bluuebunny/crossref_metadata_2025 huggingface dataset:
A retrospective look: Industry partnership and transparency in phase III randomized clinical trials of breast cancer targeted therapies across two decades.
Authors: Ruan Qiao , Mann-Grewal Amandeep Kaur , Johnson Caitlin Ruth , Behler Caroline , Kapp Daniel Stuart , Chan John K
Published: May 2024

580

Background: To unveil industry involvement with respect to sponsorship, authorship, and demographic shifts in the trends of randomized clinical trials for breast cancer targeted therapies over the past two decades. Methods: All randomized phase III clinical trials focusing on targeted therapies for breast cancer were systematically identified from clinicaltrials.gov and reviewed using peer-reviewed publications. Trials that focused solely on chemotherapy and hormonal therapy were excluded. SAS Enterprise Guide v7.1 was used to analyze trial characteristics, authorship, and demographic details with Chi-square and Fisher’s exact tests. Results: From 2005-2023, 998 breast cancer treatment clinical trials were identified; 110 trials were included in the final analysis. Overall, 8.2% were limited to the U.S. and Canada while 67.3% were carried out internationally. 34.5% were led by cooperative (Co-op) groups vs 65.5% by pharmaceutical industries. 19.1% of trials were published in the New England Journal of Medicine (NEJM); all NEJM published trials reported positive results and 76.2% of were industry led. In contrast, of the 4.5% of trials featured in The Lancet, only 60% showed positive findings and 60% had major industry sponsorship. The most common industry partnerships were with Roche (27.3%), Novartis (12.7%), and Pfizer (7.3%) while the most common leading Co-op group was the National Cancer Institute (7.3%). To evaluate trends, trials were split into 3 time periods based on publication dates: 2005-2011, 2012-2017, and 2018-2023. The number of trial publications increased from 13 to 43 to 54. Of the 70% of trials that reported race/ethnicity data, the proportion of White patients decreased (84.5%, 78.8%, 79.3%; p<0.001) and the proportion of Asian patients increased (8.9%, 18.4%, 16.7%; p<0.001). However, enrollment of Black (6.6%, 2.8%, 4.0%; p<0.001) and Hispanic (7.0%, 2.8%, 5.0%; p<0.001) patients remained low. There were no statistically significant changes in international participation (46.2%, 69.8%, 70.4%; p=0.22), the proportion of exclusively industry-led (46.2%, 74.4%, 63.0%; p=0.15) or Co-op group-designed trials (61.5%, 35.7%, 26.4%; p=0.10). Industry-involved data collection increased from 23.1% to 64.2% to 73.6% (p=0.01) while industry sponsored data analysis (38.5%, 61.9%, 66.0%; p=0.49) and manuscript drafting (38.5%, 66.7%, 71.7%; p=0.09) did not significantly change. Conclusions: Over time, there was a notable rise in the number of phase III clinical trials for breast cancer targeted therapies. More than 70% of these trials now engage in international collaboration. Despite this progress, there remains an underrepresentation of Black and Hispanic participants in trial enrollment. Today, nearly 70% of trials have major industry sponsorship in study design, data analysis, and manuscript preparation.
Comparing 18F-FDG positron emission tomography (PET) and breast magnetic resonance imaging (MRI) to predict pathological complete response (pCR) and 3-year invasive disease-free survival (3-y iDFS) in patients (pts) with HER2+ early breast cancer (EBC): An unplanned exploratory analysis of PHERGain trial.
Authors: Pérez García José Manuel , Cortes Javier , Ruiz-Borrego Manuel , Stradella Agostina , Bermejo Begoña , Escrivá-de-Romaní Santiago , Calvo Lourdes , Gebhart Geraldine , Kerrou Khaldoun , García-Mosquera Juan José , Gion Maria , Antonarelli Gabriele , López-Montero Laura , Rodríguez-Morató José , Mina Leonardo , Sampayo-Cordero Miguel , Llombart-Cussac Antonio
Published: May 2024

586

Background: The PHERGain phase II trial (1) (NCT03161353) demonstrated the feasibility of chemotherapy (CT)-free treatment using a PET-based, pCR-adapted strategy in HER2+ EBC pts treated with dual HER2 blockade (trastuzumab pertuzumab; HP). Due to limited PET availability, breast MRI is warranted as an alternative tool for assessing early treatment response. Methods: Briefly, group B pts in PHERGain were initially treated with HP, and CT was subsequently introduced according to on-treatment PET results. Adjuvant therapy was determined based on prior neoadjuvant treatment (NAT) and pCR. All pts completed up to 18 HP cycles. PET and MRI were performed before randomization and after 2 treatment cycles, with an additional MRI performed before surgery. PET response was centrally assessed per EORTC criteria. Locally assessed MRI response was defined as a ≥30% decrease in the sum of diameters of the target lesions. MRI reduction was defined ad hoc as any shrinkage in the diameter of target lesions after 2 cycles without new lesions or progressive disease in non-target lesions. Results: After 2 HP cycles, 79.6% (227/285) of group B pts were PET responders, 47% (134/285) had an MRI response, and 82.5% (235/285) achieved an MRI reduction. A high association was observed between PET response and MRI reduction. Similar rates of pCR and 3-y iDFS were observed between pts with a PET response or an MRI reduction. PET-nonresponders without MRI reduction had the worst 3-y iDFS despite receiving standard NAT with CT and HP (Table). Conclusions: The complex design of this study does not allow a direct comparison between PET and MRI. Although PET is the recommended imaging technique for early treatment response, these data suggest that MRI-assessed tumor shrinkage could alternatively guide NAT after the first 2 HP cycles in HER2+ EBC pts following the PHERGain strategy when PET is not available. 1. Pérez-García JM, Lancet Oncol 2021. Clinical trial information: NCT03161353 . [Table: see text]
Impact of extent of disease at presentation on oncologic outcomes according to pathologic response to neoadjuvant systemic therapy among participants of the I-SPY2 clinical trial.
Authors: Leon-Ferre Roberto Antonio , Dimitroff Katrina , Yau Christina , Giridhar Karthik , Mukhtar Rita A. , Hirst Gillian L. , Hylton Nola , Symmans W. Fraser Fraser , Goetz Matthew P. , Esserman Laura , Boughey Judy Caroline
Published: May 2024

