bluuebunny/crossref_metadata_2025 huggingface dataset:
Using community health advisors to increase lung cancer screening awareness in the Black Belt: A pilot study.
Authors: Niranjan Soumya J. , Opoku-Agyeman William , Bowman Tara , Hardy Claudia M. , Baskin Monica L. , Dransfield Mark T.
Published: September 2021

117

Background: Disease stage at the time of diagnosis is the most important determinant of prognosis for lung cancer. Despite demonstrated effectiveness of lung cancer screening (LCS) in reducing lung cancer mortality, early detection continues to elude populations with the highest risk for lung cancer death. Consistent with the national rate, current screening rate in Alabama is dismal at 4.2%. While public awareness of LCS may be a likely cause there are no studies that have thoroughly evaluated current knowledge of LCS within the Deep South. Therefore, we measured (LCS) knowledge before and after receiving education delivered by Community Health Advisors (CHAs) among high-risk individuals living in medically-underserved communities of Alabama and to determine impact of psychological, demographic, health status and cognitive factors on rate of lung cancer screening participation. Methods: Participants were recruited from one urban county and six rural Black Belt counties (characterized by poverty, rurality, unemployment, low educational attainment and disproportionate lack of access to health services).100 individuals (i) aged between 55 to 80 years (ii) Currently smoke or have quit within the past 15 years. (iii) Have at least a total of 30-pack-year smoking history were recruited. Knowledge scores to assess lung cancer knowledge were calculated. Paired t-test was used to assess pre and post knowledge score improvement. Screening for lung cancer was modeled as a function of predisposed factors (age, gender, insurance, education, fatalism, smoking status, and history of family lung cancer). Results: Average age was 62.94(SD = 6.28), mostly female (54%); mostly current smokers (53% ). Most participants (80.85%) reported no family history of cancer. Fatalism was low, with a majority of the participants disagreeing that a cancer diagnosis is pre-destined (67.7%) and that there are no treatments for lung cancer (88.66%). Overall, lung cancer knowledge increased significantly from baseline of 4.64(SD = 2.37) to 7.61(SD = 2.26). Of the 100 participants, only 23 underwent screening due to lack of access to primary care providers and reluctance of PCPs to provide referral to LCS. 65% of those who were screened reported family history of lung cancer. Regression analysis revealed no significant association between risk factors and the decision to get screened by participants. Conclusions: Our study demonstrates that while CHA delivered education initiatives increases lung cancer screening knowledge, there are significant structural barriers that prohibit effective utilization of LCS which needs to be addressed.
Prostate-specific antigen response among Black and non-Black patients with advanced prostate cancer treated with apalutamide in a urology setting.
Authors: Durkin Michael , Pilon Dominic , Rossi Carmine , Khilfeh Ibrahim , Kinkead Frederic , Wu Caterina , Ellis Lorie , Lefebvre Patrick
Published: September 2021

124

Background: Apalutamide (APA) is approved to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC) in the United States (US) but low enrollment of Black patients in clinical trials has led to limited clinical data about APA for this population. This study describes prostate-specific antigen (PSA) responses among Black and non-Black patients with nmCRPC or mCSPC treated with APA in a real-world community urology setting. Methods: Clinical data from 2/2018 to 3/2021 collected at 69 US urology practices were used to evaluate nmCRPC or mCSPC patients who received ≥1 APA prescription fill (index date). Baseline PSA was reported based with the most recent baseline PSA value and PSA doubling time (PSADT) in months (mo) was calculated in patients with at least 2 PSA tests before APA initiation. PSA response defined as the proportion of patients achieving either a reduction of 50% (PSA50) or 90% (PSA90) from baseline and was evaluated in patients with a PSA test result 8 weeks or later after initiating APA. Among patients with a response, the time from the index date to the response was also evaluated. Study results for Black and non-Black cohorts were summarized separately. Results: Data from 289 nmCRPC (19% Black) and 237 mCSPC (19% Black) patients were identified. Median baseline PSA, median baseline PSADT and post-index PSA responses are shown in Table. A PSA50 response was attained by numerically similar proportions of Black and non-Black patients with nmCRPC or mCSPC. A PSA90 response was observed in a numerically higher proportion of Black than non-Black nmCRPC patients. Median time to PSA50 and PSA90 was also similar between groups. Conclusions: This real-world study of nmCRPC and mCSPC patients demonstrates that PSA50 and PSA90 responses are achieved by high proportions of both Black and non-Black patients. Moreover, the PSA50 and PSA90 responses observed in this study are highly consistent with those observed in APA’s Phase 3 registrational trials for nmCRPC (SPARTAN)1 and for mCSPC (TITAN)2. References: 1Smith MR, et al. N Engl J Med. 2018;378:1408-1418. 2Chi KN, et al. N Engl J Med. 2019;381:13-24. Funding Source: Janssen Scientific Affairs, LLC.[Table: see text]
HPV vaccination and factors influencing vaccine uptake among people of Indian ancestry living in the United States.
Authors: Ratnasamy Philip , Chagpar Anees B.
Published: September 2021

