bluuebunny/crossref_metadata_2025 huggingface dataset:
Head and neck cancer survivors: Long-term nutrition impact symptoms, eating problems, and barriers to care impact psychosocial health.
Authors: Saxton M Claire , Ruwala Richa , Jaisle Alyssa , Fearnley Kirstin , Andac-Jones Elif
Published: June 2024

12044

Background: Head and neck cancer (HNC) survivors experience significant long-term side effects of their treatment, and health-related quality-of-life (HRQoL) assessments of HNC survivors are still early in development. This survey captured long-term nutrition impact symptoms, eating problems, psychosocial impact, and barriers to accessing health care of HNC survivors. Methods: The Cancer Support Community (CSC) conducted an online survey with participants from CSC, Head and Neck Cancer Alliance, and Support for People with Oral and Head and Neck Cancer (SPOHNC). 172 “long-term survivors” (LTS), at least 2 years past initial diagnosis completed the survey. Most respondents were white (94%) & female (58%). The average age was 64. The most common treatments reported were radiation (93%), surgery (66%), and chemotherapy (59%). Results: Physical and psychosocial issues are prevalent and persistent among LTS. Almost all (99%) LTS reported experiencing eating problems since diagnosis, and 92% had symptoms persist into the last 7 days. Dry mouth (85% ever/68% in last week) and problems swallowing (82%/62%) were most common. Prevalence of side effects was independent of stage of cancer and time since initial diagnosis. 42% of LTS reported still not eating a solid food diet (30% “soft” food; 9% feeding tube; 4% liquid or pureed food). 63% ever used a feeding tube. For those no longer using a feeding tube, 71% used it for ≤6 months. Current users had feeding tubes for a median of 39 months. Weaning from a feeding tube was most likely before 14 months. 62% of LTS reported still feeling self-conscious when eating, 45% feeling embarrassed about their eating habits, 44% having their daily activities affected by eating problems, 37% said they avoid going out in public when it involves eating or drinking. Despite this, 27% reported never seeing a health care professional (HCP) or mental health professional (MHP) to manage their eating problems & psychosocial impact. Only 11% of LTS ever met with MHPs to address their distress. Female LTS of younger age and those with Medicare insurance were more likely to meet with HCPs (except dentists for Medicare recipients) and MHPs. Financial, transportation, & logistical concerns were top barriers to receiving care. 19% reported cost of care as a moderate to great barrier to cancer treatment. LTS reported difficulty paying for dental work (29%), supplemental nutrition drinks (11%), and other products to manage eating problems (9%). Conclusions: Although HNC’S are generally considered “curable,” the nature of the disease and the required aggressive treatment regimens leave LTS with a broad range of common physical and psychosocial issues that are rarely addressed. Survey data highlight almost universal, long-term persistence of eating and nutrition problems which cause significant psychosocial impact over LTS’s lifetime.
Self-expressed needs and gaps in our care of metastatic breast cancer (MBC): An all-Ireland patient-led online survey (CTRIAL-IE 23-05).
Authors: Gaynor Siobhan , Duane Frances K , Mulvaney Emer , Weadick Catherine , Greally Helen , Keogh Rachel J , O'Meara Yvonne , O'Leary Mary Jane , McBrien Ann , Mulroe Eibhlin , Teiserskyte Ieva , Beristain Isabel , Marron Jacinta , McLoughlin Sarah , Donachie Victoria , O'Reilly Seamus
Published: June 2024

12058

Background: Therapeutic advances have improved MBC survival rates, but patient self-expressed information needs have not been evaluated in Ireland to date. Heretofore, the patient’s voice has not been central to such an assessment, potentially leading to incorrect assumptions about MBC care. Methods: An anonymous online survey was designed by a cohort of 30 patients with MBC facilitated by a multidisciplinary breast cancer specialist taskforce. A questionnaire asked individuals to report their experience across three domains: credible information sources, palliative care access, and mental health. Patients with MBC 18 years or older living on the Island of Ireland were eligible to participate. The survey was publicised in the media and in oncology clinics nationally and was available for 10 weeks. The survey consisted of a mixture of open and closed questions and results were summarized by means of counts and percentages for categorical variables and by means of mean, standard deviation, median and range for continuous variables. Results: Between July-October 2023, 246 patients completed the survey. The median age of responders was 52.5. 99.4% of patients wished to have access to their personal medical records. Over 95% sought information about metastatic breast cancer outside of the clinic. The go-to information source varied (mostly online). No dedicated comprehensive information source on MBC was identified. Over 83% of patients with MBC were amenable to early palliative care referral but oncology teams did not raise this to the majority. Over 87% of patients reported mental health issues and the majority did seek support (88.4%). Living with uncertainty while awaiting scan results commonly led to feelings of anxiousness (79.5%), fearfulness (54.1%) and depression (15.2%). Conclusions: Patient-led research demonstrates that the patients’ voice is imperative to identify meaningful health interventions. System change including rapid streamlined access to personal medical records and the provision of a credible online information source dedicated to MBC may empower patients to enable them to live well for as long as possible. Routine discussion around early palliative care referral and an opt out approach may be of benefit. Acknowledging the high burden of mental health issues among this patient group and ongoing development of support services is crucial. Minimising the time patients live with uncertainty waiting for scan results should be prioritised.
A meta-analysis GWAS of taxane-induced peripheral neuropathy in patients with breast cancer.
Authors: Yang Yuanchu James , Schaffer Kerry Roe , Jiang Guanglong , Tran Tam C , Sauer Peter J , Zeng Chenjie , Schneider Bryan P. , Park Ben Ho , Denny Joshua C
Published: June 2024

