Private Oncology Research Articles

Predictors of response and surgical approach after neoadjuvant chemotherapy in receptor-positive/HER2-negative stage II-III breast cancer patients treated in two private cancer care centers in Lima, Peru: Real-world data.

e12659 Background: The role of neoadjuvant chemotherapy (NAC) in hormone receptor-positive HER2-negative breast cancer (BC) is controversial, its main benefit being to improve the surgical outcome in both breast and axilla. The aim of this study was to evaluate the response to NAC, as well as possible predictors and the type surgery performed after primary treatment. Methods: Observational, retrospective study from a database of 1356 consecutive cases of BC between 2016 and 2022 in two private oncology centers in Lima Metropolitana. There were 726 new cases of hormone receptor-positive HER2-negative BC (53.5%), of which those patients with clinical stage II-III who received NAC were considered (n=122, 16.8 % of luminal HER2-negative). Results: The average age of the sample was 46.6 years (range 25-72) with a predominance of luminal B subtype (60.7%) and clinical stage II disease (51.6%), as well as an average delay time to treatment of 33.9 days. Chemotherapy choice was AC every 3 weeks followed by weekly paclitaxel (98.4%). The pathological complete response (pCR) rate was of 16.4% in the breast, 29.1% in the lymph nodes and 13.9% in both. None of the variables studied (age, histologic grade and type, clinical stage, tumor size, number of nodes, hormone receptors, Ki-67 and HER2 low) were predictors of pCR. According to RECIST criteria, tumor shrinking in the breast occurred in the majority of patients (partial and complete response: 86.1%) and eight out of ten patients achieved a tumor size reduction of more than 50%. The rate of mastectomy was 67.2% and radical axillary dissection, 70.5%. Conclusions: In our cohort, we found a pCR rate similar to that reported in the world literature. No predictors of pCR were found. Despite the high proportion of tumor response at breast and node level, the surgical approach was mostly radical. The multidisciplinary BC committee in our setting should be strengthened in order to make better decisions on the surgical approach for patients with hormone receptor-positive HER2-negative stage II-III BC who receive NAC.

Implementing a mutidisciplinary approach for older adults with cancer: Challenges and achievements in a geriatric oncology program in Sao Paulo, Brazil.

e13769 Background: Treating an older adult with cancer is complex and requires multidisciplinary effort. Multiple studies demonstrate the benefits of timely integration of Geriatric Oncology (GO) with routine oncologic care. Despite this growing body of evidence, there are very few cancer centers around the world that have a dedicated GO program, notably in low- and middle- income countries (LMIC). The objective of this abstract is to describe the first year of the GO program in a private oncology center in São Paulo, Brazil. Methods: As an effort of oncologists, geriatricians and nurses, the team built a consultative model with a nurse performing the G8 triage score to every cancer patient aged ≥ 70 years. For those with a G8 less than 14 points, a comprehensive geriatric assessment (CGA) was performed. The results of the CGA were than provided as a report to the treating physician and all the members of the multidisciplinary team, so that a geriatric assessment (GA) driven intervention could be planned. The patients were then followed for 3, 6, and 12 months to detect falls, emergency rooms visits, hospitalizations, and death. Results: From January 2023 to January 2024, 110 patients with a median age of 79 were evaluated, with 57% having a G8 less than 14. 70 patients we submitted to a CGA. The majority of the tumors were gastrointestinal (30%), lung (20%) and genito-urinary (17%). Regarding the GA domains: 70% of the patients had a possible or probable cognitive impairment by the 10-point cognitive screener; 53% mild psychological distress by PHQ-4 Screening Tool; 47% showed important reduction in hand grip strength scale calling the attention to sarcopenia; 48% were found to be at nutritional risk and 42% were classified as malnourished at the mini-nutritional assessment; polypharmacy was detected in 67% of the patients. Despite these findings, 78% of the patients we classified as ECOG 0 or 1. After GA driven interventions, at 3 and 6 months follow up, 88% of the patients remained with no falls, with a mild rate of hospitalizations (40%) and a low rate of treatment discontinuation (15%). By the end of 6 month follow up, 24% of the patients have died. Conclusions: Geriatric conditions such as functional impairment are common and frequently unrecognized or inadequately addressed in older adults with cancer. Identifying geriatric conditions by performing a GA can help the health team to manage these conditions and provide better oncology care.

Abstract PO4-02-11: Optimizing Taxane-based Chemotherapy in Breast Cancer: Retrospective study comparing 4 cycles of TC to 6 cycles of TC