126

Background: Despite HPV vaccine availability, approximately one-third of annual global cervical cancer deaths occur in India. This may be related to cultural norms that lead to vaccine hesitancy. We sought to determine whether people of Indian ancestry (POIA) who move to the US continue to have disproportionately lower HPV vaccination rates than the rest of the US population and factors that influence HPV vaccine uptake in this group. Methods: The National Health Interview Survey (NHIS) is the largest source of health information for Americans and is designed to be representative of the entire civilian non-institutionalized US population. We utilized the 2018 NHIS to compare HPV vaccine initiation and completion rates between POIA and the general US population and factors correlating with HPV vaccine uptake in this group. Results: There were 17,004 people, representing 185,065,802 in the population, who were between the ages of 18-64 and who responded to questions regarding racial ancestry and HPV vaccination. Of this cohort, 1.69% identified themselves as being of Indian ancestry. Compared to other racial groups, POIA had a significantly lower rate of HPV vaccination (8.18% vs. 12.16%, 14.70%, 16.07%, and 12.41%, in White, Black, Other Asian, and those of other/mixed ancestry, respectively, p = 0.003). However, of those who received one HPV shot there was no difference in vaccine series completion between racial groups (3.17% vs. 4.27%, 3.51%, 4.31%, and 5.04% for POIA vs. White, Black, Other Asian, and those of other/mixed ancestry, respectively, p = 0.465). Among POIA, younger individuals and those who were single were more likely to obtain HPV vaccination (vaccination rates of 38.12%, 6.45% and 1.79% for ages 18-25, 26-45, and 46-64, respectively, p = 0.018, and 29.53% vs. 3.11% for single vs. married, respectively, p = 0.006). All individuals who were vaccinated had some form of health insurance (p = 0.020). Those born in the US had a higher rate of vaccination than those who were not (p = 0.019); however, duration of residence in the US did not influence vaccination rates among POIA (p = 0.502). While high levels of English proficiency were associated with a higher vaccination rate (p = 0.029), education status was not correlated (p = 0.231). Interestingly, both male and female POIA had equivalent rates of vaccination (3.12% and 2.81%, respectively, p = 0.949). Conclusions: POIA are significantly less likely to receive HPV vaccination than the general US population but are equally likely to complete the vaccine series if initiated. Age, insurance status, being born in the US, English speaking proficiency, and marital status significantly influence HPV vaccine initiation among POIA. These data suggest that public health measures promoting HPV vaccination among POIA immigrants may significantly improve vaccination rates among this population.
Social determinants of health and the Barrio Advantage among Hispanics during the COVID-19 pandemic.
Authors: Lopetegui-Lia Nerea , Hundal Jasmin , Bade Katarina , Hsu Emily , Chhabra Jyoti , Serrano Oscar , Menendez Alvaro G.
Published: September 2021

133

Background: Institutional data confirmed that despite Hispanics having a higher morbidity related to COVID19, mortality and outcomes were more favorable compared to other ethnic counterparts. We decided to study the role of the Barrio Advantage (BA), living in ethnically similar communities leading to health advantage, by taking into account acculturation in our patients in hopes of identifying potential avenues to educate our population and minimize healthcare delivery gaps. Methods: A 15-item IRB-approved questionnaire was administered to cancer patients receiving care at participating cancer centers in English and Spanish. Multivariable analysis was performed using Chi Square test to determine associations between examined variables which included socio-demographic information, fears and attitudes related to COVID19. Results: A total of 251 surveys were analyzed. 43.4% were Hispanic with 72% of them listing Spanish and 28% English as their preferred language. Similar amount of English Speaking Hispanics (ESH) and Spanish Speaking Hispanics (SSH) had no personal or family exposure to COVID19 (66.7% and 59.5%, respectively). SSH have a lower degree of education (33% with at least some college, vs 53.3%). More SSH depend on government issued insurance or have no insurance at all (78.5% vs 63.3%). COVID19 has disproportionately worsened fears in SSH (Table). The Barrio Advantage effect was evidenced by the fact that SSH rely more on faith-based institutions or family/friends for emotional support and healthcare inquiries (22.8% vs 13.3%) although more ESH would do so in the case of food security (53.3% vs 41.8%). Comparison of fears to financial, personal and community health based on English proficiency. Conclusions: Financial, personal and community health concerns are deepened in Hispanics, particularly for SSH, potentially due to the lack of acculturation process. Understanding Hispanics and other underrepresented populations are far from monolithic. Loco-regional social determinants of health must be studied in an attempt minimize health disparities including those related to COVID19. The BA, English proficiency and the acculturation process should be considered when developing interventions aimed at decreasing negative outcomes in this dynamic population.[Table: see text]
Factors associated with palliative care utilization in advanced and metastatic renal cell carcinoma.
Authors: Patel Hiren V. , Sterling Joshua , Srivastava Arnav , Kim Sinae , Saraiya Biren , Mayer Tina M. , Kim Isaac Yi , Ghodoussipour Saum , Jang Thomas L. , Singer Eric A.
Published: September 2021

