Community-based Oncology Practices Research Articles

Fostering resilience in adolescence and young adulthood: Considerations for evidence-based, patient-centered oncology care.

Adolescence and young adulthood are times of growth and change. For adolescents and young adults (AYAs) who are diagnosed with cancer, the demands of illness may compound normal developmental challenges and adversely affect physical, emotional, and social health. Nevertheless, AYAs have a tremendous capacity for psychosocial adaptation and resilience. Informed by the Transactional Model of Stress and Coping, observational studies in AYA oncology suggest consistent individual, social, and existential resources that may promote resilience. To date, few interventions have been designed to examine whether resilience can be taught and whether doing so affects patient-centered outcomes. Findings point to the potential value of multicomponent programs that include various skills-building strategies, such as stress management, mindfulness, gratitude, and positive reappraisal coping, among others. New research directions include the need to evaluate delivery strategies to enhance participant adherence and retention (e.g., eHealth modalities, optimization studies) and to examine program effectiveness in community-based oncology practices (e.g., less resource-rich settings in which most AYAs receive care). Ultimately, this scholarship may inform, refine, and strengthen intervention science in resilience more broadly.

The development of an ASCO-compliant, user-friendly electronic template to improve documentation and retrieval of advance care planning conversations: The approach of a community-based oncology practice.

36 Background: Advance Care Planning (ACP) discussions are essential components of patient care. These conversations take place routinely in oncology settings, but their documentation is time consuming and difficult to extract. Methods: Blue Ridge Cancer Care (BRCC), is certified in the ASCO/COA APC4 pilot, planned to improve its documentation of ACP discussions, and took the initiative to create a succinct, user-friendly ACP template that could be documented electronically and easily extracted for data analysis. The ASCO requirements for ACP conversations were reviewed and applied to edit an ACP template created in compliance with the Joint Commission’s requirements for the advanced certification in Palliative Care. The new template was then presented to different groups of providers in the local practice and in the larger network that the practice is part of. Results: BRCC serves about 15,000 active patients a year, with 8, 000 new consults and a total of more than 70,000 visits. The documentation of ACP conversation at the beginning of the project was 76% (n=304). Over a period of 4 months (January-April 2023) the BRCC’s Quality Programs & Process Improvement team created the new ACP template and presented it at the monthly meeting of clinical providers in three different sites. The template was also presented at one of the monthly meetings of the US Oncology Palliative Care Team. Twenty-five feedbacks were collected. There were extensive conversations about the role of different level providers in performing and documenting the conversation, i.e. physicians, Advance Care Practice Providers (APP), social workers and Nurse Navigators. The feedback process resulted in 2 edits and 3 action plans. Interestingly, the compliance increased to 83% (n=622) during this period of time, likely due to increased awareness. The form will be implemented in the coming months and the report of the results will follow. Conclusions: The development of an efficient template to document ACP conversation requires extensive feedback from users, promotes insightful discussions and strengthens providers’ engagement to ensure sustainability.

Real-world treatment patterns of bruton tyrosine kinase inhibitors (BTKi) in patients with mantle cell lymphoma (MCL) in community oncology practices in the United States (US).

e19525 Background: Real-world data on BTKi use in MCL remain limited. This study aimed to examine US real-world BTKi treatment pattern, duration, and adherence in MCL patients. Methods: This retrospective observational study used electronic medical records (EMR) data from Integra Connect database in 18 US community-based oncology practices. Adults with MCL diagnosis on ≥2 separate dates who started BTKi therapy between 1/1/2019 and 11/30/2021 were included. EMR data was collected to ensure adequate medical history and ≥6-months follow up period. Index date was defined based on the use of one of the 3 BTKi: zanubrutinib, acalabrutinib, and ibrutinib for 3 BTKi patient cohorts. Baseline comorbidities were collected ≤90 days prior to index date based on diagnosis records. Sociodemographic and clinical characteristics, comorbidities, and treatment patterns were examined by each BTKi group. Treatment duration was calculated based on EMR and claims until end of follow up. Discontinuation data was based on unstructured physician notes. Kaplan-Meier analysis was used to compare treatment duration between the 3 BTKi groups. Results: In 402 MCL patients identified to start BTKi therapy (44 zanubrutinib; 161 acalabrutinib; 197 ibrutinib), the median age (range) at BTKi therapy start was 75 (56-89) years in zanubrutinib, 76 (36-89) in acalabrutinib, and 72 (36-89) in ibrutinib group ( P<0.01; Table). There is no significant difference between the 3 BTKi groups in other baseline characteristics. Half of zanubrutinib patients used other BTKi in prior therapy, with 31.8% switched from other BTKis to zanubrutinib ≤60 days of treatment start. In acalabrutinib group, 29% had prior BTKi use. Given a later approval date, zanubrutinib group had a relative shorter mean follow-up period (493 days [d]) vs acalabrutinib (701 d) and ibrutinib (746 d). Nevertheless, zanubrutinib patients had significantly longer median treatment duration (292 d) vs acalabrutinib (259 d) and ibrutinib (149 d) ( P<.01). Conclusions: Real-world EMR data from US community-based oncology practices suggested significantly longer treatment duration and adherence in MCL patients treated with zanubrutinib compared with acalabrutinib or ibrutinib. Further analyses on long term utilization are needed upon data maturation. [Table: see text]

Analysis of delivery of cancer survivorship education to community healthcare professionals.