12089

Background: Taxane-induced peripheral neuropathy (TIPN) is a common dose-limiting toxicity in the medical management of breast cancer patients. Despite the clinical efficacy of taxane treatment, there is significant heterogeneity in the development of neuropathy and its severity, and no clear genetic etiologies have yet been identified. We sought to discover genetic risk variants in two large electronic health record linked DNA biobanks. Methods: A meta-analysis genome wide association study (GWAS) was performed with participants in the All of Us Research Program and BioVU biobanks. All participants of the study population were of female sex at birth and had a breast cancer diagnosis. Cases were defined as taxane-exposed participants who received their first neuropathy diagnosis code within one year after first taxane exposure. Controls were defined as taxane-exposed participants without a neuropathy diagnosis code and without gabapentin initiation after taxane exposure. GWAS was performed with PLINK version 2.0 using age at taxane initiation, number of taxane cycles received, and the first 10 principal components as covariates. Expression quantitative trait loci (eQTL) analysis was performed with the GTEx 8.0 and EyeGEx databases. Results: The All of Us cohort had 196 cases and 254 controls. The BioVU cohort had 244 cases and 528 controls. In our meta-analysis GWAS, rs3065465 (chr11:69138693; closest gene by distance is LOC338694) was associated with TIPN (OR=2.14, P= 8.27E-09) and was similar across different genetic ancestries (Table). The eQTL analysis of rs3065465 shows significant association with mRNA expression of TPCN2(P= 6.44E-06), a cation channel involved in neuronal differentiation and intracellular calcium homeostasis. Conclusions: rs3065465 represents a potential novel genetic marker for TIPN risk in breast cancer patients.[Table: see text]
Psychological adjustment and perception of patients’ relatives and healthcare providers regarding continuous deep sedation until death: A mixed-methods study.
Authors: Fasse Leonor , Locatelli Marie , Luis Ines Maria Vaz Duarte , Le-Provost Jean Bernard , Scotte Florian , Joffin Ingrid , Evin Adrien , Flahault Cécile
Published: June 2024

12098

Background: France is currently in the midst of societal discussions concerning new legislation on active assistance in dying. Continuous Deep Sedation Until Death (CDSUD) is considered by some a “French exception” since 2016, but 8 years later, findings suggest that this procedure is not really clear to all, including patients, their relatives and their healthcare providers (HCP). The primary objective of this original research is to document the psychological adjustment of patients’ relatives and HCPs in the cancer context. Methods: APSY-SED (ID-RCB 2021-A03042-39) is a multicentric prospective, longitudinal and observational study, using a mixed-methods design. A lexicometric analysis of the semi-structured interviews was performed using Iramuteq software. A questionnaire survey was conducted, encompassing for relatives: anxiety and depressive symptoms (STAI-S, BDI-II); for HCPs: Professional Stress and Professional experience (Karasek questionnaire). We present here the main results at T1 (when CDSUD is implemented). Results: Main quantitative results are presented in Table I. Regarding qualitative findings, fifteen research interviews with relatives and 15 interviews with HCP were analyzed. Most frequent words associated with CDSUD were its “objectives”, its specific “temporality”, the mention of “euthanasia”, and “saying goodbye”. Confusion between CDSUD and euthanasia persists in relatives and HCPs. Conclusions: On average, relatives reported severe anxiety in the context of CDSUD. The qualitative findings regarding the main concerns shared by the relatives concerning the CDSUD temporality perceived as brutal, shed light on this anxiety. The second assessment time of this study, 6 months after death, including measures of depression, anxiety, intensity of grief reactions, will allow to specify the adjustement at mid-term. This is the first empirical study carried out in France on the adjustment of relatives and HCPs caring for patients with cancer for whom CDSUD is discussed. [Table: see text]
Sensitivity and specificity of 61 commercial disease detection products: A systematic review and meta-analysis of 80 cohorts with approximately 445,000 enrolled samples.
Authors: Shi Yujie , Li Yingxiang , Cheng Shaochen , Liu Tianliang
Published: June 2024