146

Background: Palliative care (PC) offers various benefits for patient with cancer that include, but are not limited to, decrease in disease-specific symptoms and improvement in functional status. Several oncological guidelines have adopted early integration of PC into oncologic care to improve quality of life among patients with advanced malignancies. However, PC utilization patterns and factors associated with its use in advanced renal cell carcinoma (RCC) remain poorly understood. Methods: Using the National Cancer Database (NCDB), we abstracted patients with Stage III and IV RCC from 2004-2014 and evaluated PC utilization amongst this cohort. Socioeconomic and clinical factors were compared for patient receiving and not receiving PC for advanced RCC. Multivariable logistic regression identified factors that were associated with receipt of PC among the overall cohort and treatment-based cohorts. Results: Among 20,122 and 42,014 patients with Stage III and IV RCC, 329 and 9,317 patients received PC, respectively. From 2004 to 2014, PC utilization was stable at ̃1% for Stage III RCC and minimally increased from 17% to 20% for Stage IV RCC. Multivariable analysis demonstrated that increased comorbidities, insurance status, higher education status, facility location, care at a comprehensive cancer program or integrated network, sarcomatoid histology, and prior treatments significantly increased likelihood of palliative care utilization. We uncover socioeconomic and clinical factors that are associated with receipt of palliative care use in a treatment-specific manner. Conclusions: While PC utilization has minimally increased for Stage IV RCC, there are several demographic, socioeconomic, and clinical factors that predict PC use, especially in a treatment-specific manner, among patients with advanced RCC. Taken together, this suggests the need for more equitable and systematic use of PC among patients with advanced RCC.
Building out lifelines for safety, trust, empowerment, and renewal: Development, feasibility, and acceptability of the BOLSTER intervention for patients with gynecologic cancers and their caregivers.
Authors: Pozzar Rachel A. , Enzinger Andrea Catherine , Orechia Meghan , Thompson Embree , Furey Ann , Fenton Anny THR , Poort Hanneke , Cooley Mary E. , Donovan Heidi AS , Braun Ilana , Dinardo Margaret , Demarsh Andrea , Wright Alexi A.
Published: September 2021

187

Background: Peritoneal carcinomatosis (PC) afflicts over half of women with advanced gynecologic (GYN) cancers. Patients with PC often require ostomies, gastric tubes, or catheters to palliate their symptoms, yet patients and caregivers report feeling unprepared to manage these devices at home. Our aims were to develop and assess the feasibility and acceptability of an intervention (BOLSTER) to support patients with GYN cancers and their caregivers after hospitalization for PC. Methods: We used the ADAPT-ITT approach to adapt components of the Standard Nursing Intervention Protocol for the target population. First, we assembled a team of stakeholders and topical experts to identify gaps in patient resources. Next, we developed patient- and family-centered educational materials. We augmented written materials with illustrations and produced short videos of patients and caregivers managing medical devices. We developed a protocolized manual for a baccalaureate-prepared nurse to provide care coordination, skills training, and symptom management education across several in-person or telehealth visits. We also created a smartphone application to assess patient-reported outcomes, deliver tailored educational content, and trigger clinical action between visits. Finally, we assessed the feasibility and acceptability of two iterations of BOLSTER in single-arm pilot studies of English-speaking adult patients hospitalized for PC and their caregivers. We defined feasibility as a ≥50% consent-to-approach ratio and acceptability as ≥70% of participants recommending BOLSTER. Results: Intervention characteristics during and the results of each single-arm pilot study are shown in Table. In the first single-arm pilot, 2/4 participants declined home visits, 2/4 wished BOLSTER were shorter, and 3/4 desired access to BOLSTER earlier in their disease course. For the second single-arm pilot, we expanded participant eligibility criteria, eliminated home visits, and reduced the duration of the intervention. Conclusions: BOLSTER is a technology-enhanced, nurse-led care management intervention that is feasible and acceptable to patients with GYN cancer-associated PC and their caregivers. A randomized controlled pilot study of BOLSTER represents a logical next step. Clinical trial information: NCT03367247. [Table: see text]
Implementing the cancer and aging research group (CARG) tool in the ambulatory oncology setting to drive informed treatment selection.
Authors: Mbewe Alexander , Pike Paula , Lewis Russell , Kortmansky Jeremy S. , Chiang Anne C. , Kanowitz Jane
Published: September 2021

209

Background: Smilow Cancer Hospital is a NCI designated cancer center in Connecticut that has built a network of 15 community-based oncology (CBO) clinics. Older patients present with unique clinical challenges including multiple comorbidities, decreased functional status, and cognitive impairment. ASCO Geriatric Oncology guidelines recommend completing both a comprehensive geriatric assessment and a chemotherapy toxicity risk assessment on all oncology patients ≥65 years old for informed treatment selection. The CARG calculator is a simple, validated tool to assess chemotherapy toxicity risk in older patients with solid tumors. Despite ASCO guidelines, the existence of validated tools, and literature confirming improved patient outcomes, oncologists’ utilization of risk calculators is limited; therefore, we conducted a pilot CARG quality improvement initiative throughout our CBO network. Methods: 36 CBO physicians agreed to complete five CARG tools, document toxicity scores in the EMR, and complete a post-survey between March and June 2021. PDSA cycles included interventions of a hyperlink to the CARG tool incorporated in the EMR and creating a dot phrase built to simplify documentation. Education was provided on both the CARG and the survey. The survey captured perceived clinical value, time commitment, and barriers to implementation. Baseline data was collected during February 2021 and included geriatric patients receiving a new chemotherapy regimen for a solid tumor. Results: 180 consecutive new chemotherapy starts in geriatric patients were monitored. The CARG score utilization in new chemotherapy starts increased from 6.5% of new cases during the first month, to 26.4% in the third month. 82% of providers found the CARG score helpful in discussing chemotherapy risks with patients. In 32% of cases, the CARG score led to a decision to dose attenuate, and in 15% of cases, the CARG score led to a different treatment regimen. Most oncologists (65%) reported spending ≤5 minutes calculating toxicity, and 88% spent ≤10 minutes. 89% of oncologists reported the CARG score was worth the added time. Conclusions: This QI initiative demonstrates feasibility and increased use of the CARG geriatric chemotherapy toxicity tool in accordance with ASCO geriatric guideline-based care. Physician education and EMR workflow modification were utilized. In the CBO setting, oncologists found the CARG tool to be quick and helpful in discussing treatment risks with patients. Use of the CARG tool led to meaningful changes in treatment, including chemotherapy dose attenuation. Further study metrics such as palliative and supportive care referrals, ED visits, and hospitalizations will fuel sustainability.
Core elements for the implementation of primary care-based prostate cancer follow-up: A process evaluation of a randomized controlled trial.
Authors: Wollersheim Barbara M. , van Asselt Kristel M. , Akdemir Emine , Crouse Shifra , Pos Floris J. , van der Poel Henk G. , van de Poll-Franse Lonneke V , Boekhout Annelies H.
Published: September 2021

