bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends in germline genetic testing and results into survivorship for women diagnosed with breast cancer or ovarian cancer, 2013 to 2017.
Authors: Katz Steven J. , Morrow Monica , Kurian Allison W. 
Published: October 2020

273 Background: Genetic testing is increasingly central to breast and ovarian cancer prevention and treatment. Yet, little is known about trends and disparities in receipt of testing and test results after diagnosis. Methods: We linked all female patients with breast or ovarian cancer diagnosed from 2013-2017 in Georgia and California and reported to SEER registries to genetic testing results from four laboratories (Ambry Genetics, GeneDx, Invitae, Myriad Genetics). We combined test results from all labs with SEER data. We classified a test as a multigene panel (MGP) if it included other genes in addition to BRCA1/2. We grouped pathogenic variants (PVs) by level of evidence that supported clinical testing: BRCA1/2; other genes associated with well-established syndromes (syndromic genes); genes whose cancer association is less certain (emerging genes); and any other tested genes (other genes). We categorized patients with a variant of unknown significance (VUS) in any gene but no PVs as VUS-only. We examined trends in receipt of testing and test results overall and by race/ethnic groups. Results: One quarter (25.5%) of 198,001 breast cancer patients, and 34.5% of 15,461 ovarian cancer patients had genetic tests. Test rates increased by only 2% annually; while the number of genes tested per patient increased by 28%. The mean number of genes tested rose from 10 to 35 during the study period. In early 2013, 18.3% of testers had a PV or VUS result, which increased to 37.2% in late 2017. The upward trend was largely due to increase in VUS-only findings. The proportion of tested breast cancer patients with any PV increased from 9.1% to 9.9%: PVs in BRCA1/2 decreased from 7.5% to 5.0% (p<.001), while PV yield for the two other clinical categories (syndromic and emerging genes) increased from 1.6% to 4.9% (p<.001). PVs in any of the other 61 genes were very rare (<1%). By contrast, the VUS rate in breast cancer patients increased markedly from 9.6% in 2013 to 26.2% in 2017. The VUS rate was higher in racial/ethnic minorities (41.0% Asian, 36.5%% Black, 28.0% Latinas versus 25.6% non-Hispanic Whites diagnosed in 2017; p<.001). We observed similar findings for patients with ovarian cancer. Conclusions: A large gap persists in testing ovarian cancer patients (35% versus 100% recommended). Testing more genes per patient was associated with a substantial racial/ethnic gap in VUS with little difference in yield on clinically relevant PVs. Testing a limited subset of genes may optimize yield-to-noise of genetic testing, particularly for racial/ethnic minorities.
Treatment patterns of advanced or recurrent endometrial cancer following platinum-based therapy in the U.S. real-world setting.
Authors: Klink Andrew J. , DeMars Leslie , Huang Joice , Maiese Eric M. , Feinberg Bruce A. , Hurteau Jean 
Published: October 2020

274 Background: Patient (pt) prognosis is poor following disease progression on or after primary (1L) platinum-based therapy (PBT) for advanced/recurrent (A/R) endometrial cancer (EC), and no consensus on standard second-line (2L) therapy exists. This retrospective analysis aimed to understand real-world (RW) treatment patterns of pts with A/R mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) EC who progressed after 1L PBT. Methods: Physicians in Cardinal Health’s Oncology Provider Extended Network submitted retrospective data by abstracting outpatient electronic medical records of pts who received systemic treatment for A/R EC following PBT from 2016 to 2018. Demographics, clinical characteristics, treatments, and outcomes were summarized descriptively. Results: This study included 84 pts with A/R dMMR/MSI-H EC (table). The majority of participating physicians were hematologists/medical oncologists (80%) and practiced in the community setting (70%). Median duration of therapy (mDOT) in 1L was 4.9 months (95% CI, 4.47–5.57); 64% of pts discontinued treatment due to completion and 35% due to disease progression. In contrast, mDOT in 2L was 6.2 months (95% CI, 5.40–6.37); 37% of pts discontinued treatment due to completion and 44% due to disease progression. The most common MMR/MSI testing modalities were next-generation sequencing (NGS) only, immunohistochemistry (IHC) only, and polymerase chain reaction (PCR) only (table). Conclusions: RW treatment patterns in pts with A/R dMMR/MSI-H EC show that most will undergo PBT retreatment. However, progression is the main reason for discontinuation during retreatment. An urgent need exists for durable therapies that improve prognosis. Opportunities to improve timely testing of MMR/MSI exist. Funding: GlaxoSmithKline, Waltham, MA, USA. [Table: see text]
Concordance of MRI-guided and systematic prostate biopsy for the detection of prostate cancer (PCa).
Authors: Parsons Matthew , Foy Bridget , Chan Ernest , Crawford Bryan , Sommers Daniel , Bishoff Jay , Lynch Steven C , Romney Benjamin , Gill David Michael , McLean Logan 
Published: October 2020