e22505

Background: In 2020, a total of 19.29 million newly diagnosed cancer cases and 9.96 million cancer-related deaths worldwide. Timely cancer detection through disease screening technologies is crucial to reduce the burden of cancer significantly. Methods: We compiled a list of products from industry reports on early screening products and retrieved published papers testing these products from relevant company websites. Results: A comprehensive list of 80 disease detection or early screening products currently available in the market. Out of these, 61 products had published research articles. The products comprised nine multi-cancer early detection (MCED) and 52 single cancer/disease early detection (SCED) products, encompassing 26 different cancer types. Blood was the most frequently used sample type. The sensitivity and specificity of the products ranged from 27.1% to 100% and 32.5% to 100%, respectively. Many products aimed to enhance predictive accuracy by integrating various types of information, resulting in a 9% increase in specificity compared to products using only single-type factor. The average sensitivity and specificity for MCED products were 69.2% and 96.6%, respectively, while for SCED, the values were 86.4% and 80.0%. A significant disparity was observed in the number of products for different cancers/diseases, each with unique sensitivity and specificity. Conclusions: An increasing number of cohort studies provide evidence that these products can serve as complementary tools for cancer/disease screening and diagnosis. In our opinion, an ideal product should strike a balance between safety, accuracy, convenience, and cost-effectiveness. [Table: see text]
A novel multi-cancer screening approach based on screening objectives, cancer occurrence mechanism, and cost modeling.
Authors: Yu Chris Chang , Du Xuedong , Lin Yue , Tang Xing
Published: June 2024

e22509

Background: The current cancer screening approach is relatively expensive and unable to cover all general population. Certain amount of information collected is possibly “overkill” at the expense of costs and technology complexity as statistically only 2-3 individuals in very one thousand individuals have cancer. We propose a novel multi-cancer screening for general population which is based on initial screening objectives, new cancer occurrence mechanism, and cost model. Since the step following cancer screening is cancer diagnosis in which significant tests will be carried out, we strongly believe that cancer screening should mainly focus on (1) separating high cancer risk individuals from low risk group, and (2) reduce screening costs and make screening available for everyone. Methods: We analyzed our own large size, multi-year, multi-cancer data as well as other reported studies. We have also studied new cancer occurrence mechanisms developed in recent years which included correlations between immune system and micro- environment change in human body (both of which could occur before the tumor is formed) and cancer occurrence. Finally, we have analyzed cost numbers for the new and traditional approaches. Results: In our extensive multi-year, multi-cancer general population screening of over 200,000 individuals and follow-up study, only 1.4% tested classified as high risk individuals, while this small group accounted for close to 92% of all cancer cases confirmed to date in the follow-up study when enrollment is normalize for all groups. This is very significant because this demonstrates that as long as screening is statistically meaningful and effective, a lot other information is not needed in screening as high risk people will undergo diagnosis anyway. The new screening approach does not require to obtain full information (for example, traceability (cancer location information), as over 98% of people do not likely have cancer) in order to reduce screening costs. The cost analysis results are shown in Table 1. Conclusions: We proposed a new cancer screening approach which is much more cost effective while it is still workable and meets screening objectives. [Table: see text]
Epidemiological profile of Ophir Loyola Cancer Hospital: A snapshot of the incidence of solid neoplasms in the eastern Amazon.
Authors: Chavez Juliana Ramos
Published: June 2024

e22515

Background: The geographical distribution of cancer is a major concern in global public health, associated with this reality, the susceptibility of a population is closely linked to risk factors and carcinogenic profiles in different groups, which explain the heterogeneous prevalence and incidences among countries. In Brazil the region delimited by the Legal Amazon has a distinct epidemiological profile with a high prevalence of breast cancer and a low survival rate compared to countries with the highest human development index. Furthermore, the North and The Northeast has more than half of the country's penile cancer cases. In Pará, Ophir Loyola Cancer Hospital(OLCH) accounts for 71.11% of hospital visits in the state. The results of this study indicate the importance of OLCH as the reference center in Pará for the care and treatment of cancer patients. Methods: This was an ecological, exploratory, and mixed descriptive studythat investigated the epidemiological profile of patients with cancer treated at OLCH from January to December 2020. Sociodemographic data at admission were the primary variables, which were analyzed according to spatial distribution. Results: In this study, the data of 2952 patients were analyzed, with the majority being between the ages of 50 and 79 years (62.47%), and diagnosed but without previous treatment (87.30%). The most common cancers were breast (16.50%), cervical (13.40%), stomach (8.98%), and prostate (7.72%). The spatial distribution of the total number of cases, by the location of the primary solid tumor, was heterogeneous with regard to the number of cases per municipality. In Tucuruí Lake and Carajás, thyroid cancer was the second most frequent neoplasms, and in the Lower Amazon, it was the third most frequent . Previous studies have indicated the high mining activity in Carajás and the Lower Amazon with a strong relationship between methyl mercury and Mercury contamination in the Tapajós River and the adjacent gold extraction territory and and fish contamination. In some regions of Pará, cervical cancer is more prevalent than breast câncer in womans, which is different from the national data where it ranks second or third in the female population. Within the relationship between females and males, there was a higher proportion of cases of stomach cancer among men, representing the second more prevalent tumor in men, indicating a high incidence of gastric cancer in the region. Conclusions: The care profile at OLCH showed a high incidence of solid malignancies compared to other regions of Brazil, such as gastric cancer, cervical and thyroid cancer, indicating environmental and sociocultural influences on the carcinogenic profile present in the Eastern Amazon. Just as a heterogeneous incidence of tumors was seen in the regions of Pará.
A geospatial analysis of neighborhood hot spots and socioeconomic disparities associated with high lung cancer incidence for targeted intervention in south Florida.
Authors: Lee Ming , Leavitt Antonia Pryor , Kobetz Erin N.
Published: June 2024