Abstract Breast cancer remains one of the most prevalent cancers among women worldwide. First-line chemotherapy options include anthracycline (AC-T) and Taxane (TC) based regimens. While anthracycline-based chemotherapy is most commonly used, the use of anthracycline-sparing regimens is also approved. The US Oncology 9735 trial conducted in the mid 2000s showed that four cycles of docetaxel and cyclophosphamide (TC4) were superior to four cycles of Doxorubicin and cyclophosphamide (AC). The follow-up ABC trials compared six cycles of TC(TC6) to AC-T. This trial showed that while AC-T was superior to TC, the difference was modest. AC-T has remained the standard of care, but TC is an acceptable option. One retrospective analysis involving 143 patients showed TC4 was non-inferior to TC6, and suggested that TC4 had fewer adverse events; however, statistical significance was not reached. The question remains whether six cycles of TC is required, or if four cycles is adequate. Methods: Patient information was retrieved from the EMR of a large private oncology group. The EMR was screened for all breast cancer patients who began treatment with TC between 1/1/2011 and 12/31/2021. Patients were required to have continuous follow-up, documented up to at least 6/30/2022. Only patients receiving TC as the first-line setting were included, while patients with metastatic disease were excluded. Adjusted Kaplan Meier curves for overall survival (OS) and disease-free survival (DFS) were generated. A log-rank test was used to determine the statistical difference between the two curves. OS was defined from the date of the last chemotherapy given to death. DFS is defined from the date of the last chemotherapy given to disease recurrence. The Chi-square analysis test of homogeneity was conducted to evaluate the differences in reported symptoms. Statistical analysis was completed with IBM SPSS version 29. Ethical approval was obtained from The Brooklyn Hospital Center Institutional Review Board. Results: A total of 376 charts were reviewed, out of which 224 met the criteria for inclusion. Of these 191 patients received TC4 and 33 received TC6. TC4 patients were noted to be older than TC6 patients. There were a higher percentage of hormone-positive cancers in the TC4 group while the TC6 group had a larger proportion of triple-negative breast cancers. There was a larger proportion of stage III patients that received TC6 than in TC4. TC6 patients were also noted to receive neo-adjuvant chemotherapy at a substantially higher rate. A greater proportion of patients in the TC4 group received breast-conserving surgery, with radiation than the TC6 group. TC6 had a completion rate of 76 % (Table 1). There was a significant difference in DFS noted between TC4 and TC6 (p = 0.016) with TC6 patients having a higher rate of relapse. No difference was noted in the overall survival. No differences were seen in side effects between TC4 and TC6, however, there was a trend toward high rates of neutropenia, anemia, and neuropathy seen in the TC6 group (Table 2). Conclusions: This real-world retrospective study reviewed patients who received TC in a large community oncology practice. The study reaffirms conclusions seen in previous retrospective studies conducted in the academic setting that there is no difference in overall survival when using six cycles of TC compared to four cycles of TC. Slight detriment was seen in the DFS setting when using TC6 however the small sample size along with the larger proportion of patients with stage III disease make it challenging to interpret this finding. There was a trend towards higher toxicities with TC6 that did not reach significance. Until a prospective randomized study comparing four vs six cycles of TC is conducted no definitive conclusions can be drawn, however, this study contributes to the current body of evidence that four cycles of TC is adequate and could potentially improve the quality of life of patients with early breast cancer. Table. Patient characteristics Patient characteristics including age, hormone status, stage, type of surgery, radiation, and treatment setting. Table. Adverse effects Adverse effect information obtained from physician documentation, and CBC reports documented at time of treatment with TC. Citation Format: Amith Ahluwalia, Michelle Koifman, Jaspreet Nannar, Bhavya Vachhani, Kanwal Ashraf, Maxim Shulimovich. Optimizing Taxane-based Chemotherapy in Breast Cancer: Retrospective study comparing 4 cycles of TC to 6 cycles of TC [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 PO4-02-11.

Abstract PO3-17-01: Brazilian Real-world data of HR+ HER2- early-stage Breast Cancer (BC) patients are poor when compared to control arms of recent adjuvant clinical trials