277 Background: MRI/US guided biopsy (fusion biopsy) is increasingly utilized over systemic 12-core transrectal ultrasound biopsy (12-core biopsy) for men with MRI-visible prostate lesions. Methods: Patients with MRI visible prostate lesions who underwent fusion and 12-core biopsy from 2016-2020 in the Intermountain Healthcare (IHC) system were consecutively analyzed. This was in the setting of a continuous quality assurance initiative among the reading radiologists. Primary outcome was PCa detection defined by Gleason grade group (GGG) 1 or higher. Clinically significant cancer (CSC) was defined as GGG 2 or higher. Patients were stratified by date biopsy was performed, 2016-2017 and 2018-2020, and lesions were stratified by PI-RADS v2 category. For men with multiple lesions, the highest PI-RADS v2 category lesion was used. Results: A total of 142 men with 254 MRI-detectable lesions underwent both fusion and 12-core biopsies in the IHC system from 2016 to 2020. CSC was detected in 21.6% (55/254) of fusion biopsies. Comparing PI-RAD v2 categories 1-3 to PI-RADS v2 categories 4-5, the PPV for detecting CSC was 9% (15/162) compared to 44% (40/92) respectively. Fusion and 12-core biopsies were concordant for any PCa in 79% of men (112/142) and CSC in 83% (118/142). Fusion biopsy detected any PCa in 22/84 (26%) and CSC in 15/103 (15%) of men in whom 12-core biopsy was negative. 12-core biopsy detected any PCa in 8/70 (11%) and CSC in 9/97 (9%) of men in whom fusion was negative. In total, 15 patients (11%) had a CSC that would have been missed if fusion biopsy was omitted while 9 (6%) had a CSC that would have been missed without 12-core biopsy. Conclusions: Omitting fusion or 12-core biopsy for PI-RADS v2 lesions would have resulted in a missed CSC in 11% or 6% of patients from 2016-20, respectively. The combination of MRI/US-guided fusion biopsy and systematic 12-core biopsy increased detection rate of CSC. These results are in the setting of a continuous, multi-disciplinary quality assurance program and results are not necessarily applicable to other healthcare systems. [Table: see text]
Biomarker testing patterns and use of targeted therapy in Medicare Fee-for-Service (FFS) beneficiaries newly diagnosed with metastatic non-small cell lung cancer (mNSCLC).
Authors: Patel Anik , Jamotte Aurelien , Matsuda Tara , Das Partha Manas , Elkhouly Ehab , Xi Ann , Jones Barton , Murunga Anne , Petrilla Allison , Markward Nathan , Stevinson Kendall Lee 
Published: October 2020