e22525

Background: This study aims to identify the locations as well as specific socioeconomic disparities associated with high lung cancer incidences in South Florida (SF). The information is used to develop strategies for increasing smoking cessation and lung cancer screening rates in underserved communities via community outreach and engagement (COE). Methods: Sylvester Comprehensive Cancer Center’s catchment area in SF was studied and consists of three urbanized counties (Miami-Dade, Broward, and Palm Beach) as well as one rural county (Monroe), with a total population of 6 million. Age-adjusted incidence of lung cancer was calculated (2010-2019 Florida cancer registry data) for every census tract in the study area. Geospatial hot spot analysis was then applied to identify statistically significant clusters of census tracts with high age-adjusted lung cancer incidences. Socioeconomic data (American Community Survey) and smoking rates (CDC Places data) associated with the hot spot census tracts were then analyzed for risk factor identification and potential barriers to screening. Results: Hot spots census tracts for lung cancer in SF are generally associated with lower socioeconomic status, including lower income, higher percent of people living in poverty, more households with no vehicles, lower education levels, and higher percent of active smokers. Such socioeconomic disparities are most pronounced in the two highly populated counties of Miami-Dade and Broward. Palm Beach County’s hot spots include retirement communities, while those in the rural county of Monroe have the highest smoking rates. Conclusions: Using this analysis, our COE team began targeting hot spot communities for intervention with a specific focus on those where smoking rates are high, and no lung cancer screening facilities exist. The results demonstrate the utilities of geospatial data analysis for identifying locations and population segments for which increased cancer prevention efforts are needed. Targeting neighborhoods with the identified disparities for increased intervention in smoking cessation and lung cancer screening can help a COE team reach at-risk populations with limited resources more effectively. [Table: see text]
Observed germline BRCA1/2 and TP53 tumor genomic profiling allele frequencies.
Authors: Wheeler Rebecca , Terhaar Catherine , Kruzel Mark
Published: June 2024

e22533

Background: Tumor genomic profiling (TGP) is increasingly used to assist with cancer treatment planning. While these tests are not intended to find germline variants, they are a possible incidental outcome. Currently there are no clear guidelines on when to suspect if a somatic variant identified on TGP may need confirmatory germline genetic testing. Variant allele frequency (VAF) is one tool commonly used to assess if a variant may be germline. While some studies have demonstrated germline VAF ranges on TGP, the data is limited. The purpose of this study was to review VAF ranges of BRCA1/2 and TP53 variants at a large reference laboratory to better understand VAF ranges of confirmed germline variants. Methods: A retrospective review of test results from 184 patients who underwent TGP and hereditary cancer germline testing at a large reference laboratory was performed. Patients were included in the study if they had both TGP and germline testing performed, regardless of the order of testing. Results were analyzed to determine variants identified and VAF. Analysis of BRCA1/2 and TP53 variants included patients who had variants identified on TGP and had germline testing that would have confirmed the variants if present in the germline. The VAFs were obtained, and simple statistics were used to describe the findings. Results: Twenty-one patients were found to have 23 BRCA1/2 variants identified on TGP (2 patients had 2 BRCA1/2 TGP variants). Of these TGP variants, 16 were confirmed on germline testing (69.6%). The TGP VAF for these patients ranged from 38.2% to 85.1%. The mean was 61.0% and the median was 61.8%. The remaining 7 TGP variants that were not confirmed on germline testing ranged from 7.2% to 63.4%. The mean was 31.1% and the median was 28%. Thirty-eight patients were found to have 41 TP53 variants identified on TGP (3 patients had 2 TP53 TGP variants). Of these patients, 1 had a TP53 variant confirmed on germline testing with a VAF of 44.7%. The 40 remaining variants in this dataset were not confirmed on germline testing. The VAF for these 40 variants ranged from 1.3% to 95.3%. The mean was 38.4% and the median was 34.5%. Conclusions: In this study, 69.6% of BRCA1/2 TGP variants were confirmed on germline testing compared to 2.4% of TP53 TGP variants. Confirmed germline variants identified on TGP had VAFs that were > 38%. It’s important to note that TP53 variants may have very high VAFs (up to 95.3% in this study) and not be.
Staging of psychiatric disorders in patients with limited and advanced/metastatic solid cancer: A pilot study.
Authors: Sartori Raffaela Daria Giovanna , Airoldi Chiara , Dalu Davide , Biscaldi Valentina , Cona Maria Silvia , Gambaro Anna , Ruggieri Lorenzo , Amato Ottavia , Fasola Cinzia , Ferrario Sabrina , Dell'Osso Bernardo , Viganò Caterina Adele , La Verde Nicla Maria
Published: June 2024

