bluuebunny/crossref_metadata_2025 huggingface dataset:
Quality of end-of-life care for patients with multiple myeloma: A 12-year analysis of a population-based cohort.
Authors: Mohyuddin Ghulam Rehman , Sinnarajah Aynharan , Gayowsky Anastasia , Chan Kelvin K. , Seow Hsien , Mian Hira
Published: June 2022

12031

Background: Despite treatment advances, multiple myeloma (MM) remains a significant source of morbidity and mortality. The end of life for patients with MM has not previously been examined within the context of a population-based cohort in a publicly funded health system. Methods: We retrospectively analyzed patients with death attributable to MM between 2006-2018 using ICES linked databases in the public health care system in Ontario, Canada. Aggressive care was defined as two or more emergency department visits in the last 30 days before death, at least two new hospitalizations within 30 days of death, or an ICU admission within 30 days of death. Supportive care was defined as physician house call 2 weeks before death, or a palliative nursing or personal support visit at home in last 30 days before death. Multivariable logistic regression models were used to assess for factors predisposing to aggressive or supportive care. Patients were stratified based on receipt of autologous stem cell transplant (ASCT). Results: In total, 5095 patients were included (Table). Overall, 23.2% of patients received chemotherapy in last two weeks of life and 55.6% of patients died in the hospital. Most patients were admitted to hospital within the last 30 days of life (73.4%:ASCT cohort, 61.4%:non-ASCT cohort). A minority received aggressive care at end of life (28.3%:ASCT cohort, 20.4%:non-ASCT cohort), and a majority received supportive care at end of life (65.4%:ASCT cohort, 61.5%:non-ASCT cohort). Multivariate regression models showed that patients ≥ 80 years (compared to 60-69) were less likely to receive aggressive care (OR=0.54, 95% CI=0.42-0.68), and those with residence in smaller size community of < 10,000 were more likely to receive aggressive care (OR=1.89, 95% CI=1.5-2.4). Supportive care was significantly less likely to be received by patients (OR=0.72, 95% CI= 0.59 to 0.88) and more likely to be received by patients aged 18-49 (OR=1.9, 95% CI=1.2-3.1). Neighbourhoods with lowest income quintiles (OR=0.65, 95% CI=0.53-0.78) were less likely to receive supportive care. When trended over time, patients receiving supportive care at end of life increased (56.0% in 2006 to 70.3% in 2018). Conclusions: We demonstrate that despite improvements over time, a substantial number of patients with MM experience aggressive care and hospitalizations at the end of life. Despite this being a publicly funded system, disparities in end-of-life care based on age, income and area of residence are present.[Table: see text]
Nurse navigator–initiated geriatric assessments in hematology/oncology clinics.
Authors: Shaia John L. , Liu Raymond , Sun Hongxin , Kolevska Tatjana , Kotak Dinesh , Belohlav Kate , Williams Grant Richard , Arora Amit
Published: June 2022

12051

Background: As the number of older adults with cancer continues to grow, there is an urgent and unmet need to implement geriatric assessments and toxicity screening tools (G8 and CARG toxicity tool) for patients 65 and older with a cancer diagnosis in real-world settings. Studies of these tools show completion rates of 20-35% when administered by a physician. To determine if nurse navigators could increase completion rates, we implemented a pilot in seven community cancer centers within an integrated health system. Methods: A pilot project of G8 and CARG toxicity tool implementation was completed at seven community cancer centers from May 1,2021 to December 31,2021 in patients age ≥ 65 years, with solid or malignant hematologic cancer diagnosis. G8 was administered at seven sites and CARG was assessed in addition to G8 on solid tumor patients undergoing chemotherapy at four of the seven sites. Referrals to nutrition, audiology, physical therapy, psychiatry, and neurology were sent by nurse navigators based on assessment results. Results: The total number of eligible patients for G8 was 1372, with 1082 (78.9 %) successfully completing assessment, and the total number of eligible patients for CARG toxicity tool was 563 with 516 (91.6%) successfully completing assessment. The median age of patients completing assessment was 74 years old (range 65-100) and 52% were female. The cohort included Asian / Pacific Islanders (23%), Black (15%), Hispanic White (8%), and Non-Hispanic Whites (51%). Most common cancers included genitourinary cancer (18%), breast cancer (17%), upper GI cancer (15%), and thoracic cancer (13%). The assessments resulted in referrals to multiple services including nutrition (193 referrals), audiology (30), physical therapy (18), psychiatry (5), and neurology (5). Conclusions: Nurse navigators can successfully implement G8 and CARG toxicity tool in hematology-oncology clinics in a broad range of cancer types at a high rate with resultant referrals to multiple supportive services in real-world settings.
Lymphedema therapy referral is associated with improved understanding of lymphedema prevention among breast cancer survivors.
Authors: Klugman Madelyn , Patil Sujata , Finik Jackie , Kuo Ting-Ting , Eberle Carolyn E. , Pinkhasov Alexandr M. , Gillis Theresa , Gany Francesca , Blinder Victoria Susana
Published: June 2022