12136 Background: There are currently 18.1 million cancer survivors in the United States; anticipated to reach 26.0 million survivors by 2040. Educational opportunities for healthcare providers in survivorship care is needed to insure capacity for this rapidly growing population particularly in the community setting. This pilot study implemented a cancer survivorship Project ECHO model in two community hospitals within a larger community health system. Methods: Providers affiliated with the Mercy Health System were enrolled in one of two cohorts. Eligible participants included physicians, advanced practice providers, nurses, social workers, and dietitians. Six one-hour sessions were developed from a needs assessment and delivered over a 12-week period. Participants were invited to complete pre and post session surveys to evaluate the following 3 domains: professional improvement (PI), self-efficacy (SE), and knowledge (KN). A Likert scale was used with each survey item rated 1-5, where 1 represents lowest and 5 highest (agreement/confidence/knowledge). The average score for survey items within each domain was utilized to compare pre- and post-survey results. Results: Fourteen multidisciplinary providers were enrolled in both Cohort 1 and Cohort 2. Twenty-six completed the baseline survey and 22 completed the post-study survey. The mean change of each domain (PI, SE, KN) and mean overall change are summarized in the table. For cohort 1, the overall score significantly increased 0.94 (0.45,1.42) (P=0.0023). While the SE and KN domain scores increased significantly (1.1 (0.5,1.7), 1.03 (0.45,1.62) and p = 0.003, 0.0036, respectively), the PI did not change -0.09(p=0.726). For cohort 2, the overall score significantly increased 0.617 (0.042,1.193) (P=0.0378). While the SE and KN domain increased significantly (0.728(0.048,1.407), 0.665 (0.041,1.289) and p = 0.0379, 0.0387, respectively), the PI did not change (p=> 0.999). Conclusions: The Cancer Survivorship ECHO model may serve as a scalable strategy for building cancer survivorship care capacity in community-based oncology practices through equipping multidisciplinary teams to meet the needs of cancer survivors within their community. Further research is needed to assess implementation of this model into novel settings and evaluate its impact on patient outcomes. [Table: see text]

Increasing COVID-19 vaccine adherence within an immunocompromised patient population in a community practice.

e18714 Background: Patients receiving antineoplastic therapy are at increased risk of severe illness and death from COVID-19. Vaccination against COVID-19 is an effective strategy to prevent serious complications of the disease. Because immunocompromised patients may have a blunted immune response to COVID-19 vaccinations, the CDC recommends these patients receive an additional vaccine dose. CDC recommendations serve as a guideline for optimal care of hematology/oncology patients, and within which we demonstrate a quality improvement project to promote community education and assess vaccination rates. Methods: Through Epic electronic medical record (EMR) reporting, we identified 250 immunocompromised patients who had not completed their primary COVID-19 vaccination series or booster and initiated antineoplastic therapy between 12/1/2020- 12/1/2021 at a community-based oncology practice in Michigan. Patients were provided an electronic patient portal letter detailing vaccination recommendations, information on how to obtain vaccination, and a survey inquiring if patients were more likely to become vaccinated after the educational intervention. 204 patients received electronic letters and 46 patients (without portal access) were sent a letter via the US postal service. Three months post intervention, we evaluated for change in COVID vaccination status, hospitalization, death rates, and patient preferences regarding vaccination. Results: Three months post intervention, a total of 44 patients responded to the survey (39 electronically and 5 via mail). The overall improvement in vaccination rate was 10.4%. Using Fisher’s exact test, we found a statistically significant difference (p = 0.002) in vaccination rates between survey responders compared to non-responders. Vaccination rates increased by 25.0% in survey responders, compared to 7.3% in patients who did not respond. During the study period, 13 patients contracted COVID-19 (1/13 vaccinated), and one patient required hospitalization due to COVID-19 (unvaccinated). No deaths due to COVID-19 were reported. Patients’ most cited reasons for declining vaccination were concerns regarding vaccination safety and lack of understanding of the CDC recommendations. Conclusions: Our study highlights the EMR as an effective means to provide community education about COVID-19 vaccination. Limitations include delayed outreach to patients without electronic patient portal access or with infrequent patient portal use. Nonetheless, our quality study design serves as a model for other implementations of electronic community outreach in oncology patients. Future directions will assess long-term vaccination rates and outcomes in these immunocompromised patients.

Advancing TNBC care in the community oncology practice: Insights from a quality improvement initiative.

e18762 Background: New and emerging treatments for metastatic triple negative breast cancer (mTNBC) are improving outcomes for patients. However, given the fast pace of innovation, staying informed about the latest clinical trial data, guideline recommendations, and adverse event management, is challenging, particularly in community-based settings. To improve the care of mTNBC patients, we conducted a quality improvement (QI) initiative across 10 community-based oncology practices. Methods: Between 9/7/2021 and 2/11/2022, we surveyed multidisciplinary oncology team members (N = 121) at 10 community oncology clinics to assess current practices, challenges/barriers, and areas for improvement in mTNBC care. Providers then participated in audit/feedback (AF) educational sessions (N = 150) where they (a) assessed system-specific practice gaps identified via the provider surveys, (b) prioritized areas for improvement, and (c) developed action plans for addressing root causes of the identified gaps. Results: Providers reported the top challenge in caring for patients with mTNBC as sequencing treatment options across multiple lines of therapy (33%). Providers participating in the AF sessions identified impact on overall survival (55%), molecular test results (49%), and impact on patient quality of life (44%) as their primary considerations when differentiating among new and emerging targeted therapies for mTNBC. Additionally, clinicians reported having the most difficulty managing gastrointestinal distress (31%), cardiotoxicity (31%), and endocrinopathies (31%) associated with novel therapies. Providers believed improved collaboration across interprofessional teams (32%) and increased patient education for aspects of supportive care (28%) would improve care for mTNBC patients. To address the identified gaps at each location, teams developed action plans to improve coordinated mTNBC care, provide patient-centered supportive care, increase testing for targeted therapies, improve symptom and adverse event management, and create standardized order sets. Conclusions: Through this QI initiative, clinical teams identified gaps/barriers in their own practices, and developed and implemented action plans for improvement. These data and actionable insights support safe, effective, and evidence-based integration of novel therapies into mTNBC care to optimize patient outcomes. Study Sponsor Statement: The study reported in this abstract was funded by an educational grant from Gilead Sciences, Inc., who had no role in the study design, execution, analysis, or reporting.