Abstract INTRODUCTION: In Brazil, BC is the most common neoplasm among women, with 73k new cases annually. Adjuvant hormone therapy (HT) options are evolving with personalized strategies based on risk stratification. Real-world data (RWD) plays a crucial role in understanding the outcomes in BC patients (pts) in low- and middle-income countries, where significant health disparities, access gaps, and barriers to the implementation of guidelines exist. This study aims to assess the epidemiologic profile, practice patterns, and real-world outcomes of pts with ER+ HER2- stage I-III BC treated in the largest network of private oncology services in Brazil and compare results with control arms of recent clinical trials evaluating CDK4/6 inhibitors in adjuvant setting. METHODS: Retrospective RWD study from Oncoclínicas Group with longitudinal EHR data from 2017 to 2022 merged in a platform where structured variables (demographics, tumor staging, pharmacy records) are integrated with unstructured data from physician notes and digitized pathology-molecular reports using technology-based abstraction performed by expert human curators that follow mCODE standards and predefined ontology. Treatment patterns and invasive disease-free survival (IDFS) outcomes were collected. Regarding risk stratification, pts were classified as high-risk (HR) if: (i) 4+ axillary lymph nodes (LN), or (ii) 1-3 LN and grade 3 and/or Ki620% and/or high-risk ODX/Mammaprint; intermediate-risk (IR) if: (iii) 1-3 LN with grade 1-2 and/or Ki67 < 20% and/or non-high-risk ODX/Mammaprint, or (iv) N0 with grade 2-3 and/or Ki67 >20% and/or high-risk ODX/Mammaprint; and low-risk (LR) if: (v) all other stages I and IIA not having the risk factors above. RESULTS: From over 30k BC pts in Oncoclínicas Database, 19k had HR+/HER2- early BC, 12k were treated in high-volume clinics, and 1,786 cases were selected for the study (diagnosis and first treatment in the last 6 years, complete histopathology and pharmacy registries). The median age was 57 years (27-96), 566 (32%) pts were premenopausal, 1052 (59%) had stage I disease, 372 (21%) stage IIA, 165 (9%) stage IIB and 197 (11%) stage III BC. Regarding risk stratification, 1,179 (66%) were LR, 351 (20%) IR, and 256 (14%) HR. In post-menopausal pts, aromatase inhibitor (AI) was used by 74% of pts with LR, 79% with IR and 83% with HR. In premenopausal pts, ovarian function suppression (OFS) – combined with tamoxifen or AI – was prescribed to 18% of LR pts, 15% of IR pts, and 48% of HR pts. Chemotherapy (CT) was offered to 32%, 38%, and 73% of postmenopausal pts in LR, IR, and HR groups. In premenopausal pts, 55%, 57%, and 78% received CT in LR, IR, and HR groups. The 3-year iDFS in the general population was 85%, reaching 80% in premenopausal and 86% in postmenopausal pts. The overall 3y iDFS was 87% in the LR, 86% in IR, and 72% in HR. Among premenopausal pts, the 3y iDFS was 81% in LR, 92% in IR, and 64% in the HR group. While the risk distribution of our cohort is similar to recent clinical trials, the 3y iDFS outcomes were numerically lower to those observed in the control groups of the pivotal trials evaluating adjuvant CDK4/6 inhibitors. In the HR group, the 3y iDFS was 72% (versus 84% 3y iDFS in the control arm of the MonarchE trial). Combining the IR/HR groups, the 3y iDFS was 80% (versus 87% in the control arm of NATALEE trial). CONCLUSION: In this large RWD cohort treated in a private setting in Brazil, most pts are diagnosed with stage I and LR BC. In this cohort, a significant proportion of premenopausal pts with IR/HR are not treated with OFS and do not receive CT. Real-world survival outcomes of Brazilian women with HR+ HER2- early BC treated in private clinic are inferior to those observed in recent clinical trials, especially in the premenopausal pts. In public healthcare system, where prevalence of HR disease is higher and access to essential treatments more limited, outcomes might even be worsened compared to the ones presented here. Citation Format: Aline Goncalves, Tomas Reinert, Max S. Mano, Heloisa Cruz, Cristiano Resende, Gustavo Bretas, Carlos Barrios, Matheus Costa e Silva, Rafael Paes, Guilherme Silva, Erika Martins, Fernanda Koyama, Bruno Ferrari, Carlos Gil Ferreira, Pedro Aguiar Junior, Rodrigo Dienstmann. Brazilian Real-world data of HR+ HER2- early-stage Breast Cancer (BC) patients are poor when compared to control arms of recent adjuvant clinical trials [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 PO3-17-01.

Abstract PO1-27-09: TRIPTORELIN (11.25MG) vs TRIPTORELIN (3.75MG) IN PREMENOPAUSAL WOMEN WITH HIGH-RISK EARLY STAGE BREAST CANCER RH(+) and HER2(-) REAL WORLD EXPERIENCE. TRIPTO3 RESULTS

Abstract Background. Premenopausal women with high risk early stage BC HR+/Her2- present as a complex disease and generally have worse survival outcomes compared to postmenopausal women with the same disease. There are pathological clinical factors and genomic platforms that help us in therapeutic decisions. The use of triptorelin 3.75mg associated with AI promotes favorable results in terms of survival for premenopausal women with high-risk Early stage BC. TEXT/SOFT trial. TRIPTO3 study evaluates the use of Triptorelin 11.25mg vs. Triptorelin 3.75mg in this specific patient population. Methods: We reviewed medical records of premenopausal female patients with high-risk early stage breast cancer who have been treated and received triptorelin 3.75mg and triptorelin 11.25mg as part of their treatment. All patients were treated at a private Oncology Center between 2013 and 2020. The primary objective was disease-free survival. Results: 52 patients were found who met the inclusion criteria. 28(53.8%) patients received triptorelin 11.25mg and 24(46.2%) patients received triptorelin 3.75mg respectively. The median follow-up was 63 months and the disease-free survival for the Triptorelin 11.25mg group was 91.2% and for the Triptorelin 3.75mg group was 86.8% respectively (Hazard Ratio of disease-free survival was 1.2; 95% IC (0.2-7.2). Disease-free survival for both groups regardless of triptorelin dose was 89% at 5 years. The median disease-free survival was not reached in both groups. Conclusions: Our findings show that triptorelin 11.25 mg is similar to the use of triptorelin 3.75 mg in terms of disease-free survival for premenopausal women with high-risk early stage breast cancer. Citation Format: Ronald Limon, Mariano Lopez-Pereyra, Mario Gianella, Neysa Espinoza, Denize Ramirez, Carlos Antelo, Claudia Sitic, Wara Cortez, Oscar Niño De Guzman, Silvia Neciosup, Natalia Valdivieso. TRIPTORELIN (11.25MG) vs TRIPTORELIN (3.75MG) IN PREMENOPAUSAL WOMEN WITH HIGH-RISK EARLY STAGE BREAST CANCER RH(+) and HER2(-) REAL WORLD EXPERIENCE. TRIPTO3 RESULTS [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 PO1-27-09.