12069

Background: Lymphedema is common among breast cancer survivors (BCS) and negatively affects quality of life. There are modifiable factors to reduce lymphedema risk and exacerbation; it is unknown how aware survivors are of these factors. We hypothesized referral to lymphedema therapy (LT) to be associated with improved lymphedema knowledge. Methods: BCS were approached during follow-up visits at an NCI-designated cancer center between 2014-2015 and asked to complete an anonymous survey. Eligibility criteria: age ≥18, English-speaking, > 6 months post-surgery, no cancer recurrence, no prior or subsequent second cancer. Surveys included 10 true/false questions to assess beliefs of common lymphedema misconceptions and questions about sociodemographics, cancer treatment, and prior LT referral. Charts were reviewed to determine history of axillary lymph node dissection (ALND) or sentinel node biopsy (SLNB). Multivariable logistic regression assessed the relationship between prior LT referral and correctly answering questions about lymphedema misconceptions. Results: Of 209 participants, 67% identified as non-Latinx white, 13% Black, 10% Latinx and 8% Asian. 53 (25%) had been referred to LT. Those who had SLNB were less frequently referred to LT [15 (14%)] than those who had ALND [38 (39%)]. There were 5 lymphedema knowledge questions with < 80% correct responses (Table). Those previously referred to LT more often correctly answered the questions about weight gain and using the arm on an airplane than those not referred (chi-2: p <0.01 and p < 0.01), but they were less likely to answer correctly about carrying > 10 lbs or strenuous activity at work (p < 0.01 and p = 0.02, respectively) (Table). These associations remained in multivariable analyses, other than strenuous work activity (Table). Conclusions: We identified several misconceptions regarding lymphedema among BCS. LT referral is a potential opportunity to debunk common misunderstandings regarding lymphedema risk reduction; providers should have a low threshold to refer patients. Lymphedema therapists teach progressive exercise strategies, which may have inadvertently caused participants to think they should avoid carrying objects > 10 lbs.[Table: see text]
Time for paying attention to fluoropyrimidine-associated cardiotoxicity: A pooled data analysis for epidemiology based on 60537 cases.
Authors: Lu Yajie , Long Zuoyao , Pan Wei , Deng Shi-Zhou , Dou Qiong-Yi , Wang Xiang-Xu , Wang Zhen , Zhang Hong-Mei
Published: June 2022

12071

Background: With the rise of cardio-oncology discipline, treatment-related cardiotoxicity has become a growing concern. However, fluoropyrimidine induced cardiotoxicity has been underestimated for a long time. The aim of this study was to comprehensively investigate the incidence and profiles of the cardiotoxicity associated with fluoropyrimidine using a pooled data meta-analysis. Methods: A systematic literature review was performed using PubMed, Embase, Medline, Web of Science, Cochrane library databases and clinical trials on studies published between the establishment of each database and March 31, 2021, investigating fluoropyrimidine associated cardiotoxicity (FAC). The main outcome was pooled incidence of FAC, and the secondary outcome were specific treatment-related cardiac AEs. Random-effects or fixed-effects modeling was used for analyses according to the heterogeneity assessed by Cochran’s Q test. Subgroup analysis and meta-regression were conducted to explore the source of heterogeneity, and the incidence of FAC was compared among different clinical characteristics. The protocol was registered in PROSPERO (No. CRD42021282155). Results: Two hundred and six studies involving 60537 patients were included in this meta-analysis, covering 31 countries or regions in the world. The pooled incidence of FAC was 5.18% (95% CI 4.32%-6.10%) for all grade and 1.5% (95% CI 1.09%-1.96%) for grade 3 or higher. A total of 0.29% of patients died from severe cardiotoxicity. Cardiac ischemia and arrhythmia were the two most common cardiac AEs, occurring in 2.31% (95% CI 1.70%-3.00%) and 1.69% (95% CI 1.08%-2.42%) of patients, respectively. ECG alterations occurred in 5.85% (95% CI 3.4%-8.9%) of patients, indicating asymptomatic ECG alterations in a subset of the population. The incidence of cardiotoxicity varied among different regions, gender, cancer types and treatment regimens. Studies conducted in Asia outlined a significant higher pooled incidence of FAC than in Europe (χ2 = 4.47, p = 0.03) and America (χ2 = 4.49, p = 0.03). Female population had a lower pooled incidence than general population (χ2 = 9.90, p= 0.01). The highest pooled incidence was observed in esophagus cancer (10.53%, 95% CI 5.8%-16.35%), and the lowest occurred in breast cancer (3.66%, 95% CI 2.4%-5.12%). In addition, combination therapy, high cumulative dose, anthracycline addition, and pre-existing cardiac disorder significantly increased the risk of FAC ( p< 0.05). No obvious publication bias was detected by funnel plots and Egger’s test (p < 0.05), and the stability of our results was confirmed by the sensitivity analysis. Conclusions: FAC is not a rare condition during treatment containing fluoropyrimidines. Our results provide comprehensive global data on epidemiology of FAC, potentially representing an important reference on cancer management in clinical practice.
An open-label, randomized, controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.
Authors: Lagampan Chalita , Teeyapan Nattaya , Poovorawan Nattaya , Sitthideatphaiboon Piyada , Parinyanitikul Napa , Vinayanuwattikun Chanida , Sriuranpong Virote , Tanasanvimon Suebpong
Published: June 2022