242

Background: To improve the quality and efficiency of prostate cancer survivorship care, a randomized controlled trial (RCT) is currently comparing the safety and effectiveness of specialist- (usual care) versus primary care-based (intervention) prostate cancer follow-up. This process evaluation assessed the reach and identified constructs for the implementation of primary care-based follow-up in a RCT setting. Methods: A mixed-methods approach was used through the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR). We used quantitative data to evaluate the reach of the RCT and qualitative data (interviews) to indicate the perspectives of patients, general practitioners (GPs) and specialists. Thematic analysis was used to analyze the interview transcripts. Results: In total, 569 patients with localized prostate cancer from 12 hospitals were invited to participate in the trial. 18 patients were not eligible, 145 patients declined (of whom most preferred follow-up in the hospital), whereas 21 GPs declined to participate. Finally, 385 patients were randomized to specialist- (n=192) or to primary care-based (n=193) follow-up. In addition, we interviewed 15 patients, 10 GPs and 8 specialists. Participants identified several advantages of primary care- versus specialist-based follow-up: it is closer to home, more accessible, the relationship is more personal, and the hospital can focus on patients undergoing active treatment. Nevertheless, participants also identified challenges: evidence-based guidelines should be implemented, communication and collaboration between primary and secondary care should be accessible and transparent, quality indicators (i.e. PSA levels) should be collected, and GPs expect compensation (money or extra capacity). Conclusions: If the RCT shows that primary care- is equally effective as specialist-based follow-up, this study could enable the transition of prostate cancer follow-up to primary care by presenting information on the reach of an RCT and by providing advantages and challenges of primary care-based prostate cancer follow-up.
Evaluation of direct oral anticoagulant use for cancer-associated venous thromboembolism (VTE) in lung cancer.
Authors: Rostamnjad Leila , Dagogo-Jack Ibiayi
Published: September 2021

243

Background: National Comprehensive Cancer Network recommends direct oral anticoagulants (DOACs) as preferred agents for treatment of cancer associated VTE in patients without gastric or gastroesophageal lesions. Currently at Massachusetts General hospital (MGH), DOACs are used in treatment of cancer associated VTE. This study was performed to evaluate the safety and efficacy of DOACs for treatment of VTE in patients with metastatic lung cancer. Methods: Retrospective chart review of patients at MGH with diagnosis of metastatic lung cancer who were prescribed edoxaban, rivaroxaban, or apixaban for treatment of VTE between January 2018 and January 2021 was performed. Patients were identified using electronic medical record reports. Data was collected on age, anticoagulation regimen, intent of anticoagulation therapy, presence of brain metastasis, renal function, liver function and platelet counts. The primary outcome was to assess the incidence of treatment failure, defined as VTE recurrence or major bleeding leading to a change in anticoagulation therapy. Results: 152 patients were evaluated, of which 57 received apixaban, 44 rivaroxaban, and 7 edoxaban. Most (n = 93) patients received enoxaparin for 14-90 days prior to transitioning to DOACs. Median age and creatinine clearance were 69 years and 63 mL/min, respectively. All patients had platelet count ≥ 50K/uL. Brain metastasis was present in n = 39 patients. Pulmonary embolism (PE)(n = 98), deep vein thrombosis (DVT) (n = 52), or both (n = 2) were the indication for DOAC therapy. Bleeding occurred in 14 patients including gastrointestinal bleeding (n = 5), hematuria (n = 4), epistaxis (n = 1), and hemoptysis (n = 4). Among patients with bleeding events, 7 received rivaroxaban and 7 received apixaban. Major recurrent VTE while on DOACs occurred in 5 of patients, including DVT (n = 2) and PE (n = 3). Patients with recurrent VTE received rivaroxaban (n = 7), apixaban (n = 3) and edoxaban (n = 1). All patient whom experienced bleeding and VTE were ≥ 60 years old. Brain metastasis was present in n = 2 of patients with bleeding events and n = 2 patients with recurrent VTE. Majority of patients (n = 93) received enoxaparin for 14-90 days prior to transitioning to DOACs. The median interval between initiation of DOACs and bleeding was 60 days (range 30-365) and recurrent VTE event was 90 days (range 60‐365). Conclusions: The results of this study suggest that outcomes of DOAC use for the treatment of cancer-associated VTE in patients with metastatic lung cancer are comparable to the results of large randomized controlled trials. DOAC therapy is a safe and effective anticoagulation option for lung cancer patients with cancer-associated thromboembolism.
Development of patient reported outcomes-based machine learning algorithm for the six-month mortality prediction in patients with advanced cancer.
Authors: Subbiah Ishwaria Mohan , Xu Cai , Lu Sheng-Chieh , Haider Ali , Azhar Ahsan , Swan Amy E , Amaram-Davila Jaya Sheela , Tang Michael J , Heung Yvonne , Shih Kaoswi Karina , Bruera Eduardo , Sidey-Gibbons Chris
Published: September 2021

