115 results
Search Results
2. Childhood cancer risk in offspring of parents occupationally exposed to dusts: A register‐based nested case‐control study from Sweden of 5 decades.
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Rossides, Marios, Kampitsi, Christina‐Evmorfia, Talbäck, Mats, Wiebert, Pernilla, Feychting, Maria, and Tettamanti, Giorgio
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CHILDHOOD cancer ,CENTRAL nervous system tumors ,OCCUPATIONAL exposure ,DISEASE risk factors ,DUST ,CASE-control method - Abstract
Background: Some largely inconsistent associations between parental occupational dust exposure and childhood cancer have been reported, with maternal exposures inadequately studied. The authors examined whether maternal or paternal occupational exposure to animal, wood, textile, or paper dust around a child's birth was associated with an increased risk of childhood cancer, both overall and by type (leukemias, lymphomas, central nervous system tumors, and other cancers). Methods: In this nationwide, register‐based, case‐control study, children who were diagnosed with cancer from 1960 to 2015 were compared with up to 25 matched controls regarding maternal and paternal occupational dust exposure (9653 cases in maternal analyses and 12,521 cases in paternal analyses). Exposures were assessed using a job‐exposure matrix and occupational information from census and register data. By using conditional logistic regression models, adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results: Neither maternal nor paternal occupational exposure to animal, wood, textile, or paper dust was associated with childhood cancer overall, leukemias, or central nervous system tumors. Maternal, but not paternal, wood dust exposure was associated with an increased risk of lymphoma (OR, 1.42; 95% CI, 1.10‐1.84), particularly non‐Hodgkin lymphoma (OR, 2.03; 95% CI, 1.21‐3.40). Conclusions: The current study did not confirm the associations reported previously but is the first to suggest a link between maternal occupational exposure to wood dust around pregnancy and lymphoma in the offspring. This large study does not confirm associations reported previously for leukemia and central nervous system tumors but is the first to suggest a link between maternal occupational exposure to wood dust around pregnancy and lymphoma in the offspring. [ABSTRACT FROM AUTHOR]
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- 2022
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3. NRG‐GY012: Randomized phase 2 study comparing olaparib, cediranib, and the combination of cediranib/olaparib in women with recurrent, persistent, or metastatic endometrial cancer.
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Rimel, Bobbie J., Enserro, Danielle, Bender, David P., Jackson, Camille Gunderson, Tan, Annie, Alluri, Nitya, Borowsky, Mark, Moroney, John, Hendrickson, Andrea Wahner, Backes, Floor, Swisher, Elizabeth, Powell, Matthew, and MacKay, Helen
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ENDOMETRIAL cancer , *OLAPARIB , *METASTASIS , *CANCER patients , *PROGRESSION-free survival - Abstract
Purpose: This paper reports the efficacy of the poly (ADP‐ribose) polymerase inhibitor olaparib alone and in combination with the antiangiogenesis agent cediranib compared with cediranib alone in patients with advanced endometrial cancer. Methods: This was open‐label, randomized, phase 2 trial (NCT03660826). Eligible patients had recurrent endometrial cancer, received at least one (<3) prior lines of chemotherapy, and were Eastern Cooperative Oncology Group performance status 0 to 2. Patients were randomly assigned (1:1:1), stratified by histology (serous vs. other) to receive cediranib alone (reference arm), olaparib, or olaparib and cediranib for 28‐day cycles until progression or unacceptable toxicity. The primary end point was progression‐free survival in the intention‐to‐treat population. Homologous repair deficiency was explored using the BROCA‐GO sequencing panel. Results: A total of 120 patients were enrolled and all were included in the intention‐to‐treat analysis. Median age was 66 (range, 41–86) years and 47 (39.2%) had serous histology. Median progression‐free survival for cediranib was 3.8 months compared with 2.0 months for olaparib (hazard ratio, 1.45 [95% CI, 0.91‐2.3] p =.935) and 5.5 months for olaparib/cediranib (hazard ratio, 0.7 [95% CI, 0.43–1.14] p =.064). Four patients receiving the combination had a durable response lasting more than 20 months. The most common grade 3/4 toxicities were hypertension in the cediranib (36%) and olaparib/cediranib (33%) arms, fatigue (20.5% olaparib/cediranib), and diarrhea (17.9% cediranib). The BROCA‐GO panel results were not associated with response. Conclusion: The combination of cediranib and olaparib demonstrated modest clinical efficacy; however, the primary end point of the study was not met. The combination was safe without unexpected toxicity. Randomized study of cediranib compared with olaparib and the combination for advanced or recurrent endometrial cancer demonstrated progression‐free survival of 3.8, 2.0, and 5.5 months respectively. The treatment toxicities were manageable but the study did not meet its primary end point. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Evaluating the impact of multicancer early detection testing on health and economic outcomes: Toward a decision modeling strategy.