12099

Background: Hypersensitivity reaction (HSR) is a common toxicity in patients receiving repeated oxaliplatin. Oxaliplatin induced HSR could be severe and results in treatment discontinuation. There is no standard recommendation for prevention of oxaliplatin induced HSR. Methods: We conducted a prospective, single center, open-label, randomized controlled trial comparing the standard premedication and 2-hour infusion protocol to the additional antihistamine premedication, intravenous chlorpheniramine, and 3-hour infusion protocol. After three months of chemotherapy, the randomization was done at 5thand 7th cycles of 3-week and 2-week oxaliplatin based regimens, respectively. The primary endpoint was the incidence of HSR. Results: From July 2020 to March 2021, a total of 160 patients underwent randomization (80 patients in both intervention and control groups). After 11 months follow-up, all patients had completed planned treatment cycles. HSRs occurred in 1 (1.3 %) and 10 (12.5%) patients in intervention and control groups, respectively, p = 0.005). There were 6 (7.5%) patients with more than grade 1 HSRs in control groups, but none in intervention group. In the intervention group, one patient with HSR experienced grade 1 erythema and palpitation. There is no report of significant adverse event from anti-histamine premedication or oxaliplatin infusion prolongation. Conclusions: Additional antihistamine premedication and infusion prolongation started in 2nd half of treatment course can significantly reduced HSR incidence in patients receiving oxaliplatin. Clinical trial information: TCTR20210506001.
Racial differences in interest and use of integrative medicine among patients with breast cancer.
Authors: Sheade Jori , Freeman Jincong Q. , Zhao Fangyuan , Olopade Olufunmilayo I. , Huo Dezheng , Nanda Rita
Published: June 2022

12101

Background: Breast cancer treatment can be associated with side effects (SEs) that negatively impact quality of life. While some SEs can be treated with medications, such interventions come with additional SEs. Acupuncture, massage, meditation, music therapy and yoga have received ASCO endorsement for the management of therapy-related SEs. Many patients are interested in integrative services, but little is known about racial differences in interest and use of integrative services among patients with breast cancer. Methods: Breast cancer patients enrolled in the Chicago Multiethnic Epidemiologic Cohort study were sent a survey regarding their interest and use of five integrative services: acupuncture, massage, meditation, music therapy and yoga. Participants were asked how interested they would be in these services if offered, using a five-point Likert scale. Prior use was self-reported. Proportional odds were modeled for “interest” and binary logistic regression was modeled for “self-reported use.” Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were calculated, controlling for age, education, marital status, household income, insurance, Carlson comorbidity index, molecular subtype and stage. Results: 1,300 patients responded to the survey, 928 White and 285 Black. Compared with White patients in this cohort, Black patients were less educated, had a lower household income, were more likely enrolled in Medicaid/Medicare, and had a greater Carlson comorbidity index. Over 97% of patients had stage 0-III breast cancer. While there was no difference in interest in acupuncture between Black and White patients (aOR 1.1, 95% CI 0.8-1.7), Black patients were significantly more interested in the use of massage (aOR 1.9, 95% CI 1.3-2.8), meditation (aOR 2.0, 95% CI 1.4-3.0), music therapy (aOR 2.7, 95% CI 1.8-4.0) and yoga (aOR 2.1, 95% CI 1.4-3.1). Black patients were significantly less likely than Whites to report acupuncture use (aOR 0.5, 95% CI 0.3-0.8); but there were no racial differences in self-reported use of massage (aOR 0.8, 95% CI 0.5-1.3), meditation (aOR 0.8, 95% CI 0.5-1.4), music therapy (aOR 1.7, 95% CI 0.8-3.3) and yoga (aOR 0.7, 95% CI 0.4-1.2). Conclusions: Black patients with breast cancer expressed more interest in integrative services than their White counterparts; there were no racial differences in self-reported use of integrative services except an increased use of acupuncture among White patients. A breast program focused on equity should provide access to these resources for all patients. Interest and self-reported use of integrative services among patients with breast cancer, by race. [Table: see text]
Efficacy of a nurse monitoring service at preventing disease- or therapy-related symptoms in patients receiving targeted therapy or immunotherapy.
Authors: Sbrana Andrea , Antonuzzo Andrea , Ripamonti Carla Ida , Roila Fausto , Santini Daniele , Fabi Alessandra , Ermacora Paola , Numico Gianmauro , Barbara Raffaele , Coletta Deborah , Velutti Laura , Corsi Domenico C. , Berruti Alfredo , Mariani Gabriella , Bossi Paolo ,   On behalf of NICSO Network Italiano Cure di Supporto in Oncologia
Published: June 2022