273

Background: To date, studies of machine learning (ML) algorithms within oncology for mortality prediction have focused on structured electronic health record (EHR) data. Given the complex symptom burden of patients with advanced cancers, ML models may be better suited to identify patterns and interactions between symptom burden and outcomes compared to traditional statistical methods. To that end, in this study, we leverage the patient reported outcomes (PRO) data together with clinical EHR-based variables to assess the performance of ML algorithms to predict mortality in patients with advanced cancers. Methods: We randomly selected 689 patients with advanced cancer who had their first Palliative Care encounter between January 2012 and December 2017. 59 patients were lost to follow-up and were excluded from this analysis. The remaining cohort of 630 patients was split 4:1 randomly into a training and validation set to develop and test a supervised ML algorithm (Extreme Gradient Boosting [XGB] tree) to predict the 6-month mortality. Candidate variables for algorithm development included gender, age, ECOG performance status (PS), number of prior systemic therapies, and scores on the Edmonton Symptom Assessment System (ESAS)-FS, a 12-item PRO measure of physical and psychosocial symptom burden include the composite Physical Symptom Score (PHS), a sum of the physical ESAS symptoms (pain, fatigue, nausea, drowsiness, shortness of breath, appetite, wellbeing, sleep). Results: Overall, 630 patients were included in this 6-month mortality prediction; mean age 59 years, 354 (56%) female; 276 (44%) male. Variables with the most significant impact on the XGB tree mortality prediction were the ESAS symptoms of shortness of breath (1-AUC, 0.295), appetite, ESAS PHS, financial distress, age, and appetite as well as ECOG PS and number of prior systemic therapies. The XGB tree algorithm demonstrated the best overall prediction performance of 6-month mortality in the independent testing set, AUC 0.716 (95% CI 0.63 - 0.81), sensitivity 0.75 (95% CI 0.66 - 0.87), and a positive predictive value 0.67 (95% CI 0.57 - 0.79). Conclusions: Our ML model leveraged PRO-based assessment of symptom burden to correctly identify the majority of patients who died within 6 months. These models are uniquely positioned to not only automatically identify patients at high risk for short-term mortality but also the specific symptoms of concern for clinical intervention. Such models can be applied to available clinical and PRO data to facilitate clinical decision-making. Futures studies on improving model performance with the inclusion of interventions to modify symptom burden are in design.
Development of a breast cancer-specific prognostic tool using CancerLinQ Discovery.
Authors: Ray Emily Miller , Zhang Xinyi , Dunham Lisette , Tan Xianming , Lafata Jennifer Elston , Reeder-Hayes Katherine Elizabeth
Published: September 2021

275

Background: Oncologists often struggle to know which patients are near end of life to enable a timely transition to supportive care. We developed a breast cancer-specific prognostic tool, using electronic health record data from CancerLinQ Discovery (CLQD), to help identify patients at high risk of near-term death. We created multiple candidate models with varying thresholds for defining high risk that will be considered for future clinical use. Methods: We included patients with breast cancer diagnosed between 1/1/2000 to 6/1/2020 who had at least one encounter with vital signs and evidence of metastatic breast cancer (MBC). All encounters from 1/1/2000 to 7/5/2020 were included. We used multiple imputation (MI) to impute missing numeric variables and treated missing values as a new level for categorical variables. We sampled one encounter per patient and oversampled within 30 days of death, so that the event rate (death within 30 days of encounter) was about 10%. We randomly divided these patients into training (70%) and test datasets (30%). We evaluated candidate predictors of the event using logistic regression with forward variable selection. Candidate predictors included age, vital signs, laboratory values, performance status, pain score, time since chemotherapy, and ER/PR/HER2 receptor status, and change from baseline and change rate of numeric variables. We obtained a single final model by combining resulted logistic regression model from 10 MI training sets. We evaluated this final model on the MI test sets. We varied the alert threshold (i.e., high-risk proportion) from 5% to 40%. Results: We identified 9,270 patients, representing 586,801 encounters. Significant predictors of mortality were: increased age, decreased age at diagnosis, negative change in body mass index, low albumin, high ALP, high AST, high WBC, low sodium, high creatinine, worse performance status, low pulse oximetry, increased age with increased creatinine, high pain score with no opiates, increased pulse rate, unknown/missing PR, opiate use in past 3 months, and prior chemotherapy in past 1 year but not past 30 days. Candidate models had prediction accuracy of 70-89% and positive predictive value of 31-77%. Conclusions: Demographic and clinical variables can be used to predict risk of death within 30 days of a clinical encounter for patients with MBC. Next steps include selection of a preferred model for clinical use, balancing performance characteristics and acceptability, followed by implementation and evaluation of the prognostic tool in the clinic. Candidate models, varying by threshold or percentage of patients assumed to be at high risk, for the outcome of death within 30 days among patients with metastatic breast cancer.[Table: see text]
NGS testing patterns in advanced non-small cell lung cancer (aNSCLC) and metastatic breast cancer (mBC): OneOncology (OO) sites compared to Flatiron Health Nationwide (NAT).
Authors: Vanderwalde Ari M. , Ma Esprit , Yu Elaine , Szado Tania , Price Richard , Shah Anuj , Meyer Craig S. , Abbass Ibrahim M. , Grothey Axel , Staszewski Harry , Slater Dennis , Blakely L. Johnetta , Schwartzberg Lee S.
Published: September 2021