594

Background: Recent analyses in HER2+ and triple negative (TN) breast cancer (BC) treated with neoadjuvant systemic therapy (NAST) suggest that extent of disease at presentation (tumor [T] size and nodal [N] involvement) influences outcomes independently of response to NAST, even in the context of pathologic complete response (pCR). Given this, we evaluated the association of clinical T and N status prior to NAST with long-term outcomes in I-SPY2. Methods: We identified patients (pts) with TN and HER2+ BC who received NAST on the I-SPY2 trial with available clinical T size and N status prior to NAST, pathologic response after NAST, and follow up for recurrence and survival. We conducted univariable and multivariable (MV) Cox proportional models for Event Free (EFS), Distant Recurrence Free (DRFS), and Overall Survival (OS) in TN and HER2+ BC according to response after NAST, adjusting for residual cancer burden (RCB) category. Results: Of 1,170 pts with TN or HER2+ BC, 1,013 were eligible (TN: 623 and HER2+: 390), after 157 pts were excluded due to missing critical variables. Median follow up was 4.4 years (range 0.3-10.2). Median age was 48 for TN and 49 for HER2+ BC. Following NAST, pCR was achieved in 277 (45%) pts with TN and 197 (51%) pts with HER2+ BC. Among pts with pCR, separate MV analyses for TN and HER2+ BC showed no independent association between clinical T and N category with EFS, DRFS or OS (p values all > 0.05). However, among pts with residual disease, clinical T category (but not clinical N status) prior to NAST retained independent prognostic information in both TN and HER2+ BC in a MV model adjusting for age, RCB class, and hormone receptor status (for HER2+ BC). Compared to cT1-2, cT3-4 stage at diagnosis was associated with worse EFS, DRFS, and OS in TNBC, and with worse EFS, DRFS (but not OS) in HER2+ BC (Table). Additionally, hormone receptor status was independently associated with outcomes in HER2+ BC with residual disease (data not shown). The 5y EFS for cT1-2 vs cT3-4 according to RCB class in TNBC were: RCB0: 94% vs 95%, RCB1: 90% vs 65%, RCB2: 74% vs 44% and RCB3: 45% vs 20%. The 5y EFS for cT1-2 vs cT3-4 according to RCB class in HER2+ were: RCB0: 95% vs 88%, RCB1: 89% vs 84%, RCB2: 85% vs 64% and RCB3: 56% vs 50%. Conclusions: Tumor size (but not N involvement) prior to NAST was independently associated with outcomes in TN and HER2+ BC with residual disease, independently of RCB class. TN and HER2+ BC achieving pCR exhibited favorable outcomes regardless of extent of disease prior to NAST. These data are consistent with prior findings of the Neobioscore contributing only in the context of residual disease. Clinical trial information: NCT01042379 . [Table: see text]
Risk of VTE in TNBC treated with neoadjuvant immunotherapy.
Authors: Farooqui Ayesha , Kao Jeremy , Farooqui Marwah Wafa , Danciu Oana Cristina
Published: May 2024