Closing the Testing Gap: Standardization of Comprehensive Biomarker Testing for Metastatic Non-Small-Cell Lung Cancer in a Large Community Oncology Practice.

Non-small-cell lung cancer (NSCLC), the leading cause of cancer death in the United States, accounts for 85% of all lung cancer cases. Biomarker testing is an integral part of the care of patients with NSCLC. Despite broad consensus recommendations that all patients with metastatic NSCLC (mNSCLC) undergo comprehensive biomarker testing (comprehensive genomic profiling and PD-L1), testing rates remain suboptimal. The primary goal of this project was to apply National Comprehensive Cancer Network (NCCN) guidelines for comprehensive biomarker testing to all new patients with mNSCLC within a large community practice. Plan-Do-Study-Act methodology was used, with cycle 1 focused on provider education and the creation of a mNSCLC initial consult Note (electronic health record template/McKesson iKnowMed G2) and accompanying order set. Staging, template/order set utilization, and comprehensive biomarker testing rates were recorded while workflow processes were monitored. Cycle 2 centered on improved cancer staging, data analytic reporting, auditing, and reeducation. The comprehensive biomarker testing rates increased from a historic rate of 68% to 92.7% during the 1-year intervention period. The template utilization rate was 71% with complete staging (TNM stage and relevant biomarkers) documented in 40%. Implementation and standardization of comprehensive biomarker testing of patients with mNSCLC in a large multisite community-based oncology practice is feasible and results in significant improvement in comprehensive biomarker testing and reporting. Establishing reliable and measurable tracking metrics to ensure that these new processes are used and maintained can assist in scaling these processes. Efforts to scale this best practice are planned across the US Oncology Network.

Universal Genetic Testing vs. Guideline-Directed Testing for Hereditary Cancer Syndromes Among Traditionally Underrepresented Patients in a Community Oncology Program.

Background Detection of pathogenic germline variants (PGVs) has implications for cancer screening, prognosis, treatment selection, clinical trial enrollment, and family testing. Published guidelines provide indications for PGV testing, determined by clinical and demographic factors, but their applicability in an ethnically and racially diverse community hospital population is unknown. This study describes the diagnostic and incremental yield of universal multi-gene panel testing in a diverse population in a community cancer practice. Methods We completed a prospective study of proactive germline genetic sequencing among patients with solid tumor malignancies at a community-based oncology practice in downtown Jacksonville, FL, between June 2020 and September 2021. The patients were unselected for cancer type, stage, family history, race/ethnicity, and age. PGVs identified using an 84-gene next-generation sequencing (NGS) tumor genomic testing platform were stratified by penetrance. National Comprehensive Cancer Networks (NCCN) guidelines determined incremental PGV rates. Results Two hundred twenty-three patients were enrolled, with a median age of 63 years, 78.5% female. 32.7% were Black/African American, and 5.4% were Hispanic. 39.9% of patients were commercially insured, Medicare/Medicaid insured 52.5%, and 2.7% were uninsured. The most common cancers in this cohort were breast (61.9%), lung (10.3%), and colorectal (7.2%). Twenty-three patients (10.3%) carried one or more PGVs, and 50.2% carried a variant of uncertain significance (VUS). Though there was no significant difference in the rate of PGVs based on race/ethnicity, African Americans were numerically more likely to have a VUS reported than whites (P=0.059). Eighteen (8.1%) patients had incremental clinically actionable findings that practice guidelines would not have detected, which was higher in non-whites. Conclusions In this racially/ethnically and socioeconomically diverse cohort, universal multi-gene panel testing (MGPT) increased diagnostic yield over targeted guideline-informed testing. Rates of VUS and incremental PGV were higher in non-white populations.

MP67-14 VARIATION OF HORMONAL AGENT USAGE WITH POSTOPERATIVE RADIATION THERAPY: RESULTS FROM A POPULATION BASED COHORT OF PROSTATE CANCER PATIENTS IN COMMUNITY ONCOLOGY PRACTICES