278 Background: The number of targeted therapies approved for treatment of mNSCLC has increased over the past 5 years. Strategies to identify eligible patients with actionable mutations for targeted therapy include simultaneous testing of ≥ 2 genes via next generation sequencing (NGS) or multiple simultaneous gene testing (MSGT) and sequential single gene testing (SSGT). Current clinical practice guidelines strongly recommend broad molecular profiling in all patients for the simultaneous assessment of multiple genes, including EGFR, ALK and ROS1, that may have potential roles in cancer development. Limited real-world (RW) evidence is available describing the uptake of these strategies and receipt of targeted therapy. Methods: Medicare beneficiaries age 65 years or older, newly diagnosed with mNSCLC and tested for mutations of interest in mNSCLC (ALK, EGFR, ROS1, BRAF, HER2, KRAS, MET, NTRK, RET) from July 2014 - June 2018 were identified using Medicare FFS claims (100% sample) linked to biomarker results in PROGNOS NSCLC Explorer. Patients were followed from date of first metastatic diagnosis and stratified by line of therapy, testing strategy, and year of mNSCLC diagnosis. Those testing positive for an actionable biomarker were identified and then segmented by timing of receipt of a subsequent targeted therapy. Results: 12,272 beneficiaries met inclusion criteria: median age: 75 years, 51% were female, 86% white. Among mNSCLC patients with at least one biomarker test result, EGFR and ALK mutation status were the most commonly tested and reported in 85% and 63% respectively. Overall, 1540 (12.5%) tested positive for EGFR, ALK or ROS1. The relative use of NGS or MSGT vs. SSGT for biomarker testing increased over time, from 63% in 2014 to 80% in 2018. During this period, 789 patients were identified as having at least one positive biomarker test result prior to initiating 1L therapy: 635 were identified via NGS or MSGT while 154 were identified via SSGT. Despite a positive test for mutations of interest, only 292 patients received a targeted drug at 1L. Conclusions: This RW study of mNSCLC patients demonstrates an increasing trend to test patients for multiple biomarkers at once via NGS or other MSGT methods. The number of patients receiving appropriate targeted therapies was low, suggesting the need to address the barriers to administration of guideline-recommended therapy.
Palliative care referrals in patients with advanced cancer on early-phase cancer clinical trials (EP-CTs).
Authors: Healy Megan , Jimenez Rachel , Nipp Ryan David , Shin Jennifer Adrienne , Johnson Andrew , Capasso Virginia , McIntyre Casandra , Cashavelly Barbara J. , Juric Dejan , Lundquist Debra 
Published: October 2020

29 Background: EP-CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the utilization of supportive care services, specifically palliative care (PC), in this population. Methods: We conducted a retrospective review of consecutive patients enrolled on EP-CTs at the MGH Cancer Center from 2017-2019. Sociodemographic and clinical variables, including utilization of PC services, were obtained via chart review. Details of the PC evaluation were compared between patients who received first referral to PC while enrolled on an EP-CT versus those who received a PC referral at any point after diagnosis. Results: Among 426 patients enrolled on EP-CTs (median age 63 years; 44% male), 249 (59%) received a PC referral at any time following a diagnosis of cancer (median age 57 years, 58% male). Eighty-six (35%) were referred prior to enrollment on EP-CT, 44 (18%) were referred while on EP-CT, and 119 (48%) were referred post-EP-CT. Patients referred on EP-CT were younger (median 56 vs 63 years, p < 0.0001) than those enrolled on EP-CTs. For patients referred while on EP-CT, 48% had a PC consult within 30 days of enrollment (range: 0-530 days); median number of PC visits was 3 (range: 0-37); median time from first PC consult to death or termination of EP-CT was 32 days (range: 1-213). Of 44 patients referred on EP-CT, 2 (5%) died while on EP-CT. Of the remaining patients, median time from first PC consult to date of death was 79 days (IQR: 45-178 days). Most common reasons for referral included pain (22, 50%), non-pain symptoms (21, 48%), and goals of care/advanced care planning (20, 45%). Of these referrals, 13 (30%) were initiated as inpatients versus 31 (70%) as outpatients. Pain was most commonly cited for outpatient referral (35%), followed by non-pain symptoms (25%) and goals of care (23%). Non-pain symptoms (40%) and goals of care (36%) were most commonly cited reasons for inpatient referral, followed by pain (24%). Of referrals while on EP-CT, 23 (52%) were made by EP-CT staff, including MD and APP, 7 (16%) from the primary oncologist, and 1 (2%) was self-referral. 26 (57%) of patients referred to PC during trial were also referred to hospice, with a median time from last PC consult to hospice referral of 24 days (range: -2-322). Conclusions: A majority of patients with advanced cancer enrolled on EP-CTs received a PC referral. The timeline and method of referral varied, but most patients did not receive a referral until or following enrollment on an EP-CT. Future work will focus on developing a standard referral protocol for patients enrolled on EP-CTs.
Oncologist experiences regarding patient-recorded clinical encounters: Implications for the patient-doctor relationship.
Authors: Jimenez Rachel , Johnson Andrew , Horick Nora K. , Hlubocky Fay J. , Lei Yvonne Y. , Matsen Cindy Brown , Mayer Erica L. , Collyar Deborah E. , LeBlanc Thomas William , Donelan Karen , Mello Michelle , Peppercorn Jeffrey M. 
Published: October 2020