288

Background: Personalized treatment (tx) decisions can be improved through diagnostic tests with NGS by detecting different actionable mutations. OO, a research-focused network of community practices, has a network-wide precision oncology initiative and has advocated for NGS testing in advanced cancers since 2019. This study evaluated NGS testing patterns in aNSCLC and mBC populations descriptively in OO community sites and Flatiron Health NAT. Methods: This study used the Flatiron Health EHR derived de-identified database from [1] four OO sites, and [2] NAT. Patients (pts) diagnosed (Dx) with aNSCLC (stage ≥ IIIb) or mBC from 1/1/2015 to 5/31/2020, aged ≥ 18 years, had ≥ 1 visit ≤ 90 days (d) of advanced or metastatic Dx, and had ≥ 1 biomarker test were included. NAT NGS was confirmed via abstraction from patient records. Descriptive analyses were conducted to assess NGS testing patterns and pts characteristics by tumor type. Results: Of biomarker tested pts at OO vs. NAT (community:academic: 90%:10% aNSCLC; 93%:7% mBC), 2,029 of 3,152 (64%) OO vs. 13,681 of 29,572 (46%) NAT in aNSCLC and 514 of 1,282 (40%) OO vs. 2,458 of 12,175 (20%) NAT in mBC received NGS ± other tests. Testing rate of all 5 aNSCLC biomarkers (ALK, BRAF, EGFR, ROS-1, and KRAS) was higher with NGS vs. other tests for OO (87% vs. 6%) and NAT (87% vs. 11%). In mBC, a higher testing rate of BRCA with NGS vs. other tests (OO: 68% vs. 26%, NAT: 71% vs. 28%) and similar testing rate on HER2 (OO: 98% vs. 98%, NAT: 100% vs. 99%). Median time from Dx to NGS test result at OO vs. NAT was 33 d vs. 32 d in aNSCLC and 70 d vs. 188 d in mBC. NGS testing rates increased over time, with higher rates at OO vs. NAT [Table]. Pts with NGS vs. other tests were slightly younger in aNSCLC (OO: 68 y vs. 70 y, p = 0.001; NAT: 69 y vs. 70 yr, p < 0.001) and mBC (OO: 61 y vs. 67 y, p < 0.001; NAT: 61 y vs. 66 y, p < 0.001), and slightly more commercially insured in aNSCLC (OO: 48% vs. 45%, p = 0.3; NAT: 37% vs. 33%, p < 0.001) and mBC (OO: 54% vs. 48% OO, p = 0.053; NAT: 42 % vs. 36 %, p < 0.001). Conclusions: The adoption of NGS differed by cancer type and NGS testing rates have increased over time in aNSCLC and mBC. While some pts may have received testing outside of the Flatiron network, OO had a higher NGS uptake than NAT, and had a shorter time to testing in mBC that was possibly related to a network wide strategy recommending testing at Dx of advanced disease. Future studies on tx pattern after NGS testing are warranted to improve the actionability of NGS to foster personalized tx. [Table: see text]
Trends in use of one, two, and three-line NCCNcategory 1 regimens among Medicare fee-for-service (FFS) patients receiving treatment for metastatic pancreatic cancer.
Authors: Dieguez Gabriela , Tomicki Samantha , DeStephano David , Cockrum Paul
Published: September 2021

297

Background: There is limited research evaluating the share of patients (pts) with metastatic pancreatic cancer (m-PANC) treated according to NCCN guidelines. Methods: We identified pts with m-PANC using ICD-10 diagnosis codes in the 2016-2019 Medicare Parts A/B/D 100% Research Identifiable Files. Study pts had 2+ claims with a pancreatic cancer diagnosis and Medicare FFS coverage for 6 months pre- and 3 months post-metastatic disease diagnosis. A line of therapy (LOT) was assigned based on the order and number of therapies used. Pts with one, two, or three LOTs were defined as treated according to NCCN Category 1 guidelines if, in each LOT, pts used one of the following regimens: FOLFIRINOX (FFX), gemcitabine/nab-paclitaxel (gem/nab), gemcitabine + erlotinib, gemcitabine monotherapy, or 5-FU + leucovorin + liposomal irinotecan. Multi-drug LOTs were excluded from the analysis. Results: We identified 31,782 pts with m-PANC. 21,304 received one LOT, 7,352 received two LOTs, and 3,126 received three LOTs between 2016 and 2019. Among pts who received one or two LOTs, a higher portion were treated according to NCCN Category 1 guidelines in 2019 (72% and 43%, respectively) than in 2016 (64% and 33%, respectively). Among pts who received three LOTs, a higher portion were treated according to NCCN Category 1 guidelines in 2019 (17%) than in 2017 (12%); too few pts were treated in 2016 to make a comparison. From 2016 to 2019, FFX had the largest increase in share of pts receiving only one NCCN Category 1 LOT (11% to 27%) and gem-mono had the largest decrease (30% to 17%). Among pts receiving two NCCN Category 1 LOTs, gem/nab to liposomal irinotecan sequences had the largest increase in share of pts (18% to 32%) and gem/nab to FFX had the largest decrease (17% to 10%). Among pts receiving three NCCN Category 1 LOTs, patient share for FFX to gem/nab to Liposomal irinotecan was 35% in 2019, while gem/nab to FFX to Liposomal was 8%; pt counts in earlier years were too small to calculate patient share. Conclusions: The use of NCCN Category 1 therapies increased consistently from 2016 to 2019 among pts that received one, two, and three lines of therapy. FFX drove increases in NCCN Category 1 utilization among patients receiving one line of therapy, and gem/nab to liposomal irinotecan sequences were the primary drivers of the increase among patients receiving two lines of therapy. FFX to gem/nab to liposomal irinotecan was the primary driver of increase among patients receiving three lines of therapy.
Real-world outcomes in patients with metastatic renal cell carcinoma treated with first-line nivolumab plus ipilimumab.
Authors: Doshi Gurjyot K. , Robert Nicholas J. , Chen Liwei , Chan Philip K , Del Tejo Viviana , Stwalley Brian , Huo Stephen , Geynisman Daniel M.
Published: September 2021