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Lipscomb, Joseph, Horton, Susan, Kuo, Albert, and Tomasetti, Cristian
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ECONOMIC impact ,EARLY detection of cancer ,MEDICAL care costs ,MEDICAL screening ,COST effectiveness - Abstract
Emerging data provide initial support for the concept that a single, minimally invasive liquid biopsy test, performed in conjunction with confirmatory radiologic or other diagnostic testing, when indicated, could be deployed on a broad scale to screen individuals for multiple types of cancer. Ideally, such a test could do this in a way that yields a clinically important percentage of true-positive indications of cancer while minimizing false-positive signals. Modern decision modeling approaches can and should be deployed to investigate the health and economic consequences of such multicancer early detection (MCED) testing within defined at-risk populations. In this paper, through small-scale analyses involving 3 hypothetical MCED-detectible cancers, the authors illustrate the potential for MCED testing to be cost-effective, along with the pivotal role of test-induced stage shift on results. The time is ripe for additional, prospective investigations of the clinical value of MCED testing, the benefits versus the risks for screened populations, and the overall projected impact on health outcomes and costs over time. [ABSTRACT FROM AUTHOR]
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- 2022
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5. Virginia G. Kaklamani, MD, highlights important news from SABCS: Updates from research on therapies for the treatment of breast cancer show promise: Updates from research on therapies for the treatment of breast cancer show promise.
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O'Rourke, Kate
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HORMONE receptor positive breast cancer ,BREAST cancer ,HER2 positive breast cancer ,CANCER treatment ,METASTATIC breast cancer ,TRIPLE-negative breast cancer ,BREAST tumors - Abstract
Triple-Negative Breast Cancer Therapy Dr. Kaklamani says that 1 important theme was immunotherapy in triple-negative breast cancer. Groundbreaking, insightful research was presented during the 2021 San Antonio Breast Cancer Symposium, which was held from December 7 to 10 in San Antonio, Texas. Virginia G. Kaklamani, MD, highlights important news from SABCS: Updates from research on therapies for the treatment of breast cancer show promise. [Extracted from the article]
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- 2022
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6. Depression, anxiety, and the risk of cancer: An individual participant data meta‐analysis.
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van Tuijl, Lonneke A., Basten, Maartje, Pan, Kuan‐Yu, Vermeulen, Roel, Portengen, Lützen, de Graeff, Alexander, Dekker, Joost, Geerlings, Mirjam I., Hoogendoorn, Adriaan, Lamers, Femke, Voogd, Adri C., Abell, Jessica, Awadalla, Philip, Beekman, Aartjan T. F., Bjerkeset, Ottar, Boyd, Andy, Cui, Yunsong, Frank, Philipp, Galenkamp, Henrike, and Garssen, Bert
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DISEASE risk factors ,ANXIETY ,WORRY ,MENTAL depression ,BODY mass index ,HEALTH behavior ,PSYCHOSOCIAL factors - Abstract
Background: Depression and anxiety have long been hypothesized to be related to an increased cancer risk. Despite the great amount of research that has been conducted, findings are inconclusive. To provide a stronger basis for addressing the associations between depression, anxiety, and the incidence of various cancer types (overall, breast, lung, prostate, colorectal, alcohol‐related, and smoking‐related cancers), individual participant data (IPD) meta‐analyses were performed within the Psychosocial Factors and Cancer Incidence (PSY‐CA) consortium. Methods: The PSY‐CA consortium includes data from 18 cohorts with measures of depression or anxiety (up to N = 319,613; cancer incidences, 25,803; person‐years of follow‐up, 3,254,714). Both symptoms and a diagnosis of depression and anxiety were examined as predictors of future cancer risk. Two‐stage IPD meta‐analyses were run, first by using Cox regression models in each cohort (stage 1), and then by aggregating the results in random‐effects meta‐analyses (stage 2). Results: No associations were found between depression or anxiety and overall, breast, prostate, colorectal, and alcohol‐related cancers. Depression and anxiety (symptoms and diagnoses) were associated with the incidence of lung cancer and smoking‐related cancers (hazard ratios [HRs], 1.06–1.60). However, these associations were substantially attenuated when additionally adjusting for known risk factors including smoking, alcohol use, and body mass index (HRs, 1.04–1.23). Conclusions: Depression and anxiety are not related to increased risk for most cancer outcomes, except for lung and smoking‐related cancers. This study shows that key covariates are likely to explain the relationship between depression, anxiety, and lung and smoking‐related cancers. Preregistration number: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=157677. In the present study, individual participant data meta‐analyses were conducted to test the associations between anxiety, depression, and the incidence of cancer. Results indicated that depression and anxiety were not associated with an increased risk for cancer, nor when looking at most specific types. The exception to this was lung cancer and smoking‐related cancers; however, this association was substantially reduced when adjusting for several health behaviors. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Breast cancer survivorship experiences among Black women.