You have accessJournal of UrologyCME1 Apr 2023MP67-14 VARIATION OF HORMONAL AGENT USAGE WITH POSTOPERATIVE RADIATION THERAPY: RESULTS FROM A POPULATION BASED COHORT OF PROSTATE CANCER PATIENTS IN COMMUNITY ONCOLOGY PRACTICES Rodrigo R Pessoa, Tyler Robin, Thomas Flaig, Elizabeth Molina, Boris Gershman, Eric Ballon-Landa, Corbin Eule, Elizabeth Kessler, Brian Chapin, Marc C Smaldone, and Simon P Kim Rodrigo R PessoaRodrigo R Pessoa More articles by this author , Tyler RobinTyler Robin More articles by this author , Thomas FlaigThomas Flaig More articles by this author , Elizabeth MolinaElizabeth Molina More articles by this author , Boris GershmanBoris Gershman More articles by this author , Eric Ballon-LandaEric Ballon-Landa More articles by this author , Corbin EuleCorbin Eule More articles by this author , Elizabeth KesslerElizabeth Kessler More articles by this author , Brian ChapinBrian Chapin More articles by this author , Marc C SmaldoneMarc C Smaldone More articles by this author , and Simon P KimSimon P Kim More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The optimal hormonal agent for postoperative radiation therapy remains to be defined with either LH-RH agents or androgen receptor blockers. Androgen deprivation therapy appears to be important for some patients receiving postoperative radiation therapy but there are differences in side effects and quality of life. Thus, we used a large national database of community practices to identify practice patterns with hormonal agents in the postoperative radiation therapy settings. METHODS: From the CancerLinQ database, which represents more than a 100 community oncology practices in the U.S., we included all men who underwent radical prostatectomy and then received adjuvant or salvage radiation therapy from 2000 to 2021. The primary outcome was concomitant use of hormonal therapy including luteinizing hormone – releasing hormone (LH-RH) agents or androgen receptor blockers. Multivariable logistic regression analyses were used to elucidate patient characteristics associated with use of each class of hormonal agents. RESULTS: Among the 390 surgically treated patients receiving postoperative radiation therapy, 50.7%(n=198) received no hormonal agents, 23.6 % (n=92) received LH-RH agents, and 22.82% (n=89) received both LH-RH agents and androgen receptor blocker. Only 2.8% (n=11) received androgen receptor blocker alone. Among patients with salvage radiation therapy at PSA>0.7 ng/dl, 51.6% did not receive any form of hormonal therapy. On multivariable analysis, patients with pN1+ compared with pN0 had higher odds of receiving LH-RH agents (OR: 3.21; p=0.01) during postoperative radiation therapy. Conversely, African American men were less likely to receive androgen receptor blockers compared to white men (OR: 0.24; p=0.004). Use of hormonal agents were not associated with postoperative radiation therapy intent. CONCLUSIONS: Among patients treated in community-based oncology practices in the U.S., most are not receiving any form of hormonal agents with postoperative radiation therapy. Racial disparities also exist in the use of androgen receptor blockers during post-prostatectomy radiation therapy. Increased attention is needed to disseminate evidence into clinical practice. Source of Funding: Schramm Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e948 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rodrigo R Pessoa More articles by this author Tyler Robin More articles by this author Thomas Flaig More articles by this author Elizabeth Molina More articles by this author Boris Gershman More articles by this author Eric Ballon-Landa More articles by this author Corbin Eule More articles by this author Elizabeth Kessler More articles by this author Brian Chapin More articles by this author Marc C Smaldone More articles by this author Simon P Kim More articles by this author Expand All Advertisement PDF downloadLoading ...

Real-World Biomarker Testing Patterns in Patients With Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) in a US Community-Based Oncology Practice Setting

Introduction/BackgroundThis study was designed to describe real-world changes in biomarker testing among patients with non-squamous, metastatic non-small cell lung cancer (mNSCLC) in a community oncology setting from 2015 to 2020. Patients and MethodsThis retrospective study randomly selected 500 adult patients diagnosed with nonsquamous mNSCLC to undergo chart review and data extraction. Data were extracted and validated by 2 independent abstractors. Biomarker testing rates were described before and after national guideline updates and FDA approval of targeted agents. ResultsAt least 1 biomarker test was received by 89.4% of patients with mNSCLC. Of all patients, 46.6%, 34.6%, and 8.2% received both single-gene and next generation sequencing (NGS)-based testing, single-gene testing only, and NGS-based testing only, respectively. However, there were changes in testing rates at the time of drug approvals for targeted agents. Biomarker testing increased for ALK (45.0% before to 78.3% after ALK-targeted drug approval), BRAF (from 20.0% to 67.8%), EGFR (from 20.0% to 78.2%), NTRK (from 34.6% to 55.7%), and ROS1 (increased from 29.6% before approval to 74.2% after). Biomarker testing increased after changes were made to national guidelines for BRAF (from 18.8% before to 68.1% after inclusion in guidelines), NTRK (from 37.2% to 56.5%), and ROS1 (increased from 40.8% to 74.5% after guideline updates). Targeted therapy was received by 62.4% of patients with a positive biomarker. ConclusionIncreases in biomarker testing rates were observed relative to targeted agent approvals and national guideline updates. However, many patients with non-squamous mNSCLC did not receive full genotyping in accordance with national guidelines and represent an opportunity to identify reasons and solutions for barriers to care.

Identifying and Overcoming Racial Disparities in Multiple Myeloma Care: Results from a Large-Scale Equity-Focused Quality Improvement Initiative