e12658

Background: Triple-negative breast cancer (TNBC) has limited treatment options. KEYNOTE 522 led to the approval of neoadjuvant (NT) Pembrolizumab in July 2021 changing the treatment paradigm for early stage TNBC. While improving pathologic complete response it also slightly increased treatment related adverse events. Some studies show increased risk of venous thromboembolism (VTE) with Pembrolizumab; however, it is unclear if immunotherapy (IO) increases the risk of VTE in a NT setting. Breast cancer is not classically associated with high risk for VTE. Here, we assess the incidence of VTE in TNBC patients receiving NT Pembrolizumab. Methods: All women diagnosed with TNBC and treated with NT Pembrolizumab between August 2021-December 2023 (t = 29 months) at our institution were included (N = 26). Stage 4 disease at time of diagnosis was excluded. The study endpoint was the development of VTE at any time following the initiation of Pembrolizumab as identified by CT chest angiography or venous duplex ultrasound. Risk factors and protective factors for VTE including body mass index, prior VTE, concurrent chest port, illicit drug use, smoking, hypertension, diabetes, kidney disease, hyperlipidemia, and prior antiplatelet/anticoagulant use were assessed for each patient. Results: In our study population, 1 patient developed VTE following initiation of Pembrolizumab (3.8%). This patient developed a pulmonary embolism 13 days after the 2nd dose of Pembrolizumab (179 days after 1st dose). Risk factors for this patient were obesity (BMI = 52.9), concurrent chest port, and hypertension. Protective factors included no prior history of VTE, illicit drug use, smoking, diabetes, kidney disease, or hyperlipidemia. A comparison of the risk factors is summarized (Table). Conclusions: The cumulative VTE incidence for all immune therapies is reported as 7-10% in the 1st year. Patients with breast cancer have a 6% incidence of VTE in the 1st year. This rate does not account for cancer subtype, stage, or treatment type. Our exploratory study is novel in looking at incidence of VTE in the NT immunotherapy use setting. These results suggest a lower incidence compared to the cumulative studies previously mentioned. There is a possible synergistic interaction between Pembrolizumab therapy and other traditional risk factors in the development of VTE in TNBC. Further analysis will seek to stratify the individual risk of Pembrolizumab in VTE compared to other risk factors. Future work will include expanding our study population to additional solid tumors utilizing NT Pembrolizumab including melanoma and non-small cell lung carcinoma. Once risk is definitively established, it will be important to take measures to mitigate the risks to improve cancer related outcomes. [Table: see text]
Comparative analysis of Keynote522 treatment outcomes in Hispanic versus non-Hispanic patients with breast cancer: A single tertiary center experience.
Authors: Banwait Ranjit Singh , Shaker Sarah , Sharma Aditi , Parekh Jay , Mazo- Canola Marcela
Published: May 2024

e12661

Background: The addition of pembrolizumab to neoadjuvant chemotherapy on the Keynote522 (KN522) clinical trial, changed the standard of care for early stage triple negative breast cancer (TNBC). This regimen demonstrated longer event free survival and higher percentage of patients with pathologic complete responses (pCR). However, limited data exist on the comparative outcomes between Hispanic and non-Hispanic patients in real-world settings as this patient population was likely underrepresented on the original trial. Methods: We conducted a retrospective analysis of patients with early stage TNBC treated on KN522 regimen and undergoing surgery at a single tertiary center from July 2021 to present. Patients were stratified into Hispanic and non-Hispanic ethnicity cohorts. The primary endpoint was pCR rate, and secondary endpoints was incidence of adverse effects (AEs). Results: Among a cohort of 41 patients identified, 26 (63%) were of Hispanic and 15 (37%) were non-Hispanic. The pCR rate was 50% among Hispanic and 53% among non-Hispanic patients (p=0.83). Hispanic patients experienced higher rates of anemia (88% vs. 67%, p=0.06), fatigue (85% vs. 60%, p=0.07), skin rash (46% vs. 27%, p=0.21), and endocrine toxicities (23% vs. 13%, p=0.21). However, Hispanic patient also had fewer hospitalizations (35% vs. 47%, p=0.44), dose-modifications (12% vs. 40%, p=0.53), dose omissions (19% vs. 33%, p=0.31), and showed higher KN522 completion rates (81% vs. 53%, p=0.06). Conclusions: Our findings indicate a comparable pCR rate between Hispanic and non-Hispanic patients with early-stage TNBC receiving KN522 therapy. While Hispanic patients exhibited higher incidences of certain adverse effects, they demonstrated lower rates of hospitalizations, dose modifications, and omissions, alongside a notably higher completion rate of the KN522 regimen. These trends may be attributed to various factors such as genetic predispositions, and potentially differential physiological responses to therapy within this ethnic group. These findings underscore the importance of including minorities, such as Hispanic patients, in clinical trial populations to ensure that treatment outcomes are representative of diverse patient demographics. [Table: see text]
Bridging gaps with navigator support and its influence on breast cancer clinical trial matching and accessibility.
Authors: Mayhew Sabrina , Horton Sara L. , Esserman Laura , Patel Leeza , Colen Susan
Published: May 2024

e13509

Background: Breast cancer patients face challenges navigating clinical trials. Online trial matching platforms like BreastCancerTrials.org (BCT) and MetastaticTrialSearch (MTS) are important resources to assist patients in identifying suitable clinical trials. However, data collected from users shows a concerning underrepresentation of ethnic minorities using this technology. Acknowledging the need to address this inequality through personalized support, we have incorporated a Clinical Trial Navigator. The navigator has engaged in partnerships with diverse community organizations and is committed to offering continuous support to patients throughout their experience. Methods: We analyzed data from our online trial matching sites spanning the period 2009–2023 (BCT) and data from our new platform MTS covering the years 2018-2023. Users visiting these sites provided details about their breast cancer type and medical history to identify appropriate clinical trials. Demographic information including race, gender, and education level was collected. The utilization and effectiveness of these features in facilitating patient access to relevant clinical trials were evaluated. Results: Analysis of the data reveals information about the characteristics of patients actively using the BreastCancerTrials.org matching service. Although BCT and MTS strives to reach a diverse patient population, 87% of BCT users identified as white women, with African American users making up only 5%. Education level of all users was high with 73% stating a college degree or higher. On the MTS site, 80% of users identified as white, while 7% identified as African American.This emphasized the need for specific interventions designed to tackle the underrepresentation of ethnic minorities and underserved populations when utilizing BCT and MTS. Conclusions: For more than 15 years, BCT has offered a patient-centric trial matching service. Within the last six years, with the enhancements to the website, BCT has served over 281,197 users. To improve minority enrollment in trials, we have developed a comprehensive clinical trial breast cancer navigation program. We plan to use this program to expand our outreach to underserved populations. Navigators can enhance patient engagement, help patients make informed decisions, and ultimately improve access to participation in breast cancer research.
Improving access to infusion services: Results of an operational sprint.
Authors: Wilson Michelle , Fonte-Smith Paula , Kalish Jonathan , George Alexander , Dumercy McHenry Dina Bernie , Suarez Maria , Caraway Vicki , Davis Mark
Published: May 2024