e22545

Background: 38% of cancer patients (pts) receive diagnosis of major depressive disorder. According with the clinimetric approach of the staging of psychiatric disease, the 5-step model of unipolar depression allows for the evaluation of the extent of the disorder, its severity, and characteristics at a specific time in the course of the disease. This study was aimed: a) to assess mental health and quality of life of cancer patients with limited (LS) and advanced/metastatic (AS) solid cancer through the join evaluation of the staging of psychiatric disorders; b) to explore the potential role of severity of oncological disease in anxious/depressive disease development. Methods: A cross-sectional study was conducted at the Oncology Unit of Luigi Sacco Hospital of Milan during the first session of a psychological support path. Patients’ cancer diagnosis and stage, as well as regular engagement in work, leisure and social activities were explored. Hospital and Depression Anxiety Scale (HADS), the Revised Illness Perception Questionnaire (IPQ-R) and Mental Health Continuum Short-Form (MHC-SF) were also administered. Results: 104 pts were included: F 86, M 18, median age 57,5 (27-84), 30% AS, and 70% LS. Pts’ anxious/depressive symptoms were assessed by HADS scoring and they were divided into 3 groups according to the model of unipolar depression: Group 1a (prodromal phase – no symptoms), Group 1b (prodromal phase – mood symptoms) and Group 2 (anxious/depressive disorder). Pts in group 2 were significantly more frequently AS pts, while in group 1a pts in LS stage (χ² = 7.78, p < .05). Based on MHC-SF scores, flourishing and languishing were significantly more frequently reported by pts in group 1a (55,5% and 46% of pts, respectively), and moderate mental health in group 2 (45,9% of pts, χ² = 18.1, p < .001). Regression analysis highlighted non-hobbyist vs. hobbyists, AS vs. LS cancer pts, asthenic vs. non asthenic pts, and moderate vs flourishing metal health were more likely to receive a provisional anxious depressive disorder diagnosis (Stage 2). No association emerged for other physical symptoms, work, and socialization. Conclusions: AS pts with asthenia, no engagement in structured activities and moderate mental health had a higher risk of developing anxious/depressive disorders. Screening psychiatric disorders in cancer pts may improve the physician's ability to recognize earlier phase of psychopathological disease and guide pts to tailored treatment. These may prevent progression of psychiatric disease and promote mental health and positive quality of life.
Examining knowledge of cancer-related family history in an urban underserved patient population.
Authors: Jones Monet , Ludi Daniel , Martinez Irann , Naylor Keith
Published: June 2024

e22550

Background: An accurate assessment of family history of cancer is essential in assigning cancer risk, and in decision making regarding the timing and method of cancer screening. However, obtaining a complete and accurate cancer-related family history, including first- and second-degree relatives, is often challenging in underserved communities. Familial dynamics such as single parent households, kinship care, and estrangement may act as barriers to an individual’s knowledge of their family health history. Presently, Electronic Medical Record systems constrain users to a binary documentation of cancer history as either ‘yes’ or ‘no’. However, patients may be unaware or uncertain of their family’s cancer history. These unknowns are not captured, resulting in poor understanding of patient knowledge regarding their family history of cancer. Objective: To assess knowledge of cancer-related family history for first- and second-degree relatives among an urban underserved patient population. Funding source: The American Cancer Society. Methods: University of Illinois Health patients aged 45-75 years without a history of colorectal cancer, who received an order for colorectal cancer screening through fecal immunochemical testing or screening colonoscopy were eligible to participate. A total of 88 respondents completed a 23-item telephone survey assessing knowledge of their family cancer health history using a 5-point Likert scale. Surveys were administered in both English and Spanish languages. Results: Of the 88 survey participants, 50 (57%) were female, 54 (61%) were of black or African American race, and 31 (36%) were of Hispanic or Latino ethnicity. On a single-item question assessing overall knowledge of their cancer-related family history, 35 (39.7%) responded they know it well or very well, versus 13 (14.8%) with little or no knowledge. On knowledge of maternal cancer related history, 8 participants (9.1%) reported little or no knowledge of their mother’s cancer history, and 29 participants (33%) reported little or no knowledge of their maternal relatives’ cancer history. On knowledge of their father’s cancer history, 35 (39.8%) reported little or no knowledge of their father’s cancer history, and 48 participants (54.5%) reported little or no knowledge of their paternal relatives’ cancer history. Conclusions: This original research study addresses the current gap in understanding patient knowledge regarding familial cancer health history. Survey results demonstrate a striking discrepancy between respondent reported overall knowledge of cancer-related family history, and knowledge of their maternal and paternal cancer histories. Moreover, respondents reported increased knowledge of their mother’s versus father’s cancer history p < 0.0001. Improved recognition of unknown family history in first- and second-degree family members may improve cancer-risk assessment.
Adherence to cancer screening for patients with Li-Fraumeni syndrome: A report on our experience at Fred Hutchinson Cancer Center.
Authors: Bribiesca Rodriguez Josefine , Tatunay Kevin , Laurino Mercy Y , Dubard-Gault Marianne E
Published: June 2024