290 Background: The high prevalence of smartphone use means that most patients can easily audio record medical consultations. Oncologists’ attitudes towards recording visits are unknown yet may impact patient care. Methods: A mail survey of oncologists practicing at 5 U.S. Alliance for Clinical Trials in Oncology sites collected information on clinicians’ beliefs, preferences, and practices regarding patient-initiated recordings, along with sociodemographic and practice characteristics. Descriptive statistics and bivariate analyses were calculated. Results: Of 523 eligible oncologists, 352 (67%) completed the survey. Median age was 47 years, 33% were female, and 86% worked in an academic setting. 53% were medical oncologists, 30% surgical oncologists, and 17% radiation oncologists. Virtually all (93%) reported experience with patients recording visits, 79% at least weekly. The majority (74%) perceived that patients record visits in order to help understand treatment choices. While 79% reported that they “always” agree to recordings, 26% reported discomfort. Nearly one-third (29%) reported concerns about liability, 26% felt recording made discussion less natural, and 18% felt recording changed the way they conveyed information. Although 86% agreed that patients have the right to record visits, nearly all felt physician permission was required and 53% reported having been previously recorded without permission. Only 51% believed recording had a positive impact on the patient-doctor relationship. One-quarter (28%) felt that recording led to a less detailed conversation and 33% felt it contributed to avoidance of difficult topics, such as prognosis. Most preferred the patient/family taking notes or having access to a written summary. Views did not vary significantly based on practice setting, specialty, or region of the country. Older age and greater years in practice were associated with both greater comfort with recording and the perception that recording has a positive impact on the patient-doctor relationship (p < 0.001). Conclusions: While most oncologists report comfort with audio recording and recognize benefits for patients, a substantial minority have reservations about its impact on clinical discussions and their liability exposure. Adopting clear institutional policies about recording could help address some concerns, such as surreptitious recording, while ensuring that patients’ interests are served.
Identifying resources available to physicians for management of financial toxicity: A Fellow-driven QI initiative.
Authors: Fischer Katrina , Anand Sidharth , Walling Anne M. , Larson Sarah Marie , Glaspy John 
Published: October 2020

294 Background: Insufficient patient-physician cost communication stems in part from limited physician awareness of actionable interventions when cost issues arise. Oncologists report low awareness of resources to help patients with financial toxicity and often feel underprepared to discuss and navigate this issue. Methods: All oncology fellows (n = 19) at the University of California, Los Angeles were invited to participate in QI project during the fall of 2019. As part of the curriculum, fellows were individually paired with an experienced attending and asked to review a hypothetical case of financial toxicity. The case described an elderly widow on Medicare, living hours from the cancer center who was non-adherent to her oral cancer therapy due to high copays. Participants were asked to identify at least four financial toxicity risk factors in the case, and to identify resources and strategies that a physician could use help navigate her financial concerns. A cost-health literacy survey was administered at baseline and at the conclusion of the curriculum to evaluate the impact of the program. Results: Of 19 participants, 16 completed the case based scenario. Nine categories of risk factors were identified (63% of participants identified an insurance issue, 44% lack of social support, 44% drug cost, 50% fixed income, 50% distance from treatment center, 31% logistical transportation concern). Physician directed solutions were primarily focused on three categories: drug cost, insurance issue, and transportation concerns. Together, an institutional specific financial toxicity tip sheet was generated for further dispersal at the cancer center. After participation in the intervention, more fellows agreed/strongly agreed that they could help a patient experiencing financial toxicity (62% v 6%, p = 0.005). Conclusions: A focused intervention can increase awareness of resources and strategies available to physicians in the management of patient financial concerns, which may impact physician engagement with issues of financial toxicity. Standardized education programs to further educate physicians on financial toxicity management strategies is warranted.
Development of self-management tip sheets for medical oncology and surgical patients electronically reporting symptoms in the home-care recovery setting.
Authors: Schrag Deborah , Osarogiagbon Raymond U. , Wong Sandra L. , Hazard Hannah , Bian Jessica J , Dizon Don S. , Cronin Christine , Hassett Michael J. ,   eSyM Project Managers
Published: October 2020