e13522

Background: As a large clinical academic cancer center growing from 40,772 unique patients in 2021 to 44,416 patients in 2022, access for patients to begin therapy in the infusion suite was delayed by 3.2 days. In addition to delays in care the center experienced decreased patient satisfaction related to timeliness of scheduling and an inflexible scheduling template that did not allow for the maximization of chair assets. An infusion sprint was launched to address the challenges with the main goal of providing a seamless patient experience while ensuring that all 60 chair assets were maximally utilized. The multi-disciplinary team sought to accomplish this through a disciplined evaluation and intervention program with the goals of increasing access, improving patient satisfaction and growing operating income. Methods: In February 2022, a multi-disciplinary team was assembled to develop and implement a plan to increase access to the infusion suite over a period of 6 months. The team utilized LEAN-Six Sigma principles to characterize current state, desired future state and tactical interventions with metrics. Access data, available infusion appointments and activities occurring in chairs were analyzed with the goal of maximizing utilization. This was accomplished through the development of an active asset management methodology that compared available infusion appointment hours in the schedule to the actual completed hours which allowed the center to determine the growth opportunity within the current chair count. Financial performance was reviewed, and a pilot of an AI-based scheduling platform was launched. Results: Data collected in December 2022 showed that the pilot increased average daily chemotherapy infusion patient volume by 10% and overall volume by 11% over prior fiscal year from October 2021 to September 2022. Daily scheduling escalations manually resolved by leadership decreased 54% between May 2022 and September 2022. Newly created chair utilization methodology showed increased utilization from 62% to 82% in 7 months and patient satisfaction increased from 76.97% to 81.18% for “Timeliness of Scheduling.” These initiatives also resulted in an 18% increase in infusion/pharmacy income from operations from October 2021 to September 2022. All of this was accomplished without adding staff to the workforce or chairs to the infusion suite. Conclusions: A focused, intentional, multi-disciplinary infusion sprint conducted over 6 months resulted in increases of patient access, increased patient satisfaction and revenue. External validity is limited by its one site design with future investigation planned at other sites within the cancer care network to determine if results can be reproduced.
Exploring the potential of the traditional Indian system of medicine, Ayurveda, for developing an evidence-based integrative model of cancer care in elderly patients with cancer.
Authors: Bendale Yogesh Narayan , Kadam Avinash , Birari-Gawande Poonam , Patil Anandrao , Ingale Dhanashri
Published: May 2024

e13527

Background: Available evidence suggests that age is a deterrent to accepting cancer-directed treatment, with up to 38% of advanced-stage elderly cancer patients declining conventional anticancer therapy. Such patients opt for various complementary and alternative medicine (CAM). Considering the paucity of available evidence about CAM, it is necessary that the outcomes of CAM in elderly cancer patients should be studied and an evidence-based integrated model for cancer care should be developed. In the present study, we evaluated various characteristics and outcomes of elderly cancer patients from India who voluntarily opt for Ayurveda cancer therapy, either after having a persistent disease after completing conventional therapies or declining conventional therapy. Methods: This observational study was conducted on the elderly population (age> 65 years) approaching treatment at our specialty Ayurveda cancer clinic in India. Data about demography, comorbidity, and efficacy outcome variables like QoL (FACT-G), Performance status (ECOG), anxiety and depression (HADS) was obtained through chart review based on the computerized database of patients who approached treatment between years 2020 to 2023. This being a preliminary proof of concept study the obtained data was subjected to per protocol analysis for avoiding the effect of various confounding variables which can lead to dropouts and poor compliance. As such, study analysis includes only those patients who completed at least 180 days of treatment with more than 80% compliance to the therapy for at least 6 months. Results: From database of 1010 elderly cancer patients, data from 172 patients (92 males and 80 females) who fulfilled the eligibility criteria was selected. Amongst the total sample size, 131 patients were of stage III and IV. The number of patients with uncontrolled hypertension, uncontrolled diabetes, and a history of cardiovascular accidents was 45 (26.1%), 83 (48.2%) and 8 (4.6%) respectively. More than one comorbidity was present in 70 patients (40.6%), whereas 64 patients (37%) patients voluntarily refused anticancer therapies. The duration of treatment was 459.58 (±246.89) days. At the end of 90 and 180 days, a significant improvement was observed in Qol, Performance status, depression, and anxiety (all P>0.01). Conclusions: This study suggests that amongst the elderly Indian cancer patients who opt for Ayurveda therapy, around 38% of them decline conventional therapy whereas others opt for Ayurveda therapy after completing conventional anti-cancer therapies. Ayurveda therapy has been shown to improve health-related Quality of life, performance status, anxiety, and depression. This finding warrants further prospective pragmatic studies which can act as a basis to develop an evidence-based integrative model for cancer care in the elderly population.
Improving sleep outcomes in patients with cancer with chronic insomnia using cognitive behavioral therapy: A retrospective study.
Authors: Martinez Constanza , Kato Martha M , Currier Maria
Published: May 2024