Implementation of a Cancer Care Line: Experience of a Brazilian Private Oncology Institution

Implementation of a Cancer Care Line: Experience of a Brazilian Private Oncology Institution

Spotlight on the real-world treatment of CML pts in Germany: a retrospective survey in private oncology practices

Clinical trials in chronic myeloid leukemia (CML) are usually carried out in specialized centers whereas primary care for patients (pts) with CML is mainly provided by local oncology practices. The aim of this study was to assess treatment practices in pts with CML in the setting of private oncology practices in Germany. We collected data of 819 pts with a confirmed diagnosis (dx) of CML in 2013 or later from 43 practices. At dx, 84.2% (n=690) and 9.4% (n=77) of pts were in chronic or accelerated phase, 0.7% (n=6) had a blast crisis. Molecular monitoring was provided by EUTOS certified laboratories in 87.7% of pts. Typical BCR::ABL1 transcripts were detected in 86.6% (n=709). Molecular response was assessed after 2.8, 6.0, 9.4 and 12.9 m (mean) after start of treatment. Of the pts with available data, 11.1% did not achieve early molecular response and at 18 m, 83.7% had at least a major molecular response. 288 (35.2%) of pts switched to 2nd line (2L) treatment after a mean of 21.0 months. Reasons for 2L treatment were side effects in 43.4% and suboptimal response or failure in 31.4% of pts. 106 pts went on to third line (3L) treatment. 36.8 % of pts switched to and 92.8 % of pts still on 3L treatment achieved BCR::ABL1IS ≤1% at 12 m. In conclusion, in Germany pts with CML are routinely monitored by qPCR and good responses are achieved in the majority. Treatment changes are mainly due to adverse events rather than suboptimal responses.

Lutetium-177 Labelled Anti-PSMA Monoclonal Antibody (Lu-TLX591) Therapy for Metastatic Prostate Cancer: Treatment Toxicity and Outcomes.

Whilst prostate cancer is the fourth most common cancer globally, effective therapies for patients with advanced disease are lacking. In recent years, interest in using theranostic agents to treat castrate-resistant prostate cancer (CRPC) and metastatic prostate cancer has emerged. Lu-TLX591 monoclonal antibody is a potential agent of significance; however, to date, reports on its toxicity and efficacy have been limited to small clinical trials in heavily pretreated patients. This retrospective study describes the real-world toxicity and efficacy profile of Lu-TLX591. Eighteen patients received Lu-TLX591 at two private oncology centres in Australia. Patients were eligible if they had CRPC or metastatic prostate cancer and prostate-specific membrane antigen (PSMA)-avid disease confirmed by PSMA-positron emission tomography (PET). Patients received two cycles of Lu-TLX591 monoclonal antibody (177 Lu-DOTA-rosopatamab) each dosed from 1.01-2.85 GBq, 14 days apart. Patient side effects, blood test results and radiology reports were recorded on the patient's electronic medical record (eMR). Prominent side effects included fatigue (55.6%), anorexia (16.7%), nausea (11.1%), and transfusion reactions (11.1%). All-grade haematological toxicities included lymphopenia (61.1%), anaemia (22.2%), leukopenia (27.8%), neutropenia (27.8%), and thrombocytopenia (27.8%). Grade 4 toxicity included lymphopenia (6.7%) and thrombocytopenia (6.7%). Patients' prostate-specific antigen (PSA) responses were as follows; ≥ 30% PSA decline (27.8%), ≥ 50% PSA decline (11.4%) and any PSA decline (38.9%). Follow-up radiology revealed 54.5% stable disease, 45.4% disease progression and 9.1% disease regression. Lu-TLX591 was safely administered at acceptable toxicity and its efficacy reflects previous clinical trials. Larger studies are required and are underway (NCT04786847; NCT05146973; NCT04876651) to determine Lu-TLX591 effectiveness amongst different prostate cancer populations and compare its efficacy against peptide-based radiopharmaceutical agents.

Imaging Characteristics and Hormonal Receptor Correlations in Varieties of Breast Cancer