Background A prior quality improvement (QI) initiative (Mikhael ASH 2020) was conducted to address root causes of racial disparities in care delivery among patients with relapsed/refractory (R/R) multiple myeloma (MM) in 2 large oncology systems. Preliminary survey data suggested discordant beliefs regarding patients’ primary treatment concerns. Thus, this study was scaled up to 4 community-based oncology practices to greater evaluate disparities with electronic medical record (EMR) audits and team-based audit-feedback (AF) sessions to identify factors which could enhance more equitable care. Methods This QI initiative included patient and provider surveys, baseline and follow-up EMR audits, and small-group, team-based AF sessions at each participating clinic. Surveys were completed by 59 hematology/oncology healthcare providers (HCPs) and 100 R/R MM patients (Table 1; N=47 Black, N=50 White/Non-Hispanic) to examine alignments and discordances in attitudes, beliefs, perceptions, and practices regarding MM care. A baseline EMR audit of 200 R/R MM patients (Table 1; N=32 Black, N=122 White/Non-Hispanic) was conducted to identify patient/disease characteristics, treatment history, clinical practice metrics, and patient-centered measures (e.g., shared decision-making). During 1-hour AF sessions, HCP cohorts (Table 1) (a) assessed clinic-specific practice gaps identified by the patient-provider surveys and baseline EMR audit, (b) prioritized areas for improvement, and (c) developed action plans to address root causes. Surveys completed before (N=59) and after (N=41) the AF sessions measured changes in participants’ beliefs and confidence in care delivery. A follow-up EMR audit after completion of the AF sessions was performed to assess behavioral and practice change. Results Patient and HCP tethered survey data revealed discordant beliefs about patients’ primary treatment concerns. HCPs overestimated patients concern regarding treatment cost (32% vs 9%) and treatmentrisks (55% vs 29%), but underestimated patient's largest reported challenge in feeling confident that their treatment plan is the best for their cancer (18% vs 32%). Providers reported the most challenging aspect of MM management was individualizing treatment plans. There was large divergence between HCPs and all patients’ top goals (Figure 1) and stark racial disparities were observed in improving quality of life, preventing progression or recurrence, and surviving as long as possible (Figure 1). Disparities also persisted among patients who reported being on track or somewhat on track to achieve their treatment goals (76% White vs 54% Black/Hispanic, p = 0.021). Regarding shared decision-making (SDM) with their HCP, only 14% of Black/Hispanic patients felt completely involved in treatment decision making compared to 54% of White patients (p = < 0.001). EMR audits revealed fewer Black patients using maintenance therapy (63% vs 71% non-Black) and greater numbers of stem cell transplants (53% Black vs 44% non-Black). Following AF sessions 55% of HCPs set action plans to incorporate strategies to eliminate disparities in care for diverse MM patient populations and 48% to develop personalized treatment plans incorporating patient-specific factors and preferences. To achieve these goals, providers committed to engage patients in shared decision-making (17% pre-AF vs 38% post-AF), and provide adequate patient education about treatments (17% pre-AF vs 28% post-AF). Participants’ views of the impact of race and socioeconomic factors on equitable MM care changed as a result of the program increasing from 37% to 54% reporting a considerable or a great deal of impact. Conclusions Barriers to equitable, patient-centered care in patients with R/R MM included inadequate education and personalizing of treatment plans by HCPs as well as ineffective SDM. Discordances were observed between providers and all patients in describing the goals of treatment, and between White and Black/Hispanic patients in the challenges faced in their MM care. Action plans developed during this QI initiative intend to address identified gaps and improve equitable care for patients with R/R MM. Study Sponsor Statement The study reported in this abstract was funded by independent educational grants from AbbVie, Inc. Bristol-Myers Squibb, and Janssen Biotech Inc., who had no role in the study design, execution, analysis, or reporting. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Universal genetic testing versus guideline-directed testing for hereditary cancer syndromes among traditionally underrepresented patients in a community oncology program.

10588 Background: Detection of pathogenic germline variants (PGVs) has implications for cancer screening, prognostication, treatment selection, clinical trial enrollment and family testing. Published guidelines provide indications for PGV testing, determined by clinical and demographic factors, but these leave a significant number of cases missed by guideline-directed testing (incremental PGV). We have previously shown that 50% of patients with PVGs would not have been detected with guideline-based testing alone. In this project, we aimed to determine the feasibility and generalizability of this approach within a more racially/ethnically diverse cohort from a community cancer practice. Methods: We completed a prospective study of proactive germline genetic sequencing among patients with solid tumor malignancies at a community-based oncology practice in downtown Jacksonville, FL between June 2020, and September 2021. The patients were unselected for cancer type, stage, family history, race/ethnicity, and age. PGVs identified using an 84-gene NGS platform were stratified by penetrance. National Comprehensive Cancer Networks (NCCN) guidelines were used to determine incremental PGV rates. Results: 221 patients were enrolled, median age 63.0 years, 21.7% male. 56.6% of patients were white (non-Hispanic), 32.6% were black/African American, 5.4% were Hispanic. 39.8% of patients were commercially insured, 52.4% insured by Medicare/Medicaid and 2.7% uninsured. The cohort was comprised predominantly of breast cancer (61.5%), lung cancer (10.4%) and colon cancer (7.2%) patients. A total of 27 PGVs were identified in 23 patients. We found no significant difference in the rate of PGVs based on race/ethnicity. The overall rate of variants of uncertain significance (VUS) was numerically higher in black/African American patients (61.1%) compared with other ancestry (45%). 13 of 23 (56.5%) patients with detected PGVs did not meet NCCN guidelines for germline genetic screening (incremental PGVs). Conclusions: This prospective study found that universal multi-gene panel testing among patients from a racially/ethnically diverse cohort from a community cancer practice was associated with an increased detection of heritable variants with treatment implications over the predicted yield of targeted testing based on guidelines. This study is the first to evaluate this approach in an exclusively community-based practice. Clinical trial information: NCT04456140.

De novo EGFR T790M mutations in a community-based oncology practice.

3146 Background: With the 2018 FDA approval of osimertinib for first-line treatment in EGFR-mutated lung cancers, the prevalence of acquired EGFR T790M mutations is expected to decrease, heightening the significance of de novo T790M mutations. Previous studies have reported a wide range of de novo T790M prevalence, and smaller retrospective studies have indicated that germline T790M may comprise the majority of de novo T790M mutations. Here, we assess the frequency of de novo T790M mutations in a community-based setting and report on germline T790M mutations occurring within this population. Methods: Patients with T790M-positive lung cancer were identified using Sarah Cannon’s clinicogenomics database containing information for patients treated within the Sarah Cannon research network. All T790M mutations were detected on tissue- and plasma-based NGS tests delivered as part of routine care. De novo and germline EGFR T790M status was determined via manual electronic health record chart review. When available, allele fraction and %cfDNA values were extracted from the structured NGS report and analyzed separately. Results: Of T790M-positive lung cancers with available pretreatment testing results, 36% (16/44) were confirmed to be T790M+ prior to EGFR TKI exposure; five of these patients received germline testing, and all five were confirmed to have originated in the germline. Two patients with germline T790M mutations detected on testing ordered by external providers were added to our de novo T790M+ patient analysis after chart review. Co-occurring EGFR mutations, including L858R, were detected in pre-TKI samples for 78% (14/18) of de novo T790M+ patients (Table). Co-occurring mutations in TP53, KRAS, PTEN, or RB1 were detected in pre-TKI samples of all patients without co-occurring EGFR mutations. EGFR C797S was observed after osimertinib treatment in one of four patients with post-TKI testing results. Of confirmed germline T790M+ cases with available allele frequencies, 100% (4/4) had allele fractions &gt;0.5 (tissue) and/or %cfDNA values &gt;50% (plasma). Average allele fraction and %cfDNA values were higher for de novo T790M mutations (allele fraction: 0.5 ± 0.2; %cfDNA: 40% ± 20%) than for acquired T790M mutations (allele fraction: 0.3 ± 0.2; %cfDNA: 2% ± 2%). Conclusions: Roughly one-third of T790M mutations detected in real-world settings occur before EGFR TKI exposure and may be associated with germline inheritance. Allele frequency may be a potential indicator of de novo T790M mutations in scenarios where pre-treatment data is not available. Future studies will investigate the impact of de novo T790M mutations on treatment response and evolution of resistance mechanisms in osimertinib-treated patients. [Table: see text]