12118

Background: The safety profile of Targeted therapies (TT) and immunotherapy (IT) may be underestimated and negatively affect the clinical outcome. Methods: A nationwide, randomized, open-label trial (NCT04726020) conducted among 29 Italian centers involved two cohorts of 223 adult patients (pts) with a solid tumor, receiving TT (group B, 119 pts) or IT (group C, 104 pts). Pts were randomized to receive a weekly nurse monitoring phone call, together with an educational leaflet with some practical advice about toxicities (experimental arm), or only the educational leaflet (control arm). In the experimental arm, pts received their monitoring phone call before their treatment began, then every week for up to 16 weeks of treatment were completed. The primary objective was the evaluation of the difference in toxicities according to patient-reported outcome (PRO)-CTCAE. Results: Both arms were comparable in terms of pts’ characteristics (e.g. site of primary tumor, line of treatment). The adherence to the project (that is the completion of every expected call) was 62.1% in group B and 66.9% in group C. In group B, in the experimental arm, we found a higher number of pts without pain (53.7 vs 39.9%, p = 0.047); a trend of lower fatigue (29.2 vs 18%, p = 0.067) was also observed. In group C, a higher number of pts did not report fatigue (29.1 vs 17.5%, p = 0.043), shortness of breath (61.4 vs 38.5%, p = 0.002) or dry skin (72 vs 52.3%, p = 0.004). More pts also referred to be without pain (51.6 vs 38.8%, p = 0.065) and pruritus (75.9 vs 64.5%, p = 0.088), even if these difference were not statistically significant. Conclusions: The use of PRO assessment through active nurse monitoring might lead to a better tolerance of TT and IT with possible implications on pts’ quality of life and ultimately on treatment outcome. In particular, in the IT group, several symptoms were prevented from occurring, thus encouraging a major effort to implement such active monitoring in this population. Clinical trial information: NCT04726020.
Impact of an augmented intelligence-based tool upon the timeliness of referrals to palliative care and hospice in patients with advanced cancer in the real-world setting.
Authors: Gajra Ajeet , Jeune-Smith Yolaine , Balanean Alexandrina , Ellis Amy R. , Miller Kelly A. , Showalter John , Bergman Danielle , Blau Sibel
Published: June 2022

12127

Background: Timely integration of palliative care (PC) and hospice management for patients with advanced cancer requires informed clinical decision-making and expectation-setting to help patients realize their end-of-life (EOL) goals. Longer stay with hospice is a quality indicator in oncology care that requires earlier referral to PC and hospice. We have previously demonstrated that an augmented intelligence (AI) tool used to predict 30-day mortality can assist with an increase in referrals to PC and hospice. In this secondary analysis, we report on the impact of the AI tool on the timeliness of referral to PC and hospice prior to death. However, calculating days with hospice across multiple hospice providers and geographies can be challenging. Thus, we used a real-world (RW) measure of 14 to 90 days prior to death as a surrogate for timeliness for hospice and 90 to 180 days prior to death for a PC referral. Methods: Medical records of patients at a large community-based hematology/oncology practice in the Pacific Northwest who experienced a mortality event pre-deployment (January 2017 to April 2018) or post-deployment (May 2018 to June 2021) of the AI tool were electronically reviewed for evidence of a PC or hospice referral. Patients were included if the referral was between 14 to 90 days of the mortality event for hospice care or between 90 to 180 days prior to death for PC. Outcomes for additional timepoints (1-3 days and 4-13 days and >90 days) will be provided at the final presentation. Data were analyzed using a statistical process control chart. Results: Of the patients who experienced a mortality event, the following percentages had been referred pre- and post-deployment of the AI tool: PC 7.1% pre- and 15.0% post-deployment; hospice 11.5% pre- and 32.1% post-deployment. A system shift (≥6 points in a row steadily increasing or decreasing) occurred early after deployment, in June 2018. The overall improvements were 111.0% in PC referrals and 179.1% in hospice referrals within the respective timeframes. Conclusions: Deployment of an AI tool at a hematology/oncology practice substantially increased the proportions of patients referred to PC 90-180 days prior to death and hospice between 14 -90 days prior to death, suggesting a favorable impact on timeliness of referrals. If confirmed in additional studies, the AI-based tool can be utilized to integrate PC early in the management of patients with advanced cancer.[Table: see text]
Can personality feedback improve the process of self-management in cancer? Results from a randomized controlled trial.
Authors: Perry Laura M , Mossman Brenna , Rochefort Catherine , Walsh Leah E , Lewson Ashley B , Hoerger Michael
Published: June 2022

12130

Background: Although personality characteristics predict emotional and physical quality of life in cancer, personality assessments are rarely used to inform care. This study examined whether a personality feedback intervention improved three patient-reported outcomes underlying the process of cancer self-management: 1) self-awareness, 2) self-efficacy for managing symptoms, treatment/medication, and emotions, and 3) positive affect. Methods: A sample of 372 adults with a history of cancer participated in a single-session, pre-post randomized controlled trial via Qualtrics (Control n= 188, Intervention n= 184). The sample was recruited online through ResearchMatch.org and cancer social media sites. Participants completed a baseline survey of demographics, Big Five personality traits, and study outcomes using validated measures. Next, they were immediately randomized to receive either intervention or control materials, followed by a post-test of study outcomes. Intervention participants received a feedback report of their personality results and tailored self-management tips, while control participants received only a general description of the Big Five personality traits. Three general linear models tested between-group differences in changes from baseline to post-test on each outcome, while controlling for baseline scores and demographic and health characteristics. Significance thresholds for all coefficients across all three models were simultaneously adjusted for a false discovery rate of 15%. Intervention participants also responded to a 5-item acceptability scale. Results: Participants were mostly non-Latino/a White (91%), middle-to-older aged ( M= 58.40, SD= 13.56), women (72%), and diagnosed with cancer an average of 6.06 years prior ( SD= 3.91). Compared to controls, intervention participants experienced a greater increase on a composite measure of self-efficacy for illness self-management ( d= 0.32, p=.002), as well as on the individual domain of self-efficacy for managing symptoms ( d= 0.36, p<.001). Contrary to hypotheses, the intervention did not improve self-awareness or positive affect ( ps ≥.132). Intervention participants rated the activity’s acceptability a mean of 3.97 ( SD= 0.68) on a scale from 1 to 5. Conclusions: This was the first study to demonstrate that a personality feedback intervention can improve self-efficacy in the context of managing a chronic illness. Findings call for follow-up studies to test whether these results translate into improved self-management behaviors and quality of life among individuals living with cancer. Clinical trial information: NCT04625439.
Disparities in NCI and nonprofit organization funding and effect on cancers with high incidence rates among Black patients and mortality rates.
Authors: Kamath Suneel Deepak , Chen Yanwen
Published: June 2022

