancer (MBC) has been demonstrated to improve progression free survival (PFS) and overall survival (OS) in many randomized studies to date. Current funding policy in British Columbia (BC) restricts to two lines of HER2 directed therapy (HER2Rx) in MBC. With the development of novel HER2Rx agents, accessing continued HER2 suppression in the MBC has become complex. The financial implications of adapting future funding policies to reflect increasing lines of proven HER2Rx is unknown. Purpose The purpose of this study is to assess the proportion of patients with HER2 positive MBC eligible to receive systemic therapy beyond 2 lines of HER2Rx. We also wished to assess the proportion of eligible patients who accessed continued HER2Rx despite lack of public funding, and how their treatment beyond second line was funded. Methods The BC outcomes unit collects clinical and outcome information on 85% of all patients diagnosed with in the province of BC. In addition, all anti-neoplastic therapy delivered in the province is recorded in the BC Cancer pharmacy database. These two databases with queried and cross referenced to identify patients who received any HER2Rx for MBC dispensed by BC Cancer between 2013 and 2018, in the era where trastuzumab plus pertuzumab and TDM-1 were standard options and publically available. The number of lines of therapy received, specific treatments, and fitness to continue therapy beyond two lines were analyzed through targeted chart review. PFS and OS data were also analyzed. Expected financial implications were calculated based on current cost of most commonly used therapies in the third line. Results We identified 230 patients who met inclusion criteria with detailed information about treatment at the time of analysis. 51% (117) of these patients were eligible to continue therapy beyond second line. Of these, 86 (37% of the whole cohort) did access continued HER2-directed therapy, while 26 (11% of the whole cohort) were eligible but unable to access continued HER2Rx. The remaining 49% of were not eligible for consideration of further HER2Rx due to either stable disease on current treatment or deterioration precluding further treatment. The median lines of therapy in the entire study population was 3. Minimum lines of therapy was 1, maximum number of lines of therapy delivered was 12. Median number of cycles of therapy received beyond second line for those eligible to continue treatment was 22 cycles. Median OS for those who continued HER2Rx was 58.6 months compared to 38.0 months for those who were eligible but did not continue therapy, but this was not statistically significant (p = 0.13). The vast majority of these patients are receiving continued HER2Rx through either exceptional access or clinical trial, and very rarely through private pay or insurance. Conservative estimated cost per cycle of HER2Rx was based on currently available biosimilars to Trastuzumab. If these trends in survival continue we would expect an additional cost of $44000 per patient over current costs. Conclusion 51% of patients with HER2 positive MBC are eligible to receive more than two lines of HER2 directed systemic therapy. Of these eligible patients, the majority of patients (77%) are accessing treatment despite prohibitive funding policies, based on clinical trial or compassionate access programs. As funding policies adapt to the evolving treatment landscape for patients with HER2 positive MBC, we can expect a significant increase in cost per patient in this setting with conservative estimates of $44000 per patient above current costs. As the cost of novel therapies are likely to be higher than currently available biosimilars, there will be significant implications for both private payer and public payer healthcare systems. Citation Format: Emily B Jackson, Lauren Corke, Hyejee Ohm, Christine Simmons. Predicted financial impact of continued HER2-directed therapy in metastatic breast cancer: What is the financial toxicity in a public payer healthcare system? [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD8-09.
11531 Background: Treatment of Ewing Sarcoma (EWS) is challenging. While it is known to be sensitive to chemotherapy and radiation, the number of lines of therapy available are limited. This disease affects pediatric patients (PP) more often than adults (AP), and reported outcomes are worse for AP onset EWS in the literature. It is unclear if this is due to difference in the biology of disease in AP compared to PP, or if this is due to differences in treatment approach. Furthermore, optimal treatments and real world impact of treatment is unclear in both the PP and AP populations. This study identifies the features of therapy received by AP and PP with EWS in a large, mutli-institutional cohort, and provides real world evidence for the expected outcomes in both AP and PP with EWS. Methods: A cohort study analysis of the Sarcoma Outcomes Unit database at BC Cancer was conducted to identify patients diagnosed with EWS in British Columbia from January 1, 2000 to December 31, 2018. Data on the frequency, amount, and regimen of chemotherapy were collected. Baseline Charlson comorbidity index, age at diagnosis, progression free survival and overall survival were collected. Results: 108 patients with EWS were identified, 66 AP and 42 PP Median age at diagnosis for adults was 37 (19-86) and median age for diagnosis of pediatric patients was 14 (1-18). Real world median PFS and OS for AP were 23 mos and 79 mos, and for the PP were 32 mos and NE. Five year overall survival was 54% in AP and 77% in PP. Overall, there was no difference in the number of lines of therapy received between PP and AP, but the type of therapy was more dose-dense in the PP than in the AP, (85% vs 28% for dose dense chemo). 5 year overall survival was longer for PP who received dose dense regimens compared to non-dose dense regimens (HR 0.87), but was not different in the AP receiving dose dense regimens (HR 0.95), even when controlling for comorbidities. The most common chemotherapy regimen for AP was Vincristine, Adriamycin, cyclophosphamide alternating with Ifosfamide and Etoposide q3weeks, whereas in the pediatric population the most common chemotherapy regimen was the same but alternating q2weeks. Conclusions: The treatment plans for PP with EWS were more often dose dense compared to the AP. Outcomes for PP were vastly better than for APs, despite overall similarities in the number of lines of therapy and types of agents used. Given the lack of difference between dose dense and non-dose dense regimens for APs, this is not the likely cause of difference in survival between PPs and APs. Extrapolating pediatric protocols to the adult setting may not be appropriate given the differences in outcomes. Further work to identify effective therapies and predictive biomarkers in this disease are needed, and my further identify reasons for discrepant outcomes in pediatric and adult populations.
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