e22553

Background: Li-Fraumeni syndrome (LFS) is a high-risk cancer predisposition syndrome where patients are at risk of developing multiple primary cancers, synchronous, and metachronous cancers in their lifetimes. Patients with LFS often serve as their own advocates to request and receive appropriate cancer screening as few clinicians have experience in caring for them and few clinics are adequately staffed to provide complex cancer screening coordination. Methods: Fred Hutchinson Cancer Center (Fred Hutch) is a large academic cancer care center associated with the University of Washington. In July 2020, Fred Hutch's clinical cancer genetic service launched a high-risk surveillance clinic for patients with hereditary cancer syndromes requiring services from multiple specialties. Our clinic has since helped patients with LFS receive coordinated cancer screening. Here we report on adherence to the Toronto protocol by reviewing patient demographic, cancer history and family history, and genetic records. Furthermore, we report on the number of visits, types of screening, and cancer diagnoses patients with LFS received since enrolling in the high-risk clinic. Results: A total of 112 patients with LFS were seen in the high-risk surveillance clinic between July 2020 and December 2023. Of these patients’ paths reviewed so far, 73 patients established with the clinic and received blood work and/or MRI imaging scans, and 42 were seen in at least one follow up visit. 2 patients with LFS were diagnosed with one or more new cancer diagnosis since enrollment, both have completed treatment, and both are without evidence of disease as of February 2024. Conclusions: The high-risk surveillance clinic was promptly utilized by patients with LFS for coordination of their complex cancer screening needs and to guide their next steps when triaging symptoms and concerns. While the clinic addresses a gap in cancer screening coordination, patients with LFS need wrap around care close to where they live which is difficult to accomplish in the Pacific Northwest.
The prevalence of RCTs in PARP and immune-checkpoint blockade combination trials: An appraisal of clinical evidence generation in oncology.
Authors: Olsen T. Anders , Saez-Ibanez Ana Rosa , Upadhaya Samik , Sharon Elad
Published: June 2024

e23006

Background: PARP-inhibitors were developed to promote lethal genomic instability in cancers with homologous recombination repair (HRR) defects, ultimately receiving approval for patients with BRCA gene mutations. At the tumor microenvironment, DNA instability is linked to higher expression of immune activating signals such as PDL1. PDL1 is one of the primary targets for immune-checkpoint inhibitors (ICIs), receiving approval for numerous cancer types. In-vitro studies support mechanisms of possible synergy for PARP and ICIs in combination. Despite both therapy classes being available to oncologists for nearly a decade, the clinical benefit for these agents together remains unclear. Our study aims to appraise the global clinical trial landscape for trials testing combination PARP and PD1/PDL1 regimens. Methods: Search terms for all known approved or unapproved PD1/PDL1 and PARP inhibitors associated with trials registered on the National Library of Medicine’s website, clinicaltrials.gov, were included in the cohort as long as one interventional arm administered both agents. Qualitative and quantitative trial data features were collected from the Cancer Research Institute (CRI) Immuno-Oncology Intelligence Database and complemented with manually sourced information from trial registries and publications. Contribution of Effect (COE) was defined as trials with two or more arms that compare our combination regimen of interest to PARP or an ICI alone. The presence of randomization, eligibility for randomized-controlled trial (RCT) status as well as COE was determined by three reviewers separately with disagreements settled by committee decision. Results: In total, we found 188 clinical trials that enrolled 39,268 patients. A minority of 17 trials were phase I not considered as RCTs, leaving 37,827 patients across 171 trials for enrollment in phase II trials and beyond. Of these 171 trials, 80 (47 %) were single-arm studies without active comparator. Forty-nine (29%) used randomized assortment, 40 (23%) met criteria for an RCT and 33 (19%) met criteria for RCT with COE. In total, these 33 trials enrolled 14,803 patients. Of the 33, 17 (10%) enrolled patients with cancers that are approved for PARP blockade by the FDA and 11 (6%) employed genetic testing for HRR defects. Sponsorship ranged from 16 trials by industry, 6 by cooperative oncology group, 6 by academic institutions and 5 by the National Cancer Institute. Conclusions: Our study results highlight that the global clinical trial apparatus directs significant resources and patients towards trials with lower standards of evidence generation. Across sponsor types, there was a considerable number of trials that met the rigor of an RCT with COE. These findings show both promise and areas of improvement within the trial landscape to generate evidence relevant to the use of PARP and ICIs in combination.
The impact of end-of-life quality metrics on date of death and hospice documentation over time.
Authors: Deepak Divya , Mills Lydia , Indurlal Puneeth , Turnwald Brian , Sun Jian , Weber Dana , Garey Jody S.
Published: June 2024