1509

Background: National Cancer Institute (NCI) and nonprofit organization (NPO) funding is critical for research and advocacy, but may not be equitable across cancers or racial and ethnic groups. Methods: This study evaluated funding from the NCI and NPOs supporting lung, breast, colorectal, pancreatic, hepatobiliary, prostate, ovarian, cervical and endometrial cancers, leukemia, lymphoma and melanoma from 2015-2018. The primary objectives were to assess for disparities in NCI and NPO funding across different cancers compared to their incidence and mortality and their incidence rates across age, racial and ethnic groups. We also investigated if underfunding correlates with fewer clinical trials. Correlations between NCI and NPO funding for each cancer and its incidence, mortality and number of clinical trials were analyzed using scatter plots and Pearson correlation coefficients (PCCs). Results: Diseases with the largest combined NCI and NPO funding were breast cancer ($3.75 billion) and leukemia ($1.99 billion). Those with the least funding were endometrial ($94 million), cervical ($292 million), and hepatobiliary cancers ($348 million). Disease-specific funding correlated well with incidence, but correlated poorly with mortality (PCCs: 0.74, p = 0.006 and 0.30, p = 0.346, respectively). Breast cancer, leukemia and lymphoma were consistently well-funded, while colorectal, lung, hepatobiliary and uterine cancers were consistently underfunded. These data are summarized in the Table. NCI and NPO funding increased proportionately as incidence increased for White patients (PCC: 0.73, p = 0.007), Hispanic patients (PCC: 0.66, p = 0.02), Asian/Pacific Islanders (PCC: 0.77, p = 0.003) and Native Americans and Alaskans (PCC: 0.72, p = 0.008) while cancers with higher incidence in the Black population were underfunded (PCC: 0.52, p = 0.08). The amount of combined NCI and NPO funding for a particular cancer correlated strongly with the number of clinical trials for that disease (PCC: 0.91, p < 0.0001). Conclusions: Many cancers with high incidence and mortality are underfunded, including those with higher incidence among Black patients. Underfunding strongly correlates with fewer clinical trials, which could impede future advances in underfunded cancers. [Table: see text]
Time on treatment is prolonged in patients utilizing an ePRO based digital symptom monitoring platform in the community setting.
Authors: Parrinello Christina , Calkins Geoffrey , Kwiatkowsky Lavi , Schaefer Eric S. , Beck J. Thaddeus , Ellis Amy R. , Blau Sibel , Telivala Bijoy Pankaj , Kolodziej Michael A.
Published: June 2022

1528

Background: Earlier and more effective management of cancer-related symptoms and treatment-related toxicities might improve the survival of patients receiving systemic anti-cancer therapy. One potential mechanism for improved outcomes could be prolonging time on therapy. We have previously reported on the successful real-world implementation of an electronic patient-reported outcomes (ePRO) tool in a community oncology practice. We now report on the impact of the tool on time on therapy for common anti-cancer treatments. Methods: We evaluated time on treatment across three community oncology practices that have implemented Expain, an EMR-integrated ePRO system which enables remote symptom monitoring during therapy. We compared drug-specific cohorts of patients that had been enrolled on the ePRO tool with a concurrent cohort of patients not enrolled on the ePRO platform. We examined time on treatment using a Kaplan Meier (KM) approach. Analysis was confined to patients with no prior administration of the parenteral therapeutic agent or a 90-day treatment-free washout period; and to patients with at least three months of potential follow-up. Analysis was only conducted for drugs with at least 80 patients in the Expain arm. Results: In each drug-specific cohort, the distribution of age, sex, and primary cancer diagnosis was similar in patients enrolled vs not enrolled on the ePRO (Mann-Whitney and Chi-square p > 0.05 except for the rituximab cohort which had more males in the ePRO cohort [67 vs 52%]). The impact of the ePRO-based symptom monitoring system on time on therapy was statistically significant for 5 agents. Conclusions: We confirm in the community setting the observation that digital symptom monitoring can increase time on therapy. We believe this is due to more effective management of treatment related toxicities, as well as more effective management of malignancy related or comorbid medical emergencies which might interrupt or lead to the discontinuation of therapy. We are evaluating the robustness of these results after using various methods to address any potential non-comparability of the cohorts. We are also examining the impact of prolonging time on treatment on survival. [Table: see text]
Applicability of a web app for lung cancer risk calculation and personalized recommendations for screening in Mexico.
Authors: Muñoz Lozano Jose Felipe , Oyervides Victor , Salazar-Mejía Carlos Eduardo , Zayas Omar A. , Vidal-Gutiérrez Oscar , Pineiro-Retif Rafael , Pérez-Ibave Diana Cristina , Gomez Ricardo Andres , Garza Brenda , Renteria Larisa
Published: June 2022