Background: While there is acknowledgment of the vital role of factors such as the status of histological grades and hormone receptor (HR) in shaping targeted treatment strategies for breast cancer (BC), comprehensive research that unifies the study of imaging features with the evaluation of HR characteristics and histopathological data is notably absent in Albania, creating a critical research gap that this study endeavors to fill. This study aimed to investigate the imaging characteristics observed in ultrasound and the possible correlations between expression levels of HRs in ductal and lobular types of BC to elucidate potential prognostic and therapeutic implications. Methods and Results: This descriptive study, conceived as a series of cases, leveraged a prospective approach to scrutinize the dynamics of the study population over four years (2019-2023) in the Mother Teresa University Hospital Center and a private oncology clinic in Tirana. The convenience sampling strategy enlisted 238 female patients (mean age 60.5±12.5 years) diagnosed with BC who had been tested for HRs and consented to participate. Diagnostic imaging was facilitated using a Chison US equipped with a 10 MH linear probe. The results were adjudged based on the BI-RADS tumor classification.HR markers were discerned through rigorous immunohistochemical analyses. Utilizing SPSS version 21.0, statistical analyses incorporated a variety of tests, including Spearman's rho to assess correlations between hormonal receptors and imaging morphological characteristics and ordinal logistic regression to evaluate the relationships between hormonal receptors and cancer grades. Analyzing the localization of the tumor revealed that a slightly higher proportion had it on the left side, accounting for 52.9% compared to 47.1% on the right side. Regarding the BI-RADS classification observed through echographic examination, a vast majority were classified as BI-RADS 5 (92.8%), followed by a smaller percentage distributed amongst BI-RADS 4 (5.9%), BI-RADS 3 (0.84%), and BIRADS 6 (0.42%). Examining the cancer grades determined that 68.3% were at Grade 2, whereas Grades 1 and 3 were noticeably less common, standing at 1.7% and 30.2%, respectively. Estrogen receptor (ER) and progesterone receptor (PgR) sensitivity were high in most patients, exhibiting 77.7% and 70.6% positivity, respectively, alongside a notable presence of high Ki67 levels in 75.2% of the individuals. The investigation into HER2 status demonstrated that a significant number were negative (76.1%), as opposed to 17.6% being positive and 6.3% equivocal. Remarkably, 5.5% of the patients had a triple-negative status upon biopsy evaluation.The Spearman's rho correlations displayed a moderate positive correlation between ER and PgR (rho=0.563) and a weak negative correlation between ER and Ki67 (rho=-0.343) (P<0.05 in both cases). PgR and Ki67 show a weak negative correlation (rho=-0.353, P<0.05), suggesting a tendency for higher PgR values to correspond with lower Ki67 values. The ordinal logistic regression analysis identified a statistically significant negative relationship between the ER variable and the outcome variable, denoted by a coefficient of -2.137, P<0.05. Additionally, Ki67 showcased a positive relationship with the outcome, as indicated by a coefficient of 5.150, P<0.05. Conclusion: This study delineates the nuanced relationships between biomarkers such as ER, PgR, and Ki67 in different types of infiltrative cancers, pointing to a complex interplay that necessitates further exploration while also noting the independence of BI-RADS imagery in these correlations.

Quality of Nursing Care in a Private Oncology Setting in the Philippines

Quality of Nursing Care in a Private Oncology Setting in the Philippines

Genomic signatures in breast cancer in a real-world setting: Experience in a Brazilian Northeastern Center.

We aim to evaluate the indication and use of genomic signatures in breast cancer patients and outcomes who in patients undergoing adjuvant chemotherapy or not. This is a retrospective study of breast cancer patients managed in a private oncology clinic in Teresina, from November 2014 to February 2021. All patients with an indication of genomic signature were included. Clinical and pathological variables, use of genomic signatures, treatment and follow-up were obtained. The nomogram to predict Oncotype DX results (University of Tennessee Medical Center) was also calculated. Clinical risk calculation was based on MINDACT, using the modified version of Adjuvant Online. The genetic signatures performed were: the Oncotype, MammaPrint and EndoPredict. Fifty (50) female patients were included in the study. The mean age of the participants was 57.1 years. Among the patients receiving a genomic signature (26-52.0%), there was a change in treatment in 8 (30.7%) cases. Chemotherapy was indicated in four patients, It was contraindicated in another four patients. Treatment changed in 30.7% of the tested patients. Chemotherapy was indicated for those who would not receive it before. It was contraindicated in patients who would previously undergo chemotherapy.

Implementing a digital platform for patient navigation: Experience of a Brazilian oncology network.

560 Background: Cancer treatment involves the use of long-term therapies, mostly oral, and new drug developments are improving patients’ survival, bringing hope, but also more complexity to care delivered. Trials using digital platforms for patient remote monitoring demonstrated increased survival and patient satisfaction, but demands a great effort in implementation and multidisciplinary team engagement. Oncoclínicas Group is a large multidisciplinary private oncology network present in 35 Brazilian cities with 133 units that have specialists in the areas of oncology, radiotherapy, hematology and bone marrow transplantation, multidisciplinary teams, complementary care and the most advanced in integrated assistance and individualized treatment. Here we describe our experience in developing and implementing the platform OC por Você. Methods: In July 2022, Oncoclinicas Group partnered with Meu Médico startup to develop an EHR-integrated platform that was adherent to Oncoclínicas safety needs. The agile development process incorporated user-centered design principles that required engagement from patients, clinicians, and health care systems. Defined features: a chat center specifically designed for the patient and multidisciplinary team with decision tree for patients specifics needs; embedded telemedicine; digital prescription; sending images or documents; view of the patient chart, health professionals agenda, pathology test results; access to treatment protocols for each cancer type. In January 2023 a first wave was planned, implementing in three sites. From April through June 2023, seven waves of implementation were planned. The Oncoclínicas Digital Team trained all health professionals before launch, and educational videos and digital cards were developed for both health professionals and patients. Results: From January through April 2023, 149 users downloaded the mobile platform. There were 11 doctors, 44 non-medical health professionals and 94 patients. A total of 199 chats were initiated, with 3409 messages exchanged and 20 teleconsultations. From April through June 2023, the platform was implemented in a total of 21 units, 10 cites, where 990 users downloaded the mobile platform. There were 173 doctors, 318 non-medical health professionals and 499 patients. A total of 870 chats were initiated, with messages exchanged and 224 teleconsultations. Until December 2025 other waves of implementation will happen to complete the full implementation process. Conclusions: Implementing a digital mobile platform for cancer patient care is feasible in a private oncology practice network in Brazil. Several pitfalls were identified, especially the need for constant engagement with the care provider team. Systems of this nature should be encouraged in order to keep the communication channel open to patients and families, improving the care to be rendered.

Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial

In the single-arm, phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan showed robust activity in patients with HER2-positive metastatic breast cancer who were refractory or resistant to trastuzumab emtansine; a population with scarce effective treatments. In DESTINY-Breast02, we aimed to compare the efficacy and safety of trastuzumab deruxtecan with treatment of physician's choice in this patient population. This randomised, open-label, multicentre, phase 3 trial was conducted at 227 sites (hospitals, university hospitals, clinics, community centres, and private oncology centres) in North America, Europe, Asia, Australia, Brazil, Israel, and Türkiye. Eligible patients were aged 18 years or older, had unresectable or HER2-positive metastatic breast cancer, previously received trastuzumab emtansine, disease progression, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate renal and hepatic function. Patients were randomly assigned (2:1) to receive trastuzumab deruxtecan (intravenously at 5·4 mg/kg once every 3 weeks) or treatment of physician's choice using block randomisation. Treatment of physician's choice was either capecitabine (1250 mg/m2; orally twice per day on days 1-14) plus trastuzumab (8 mg/kg intravenously on day 1 then 6 mg/kg once per day) or capecitabine (1000 mg/m2) plus lapatinib (1250 mg orally once per day on days 1-21), with a 21-day schedule. The primary endpoint was progression-free survival based on blinded independent central review in the full analysis set. This study is registered with ClinicalTrials.gov, NCT03523585. Between Sept 6, 2018, and Dec 31, 2020, 608 patients were randomly assigned to receive trastuzumab deruxtecan (n=406; two did not receive treatment) or treatment of physician's choice (n=202; seven did not receive treatment). 608 (100%) patients were included in the full analysis set. The median age was 54·2 years (IQR 45·5-63·4) in the trastuzumab deruxtecan group and 54·7 years (48·0-63·0) in the treatment of physician's choice group. 384 (63%) patients were White, 603 (99%) were female, and five (<1%) were male. The median follow-up was 21·5 months (IQR 15·2-28·4) in the trastuzumab deruxtecan group and 18·6 months (8·8-26·0) in the treatment of physician's choice group. Median progression-free survival by blinded independent central review was 17·8 months (95% CI 14·3-20·8) in the trastuzumab deruxtecan group versus 6·9 months (5·5-8·4) in the treatment of physician's choice group (HR 0·36 [0·28-0·45]; p<0·0001). The most common treatment-emergent adverse events were nausea (293 [73%] of 404 with trastuzumab deruxtecan vs 73 [37%] of 195 with treatment of physician's choice), vomiting (152 [38%] vs 25 [13%]), alopecia (150 [37%] vs eight [4%]), fatigue (147 [36%] vs 52 [27%]), diarrhoea (109 [27%] vs 105 [54%]), and palmar-plantar erythrodysaesthesia (seven [2%] vs 100 [51%]). Grade 3 or higher treatment-emergent adverse events occurred in 213 (53%) patients receiving trastuzumab deruxtecan versus 86 (44%) receiving treatment of physician's choice; whereas drug-related interstitial lung disease occurred in 42 (10%; including two grade 5 death events) versus one (<1%). DESTINY-Breast02 shows the favourable benefit-risk profile of trastuzumab deruxtecan in patients with HER2 positive metastatic breast cancer, as previously reported in DESTINY-Breast01, and is the first randomised study to show that one antibody-drug conjugate can overcome resistance to a previous one. Daiichi Sankyo and AstraZeneca.

Abstract 5522: Does physician-patient language concordance increase clinical trial enrollment in breast cancer patients?: A real-life study in a majority-minority population

Abstract Introduction: Clinical trial accrual and enrollment are essential to break disparities seen in minority populations affected by cancer. Despite Hispanics (HI) being 18.9% of the US population and the fastest-growing minority in the US, they only represent 4% of the patients enrolled in clinical trials. These disparities are often explained by different social determinants of health, but could also be due to decreased perceived interest by oncologists in their participation simply due to lack of English proficiency. Effective doctor-patient communication is vital in establishing a healthy doctor-patient relationship, and is vital in delivering high-quality health care. In this study, we explore whether physician-patient language concordance affects clinical trial enrollment. Methods: We evaluated 233 patients diagnosed with breast cancer who consented to experimental clinical trials in a private Oncology practice in Houston, Texas, from 2008-2022. All trials had approved consent in English and Spanish. We used logistic regression to model the probability of treatment, while adjusting for the effects of cancer type, gender, race, ethnicity, and language concordance. Results: Of the 233 patients with breast cancer, 191(82%) were enrolled in a clinical trial, and 96% of these patients spoke the same language as their providers. 42 patients were not enrolled, with 95% of patients speaking the same language as their provider. There were 209 (90%) patients who spoke English, 22 (9%) were Spanish speakers and 2 (1%) were Arabic speakers. Of the Spanish speakers, 18 were enrolled, with 13 (72%) having language concordance with their provider. The ethnicity was evaluated, resulting in 72 (31%) patients being Hispanics, 55 (24%) African American, 94 (40%) Caucasian, 7 (3%) Asian, 4 (2%) Middle Eastern and 1 (0.4%) American Indian. It also evaluated the rate of consent withdrawal, showing only 6 (3%) patients. After evaluating the results, it was noted that there was no statistically significant association of physician-patient language concordance with enrollment rate (p=0.776). There was also no significant difference in consent withdrawal (p=0.626), and no change associated with gender (p=0.344) or ethnicity when evaluated (p=0.13). Conclusion: In conclusion, our analysis confirms no significant difference in breast cancer patients’ enrollment in clinical trials if there is language concordance between physician and patient. The efforts of the medical workforce to use translators and translated versions of informed consents, surveys or outcome assessments, when available, seem enough for our patients to agree to continue enrollment. Citation Format: Daniela Urueta Portillo, Ana M. Mendoza Sanchez, Nitzia E. Quilantan, Lisa Maria Mendoza Sanchez, Marcela Mazo Canola, Jonathan Gelfond, Julio A. Peguero. Does physician-patient language concordance increase clinical trial enrollment in breast cancer patients?: A real-life study in a majority-minority population. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5522.