e13555

Background: Cancer patients experience a threefold higher rate of insomnia (23-54%) than the general population. Cognitive behavioral therapy for Insomnia (CBT- i) is the gold standard treatment of chronic insomnia. Few studies, however, have demonstrated CBT- i efficacy for chronic insomnia in cancer patients. To address the needs of cancer patients with insomnia, a psycho-oncology physician trained to provide CBT- i therapy established an insomnia clinic in an ambulatory oncology center tailored for oncology patients. The objective of this study is to assess the efficacy of CBT- i for chronic insomnia among cancer patients. Methods: A retrospective review of electronic medical records was performed on consecutive referrals to an insomnia clinic in an ambulatory oncology center. All patients with ICD-10 confirmed chronic insomnia diagnosis who received at least 2 sessions up to a maximum of 7 sessions of CBT- i were included in the analysis. Demographic variables, cancer-related disease and treatment variables, and sleep parameters at initial session (T1) and last session (T2) were collected. Sleep parameters included sleep efficiency, total sleep time, sleep onset latency, number of nightly awakenings, and sleep quality. Semi-structured psychiatric clinical interviews, past medical and sleep history, and patient-rated Pittsburgh Sleep Quality Index (PSQI) scores at T1 were collected. Data analysis utilized SPSS descriptive statistics and T-test to compare differences between the baseline (T1) and post-CBT- i treatment (T2) sleep variable outcome measures. Results: The sample included 18 cancer patients (mean age 59 years; 12 Hispanics, 6 non-Hispanics; 16 females, 2 males) with ICD-10-confirmed chronic insomnia treated with CBT- i. Cancer-related variables among the sample included a mean duration of 18 months since cancer diagnosis, disease staging ranging from 0-IV, and 16 patients completed curative treatment. The sample included 13 breast cancer patients. Mean duration of insomnia was 6 years. PSQI score was 14 (PSQI score ranges from 0 to 21, scores above 5 are indicative of poor sleep quality). The mean number of sessions delivered was 5. Sleep parameters at T2 showed a significant improvement compared to those at T1 (Table). The number of nightly awakenings decreased from 3 at T1 to 2 at T2 (p=0.01), and 78% (14/18) of patients reported an improvement in their sleep quality at T2. Conclusions: Cognitive Behavioral Therapy for Insomnia demonstrates efficacy in the treatment of chronic insomnia in cancer patients and is easily administered within an ambulatory oncology center. [Table: see text]
Engaging student volunteers in non-clinical navigation: ACS community access to resources, education, and support (ACS CARES).
Authors: Morris Bonny , Rocque Gabrielle Betty , Sivendran Shanthi , Hill Emily K. , Bostock Ian , Chong Robert , Federman Noah , Waugh Charlotte , Dent D'Ambra , Del Valle Cynthia , Kamal Arif
Published: May 2024

e13577

Background: Despite known benefits of oncology patient navigation in improving patient outcomes, implementation is variable and many programs are understaffed. The American Cancer Society (ACS) developed the ACS CARES (Community Access to Resources, Education, and Support) program to expand navigation capacity through the standardized training of students from local universities as volunteers providing non-clinical navigation support. Methods: This pragmatic, real-world hybrid type 2 study utilizes the Consolidated Framework for Implementation Research (CFIR) to evaluate the implementation of student volunteer navigation for patients receiving cancer care at 3 pilot sites. Volunteers meet with patients in clinic, administer a modified NCCN distress thermometer health-related social needs (HRSNs) screen, and administer non-clinical navigation support. Initial process measures from the first 3 months of the pilot data include number and demographics of patients served, distress scores and HRSNs, and time spent by volunteers. Results: Pilot sites spanned diverse geographic regions (rural mid-West, rural-suburban Southeast, urban West) and included clinics with multiple cancer types. From 10/23/23-12/23/23, 22 volunteers navigated 73 patients who were 53% female, 22% Black, and an average age of 57. Of all patients, 46% had a moderate (score 3-6) and 37% had a severe (score 7-10) distress score. ACS CARES volunteers identified 116 HRSNs (56% practical, 18% physical, 17% emotional, 7% social, 2% spiritual). The most common practical HRSNs were finances and transportation. Volunteers spent an average of 78.6 min per patient per in-person meeting, 14 min per patient per follow-up call, 25 min per patient coordinating care and sending encrypted messages, and 90 min per patient identifying and providing resources to address barriers to care. Total time providing non-clinical navigation was over 250 hours. Conclusions: Student volunteers embedded in oncology clinics provided non-clinical navigation support to 73 patients in the first 3 months of the ACS CARES program, further extending the reach and depth of support provided by pilot site care teams. Future analyses will include survey and EMR data to examine program impact on clinical and patient reported outcomes and healthcare utilization. Clinical trial information: 2013209-1.
Utilization and trends of BRAF and MEK inhibitors among Medicare D patients: 2013-2021.
Authors: Waris Shanawar Ali , Siva Nanda , Raiker Rahul , Saifuddin Adnan , Pakhchanian Haig , Monroe Gary , Safi Salah Ud Din
Published: May 2024