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Ko, Naomi Y., Fikre, Tsion G., Buck, Anne K., Restrepo, Emily, and Warner, Erica T.
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MEDICAL personnel ,BLACK women ,BREAST cancer ,BLACK people ,EDUCATIONAL films - Abstract
Background: Black women experience significant disparities in breast cancer across the care continuum, including survivorship. Ensuring that Black women obtain high‐quality follow‐up care is critical but understudied. This study was aimed at understanding the experiences and needs of Black women during breast cancer survivorship. Methods: Black patients diagnosed with invasive breast cancer within the past 5 years were invited to participate in a focus group and complete a survey. Focus groups examined the following: (1) the transition from active treatment to survivorship; (2) interactions with health care providers; (3) survivorship experiences, information needs, and preferences; and (4) existing educational materials. Results were thematically coded and analyzed for main themes. Surveys collected information on sociodemographics, health care experiences, quality of life, lifestyle, and education needs. Results: The study enrolled 53 participants, 43 of whom completed a survey and participated in one of 11 focus groups. The median age was 54 years, 44% had private insurance, 81% were English speaking, and 86% had completed their treatment more than a year before. Participants identified the importance of relationships with health care providers, gaps in survivorship care, experiences with cancer‐related symptoms, challenges with mental health, worry about recurrence, body image, cancer financial toxicity, and coping through religion and spirituality. Unmet needs were centered around preparation for long‐term symptoms, diet and physical activity, emotional support, and more explanations of information resources. Participants reported preferences for educational videos, personal stories, and culturally relevant content. Conclusions: Some Black breast cancer survivors may have specific challenges and preferences. Supportive interventions that address these concerns can be responsive and help to ameliorate disparities. Black breast cancer survivors have specific needs, challenges, and preferences. Supportive interventions that address their concerns are responsive and can help to ameliorate disparities. [ABSTRACT FROM AUTHOR]
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- 2023
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8. Social isolation and social connectedness among young adult cancer survivors: A systematic review.
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Fox, Rina S., Armstrong, Grace E., Gaumond, Julia S., Vigoureux, Taylor F. D., Miller, Corinne H., Sanford, Stacy D., Salsman, John M., Katsanis, Emmanuel, Badger, Terry A., Reed, Damon R., Gonzalez, Brian D., Jim, Heather S. L., Warner, Echo L., Victorson, David E., and Oswald, Laura B.