The adoption of relugolix for treatment of prostate cancer (PCa) in a large community medical oncology practice.

e13541 Background: Relugolix was approved by the FDA in late 2020 as an oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adults with advanced PCa. The approval was based on a large randomized trial (Shore et al NEJM) of patients with evidence of biochemical or clinical relapse after local primary intervention with curative intent (50%), newly diagnosed mCSPCa (23%), and advanced localized disease not suitable for primary surgical intervention with curative intent (28%). Our study aims to observe the adoption of relugolix in a large community-based medical oncology practice with affiliated urologists. Methods: A retrospective study using our EMR identified 39 males with PCa for whom relugolix was initiated between January 2021 and December 2021. The charts were analyzed for demographics, indications for treatment, barriers encountered to initiation of treatment, duration of therapy, previous therapies, specialty, primary insurance, and cardiovascular history. Results: Thirty-nine (39) patients with either localized PCa (40%) or with metastases to lymph nodes or distant sites (51%) were recommended initiation of relugolix by either urology (26%) or oncology (74%). Of these, 77% actually started the medication. 9 patients did not start therapy, of which 3 were due to insurance denial, 1 due to death, 2 changed their mind, and 3 did not start for unclear reasons. Medicare covered 56% of the patients. Cardiovascular disease was notable in 87%. 28% switched from another ADT due to intolerance, 10% started relugolix due to progressive disease, and 33% started as initial ADT. 13% discontinued within 6 months. Of these, 1 completed planned therapy, 3 were intolerant, 1 was switched to alternate therapy due to progression, and 1 had complications due to COVID. In comparison, 689 patients initiated ADT with leuprolide over the same time. Conclusions: ADT using GnRH agonists or antagonists form the backbone of PCa treatment, typically given as injections. The HERO trial showed that relugolix, a newer oral therapy, is associated with lower rates of cardiovascular events compared to leuprolide. While having at least one cardiovascular risk factor is a consideration for patients to either start with or switch to relugolix, the large majority of our patients still received first-line therapy with leuprolide. This study demonstrates limitations to initiating relugolix including financial constraints (e.g., insurance coverage), patient preference, and medication intolerance.[Table: see text]

Family history assessment to identify patients at risk for hereditary cancer syndromes in community oncology practices.

e18735 Background: Identification of hereditary cancer syndromes can have implications for cancer treatment and prevention. However, only a fraction of cancer patients undergo germline genetic testing (GT). We employed a family health history tool (FHHT) to assist in identifying cancer patients eligible for GT in the outpatient oncology setting. Methods: Patients with cancer with a visit scheduled at one of two community-based oncology practices received email invitations to complete a web-based FHHT that elicits cancer type and age at diagnosis for 1st and 2nd degree relatives. NCCN guidelines were applied to identify individuals meeting clinical criteria for GT. We compared proportions of individuals eligible for GT by sex and cancer type using Fisher’s exact tests. Results: Of the 1292 cancer patients seen over a 4-month period, 276 (21.4%) completed the FHHT. Of those, 58% were female (N = 160) and breast cancer was the most common cancer diagnosis (N = 73, 26.4%), followed by prostate (N = 25, 9.1%) and colorectal cancer (CRC) (N = 15, 5.4%). 59 (21.3%) patients met criteria for GT, including 49.3% of those with breast cancer (N = 36), 66.7% of those with CRC (N = 10), 28% of those with prostate (N = 7), and 100% of those with pancreatic and ovarian cancers (N = 3 each). Breast cancer accounted for 61% of those meeting GT criteria, including personal history of breast cancer age &lt; 50 (N = 17), and personal history of breast cancer with family history of ovarian cancer (N = 7). The proportion of CRC patients meeting GT criteria was higher than for breast cancer (66.7% vs 49.3%). Seven of 10 (70%) CRC patients meeting GT criteria would not have been identified without their accompanying family history. Overall, women were more likely than men to meet GT criteria (OR 1.8, 95% CI: 1.01 to 3.47, p = 0.045). Conclusions: Approximately 1 in 5 cancer patients who were invited to complete the FHHT met NCCN guidelines for GT. While a personal history of young breast cancer was the most common GT eligibility criterion, the proportion of patients eligible for GT was highest among CRC. Across all cancer types, family history increased the number of patient meeting GT criteria by 42.4%. Implementing a patient-facing family history tool can assist community oncologists in clinically appropriate identification of cancer patients who are eligible for GT. While 48% of patients who completed the FHHT met GT criteria, generalizability is limited due to small sample size.[Table: see text]

Impact of clinical pathways on treatment patterns and outcomes for patients with non-small-cell lung cancer: real-world evidence from a community oncology practice.