305

Background: Nivolumab plus ipilimumab (NIVO+IPI), a first-in-class combination immunotherapy, was approved by the US Food and Drug Administration in April 2018 for the treatment of intermediate- or poor-risk advanced renal cell carcinoma (RCC), and the treatment paradigm has changed dramatically over the past few years. This real-world study examined treatment patterns and sequences, treatment response, safety, and survival outcomes with this novel first-line (1L) combination therapy among patients diagnosed with metastatic RCC (mRCC) in a community oncology practice setting. Methods: A retrospective analysis of the US Oncology Network’s iKnowMed medical data examined adult patients with an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognosis of intermediate- or poor-risk clear cell mRCC who received 1L NIVO+IPI between April 1, 2018, and March 31, 2020. Baseline demographic and clinical characteristics, treatment patterns, and treatment sequence were examined descriptively. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), time to treatment discontinuation (TTD), and time to treatment response (TTR) were analyzed using the Kaplan–Meier method. Treatment-related adverse events (TRAEs) and healthcare resource utilization were also analyzed. Results: A total of 193 adults with stage IV mRCC treated with 1L NIVO+IPI were identified. Median age (range) was 63 (30.0–89.0) years, 73.1% were male, 69.4% were white, 56.7% were IMDC intermediate risk, and 60.6% had a documented Eastern Cooperative Oncology Group performance status of 0 or 1. Median follow-up time (range) was 9.7 (0.1–24.7) months. Median PFS (95% CI) was 17.1 (12.6–21.2) months, and the 1-year landmark PFS rate was 58.3% (50.4–65.4). At 12 months, the OS rate (95% CI) was 75.4% (67.8–81.4). The ORR (95% CI) was 43.2% (34.6–52.1) among patients with a response assessment; the median TTR (range) was 2.8 (0.3–4.1) months and median DoR was not reached. Median TTD (95% CI) was 5.8 (4.5–7.5) months. Among the 63 (31.3%) patients who received second-line therapy, 50.8% received cabozantinib and 12.7% received pazopanib. TRAEs were reported in 47.2% of patients—the most frequently reported were fatigue (13.5%), rash (10.4%), diarrhea (6.7%), nausea (6.2%), colitis (3.6%), and pruritus (3.6%). The treatment-related hospitalization rate was 5.5% and the emergency department visit rate was 3.1%. Conclusions: This real-world study supports the clinical efficacy of 1L NIVO+IPI for patients with mRCC. Our findings also suggest that the NIVO+IPI combination was generally well tolerated in the real-world setting, with low rates of adverse events and healthcare resource utilization.
Association of primary prophylactic (PP) granulocyte-colony stimulating factor (G-CSF) use with chemotherapy dose modifications and relative dose intensity (RDI) among breast cancer patients receiving high-risk regimens for febrile neutropenia (FN).
Authors: Shaw Jaime , Schenfeld Jennifer , Balasubramanian Akhila , Jaramillo Renee , Sandschafer Darcie , Kelsh Michael Anthony , Mahtani Reshma L.
Published: September 2021

314

Background: FN is a primary driver of chemotherapy modification and reduced RDI. Breast cancer patients often receive regimens with high risk ( > 20%) for FN. PP G-CSF use is recommended to decrease incidence of infection, as manifested by FN. Real-world evidence describing the association of G-CSF with reduced RDI in breast cancer patients is lacking. Methods: We retrospectively analyzed Flatiron Health Electronic Health Record data from 2011 to 2019 of adult female breast cancer patients initiating high-risk for FN chemotherapy regimens. PP G-CSF (pegfilgrastim, filgrastim, or biosimilars) use was assessed in the first and subsequent cycles of chemotherapy overall and by modality (on-body injector [OBI] vs. pre-filled syringe [PFS]). Standard dose was defined by NCCN guidelines. RDI was defined with respect to dose and timing of delivery: (delivered dose intensity/standard dose intensity)*100 and categorized as < 85% vs ≥85%. Characteristics were described by G-CSF use and adjusted relative risks (ARRs) were estimated for the association between G-CSF use and RDI, adjusting for age, serum hemoglobin, ECOG, HER2 status, and HR status. Results: There were 27,812 breast cancer patients included with a median age of 57 years. Most (90%) received PP-G-CSF. Four cycles of TC (docetaxel + cyclophosphamide) was the most common regimen prescribed (36%) and 82% of these patients received PP-G-CSF support in the first cycle, with OBI given more often than PFS (62% vs 38%). Second most common was dd AC-T Q1W (doxorubicin + cyclophosphamide followed by paclitaxel) and 98% of these patients received PP G-CSF (59% OBI vs 41% PFS). 80% of G-CSF users (vs 48% of those with no G-CSF) completed 4 or more cycles of chemotherapy (all regimens had ≥4 planned cycles). G-CSF users had a significant reduction in risk of RDI < 85% in Cycle 1 (ARR: 0.60; 95% confidence interval [CI]: 0.43 – 0.85) and Cycle 2 (ARR: 0.76; 95% CI: 0.59 – 0.97). At the overall chemotherapy course level, the risk of RDI < 85% was not significantly different by G-CSF use (ARR: 0.83; 95% CI: 0.63 - 1.08). There was no significant difference in risk of reduced RDI between OBI and PFS (ARR: 1.13; 95% CI: 0.94 - 1.35). Conclusions: This study revealed that 90% of breast cancer patients receiving high-risk for FN chemotherapy received PP-G-CSF support and completed more cycles than those who did not receive G-CSF. G-CSF users had lower risk of a reduced RDI in Cycles 1 and 2.
Implementation of “Epic Healthy Planet” registry for survivorship care coordination.
Authors: Kinahan Karen , Desai Bijal , Volpentesta Michele , Klein Margo , Duffy Melissa , Garcia Sofia F. , Kircher Sheetal Mehta
Published: September 2021