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SOCIAL belonging ,SOCIAL isolation ,YOUNG adults ,CANCER survivors ,CANCER patients - Abstract
Background: Social isolation and connectedness are social determinants of health that have demonstrated effects on cancer‐related outcomes. These constructs have been systematically evaluated among pediatric and older adult cancer populations. In this review, the authors evaluated the prevalence, correlates, and psychosocial implications of social isolation and connectedness among young adult (YA) cancer survivors aged 18–39 years. Methods: Peer‐reviewed articles published in English before June 2021 were identified from database searches and included articles' reference lists according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) guidelines. Included articles described studies that assessed social isolation and/or connectedness among YA cancer survivors. Results: In total, 5094 unique records were identified; 4143 were excluded after title/abstract screening, and 907 were excluded after full‐text review. Forty‐four articles were included. Few studies used validated measures or directly assessed social isolation or connectedness. Social isolation was similarly prevalent among YAs and older cancer survivors and noncancer populations. Demographic, clinical, and behavioral risk and protective factors for social isolation were identified. Social isolation was related to worse psychological well‐being, whereas social connectedness was often, but not always, related to better psychological well‐being. Conclusions: This growing literature underscores the relevance of social isolation and connectedness as important health determinants among YA cancer survivors. The identified risk and protective factors can identify YAs who especially may benefit from screening for social isolation. Future studies are needed that directly, reliably, and validly evaluate social isolation and connectedness to inform the development of interventions to decrease isolation and increase connectedness. This review evaluated the prevalence, correlates, and psychosocial implications of social isolation and connectedness among young adult (YA) cancer survivors. Findings underscored the relevance of social isolation and connectedness as important health determinants among YA cancer survivors, identified risk and protective factors that can help identify YAs who may especially benefit from screening for social isolation, and provided recommendations for future research. [ABSTRACT FROM AUTHOR]
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- 2023
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9. Social cognition and adjustment in adult survivors of pediatric central nervous system tumors.
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Papini, Chiara, Willard, Victoria W., Gajjar, Amar, Merchant, Thomas E., Srivastava, Deokumar, Armstrong, Gregory T., Hudson, Melissa M., Krull, Kevin R., and Brinkman, Tara M.
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SOCIAL adjustment ,CENTRAL nervous system tumors ,SOCIAL perception ,EXECUTIVE function ,SOCIAL cues ,INFRATENTORIAL brain tumors - Abstract
Background: Survivors of pediatric central nervous system (CNS) tumors are at risk for neurocognitive and social difficulties throughout childhood. This study characterized social cognition (perception and reasoning from social cues) and adjustment in adulthood. Methods: A total of 81 adult survivors of pediatric CNS tumors (51% female; mean [SD] age, 28.0 [5.8] years), were recruited across four groups: (1) no radiation therapy (RT) [n = 21], (2) infratentorial (IT) tumors + focal RT [n = 20], (3) IT tumors + craniospinal irradiation [n = 20], and (4) supratentorial tumors + focal RT [n = 20]. Prevalence of social cognitive and adjustment impairments was compared to test norms. Multivariable models examined clinical and neurocognitive predictors of social cognition and its impact on functional outcomes. Results: Survivors demonstrated elevated risk of severe social cognitive impairments (social perception Morbidity Ratio [95% CI] 5.70 [3.46–9.20]), but self‐reported few social adjustment problems. Survivors of IT tumors treated with craniospinal irradiation performed nearly 1 SD worse than survivors treated without RT on multiple measures of social cognition (e.g., social perception: β = −0.89, p =.004). Impaired executive functioning and nonverbal reasoning were associated with worse social cognitive performance (e.g., social perception: β = −0.75, p <.001; β = –0.84, p <.001, respectively). Better social perception was associated with higher odds of attaining full‐time employment (odds ratio, 1.52 [1.17–1.97]) and at least some college education (odds ratio, 1.39 [1.11–1.74]). Conclusions: Adult survivors of CNS tumors are at elevated risk of severely impaired social cognition, but do not perceive social adjustment difficulties. Better understanding of potential mechanisms underlying social cognitive deficits may inform intervention targets to promote better functional outcomes for at‐risk survivors. Adult survivors of childhood central nervous system tumors are at elevated risk of severely impaired social cognition, but do not perceive social adjustment difficulties. Infratentorial tumor survivors treated with craniospinal radiation demonstrated worse social cognition, which was in turn associated with reduced social attainment. [ABSTRACT FROM AUTHOR]
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- 2023
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10. The feasibility, acceptability, and preliminary efficacy of a self‐advocacy serious game for women with advanced breast or gynecologic cancer.