1548

Background: Lung cancer screening continues to be an area of great opportunity in public health, especially in developing countries. In Mexico, about 10,000 new cases of lung cancer are detected annually, of which less than 5% are diagnosed in early stages. There are no national programs for timely detection of lung cancer in our country, so it is essential to seek accessible measures to prioritize resources for high-risk people. Methods: We developed a web app that consisted of a short survey to stratify patients according to their risk of lung cancer (https://cuccuanl.com/tamiz_pulmon/). The questions were based on Nelson's criteria to categorize high-risk subjects who are deemed candidates for screening. The program contained automated logic programmed using JavaScript to guide people to the low or high-risk page if they met standard risk criteria in those age 50 and older. The high-risk page alerted people of their risk, displaying general information about lung cancer as well as contact information to make an appointment at our cancer center. An appointment could be also scheduled within the app if the person so wished. The web app was launched and distributed through social media. Results: After a period of 2 months, 939 people completed the survey. The median age of the responders was 40 years, and 61% were men. Of the total, 185 participants were 50 years of age or older. 268 people (29% of the total) were sent to the high-risk page, including persons under 50 years of age with symptoms highly suggestive of lung cancer. According to their smoking status, 80% of the subjects reported active smoking, while 9% reported heavy smoking, considered as more than 20 pack-years. Among all the people evaluated, 44 high-risk subjects scheduled a specialized medical appointment within the web app. Conclusions: This pilot study showed a high response of Mexican population seeking lung cancer risk evaluation, especially among the persons who smoke regularly. The use of web apps can result in mass diffusion which will help reach people with less medical access, a common scenario in many developing countries. Further analysis should be made to measure the real impact on lung cancer diagnosis and oncological outcomes. Our study shows how effective social media is as a means of diffusion on health topics. [Table: see text][Table: see text]
Performance of an artificial intelligence-based annotation algorithm for reporting cancer genomic profiling tests.
Authors: Kage Hidenori , Aoki Takashi , Shinozaki-Ushiku Aya , Watanabe Kousuke , Akiyama Nana , Isago Hideaki , Ishigaki Kazunaga , Odawara Nariaki , Sato Yusuke , Sasaki Kazuhito , Tanaka Shota , Tanikawa Michihiro , Kato Motohiro , Tanabe Masahiko , Tatsuno Kenji , Ushiku Tetsuo , Miyagawa Kiyoshi , Nishimura Kunihiro , Aburatani Hiroyuki , Oda Katsutoshi
Published: June 2022

1551

Background: Cancer genomic profiling (CGP) tests have been approved in Japan since June 2019, with the requisite that all test results be discussed by molecular tumor boards (MTBs). More than 20,000 patients in over 200 designated hospitals have taken CGP tests by December 2021. As CGP tests have entered clinical practice, streamlining decision making by MTBs and standardizing interpretation of test results and treatment recommendations have become urgent issues. Here, we evaluated the utility of Chrovis, an annotation algorithm for reporting CGP tests to support MTBs make their recommendations. Methods: We retrospectively reviewed the reporting process of all approved CGP tests done at The University of Tokyo Hospital between December 2019 and November 2021. Chrovis provided annotation for each genetic variant by incorporating biologic, clinical, and therapeutic information by referencing several public knowledge databases and using natural language processing, and generated reports using the automated program. The MTB reviewed and made any necessary changes before finalizing the report. Changes in disclosure of germline findings were made according to the recommendations of a national guideline with consideration of past and family history. Results: Of the 243 tests, 91 changes in 81 Chrovis reports (33% of all reports) were made by the MTB. The most common type of change was germline disclosure with 26 changes (29%), followed by clinical trial information in Japan (18 changes, 20%) and recommendation of the patient-proposed national basket trial with multiple targeted agents (17 changes, 19%). Changes in germline disclosure increased from June 2021, when an update to a national guideline was released, while the proportion of changes in the latter two types remained unchanged. Gene alterations that led to the highest number of changes was TP53, with 13 changes. Changes in therapeutic recommendations were frequently observed in the RAS/MAPK pathway ( BRAF, KRAS, NF1, NRAS) with 12 changes. More changes were required with a tumor-only tissue CGP panel (57 of 149) compared with a matched tumor/normal tissue CGP panel (24 of 94, p = 0.04), mostly due to germline disclosure (24 vs. 2 changes). Conclusions: We observed that automated algorithm-based reporting was sufficient in 67% of reports. Recommendation for germline disclosure still requires manual supervision, particularly with tumor-only tissue CGP panels if algorithms do not incorporate medical history. The process of recommending clinical trials needs improvement, e.g., standardizing database formats for inclusion and exclusion criteria.
Machine learning models for accurate pretreatment prediction of chemotherapy associated LV dysfunction in patients with breast cancer and lymphoma receiving chemotherapy (WF-98213 PREVENT and CCCWFU9912 DETECT IV).
Authors: Shyamsunder Suditi , D'Agostino Ralph , O'Connell Nathaniel S. , Ladd Amy , Weaver Kathryn E. , Lesser Glenn Jay , Hundley William Gregory , Hackney Mary Helen , Melin Susan Anitra , Ge Yaorong
Published: June 2022