e23009

Background: Patient experience and quality of care at the end of life (EOL) have become increasingly important for Oncology providers with the shift to value-based care (VBC). Medicare VBC programs such as the Oncology Care Model (OCM) and Enhancing Oncology Model (EOM) encourage care transformation and use quality measurement to drive EOL quality improvements. Timely and accurate documentation allows practices to evaluate their own performance and continuously improve care transformation efforts. We studied documentation trends in the electronic health record (EHR) and compared them with Medicare claims to evaluate the impact quality metrics had on ensuring accurate practice documentation. Methods: Best practices were established, and continuous education was provided to enable capture and recording of key EOL data in the EHR beginning in July 2016. Patient level date of death (DOD) and hospice enrollment (HSP) data were provided by CMS during the OCM (July 2016 - June 2022) for 14 participating practices in The US Oncology Network (The Network). We obtained corresponding DOD and HSP data from the EHR and compared documentation trends between systems. Statistical analysis was performed for increasing/decreasing trends using the Mann Kendall test. Results: There were statistically significant increases in EHR DOD (19.37% increase, p value 0.02) and HSP (18.93% increase, p value 0.002) documentation from 2016 -2022. All practices had an average year over year increase of 16.40% in HSP documentation (range 11.94% - 18.93.%) and 16.24% increase in DOD documentation (range 6.49% - 19.37%). The median increase from 2016 to 2022 in documentation of DOD was 68% (range 37% - 92%) and HSP was 48% (range 12% - 83%) for all practices. Conclusions: As an epitome of the Hawthorne effect, EOL quality metrics drive clinical documentation improvements with DOD and HSP, further accelerated by continuous education and the establishment of best practices. Improved clinical documentation aids care transformation and quality improvement, creating a positive feedback loop. The impact of quality measurement on other structured and unstructured documentation in the EHR is apt for further exploration. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document. [Table: see text]
Examining global and gender disparities in high-impact evidence synthesis on lung cancer: A 2000-2024 analysis of Cochrane Library.
Authors: Bhat Vivek , Bellur Shreyas S , Kumar Abhishek , Kaushik Sharanya , Ozair Ahmad , Walia Harneet Kaur , Ahluwalia Manmeet Singh
Published: June 2024

e23021

Background: Most cancer-related deaths occur in low-middle-income countries (LMICs), yet LMICs are underrepresented in global oncology research. Women have also historically been underrepresented in clinical literature. High-impact evidence synthesis influences guidelines and practice worldwide, so equitable authorship can ensure that issues presented are applicable globally. The Cochrane Library is a repository of high-impact systematic reviews that can be authored from all over the world. So, we aimed to analyze the representation of LMICs and women in the authorship of lung-cancer-related Cochrane Reviews. Methods: From the topic 'Lung and Airways' in the Cochrane Library, we included all studies related to lung cancer, published till February 2, 2024. We extracted the authors’ national affiliations, categorizing them into LMICs and non-LMICs based on the 2023 World Bank income classifications. Collaboratives/ groups were considered as a single entity. Following this, we manually captured at least one webpage for each author showing their gender or gender pronouns. For authors whose gender could not be determined via manual search, we used Gender-API, an artificial intelligence-based software, to determine their gender based on their name and country. Authors with < 90% certainty of gender on Gender-API were categorized as unknown. Results: We included 42 reviews that had 233 authors, including three group authors. United Kingdom (22.32%; n = 52/233), followed by Australia (16.31%; n = 38/233), Spain (13.3%; n = 31/233), China (9.01%; n = 21/233) and France (6.87%; n = 16/233) were the most represented countries. There were no authors from LMICs. Manually, we ascertained gender for 85.04% (n = 194/228) of authors, and overall, for 94.74% (n = 216/228). Women constituted 42.6% (n = 92/216) of all authors. They were, however, better represented as first authors (50%; n = 19/38) and corresponding authors (54.05%; n = 20/37). Conclusions: Despite suffering the brunt of cancer, LMICs had no representation in lung-cancer-related Cochrane reviews. While authorship had a male preponderance overall, women were well represented as first and corresponding authors. Addressing authorship disparities in global oncology literature, via mentorship and capacity building, can improve its applicability and utilization.
Enrollment of older adults in clinical trials for oncology indications, 2010-2020: An evaluation by the FDA.
Authors: Yang Felice , Lerro Catherine C. , Feng Zhou , Akinboro Oladimeji , Curley Richard , Dilawari Asma Ali , Fiero Mallorie , Huang Yue , Ison Gwynn , Kanapuru Bindu , Leong Ruby , Liu Wei , Patel Timil , Suzman Daniel L. , Kluetz Paul Gustav , Singh Harpreet , Rivera Donna
Published: June 2024

e23029

Background: Underrepresentation of older adults (≥65 years) in clinical trials may limit important evidence for regulatory and clinical decision-making. Prior FDA analysis1 demonstrated underrepresentation of older adults in oncology clinical trials. With recent efforts to encourage inclusion of older adults, we evaluated representation in clinical trials using updated data. Methods: This analysis used patient-level data from pivotal trials supporting approvals of new drugs and biologics, and expanded indications from 2010-2020 for cancers with high incidence in the U.S. population and older adults: breast (BC), colorectal (CRC), non-small cell lung (NSCLC), prostate (PC), chronic myeloid leukemia (CML), and multiple myeloma (MM). Age distribution of trial participants compared to incident cases from the NCI SEER Program was analyzed using the Enrollment to Incidence Ratio (EIR). For each cancer-age group, EIR is the percentage of trial participants divided by percentage of incident cases. Previously established EIR categories of < 0.8, 0.80-1.20, and > 1.2 indicate under-, adequate, and over-representation, respectively. Results: The analysis included 86000 participants in 152 trials. Adults >65 yrs were underrepresented in BC trials. Adults >75 yrs were underrepresented in BC, CRC, NSCLC, CML, and MM trials (Table 1). Conclusions: Despite slight variation across cancers, adults >75 yrs appeared to be underrepresented in clinical trials, excepting PC. Given heterogeneity in the natural history by cancer site, incidence may not best represent age distribution of the intended use population for all trials. Further evaluation using prevalence as a comparator may provide additional insights. Additionally, results may be affected by clinical factors such as stage; however, comparison is limited by SEER data element availability. Planned sensitivity analyses such as stratification by drug class and line of therapy may further elucidate enrollment patterns. References: Singh H, Kanapuru B, Smith C, et al: FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. Journal of Clinical Oncology 35:10009-10009, 2017. [Table: see text]
Assessing the relevance and requirement of a prostate cancer passport: A patient-centric survey.
Authors: Aslam Razia , Shah Syed Muhammad Bilal , Hadi Danial , Mc Cann Aoife , Barron Emma
Published: June 2024