337

Background: The evolving Commission on Cancer (CoC) reporting mandate and institution’s growing survivorship program led to identifying the need for systematic tracking of survivorship patients, surveillance tests, return appointments and referrals placed. Our aim was to develop an electronic medical record (EMR) integrated registry utilizing discrete data fields to assist our team in tracking key elements of high-quality survivorship care. Methods: Stakeholders from our survivorship team (APP/RN), medical oncology, psychology, research, operations and IT analytics reached consensus on essential discrete EMR fields to be included in the registry. For implementation we utilized the EPIC module, “Healthy Planet”, where patients enter the registry by initiating an “Episode of Care” at their initial survivorship visit. SmartForm fields create unique discrete patient data points identified by the stakeholders. Results: The following domains were identified as important elements of care that require tracking in a dedicated survivorship program. The registry domains populate from two sources: 1) currently existing EMR data fields, 2) domains with no currently discrete data (e.g. lymphedema, peripheral neuropathy) were captured in the developed SmartForm (see Table). From January 1, 2019 to June 1, 2021, 778 patients were entered into the registry. Since September 4, 2020, 112 patient follow-up appointment reminders were sent via EMR which has led to a noticeable increase in return appointments. SmartForm data fields are being amended as additional malignancy types are added to our survivorship program. Conclusions: The utilization of Healthy Planet is an effective and user-friendly way to track survivorship return appointments, remind providers of diagnostic tests that are due, and track referrals for CoC reporting. As the numbers of cancer survivors continues to increase, systematic population management tools are essential to ensure adherence to survivorship guideline recommendations, follow-up care and mandatory reporting.[Table: see text]
Oncologists’ perspectives on omission of sentinel lymph node biopsy in women >70 years with early-stage hormone receptor-positive breast cancer.
Authors: Minami Christina Ahn , Bryan Ava F. , Revette Anna C. , Freedman Rachel A. , King Tari A. , Mittendorf Elizabeth A.
Published: September 2021

48

Background: Trial data show that omission of surgical axillary staging does not affect overall survival in women >70 with cT1N0 hormone receptor-positive (HR+) breast cancer, and the Society of Surgical Oncology’s Choosing Wisely recommendations advise against routine use of sentinel lymph node biopsy (SLNB) in patients with early-stage HR+ cancers. Despite this, almost 80% of women eligible for omission still undergo SLNB. We sought to explore oncologists’ perspectives of omission of SLNB in this patient population. Methods: We conducted an exploratory qualitative study using semi-structured telephone interviews with surgical, medical, and radiation breast oncologists throughout North America from 3/2020 to 1/2021. Purposive snowball sampling ensured a range of practice types. Interviews were transcribed and a team trained in qualitative analysis undertook thematic analysis guided by grounded theory to identify emergent themes. Results: Participants included sixteen surgical, six medical, and seven radiation oncologists (55% female) (Table). Overall, while oncologists in all fields expressed acceptance regarding SLNB omission in certain women >70 with cT1N0 HR+ disease, many viewed it as a complex choice based on patient comorbidities, chronologic age, patient preferences, and disease factors. Although patients’ physiologic age and life expectancy were also important decisional factors, almost all participants assessed these subjectively despite knowing that validated tools existed. Most surgeons perceived the data backing the Choosing Wisely recommendation as weak, although knowledge of specific supporting studies was low. While all participants agreed that SLNB omission does not affect survival, several radiation oncologists expressed anxiety about resultant increased regional recurrence risk. In the absence of known nodal status, medical and radiation oncologists stated they were more likely to order additional imaging, rely on OncotypeDX scores to make systemic therapy decisions, add high tangents, and be reluctant to offer partial breast irradiation. Conclusions: While surgeons are aware of the Choosing Wisely recommendation, high SLNB rates in patients eligible for omission may be driven by perceptions of the quality of the supporting data and differing ideas regarding appropriate candidacy for omission. There are downstream effects of SLNB omission on medical and radiation oncology treatment decision making and surgeons should engage in multidisciplinary discussion prior to surgery.[Table: see text]