e13581

Background: BRAF and MEK Inhibitors are selective anti-cancer medications that induce programmed cell death by targeting the BRAF/MEK pathway. BRAF and MEK were first approved in 2011 and 2013 respectively for the treatment of BRAF-mutated melanoma that include the V600E or V600K melanoma mutants. As additional BRAF/MEK inhibitors were introduced, scant data exists on national prescribing patterns and the goal was to examine this. Methods: A retrospective analysis was conducted using the Medicare Part D Prescriber datasets from 2013-2021. Data from BRAF (vemurafenib, dabrafenib, encorafenib) and MEK Inhibitors (trametinib, cobimetinib, binimetinib) prescriptions made by any healthcare providers were analyzed. Yearly claims per 100,000 beneficiaries, total drug costs, and total drug supply days were recorded. Compounded annual growth rate (CAGR) was calculated. Results: From 2013-2021, there was an 911% increase in the number of BRAF/MEK prescribers to Medicare Part D enrollees who made ≥11 claims. Majority of the prescribers were hematologists/oncologists. The highest proportion of claims and beneficiaries receiving BRAF/MEK inhibitors each year were those >65 years of age and located in the South. An increased CAGR was seen for yearly claims per 100,000 beneficiaries (CAGR=31%), total drug costs (CAGR=40%), and total drug supply days (CAGR=36%). Conclusions: BRAF/MEK Inhibitor use has seen significant growth across all healthcare providers in claims made per 100k beneficiaries, total drug costs, and total drug supply days. These findings show that the access to BRAK/MEK inhibitor is increasing and as it receives indications for other malignancies, additional studies will be needed to assess whether these trends persist or change, especially in setting of increased use of immunotherapy in melanoma.
Changes in non-small cell lung cancer (NSCLC) next-generation sequencing (NGS) rates after electronic health record (EHR) integration using large-scale, multi-institutional, real-world data.
Authors: Matrana Marc Ryan , Mergler Patrick , Posteraro Leo , Chen James Lin
Published: May 2024

e13619

Background: NSCLC treatment guidelines recommend comprehensive NGS testing to detect genomic alterations and gene expression in key biomarkers that are relevant in diagnosis, therapy selection, prognosis, and clinical trials. While 70% of patients with NSCLC will have biomarker alterations related to therapeutic options, a large minority of patients still do not receive biomarker testing. Clinical workflow challenges outside the EHR ecosystem, like paper requisitions and faxed results, have been cited as barriers to adoption. To reduce sequencing barriers, Tempus deploys NGS through direct result EHR connection. To evaluate whether integrating comprehensive NGS ordering and resulting into the EHR would improve testing rates, we retrospectively analyzed NSCLC NGS orders from 29 clinical networks which represent over 1500 medical oncologists, before and after EHR integration. Methods: Clinical networks that partnered with Tempus to perform an NGS EHR integration were identified. Only networks with at least 6 months of pre- and post-integration unique patient NGS orders were included. De-identified patient information from these sites were obtained from the Tempus laboratory information management system. NSCLC diagnosis was determined through ICD9/10 codes. NGS tests ordered were limited to xT/xR (solid tumor DNA and RNA), xE (solid tumor whole exome), or xF (circulating tumor DNA). Aggregate unique patients with orders were summated on a per site basis. Descriptive statistics were used to characterize the findings. Results: From May 2019 to July 2023, 29 clinical cancer networks (48% academic medical center, 45% regional health system) that underwent a Tempus NGS EHR integration were identified. Of the 29 networks considered, 3 were excluded due to insufficient data. Of the evaluable 26 networks, Epic EHR was used in the majority (24 of 26). In aggregate, a total of 1825 NSCLC patients were sequenced pre-integration as compared to 2796 patients sequenced post-integration, representing a 53% increase. Academic medical centers experienced a higher increase versus regional health systems (65% v 48%). When examined on a per network basis, the median and mean increase in NSCLC patients sequenced were 49% and 118%, respectively. Conclusions: In this retrospective analysis, Tempus EHR integrations increased ordering of comprehensive NSCLC NGS by 53%. Despite study limitations such as the incomplete resolution into internal alternate sequencing workflows, this large-scale analysis provides further evidence that EHR-based workflow improvements reduce the barrier to appropriate sequencing.
Systematic review of rural interventions addressing barriers and facilitators in recruitment and adherence of oncology clinical trials.
Authors: Mulley Rebecca , Thapar Ruhi
Published: May 2024