Recurrence rate in patients with stage IV breast cancer: a retrospective cohort study

Abstract Introduction: Metastatic breast cancer (mBC) remains incurable, with a median overall survival (OS) of approximately 3 years and a 5-year survival rate of approximately 25%, irrespective of the economic classification of the country where treatment is received. Cyclin-dependent kinase (CDK) inhibitors increase overall survival in both first and second-line settings in the treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative mBC. This retrospective cohort study investigated the progression-free survival in women with mBC receiving combination therapy with abemaciclib (CDK4/CDK6 inhibitor) and letrozole or fulvestrant as opposed to abemaciclib only. Methods: The study included all eligible women with stage IV breast cancer treated with abemaciclib at a private oncology facility in Johannesburg over the study period. Data were collected from medical records from April 1, 2019 to March 31, 2021. Analyses were conducted to assess the overall survival rate, progression-free survival probability, and safety of abemaciclib in women with stage IV breast cancer. Results: Thirty-two patients were eligible for inclusion in this study. The progression-free survival probability was 60% after a period of 17 months, irrespective of treatment options. After 17 months, the OS of women on a combination of abemaciclib and letrozole was 80%, on a combination of abemaciclib and fulvestrant was 80%, and on abemaciclib monotherapy was 70%. The most noted adverse effects were diarrhea (92.0%), neutropenia (92.0%), fatigue (48.0%), and hepatotoxicity (16.0%). Discussion: Abemaciclib with endocrine therapy or an aromatase inhibitor provided an improvement in the OS compared with abemaciclib monotherapy. These findings are representative of the use of abemaciclib in a local population and are similar to those of larger studies conducted internationally.

Impact of the COVID-19 Pandemic on Cancer Staging: An Analysis of Patients With Breast Cancer From a Community Practice in Brazil.

A nationwide lockdown was enforced in Brazil starting in March 2020 because of the COVID-19 pandemic when cancer screening activities were reduced. In this study, we evaluated the impact of the COVID-19 pandemic on breast cancer (BC) diagnosis. We extracted data from the medical records of patients age older than 18 years who were diagnosed with BC and started treatment or follow-up in private oncology institutions in Brazil between 2018 and 2021. The primary objective was to compare the stage distribution during the COVID-19 pandemic (2020-2021) with a historical prepandemic control cohort (2018-2019). Early BC was defined as stage I-II and advanced disease as stage IV. We collected data for 11,753 patients with an initial diagnosis of BC, with 6,493 patients in the pandemic (2020-2021) and 5,260 patients in the prepandemic period (2018-2019). We observed a lower prevalence of early-stage BC (63.6% v 68.4%) and a higher prevalence of advanced-stage BC (16.9 v 12.7%), after the onset of the pandemic (both P < .01). This pattern was similar for both estrogen receptor-positive/human epidermal growth factor receptor 2-negative and human epidermal growth factor receptor 2-positive tumors: significantly decreased in the early stage from 69% to 67% and 68% to 58%, respectively, and a considerable increase in advanced-stage disease from 13% to 15% and 13% to 20%, respectively. For triple-negative BC, there was a significantly higher percentage of patients with advanced-stage disease during the pandemic (17% v 11%). Overall, age 50 years or older and postmenopausal status were associated with a greater risk of advanced stage at diagnosis during the pandemic period. We observed a substantial increase in the number of cases of advanced-stage BC in Brazil during the COVID-19 pandemic.

Building the plane while it’s flying: implementation lessons from integrating a co-located exercise clinic into oncology care

BackgroundDespite its therapeutic role during cancer treatment, exercise is not routinely integrated into care and implementation efforts are largely absent from the literature. The aim of this study was to evaluate a strategy to integrate the workflow of a co-located exercise clinic into routine care within a private oncology setting in two clinics in the metropolitan region of Western Australia.MethodsThis prospective evaluation utilised a mixed methods approach to summarise lessons learned during the implementation of an integrated exercise workflow and supporting implementation plan. Data collection was informed by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Reports detailing utilisation of the exercise service and its referral pathways, as well as patient surveys and meeting minutes documenting the implementation process informed the evaluation.ResultsThe co-located exercise service achieved integration into routine care within the clinical oncology setting. Patient utilisation was near capacity (reach) and 100% of clinicians referred to the service during the 13-month evaluation period (adoption). Moreover, ongoing adaptations were made to improve the program (implementation) and workflows were integrated into standard operating practices at the clinic (maintenance). The workflow performed as intended for ~70% of exercise participants (effectiveness); however, gaps were identified in utilisation of the workflow by both patients and clinicians.ConclusionIntegration of exercise into standard oncology care is possible, but it requires the ongoing commitment of multiple stakeholders across an organisation. The integrated workflow and supporting implementation plan greatly improved utilisation of the co-located exercise service, demonstrating the importance of targeted implementation planning. However, challenges regarding workflow fidelity within and across sites limited its success highlighting the complexities inherent in integrating exercise into clinical oncology care in a real-world setting.