Introduction: The evolving treatment landscape for non-small-cell lung cancer (NSCLC) and complexities of regulations and reimbursement present challenges to community oncologists. Clinical pathways are tools to optimize care, but information on their value in the real world is limited. This retrospective study assessed treatment patterns and clinical outcomes in patients with stage I-III NSCLC pre- and post-pathways implementation at Tennessee Oncology, a large, community-based oncology practice in the USA. Methods & Materials: Chart data were abstracted for adults diagnosed with stage I-III NSCLC who received systemic treatment. Patients were divided into pre-pathways (treatment initiation 2014-2015) and post-pathways (treatment initiation 2016-2018) cohorts. Patient characteristics, treatment patternsand outcomes were summarized descriptively. Kaplan-Meier curves were used to assess time-dependent outcomes, andlog-rank test wasused to compare the cohorts. Results: 291 patients were included (stage I-II: 38 pre-pathways, 55 post-pathways; stage III: 105 pre-pathways, 93 post-pathways). Duration on first-line (1L) therapy was similar for stage I-II patients pre- and post-pathways (median 1.9months vs 2.1months; p =0.75), but increased for stage III patients post-pathways (2.1months vs1.4months pre-pathways; p <0.01). Achievement of a complete or partial response with 1L therapy was similar post-pathways among stage I-stage-IIII patients (60.0% vs55.2% pre-pathways), but increased for stage III patients (56.0% vs35.2% pre-pathways). Conclusion: Given that improvements in rates of treatment response post-pathways occurred only for patients diagnosed with stage III NSCLC, among whom immunotherapy uptake increased post-pathways, such improvements may be attributable to evolving practices in cancer care, including advances in treatment and care delivery, rather than clinical pathways implementation. Further research is warranted to assess the impact of clinical pathways in the current treatment era, given that immunotherapy has now become the standard of care in NSCLC.

Treatment of Metastatic Disease with Immune Checkpoint Inhibitors Nivolumab and Pembrolizumab: Effect of Performance Status on Clinical Outcomes.

IntroductionAlthough guidelines exist for appropriate use of chemotherapy in the metastatic setting based on performance status, such recommendations are less readily available for immune checkpoint inhibitors (ICIs). We sought to determine whether there is a relationship between Eastern Cooperative Oncology Group (ECOG) performance status and outcomes of immunotherapy in patients treated for metastatic disease at our community-based oncology practice.MethodsPatients (n = 253) were identified as receiving nivolumab or pembrolizumab for stage IV malignancy at Cancer Centers of Colorado, St. Joseph Hospital/SCL Health between June 2018 and November 2020. Patients who initiated therapy after May 2020 were excluded from analysis due to less than 6 months follow-up time. The remaining 183 patients were included in a retrospective cohort study comparing patients with ECOG 0, 1, and 2–4. Sex, age, type of cancer, line of therapy, time on therapy and best response to therapy were determined. These baseline factors and outcomes were compared using analysis of variance (ANOVA) for numeric variables and χ2 tests of association for categorical variables. Time from initiation of ICI to death or hospice was also compared using a log-rank test as well as a multivariate Cox proportional hazards model.ResultsOf the 183 patients included, 31.7% had an ECOG of 0, 48.6% an ECOG of 1, and 19.7% an ECOG of 2–4. Non–small cell lung cancer and melanoma represented the majority of patients in each group. Sex and line of therapy did not differ between groups. There was a significant difference in age, with mean age of 62, 66, and 70 in ECOG 0, 1, and 2–4, respectively. Patients (54.6%) remained on therapy for at least 6 months, with no significant difference between groups in ability to complete 6 months of therapy. For ECOG 0, 1, and 2–4, disease control was achieved in 67.2%, 59.6%, and 41.7%, respectively. Analysis of time to death or hospice with a log-rank test showed a significant difference between groups. A multivariate Cox proportional hazards model revealed that patients with ECOG 0 had significantly longer time to death or hospice compared with patients in both other groups after controlling for age, sex, and line of therapy.ConclusionIn this single institution retrospective study of patients receiving nivolumab or pembrolizumab for metastatic cancer, ECOG 0 was associated with disease control and increased time before death or transition to hospice.

Liquid Biopsy-based Precision Therapy in Patients with Advanced Solid Tumors: A Real-world Experience from a Community-based Oncology Practice

BackgroundLiquid biopsy testing offers a significant potential in selecting signal-matched therapies for advanced solid malignancies. The feasibility of liquid biopsy testing in a community-based oncology practice, and its actual impact on selecting signal-matched therapies, and subsequent survival effects have not previously been reported.Patients and MethodsA retrospective chart review was conducted on adult patients with advanced solid cancer tested with a liquid-biopsy assay between December 2018 and 2019, in a community oncology practice. The impact of testing on treatment assignment and survival was assessed at 1-year follow-up.ResultsA total of 178 patients underwent testing. A positive test was reported in 140/178 patients (78.7%), of whom 75% had an actionable mutation. The actual overall signal-based matching rate was 17.8%. While 85.7% of patients with no actionable mutation had a signal-based clinical trial opportunity, only 10% were referred to a trial. Survival analysis of lung, breast, and colorectal cancer patients with actionable mutations who received any therapy (n = 66) revealed a survival advantage for target-matched (n = 22) compared to unmatched therapy (n = 44): patients who received matched therapy had significantly longer progression-free survival (PFS) (mPFS: 12 months; 95%CI, 10.6-13.4 vs. 5.0 months; 95%CI, 3.4-6.6; P = .029), with a tendency towards longer overall survival (OS) (mOS: 15 months; 95%CI, 13.5-16.5 vs. 13 months; 95%CI: 11.3-14.7; P = .087).ConclusionsImplementation of liquid biopsy testing is feasible in a US community practice and impacts therapeutic choices in patients with advanced malignancies. Receipt of liquid biopsy-generated signal-matched therapies conferred added survival benefits.