e13675

Background: Rural patients are significantly underrepresented in cancer clinical trials leading to an inequitable distribution of research funding and excluding rural patients from innovative care. Properly understanding the barriers and facilitators to rural patient participation in cancer clinical trials is essential to lessen this disparity in representation. Methods: EBSCO Medline, Embase, Cinahl, Cochrane and PsycInfo were systematically searched for articles related to the primary research objective. The search strategies focused on a combination of keywords pertaining to “rural populations”, “cancer”, and “clinical trials”. Additional search terms included the presence of “barriers” or “facilitators” within the articles. Articles were removed from the study if they were not written in English, were conducted outside the U.S., focused on pediatric populations, or lacked original data. Results: A systematic review of the literature reveals that barriers and facilitators to cancer clinical trial participation by rural populations are present at the patient, physician, and healthcare system levels. Notable barriers found in this review include the burden of travel, lack of patient knowledge about clinical trial participation, insufficient provider communication and awareness of current trials, and strict eligibility criteria. Promising facilitators include caregiver support, close physician support and contact, and programs to increase patient understanding of clinical trials. Potential future interventions include telemedicine, expanding monetary support for clinical trial transportation, utilizing RUCA codes to document disparities and elucidate further interventions, and cultivating stronger partnerships between industry and rural medical facilities, as well as between the NCI, academic institutions, and rural medical facilities. Conclusions: There is a significant and urgent need to strengthen this body of literature as is underscored by the apparent lack of cancer clinical trials in rural counties, specifically in the state of Texas (CPRIT). It is evident that barriers need to be further elucidated to ascertain why rural patients have less participation in clinical trials, and facilitators need to be further explored in order to sufficiently illustrate and thus effectively harness the power of facilitators in the pursuit of lessening disparities and improving cancer outcomes for rural patients.
Improving ethnic and racial diversity within clinical trial populations through community recruitment and inclusion initiatives: Experience from MyTACTIC.
Authors: Zuniga Richard Michael , Spigel David R. , Schwartzberg Lee S. , Hong Jason , Passler Luke , Darbonne Walter C. , Szado Tania , VanderWalde Ari , Daniel Davey
Published: May 2024

e13679

Background: Clinical trial populations are not typically ethnically diverse, restricting healthcare equity and the generalizability of clinical trial data to real-world populations. Moreover, mostpatients (pts) with cancer in the US receive treatment in the more diverse community setting, where minority groups are usually better represented but with lower trial enrollment rates than academic centers. MyTACTIC (NCT04632992) is a phase II, non-randomized basket trial evaluating targeted therapies in pts with advanced solid tumors with specific biomarkers. Inclusive research practices, including mostly community recruitment, were implemented in MyTACTIC to improve access for patients who may otherwise not have been able to enroll. This retrospective analysis presents their impact on the diversity of the trial population. Methods: Adult pts with advanced solid tumors were enrolled from community cancer clinics (private practices and community hospitals) or large academic centers, into 1 of 15 arms based on biomarker alterations. Inclusive research practices implemented to diversify pt recruitment included: revision of eligibility requirements to be more inclusive for minorities; language simplification and streamlining of study protocol; training activities; free transportation. We compared race and ethnicity data between the study population and trial sites’ catchment area (geographical area of pts around the clinical site). Results: Forty pts, all of White race, were initially enrolled across 14 sites, which prompted additional focus on diversity efforts. The trial was expanded to 45 sites across 21 states: 252 pts were enrolled (83% of White race) (Table). Most (96%) selected sites (n=249 pts) were community clinics. The proportion of pts from racial minorities was generally higher in study centers from ethnically diverse catchment areas. Protocol streamlining and staff training were also beneficial to pt recruitment. Free-ride transportation removed the barrier of access to clinical trial sites. The impact of other initiatives will be presented. Conclusions: Running clinical trials at community oncology sites does not, in itself, equal increased diversity of study populations: other efforts, including but not limited to free transportation and community site selection, are also needed. Here we share some learnings from the MyTACTIC study, based on outcomes from the various inclusive research practices implemented in this trial. Clinical trial information: NCT04632992 . [Table: see text]
Availability of cranial prostheses for Black patients at comprehensive cancer centers.
Authors: Rose Lucy , Minta Abena , Shareef Sarah , Adame Stephanie , Dulmage Brittany
Published: May 2024

e13681

Background: For patients who seek to camouflage cancer-related hair loss, cranial prostheses such as wigs and hair pieces exist. We sought to determine the availability of yaki-textured, type IV curls, and afro wigs at boutiques in Comprehensive Cancer Centers (CCCs). Methods: The 56 CCCs in the United States were surveyed to see if they had an affiliated wig boutique or shop for patients experiencing hair loss. Boutique workers were then asked a series of seven questions regarding cranial prostheses options for patients seeking yaki-textured, type IV curls, and afro wigs. The availability of these wigs was compared to US Census data on population size and density of Black residents. Results: Of the 56 CCCs, 27 (46%) institutions had active affiliated hair boutiques. We were able to reach 19 of the 27 boutiques (70%), of which 53% (n=10) offered yaki-textured wigs, and 37% (n=7) offered type IV curls or afro wigs, and 47% (n= 9) offered neither. Two additional boutiques offered in-store catalogues for Black patients who were interested in naturally appearing wigs. Though two institutions offered a wig bank that was free to all patients, neither had yaki-textured or afro wigs in stock. There was no significant relationship between population or density of Black residents and availability of these wigs. Therefore, most Black patients with cancer who are seeking cranial prostheses will not have access to racially inclusive wigs where they are receiving treatment. Conclusions: Not being able to purchase wigs at CCCs poses potential financial challenges when seeking insurance coverage or reimbursement. Thus, Black patients may disproportionately experience emotional and financial hardships secondary to cancer-related hair loss. With increased inventory of racially inclusive wigs, partnerships with third-party vendors, and support for the prior authorization process, we can better support Black patients experiencing cancer-related hair loss. [Table: see text]
Association between socioeconomic factors and utilization of next-generation sequencing in metastatic breast cancer.
Authors: Kudaravalli Sriya , Carleton Neil , Rosenzweig Margaret Q. , Foldi Julia
Published: May 2024