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Thomas, Teresa Hagan, Bender, Catherine, Donovan, Heidi S., Murray, Patty Jo, Taylor, Sarah, Rosenzweig, Margaret, Sereika, Susan M., Brufsky, Adam, and Schenker, Yael
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SELF advocacy ,GYNECOLOGIC cancer ,EDUCATIONAL films ,EDUCATIONAL games ,EXIT interviewing ,PATIENT-centered care - Abstract
Background: Cancer clinicians and systems aim to provide patient‐centered care, but not all patients have the self‐advocacy skills necessary to ensure their care reflects their needs and priorities. This study examines the feasibility, acceptability, and preliminary efficacy of a self‐advocacy serious game (an educational video game) intervention in women with advanced breast or gynecologic cancer. Methods: Women with recently diagnosed (<3 months) metastatic breast or advanced gynecologic cancer were randomized 2:1 to receive a tablet‐based serious game (Strong Together) (n = 52) or enhanced care as usual (n = 26). Feasibility was based on recruitment, retention, data completion, and intervention engagement. Acceptability was assessed via a postintervention questionnaire and exit interview. Preliminary efficacy was assessed on the basis of change scores from baseline to 3 and 6 months in self‐advocacy (Female Self‐Advocacy in Cancer Survivorship Scale) using intention‐to‐treat analysis. Results: Seventy‐eight women (55.1% with breast cancer; 44.9% with gynecologic cancer) were enrolled. Feasibility was demonstrated by satisfactory recruitment (69% approach‐to‐consent rate; 93% enroll‐to‐randomize rate), retention (90% and 86% at 3 and 6 months, respectively; 85% data completion), and intervention engagement (84% completed ≥75% of the game). Participants endorsed the intervention's (75%) and trial's (87%) acceptability. Participants in the intervention group experienced significant improvements in self‐advocacy at 3 and 6 months compared to participants in the control group. Conclusions: Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising evidence of clinical efficacy. A future confirmatory trial is warranted to test the efficacy of the intervention for patient and health system outcomes. Evidence‐based interventions to enhance patients' self‐advocacy skills in advanced cancer are lacking. This pilot study supports the feasibility, acceptability, and preliminary efficacy of a self‐advocacy serious game intervention to teach women with advanced breast and gynecologic cancer self‐advocacy skills. [ABSTRACT FROM AUTHOR]
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- 2023
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11. Allocation of authorship and patient enrollment among global clinical trials in oncology.
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Rubagumya, Fidel, Fundytus, Adam, Keith‐Brown, Sophie, Hopman, Wilma M., Gyawali, Bishal, Mukherji, Deborah, Hammad, Nazik, Pramesh, CS, Aggarwal, Ajay, Eniu, Alexandru, Sengar, Manju, Riechelmann, Rachel S. R., Sullivan, Richard, and Booth, Christopher M.
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CLINICAL trials ,HIGH-income countries ,AUTHORSHIP ,RANDOMIZED controlled trials ,MIDDLE-income countries - Abstract
Background: Oncology randomized controlled trials (RCTs) are increasingly global in scope. Whether authorship is equitably shared between investigators from high‐income countries (HIC) and low‐middle/upper‐middle incomes countries (LMIC/UMIC) is not well described. The authors conducted this study to understand the allocation of authorship and patient enrollment across all oncology RCTs conducted globally. Methods: A cross‐sectional retrospective cohort study of phase 3 RCTs (published 2014–2017) that were led by investigators in HIC and recruited patients in LMIC/UMIC. Findings: During 2014–2017, 694 oncology RCTs were published; 636 (92%) were led by investigators from HIC. Among these HIC‐led trials, 186 (29%) enrolled patients in LMIC/UMIC. One‐third (33%, 62 of 186) of RCTs had no authors from LMIC/UMIC. Forty percent (74 of 186) of RCTs reported patient enrollment by country; in 50% (37 of 74) of these trials, LMIC/UMIC contributed <15% of patients. The relationship between enrollment and authorship proportion is very strong and is comparable between LMIC/UMIC and HIC (Spearman's ρ LMIC/UMIC 0.824, p <.001; HIC 0.823, p <.001). Among the 74 trials that report country enrollment, 34% (25 of 74) have no authors from LMIC/UMIC. Conclusions: Among trials that enroll patients in HIC and LMIC/UMIC, authorship appears to be proportional to patient enrollment. This finding is limited by the fact that more than half of RCTs do not report enrollment by country. Moreover, there are important outliers as a significant proportion of RCTs had no authors from LMIC/UMIC despite enrolling patients in these countries. The findings in this study reflect a complex global RCT ecosystem that still underserves cancer control outside high‐income settings. Authorship tends to be proportionate to patient enrollment in clinical trials in both high‐income countries and low‐ and upper middle‐income countries (LMIC/UMIC). This, however, is constrained by the fact that more than half of randomized controlled trials do not disclose enrollment by nation and a considerable number of randomized clinical trials do not have any authors from LMIC/UMIC despite recruiting patients from these nations. [ABSTRACT FROM AUTHOR]
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- 2023
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12. Determinants of frontline tyrosine kinase inhibitor choice for patients with chronic‐phase chronic myeloid leukemia: A study from the Registro Italiano LMC and Campus CML.