1553

Background: Cancer survivors receiving potentially cardiotoxic chemotherapy are at increased risk for developing left ventricular (LV) dysfunction. We implemented machine learning (ML) models to predict future LV dysfunction in patients with breast cancer or lymphoma scheduled to receive potentially cardiotoxic chemotherapy. Methods: We utilized prospectively collected data from NIH studies R01HL118740 (supported by the Wake Forest NCORP Research Base (UG1CA189824)) and R01CA167821. Data included measurements of LV function and demographic factors before, during, and 24 months after initiating potentially cardiotoxic chemotherapy. The two datasets were used both separately and collectively in the development of multiple ML models including penalized linear regression, support vector machine, and random forest (RF). A data preprocessing step properly handled missing information, data imbalance, and encoding. Hyperparameter tuning was performed using cross validation of training data. The final models were assessed with a 20% hold-out test dataset. Cardiotoxicity was defined as a pre- to 24-month post cancer treatment decline in LV ejection fraction (LVEF) of > 10% or to an absolute value of < 50%. Results: 276 patients were included in ML models (7% men, 93% women; age 52±13 years). The RF model based on the combined dataset had the best performance with a prediction accuracy, sensitivity, and specificity of 0.94, 0.81, and 0.98, respectively. The most important variables assessed pre-treatment as measured by the Gini impurity factor were in descending order, LVEF, global LV circumferential strain, LV end-systolic volume, body mass index, LV stroke volume, LV end-diastolic volume, and LV mass. Conclusions: Prior to cancer treatment, supervised ML methods such as RF models predicted declines in LVEF of > 10% and/or to absolute values below 50% would occur 24 months after initiating chemotherapy for breast cancer or lymphoma. With further improvement and validation using larger datasets, these models may play an important role in cardio-oncology care during and following cancer treatment.
Clinical development of new drugs for adults and children with cancer in 2010-2020: Longitudinal study of investigational drugs.
Authors: Arfe Andrea , Narang Claire , DuBois Steven G. , Reaman Gregory H. , Bourgeois Florence
Published: June 2022

1563

Background: Many investigational drugs start clinical testing to evaluate potential therapeutic benefits for oncology patients, but few eventually receive FDA approval. Moreover, only a small number is evaluated in pediatric populations, potentially contributing to the paucity of new approved drugs for young patients with cancer. Limited information is available on the development pipeline of investigational drugs, including the range of drug types entering clinical trials, trial phases at which development stalls, or rate of regulatory approval. To inform current clinical development efforts, we characterized the development and outcomes for a comprehensive sample of New Molecular Entities (NMEs) that started clinical testing worldwide in 2010-2015. Methods: We performed a longitudinal study using AdisInsight, a commercial database of global pharmaceutical research and development. This is a comprehensive database of drug development activity, which collects and curates data from trial registries, conference proceedings, journal publications, and press releases. Using these data, we identified all NMEs starting their first clinical trial for an oncology indication in 2010-2015. We followed each NME from the start of its first phase I trial to the end of 2020, and identified all associated trials, final development status, and FDA deliberations. We classified trials as pediatric-eligible if patients aged < 18 years were eligible for participation. We used the Drugs@FDA website to identify all FDA actions, including marketing approvals and requests for pediatric trials under pediatric programs (i.e. BPCA requests or PREA requirements). Results: A total of 572 NMEs started initial phase I clinical trials in 2010-2015. Among these, the most studied classes were small molecules (N, %: 316, 55%), antibodies (148, 26%), and antibody-drug conjugates (44, 8%). Overall, the NMEs were studied in 6,141 clinical trials by the end of 2020, with a median of 3 trials per NME. The highest pre-approval development phase reached by an NME was phase I for 325 (57%), phase II for 153 (27%), and phase III for 94 (16%). Only 39 NMEs (7%) were approved by the FDA by the end of 2020. Among approved NMEs, the median time (range) from start of first phase I trial to date of first approval was 6 (3-10) years. Among all NMEs, only 67 (12%) were tested in pediatric-eligible trials by the end of 2020, and 5 (< 1%) were approved for use in selected pediatric populations. Three of these had been subject to BPCA requests, and all had PREA requirements waived. Conclusions: More efficient clinical development strategies are needed to accelerate the production of new cancer therapies, especially for children. Analyses such as this one should be conducted regularly to help identify areas in need of innovation and to assess the potential impact of regulatory initiatives (e.g. the RACE act, effective since August 2020).
Mobile app in oncology: A pilot survey on Latina patients with gynecological cancers and their perception on utilizing a mobile app.
Authors: Ramirez Paulina , Toy Eugene Patrick , Lababidi Suzanne , Greenberg Harvey , Bracamontes Christina , Jones Angela , Mulla Zuber D. , Brown Jennifer L.
Published: June 2022