e13700

Background: Targeted therapies such as PI3K inhibitors have revolutionized the treatment of patients with metastatic breast cancer (MBC). Their selective use is enabled by next-generation sequencing (NGS) approaches, which help identify actionable tumor alterations. There may be socioeconomic disparities in NGS testing and NGS-guided treatment selection. This study aimed to investigate the role of socioeconomic status (SES) (race and area deprivation index [ADI]) among patients with MBC undergoing NGS. Methods: Our retrospective study included 418 adult patients (pts) with MBC treated at the Magee Women’s Cancer Center in Pittsburgh, PA between September 2016 and December 2022. Demographic information, including race and ADI, clinicopathologic information, and NGS results were collected. ADI based on zip code was derived utilizing Neighborhood Atlas. Scores range from 0-10 (higher score = higher deprivation), representing the census-based ranking of the ZIP code at the state level based on the composite of several factors, including income, education, employment, and housing quality. Descriptive statistics, chi-squared, and independent sample t tests were used. Multivariate logistic regression analysis was done to evaluate potential associations with receipt of NGS and NGS-directed therapy. Results: 89% of pts were non-Hispanic white (NHW); 11% were non-Hispanic black (NHB). A greater proportion of NHB pts were from higher ADI (6-10) neighborhoods (p=0.00001), suggesting lower SES. NHW pts were more likely to have hormone receptor (HR)+/human epidermal growth factor receptor (HER)2- tumors compared with NHB pts (p=0.022). 219 (52.4%) total pts had NGS tumor testing performed: 53% of NHW and 47.8% of NHB pts (p=0.511). 55.1% (102/185) of pts living in higher SES neighborhoods (ADI 1-5) and 50.2% (117/233) living in lower SES neighborhoods (ADI 6-10) received NGS testing (p=0.317). Of the 219 pts who got NGS testing, 62.6% (137) had a clinically actionable alteration identified, and of those, 46% (63) received corresponding targeted therapy. Of the 63 pts who received NGS-guided therapy, 88.9% were NHW and 11.1% were NHB (p=0.849), and 50.8% were from neighborhoods with ADI 1-5 and 49.2% were from neighborhoods with ADI 6-10 (p=0.571). In multivariate analysis including race, ADI, insurance status, year of MBC diagnosis, and tumor subtype, only tumor subtype (non-HR+/HER2- tumors) was significantly associated with a lower likelihood of both receiving NGS testing (p=0.032) and receiving NGS-directed therapy (p=0.001). Conclusions: There was a higher numerical rate of NGS testing and NGS-guided therapy initiation in NHW pts and pts from lower ADI (1-5 vs. 6-10) neighborhoods, but this did not reach statistical significance. Overall, in this single institution cohort limited by small numbers, there were no differences in NGS tumor testing based on race and SES.
Racial/ethnic distribution of participants in NRG oncology clinical trials: 2014-2023.
Authors: Dignam James J. , Romitti Paul A , Yom Sue S. , Feng Felix Y , Bradley Jeffrey D. , Mehta Minesh P. , Bruner Deborah Watkins , Wenzel Jennifer , Mamounas Eleftherios P. , George Thomas J. , Hong Theodore S. , Aghajanian Carol , Werner-Wasik Maria , Thomas Alexandra
Published: May 2024

e13706

Background: External validity and applicability of clinical research relies upon characteristics of trial participants matching those of the respective disease groups in the general population. Understanding the racial/ethnic distribution of patients enrolled in recent US-based, federally sponsored Phase II and III clinical trials could inform strategies to further align characteristics of trial participants with those of disease group populations. As such, we report the racial/ethnic distribution of participants in NRG Oncology studies during 2014-2023 and compare the distribution to that from the Surveillance, Epidemiology, and End Results (SEER) program data during 2014-2020 (most recent data available). Methods: Proportions of self-reported race/ethnicity were summarized for the 33,370 trial participants enrolled since Mar 1, 2014 (NRG Oncology inception) to therapeutic, symptoms management, and other interventional trials. SEER proportions were used to benchmark NRG trials for representativeness of disease burden in the population. Results: Among NRG trial participants, 71.5% were non-Hispanic (NH) White, 9.7% NH Black, 4.9% Hispanic, and 7.8% N-H Asian (Table). Examining distributions within selected cancer sites relative to cancer proportional incidence in 2014-2020 SEER data, NRG accrual to prostate, lung, cervix, and breast cancer trials is commensurate with observed disease burden for NH Blacks and modestly lower for Asians. For other sites shown, representation was 2 to 5 percentage points lower than SEER frequencies for Blacks and Asians. For all sites, accrual of individuals of Hispanic background was lower than that reported in SEER. As the NRG trials do not reflect sampling across stages and other features of a given cancer in the population, further analysis to be presented will consist of more detailed breakdowns of trial participant disease-specific cancer stage and tumor subtype and comparison to relevant observations from the 2014-2020 SEER database. Conclusions: This high-level comparison of the racial/ethnic distribution of NRG trial participants provides supportive information for population representative enrollment in several cancer sites, but also identifies opportunities to improve enrollment diversity to represent more closely the respective affected population. Areas of success identified merit further investigation to understand if there are best practices which may be applied more broadly towards expanding access to federally funded clinical trials. [Table: see text]