e23037

Background: Prostate cancer, a prevalent malignancy among men worldwide, necessitates a multifaceted approach to its management, encompassing diagnosis, treatment, and post-treatment care. The absence of a consolidated and accessible cancer information for prostate cancer patients prompts an exploration into the necessity and potential benefits of a dedicated Prostate Cancer Passport. This survey-based study seeks to elucidate patient perspectives and assess the demand for it. Methods: We Surveyed prostate cancer patients attending St James Hospital Medical Oncology OPD and day ward. The survey methodology integrated a diverse cohort of individuals representing varying demographics, encompassing age groups and socio-economic backgrounds. Questions were structured to gauge patient awareness, preferences, and perceived benefits associated with the adoption of a Prostate Passport. The survey was structured to gauge patient awareness levels regarding existing health record systems, preferences for a specialized Prostate Cancer Passport, and anticipated benefits associated with its implementation Furthermore, the survey seeked to elucidate potential concerns, barriers to adoption, and the anticipated impact on patient-provider interactions. Results: The survey’s findings indicate a significant interest among participants in the implementation of a specialized platform like the Prostate Passport, with more than 65% expressing enthusiasm about its potential benefits in improving healthcare management. However, 20% of patients reported not receiving any prostate cancer information booklet from their healthcare providers. Additionally, 30% of participants expressed dissatisfaction with communication with their medical team, while over 40% lacked confidence in their understanding of prostate cancer. Nevertheless, concerns related to data security were raised by more than 25% of patients, and approximately 23% identified potential barriers to adoption, such as interoperability with existing healthcare systems and ease of access across different healthcare settings. However, concerns regarding data security were highlighted by over 25% of patients and about 23% of patients identified interoperability with existing healthcare systems, and ease of access across various healthcare settings as potential barriers to adoption. Conclusions: The survey outcomes offer valuable perspectives on the distinct requirements and preferences of individuals facing prostate cancer. This data is crucial for customizing the Prostate Cancer Passport's design and functionalities to effectively cater to those needs. Our initial iteration of the prostate cancer passport has been completed and will be distributed to our oncology patients in the upcoming week. We plan to conduct a feedback survey in six months to gather insights and further enhance the passport based on user experiences.
CAR T-cell therapies: Measuring the growing need for increasing long-term safety protocols.
Authors: Faroun Yacoub , Winkelman Daniel F. , Gambone Nicholas , Angelastro Patrick
Published: June 2024

e23047

Background: The CAR T-Cell market has grown significantly over the last five years with six products in the U.S. market covering a range of cancer types (DLBCL, FL, MCL, MM, ALL). The number of transplant centers certified for CAR T-Cell administration has also grown from 142 centers in Q4 2020 to 200 in Q4 2023. The FDA is currently investigating the safety of CAR T-Cell therapies due to the threat of secondary malignancies. CAR T-Cell patients are treated at advanced treatment centers but after they have completed therapy, they are often referred back to their original specialist for long-term monitoring. The purpose of this research is to measure if referring Oncologists have the information required to safely manage CAR T-Cell patients. Methods: This study followed market research best practices. The study was based on a survey of the BrandImpact panel of Oncologists who refer patients and a CAR T-Cell Panel of Oncologists who administer CAR T-Cell therapies. Results: The majority of referring Oncologists (61%) report they could use more information about CAR T-Cell therapies. When asked on an unaided basis what type of information they require, the most common request was for additional safety information (57%). At the same time, one-third of Oncologists treating CAR T-Cell patients at the advanced centers feel that there needs to be improved knowledge of the long-term safety aspects of CAR T-Cell therapies. When they resume monitoring CAR T-Cell patients, they would like to better understand the relevant long-term side effects and how they differ from the short-term side effects. Conclusions: Oncologists who refer CAR T-Cell patients report that they need more information; mainly around safety/side-effects. Of the Oncologists administering CAR T-Cell therapies, one-third feel there needs to be improved knowledge of the long-term safety issues. Consideration should be given to improving the level of educational information provided on this topic to improve CAR T-Cell patient outcomes. [Table: see text]