Survival estimates of childhood malignancies treated at the Mexican telethon pediatric oncology hospital.

Pediatric cancer incidence in Mexico is ~160/million/year with leukemias making 49.8% of the cases. While survival rates have been reported in various Mexican studies, no data is available from the Telethon Pediatric Oncology Hospital-HITO, a nonprofit private institution specialized exclusively in comprehensive pediatric oncology care in the country that closely follows high-income countries' advanced standards of cancer care. To determine overall survival (OS) and relapse-free survival (RFS) in patients treated at HITO between December 2013 and February 2018. Secondary analysis of data extracted from medical records. It included 286 children aged 0-17 years diagnosed with various cancers grouped into three categories based on location: (1) Acute lymphoblastic leukemia (ALL), (2) tumors within the central nervous system (TWCNS), and (3) tumors outside the CNS (TOCNS). OS and RFS rates for patients who completed 1 (n=230) and 3 (n=132) years of follow-up after admission were computed by sex, age, and cancer location, and separately for a subsample (1-year=191, 3-years=110) who fulfilled the HITO criteria (no prior treatment, underwent surgery/chemotherapy when indicated, and initiated therapy). TOCNS accounted for 45.1%, but ALL was the most frequent single diagnosis with 28%. Three-year OS for patients with ALL, TWCNS, and TOCNS who fulfilled the HITO criteria were 91.9%, 86.7%, and 79.3%, respectively; for 3-year RFS these were 89.2%, 60%, and 72.4%. Boys showed slightly higher OS and RFS, but no major differences or trends were seen by age group. This study sets a relevant reference in terms of survival and relapse for children with cancer in Mexico treated at a private oncology center that uses a comprehensive and integrated therapeutic model.

Lessons From Implementing a Clinical Research Network in Brazil.

In this article, we discuss the strategy designed by a private oncology group to offer patients access to new technologies and treatments via a recently created research program, and we describe how the patient journey was the motivation for developing standard assistance flows and processes to integrate areas of care. The increase in Brazilians' life expectancy has raised the incidence of cancer, and it is now the second leading cause of death. Because it is a multifactorial disease, cancer treatment has several challenges. We elected to approach cancer research using a strategic program to obtain national attention and visibility. Starting in 2007, the initial project included three phases: phase I, diagnosis of units in major metropolitan areas; phase II, project design, with a central-office operation model; and phase III, implementation, with launch and integration of research activities at selected units. The foundation of the program was the construction of departmental and interdepartmental flows, standard operating processes, and guidelines (regulatory, ethical, legal, and financial). Recruitment of qualified professionals was another critical, successful determinant. The benefits of an additional central office include improved research-project distribution. Another advantage of the program is attracting and retaining trained professionals with alternative direct or indirect sources of revenue. We increased our corporate and academic partnerships, adhered to deadlines and noted an improvement in turnaround times, and we increased clinical staff engagement and motivation. Some barriers continue to challenge the program's continued expansion, including Brazilian regulatory authority approval, tax inefficiency, and a growing demand for qualified professionals. Research sites offering high-quality care are a reality in Brazil; they offer multiple lines of treatment in the public and private sectors.

Monoclonal-induced cardiotoxicity in patients with non-Hodgkin's lymphoma and breast cancer: A retrospective study in an oncology clinic.

Monoclonal antibodies, such as trastuzumab and rituximab, significantly contribute to the oncological therapeutic arsenal. However, they may be associated with the development of cardiotoxicity. This study collected data from clinical records of patients in the use of rituximab and trastuzumab in a private oncology clinic from 2017 to 2019. It also investigated cardiovascular adverse drug reactions and associated risk factors. Cardiotoxicity was defined as symptomatic in the presence of signs and symptoms suggestive of heart failure (HF) such as dyspnea, nocturnal cough, and fatigue, among others. Asymptomatic HF was confirmed by the decline in the left ventricular ejection fraction (LVEF) ≥10% of baseline or LVEF ≤50%. Among the 57 patients undergoing trastuzumab, 12 patients (21%) had cardiotoxicity and 8 patients (67%) had extreme or high-risk scores in the cardiotoxicity risk assessment algorithm. Among the 37 patients treated with rituximab, 3 patients (8%) had cardiotoxicity. The presence of previous diabetes mellitus significantly increased the risk of trastuzumab-induced cardiotoxicity (p = 0.02). However, none of the other risk factors influenced the incidence of trastuzumab- and rituximab-induced cardiotoxicity, which the sample size may explain. More studies are needed to investigate the association of risk factors with cardiotoxicity induced by trastuzumab and rituximab, aiming to establish strategies to prevent and manage this effect early.