299 Background: Patients receiving cancer treatments, including chemotherapy and surgery, often face immense morbidities. Poor symptom control frequently leads to decreased quality of life and an increased need for acute care services. For patients undergoing chemo, adverse side effects can deter them from receiving life-saving therapies. Similarly, poorly managed postoperative symptoms can delay recovery and timely receipt of adjuvant therapies. Empowering patients to proactively monitor, electronically report, and effectively treat symptoms in the home-care setting is critical to improving clinical outcomes. Methods: Through the NCI’s Moonshot-funded IMPACT consortium, 6 health systems developed a library of 70 open source symptom management tip sheets for medical oncology and surgical patients. The study team went through an iterative process with medical oncologists, surgeons, practice nurses, health educators, and patient advocates. Careful attention was paid to minimize the usage of regional dialects or idioms to ensure scalability and acceptability. The tip sheets achieved passing scores on two validated healthy literacy and readability tools. Results: Tip sheets were accessible to patients participating in the novel eSyM (electronic symptom management) program, a fully EHR-integrated ePRO model.eSyM and the incorporated tips were deployed at four health systems between fall 2019 and spring 2020 (Baptist Cancer Center, West Virginia University, Dartmouth-Hitchcock Medical Center, and Maine Medical Center). Patients enrolled in eSyM had access to the tip sheet library through their patient portal and could view them at any time. In addition, after completing an ePRO questionnaire, patients were given dedicated links to the tips for symptoms they reported. Each developed tip sheet included 4 sections: 1) things you can do on your own, 2) with over-the-counter medications, 3) with the help of your care team, 4) when to call your care team for help. This simplified structure allowed patients to determine how to manage symptoms on their own and when to seek out assistance. Conclusions: Presenting self-management tip sheets in response to patient-reported symptoms through a fully integrated patient portal platform is a novel approach to symptom management. Future efforts will include deploying the library and platform at two additional health institutions and evaluating the adoption, acceptability, and utilization of the tip sheets and their impact on clinical care outcomes.
Costs to healthcare payers associated with clinical trial (CT) participation in metastatic non-small cell lung cancer (NSCLC).
Authors: Merkhofer Cristina , Chennupati Shasank , Sun Qin , Eaton Keith D. , Martins Renato G. , Ramsey Scott David , Goulart Bernardo H. L. 
Published: October 2020

3 Background: To assess the financial implications of therapeutic CT participation for healthcare payers, we compared first-line (1L) and second-line (2L) total direct medical costs between patients enrolled in 2L CT vs non-CT participants receiving 2L therapy for metastatic NSCLC. Methods: We linked electronic health records from a single academic center with tumor registry and claims data to identify patients with metastatic NSCLC diagnosed from 1/1/2007-12/31/2015. Eligibility criteria included 60 day minimum survival, receipt of ≥ 1 anti-cancer drug within 180 days of diagnosis, insurance enrollment for ≥ 12 months after diagnosis and receipt of ≥ 2 therapy lines. Patients on 1L trials were excluded. We calculated mean per-patient-per-month (PPPM) total direct medical costs from the payer perspective for 1L and 2L. We performed a difference-of-difference analysis to estimate the effect of trial enrollment on costs by calculating the mean PPPM difference between 2L and 1L in trial (Diff trial) and non-trial enrollees (Diff non-trial). Then we calculated the difference between Diff trial and Diff non-trial. We used paired and non-paired t-tests for statistical comparisons and report all costs in 2019 US dollars. Results: Of 63 patients, 22 (35%) enrolled in a 2L CT. CT enrollees were younger (mean age 63.5 vs 66.7 years), female (73% vs 41%), had commercial insurance (36% vs 32%), were never smokers (36% vs 32%), had EGFR mutations (27% vs 22%) and fewer had brain metastases (14% vs 29%). The mean PPPM total direct medical costs decreased between 2L and 1L for patients enrolled in 2L CTs but increased in non-trial participants (Diff trial = -$5,585, SD ± $6,541; Diff non-trial = $1,532, SD ± $14,739). The mean difference of difference (Diff trial - Diff non-trial) was -$7,117 (p = 0.01; Table). Conclusions: This small observational study suggests that CT enrollment results in substantial cost-savings to payers. If confirmed in larger studies, our findings suggest that insurers support trial participation for patients with NSCLC. [Table: see text]