1571

Background: Mobile applications have changed the way that users access information and revolutionized healthcare by allowing patients to educate themselves regarding their diagnosis and treatment. Challenges in developing a mobile health application include patient satisfaction and usage over time. Barriers to usage include trust, personalization, and accessibility. Investigating the patient population’s preferences on app content and ease of use is imperative. The use of mobile applications specifically for Latina Gynecologic Oncology patients undergoing treatment has yet to be investigated. Methods: Fifty-six patients were recruited from the Gynecologic Oncology clinic at an urban academic health sciences center located on the Texas-Mexico border. Cross-sectional analyses were performed. Subjects were asked a series of 10-point Likert scale questions including how comfortable they would feel using medical applications on their smartphones. Linear regression models were fit with this scale score as the outcome. Results: The age of the 56 patients ranged from 28 to 77 years with a mean of 53.9 years (SD: 11.1). Spanish was the preferred language of 53.8% of the patients (28/52). Forty-four subjects were available for the regression analyses. Subjects were asked, “Would you feel comfortable using medical applications on your smartphone,” where 1 represented “not at all comfortable” and 10 represented “very comfortable”. The mean comfort scale score was 7.39 (SD: 2.85). Thirty of the 44 subjects (68.2%) replied “Multiple times per day” to the question about how frequently they use mobile apps on their phone. After controlling for the patient’s age in a regression model, patients who used mobile apps multiple times per day had an average comfort scale score that was 1.75 points higher than that of women who did not use mobile apps on their phone multiple times per day (p = 0.03). After adjusting for the frequency of mobile app use, there was a reduction of 0.11 points (p = 0.002) in the comfort scale score for every one year increase in the patient’s age. Conclusions: Our unique pilot study found a positive association between the frequency of current app use and anticipated comfort in using smartphone medical applications. Overall, patients demonstrated a considerable amount of comfort with the prospect of using a mobile app. These findings support the idea of creating a mobile app designed to monitor Latina Gynecologic Oncology patients in efforts to lessen patients’ postoperative burden, improve mortality and morbidity outcomes, and decrease health care system costs.[Table: see text]
PRECISE CURATE.AI: A prospective feasibility trial to dynamically modulate personalized chemotherapy dose with artificial intelligence.
Authors: Blasiak Agata , Truong Anh , Tan Wen Jeit, Lester , Kumar Kirthika Senthil , Tan Shi Bei , Teo Chong Boon , Tan Benjamin Kye Jyn , Tadeo Xavier , Tan Hon Lyn , Chee Cheng Ean , Yong Wei-Peng , Ho Dean , Sundar Raghav
Published: June 2022

1574

Background: Most treatment guidelines recommend chemotherapy at maximum tolerated doses, which does not always lead to optimal efficacy, but implicitly results in toxicity. To overcome this challenge, we developed CURATE.AI, a small data, AI-derived platform that harnesses only a patient’s own prospectively/longitudinally acquired data to dynamically identify their own optimal and personalized doses. We subsequently harnessed CURATE.AI to dynamically modulate individualized chemotherapy doses for patients in a prospective clinical trial. Methods: We conducted an open-label, multi-center, single-arm, prospective feasibility trial in patients diagnosed with advanced solid tumors and treated with single-agent capecitabine, XELOX or XELIRI (+/- biologics) (NCT04522284). The standard-of-care (SOC) capecitabine dose was 1000 mg/m2, unless adjusted by clinician to account for patient’s comorbidities and organ dysfunction. Using an AI-discovered second-order correlation between patient-specific variation of capecitabine doses and corresponding tumor marker (CEA, CA19-9 or CA-125) readouts for each cycle, CURATE.AI generated individualized patient digital avatars and recommended bespoke dose for the subsequent cycle. The clinicians were permitted to accept CURATE.AI dose recommendations, or reject the recommendations and dose based on clinical judgement. Results: Since August 2020 we recruited ten patients: single-agent capecitabine (n = 1), XELOX (n = 6), and XELIRI (n = 3). As of 20 Jan 2022, one patient remains on the trial. The prescribed dose was on average reduced by 20 % (± 13.8 %) as compared to the projected SOC dose. The nine reported patients completed 3.9 cycles (± 2.2 cycles), with the longest participation lasting 8 cycles. CURATE.AI recommendations were considered in 27 out of 40 total dosing decisions and accepted for prescription in 26 of those decisions. The reasons for not considering CURATE.AI included insufficient time from patient recruitment to the first dose administration and complex medical circumstances at the time of the dosing decisions. Conclusions: CURATE.AI has been successfully incorporated into the clinical workflow of dynamic dose selection in the treatment of solid tumors under a clinical trial. Prospective validation of CURATE.AI led to a reduction of an average prescribed capecitabine dose, which alongside additional preliminary findings may eventually play an important role in improving patient response rates and durations compared to SOC. Results from the PRECISE CURATE.AI trial support the initiation of a randomized clinical trial and potential expansion towards other oncologic indications. Clinical trial information: NCT04522284.