Utilization of next generation sequencing (NGS) in stage IV gastrointestinal (GI) cancer patients (pts) and efficacy of electronic reminder notification (ERN) in improving utilization of NGS in the private practice community-based setting.

73 Background: NGS testing allows for identification of genetic mutations/alterations that can be important in determining treatment options for advanced cancer pts. The National Comprehensive Cancer Network (NCCN) includes NGS testing as part of standard of care for many tumor types including stage IV pancreatic cancer, colon cancer, and rectal cancer and all other GI solid tumor types. Previous reports have described the utilization of NGS in clinical practice at academic centers. To our knowledge this is the first report in the private practice setting. Methods: For the historical portion, we established baseline data to quantify NGS testing frequency in stage IV GI tumor pts in our community based oncology practice by performing a retrospective chart review. In the prospective portion, the intervention of an ERN was used to alert treating physicians if NGS had not been done. Primary endpoint is the percent (%) of pts with NGS sent compared to historical control. Secondary endpoint is the % of pts with targeted therapy options made available to them. Results: In a private practice multi-office setting, 200 charts of pts with stage IV GI cancer using Flatiron’s OncoEMR software were reviewed for the retrospective cohort between July 1 to December 31, 2020. Of the 200, 44.5% (89 pts) had colon cancer, 17.5% (35 pts) had pancreatic cancer, 15% (30 pts) had rectal cancer, and 23% (46 pts) had other types of GI cancer. Of these, 87 (43.5%) pts had NGS testing; of which 41 of 89 (46.0%) are colon pts, 13 of 35 (37.1%) are pancreatic pts and 16 of 30 (53.3%) are rectal pts. For the prospective portion, between July 1 and August 15, 2021 each physician’s schedule was evaluated and an ERN was sent shortly before each Stage IV GI pt was to be seen. A total of 114 pts were reviewed, and 92 (79%) had NGS sent. Of these, 47 pts of 54 (87%) are colon pts, 12 of 15 (80%) are pancreatic pts, 16 of 21(76%) are rectal pts, and 17 of 24 (70%) are pts with other GI cancer. 2% of pts with NGS testing had a potentially actionable mutation identified. Conclusions: NGS testing is standard of care for pts with stage IV GI cancer that wish to pursue therapy. ERN was minimally helpful in increasing NGS testing. This may be in part due to the effect of the practice's emphasis on NGS testing, which increased its baseline prospective testing rate. Increased use of a team based approach in the office would be a key element to increasing compliance with the current workflow as well as use of pathways which embed the NGS testing into the treatment plan. A more robust EMR would also be vital in increasing NGS testing rates by the use of automatic reminders or order sets. Better support of the physician and use of multiple touch points is necessary until full automation is utilized for NGS testing.

Effect of a Community-Based Medical Oncology Depression Screening Program on Behavioral Health Referrals Among Patients With Breast Cancer

Implementation of guideline-recommended depression screening in medical oncology remains challenging. Evidence suggests that multicomponent care pathways with algorithm-based referral and management are effective, yet implementation of sustainable programs remains limited and implementation-science guided approaches are understudied. To evaluate the effectiveness of an implementation-strategy guided depression screening program for patients with breast cancer in a community setting. A pragmatic cluster randomized clinical trial conducted within Kaiser Permanente Southern California (KPSC). The trial included 6 medical centers and 1436 patients diagnosed with new primary breast cancer who had a consultation with medical oncology between October 1, 2017, through September 30, 2018. Patients were followed up through study end date of May 31, 2019. Six medical centers in Southern California participated and were randomized 1:1 to tailored implementation strategies (intervention, 3 sites, n = 744 patients) or education-only (control, 3 sites, n = 692 patients) groups. The program consisted of screening with the 9-item Patient Health Questionnaire (PHQ-9) and algorithm-based scoring and referral to behavioral health services based on low, moderate, or high score. Clinical teams at tailored intervention sites received program education, audit, and feedback of performance data and implementation facilitation, and clinical workflows were adapted to suit local context. Education-only controls sites received program education. The primary outcome was percent of eligible patients screened and referred (based on PHQ-9 score) at intervention vs control groups measured at the patient level. Secondary outcomes included outpatient health care utilization for behavioral health, primary care, oncology, urgent care, and emergency department. All 1436 eligible patients were randomized at the center level (mean age, 61.5 years; 99% women; 18% Asian, 17% Black, 26% Hispanic, and 37% White) and were followed up to the end of the study, insurance disenrollment, or death. Groups were similar in demographic and tumor characteristics. For the primary outcome, 7.9% (59 of 744) of patients at tailored sites were referred compared with 0.1% (1 of 692) at education-only sites (difference, 7.8%; 95% CI, 5.8%-9.8%). Referrals to a behavioral health clinician were completed by 44 of 59 patients treated at the intervention sites (75%) intervention sites vs 1 of 1 patient at the education-only sites (100%). In adjusted models patients at tailored sites had significantly fewer outpatient visits in medical oncology (rate ratio, 0.86; 95% CI, 0.86-0.89; P = .001), and no significant difference in utilization of primary care, urgent care, and emergency department visits. Among patients with breast cancer treated in community-based oncology practices, tailored strategies for implementation of routine depression screening compared with an education-only control group resulted in a greater proportion of referrals to behavioral care. Further research is needed to understand the clinical benefit and cost-effectiveness of this program. ClinicalTrials.gov Identifier: NCT02941614.