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Tiribelli, Mario, Latagliata, Roberto, Breccia, Massimo, Capodanno, Isabella, Miggiano, Maria Cristina, Cavazzini, Francesco, Bucelli, Cristina, Attolico, Immacolata, Crescenzi, Sabrina Leonetti, Russo, Sabina, Annunziata, Mario, Sorà, Federica, Bonifacio, Massimiliano, Mulas, Olga, Loglisci, Giuseppina, Maggi, Alessandro, Binotto, Gianni, Crisà, Elena, Scortechini, Anna Rita, and Leporace, Anna Paola
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DASATINIB ,NILOTINIB ,CHRONIC myeloid leukemia ,PROTEIN-tyrosine kinase inhibitors ,CHRONIC obstructive pulmonary disease ,MYOCARDIAL ischemia ,CONCOMITANT drugs - Abstract
Background: Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic‐phase chronic myeloid leukemia (CP‐CML). The choice of TKI is based on a combined evaluation of the patient's and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP‐CML to correlate the choice with the patient's features. Methods: A total of 1967 patients with CP‐CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second‐generation (2G) TKI. Results: Second‐generation TKIs were chosen for most patients aged <45 years (69.2%), whereas imatinib was used in 76.7% of patients aged >65 years (p <.001). There was a predominant use of imatinib in intermediate/high European long–term survival risk patients (60.0%/66.0% vs. 49.7% in low‐risk patients) and a limited use of 2G‐TKIs in patients with comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, or stroke and in those with >3 concomitant drugs. We observed a greater use of imatinib (61.1%) in patients diagnosed in 2018–2019 compared to 2012–2017 (53.2%; p =.002). In multivariable analysis, factors correlated with imatinib use were age > 65 years, spleen size, the presence of comorbidities, and ≥3 concomitant medications. Conclusions: This observational study of almost 2000 cases of CML shows that imatinib is the frontline drug of choice in 55% of Italian patients with CP‐CML, with 2G‐TKIs prevalently used in younger patients and in those with no concomitant clinical conditions. Introduction of the generic formulation in 2018 seems to have fostered imatinib use. Among 1967 Italian patients diagnosed between 2012 and 2019 with chronic‐phase chronic myeloid leukemia (CP‐CML), 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second‐generation tyrosine kinase inhibitor: nilotinib or dasatinib. Factors associated with the predominant use of imatinib were age >65 years, enlarged spleen, the presence of comorbidities (hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, and stroke), and ≥3 concomitant medications at the time of CML diagnosis. [ABSTRACT FROM AUTHOR]
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- 2023
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13. International validation of two EORTC questionnaires for assessment of health‐related quality of life for patients with high‐grade non‐Hodgkin lymphoma (QLQ‐NHL‐HG29) and low‐grade non‐Hodgkin lymphoma (QLQ‐NHL‐LG20)
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Oerlemans, Simone, Efficace, Fabio, Kyriakou, Charalampia, Freitas, Ana Carolina, Shamieh, Omar, Creutzberg, Carien L., Lehmann, Jens, Petranovic, Duska, Nagele, Eva, Bredart, Anne, Dong, Dong, Scholz, Christian W., Caocci, Giovanni, Molica, Stefano, Griskevicius, Laimonas, Xochelli, Aliki, Kieffer, Jacobien M., Agelink van Rentergem, Joost A., Alrjoub, Waleed, and Mueller, Anja
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NON-Hodgkin's lymphoma ,QUALITY of life ,CONFIRMATORY factor analysis ,TEST validity ,PSYCHOMETRICS - Abstract
Background: Health‐related quality of life (HRQOL) is a critical aspect to consider when making treatment decisions for patients with non‐Hodgkin‐lymphoma (NHL). This international study by the European Organisation for Research and Treatment of Cancer (EORTC) tested the psychometric properties of two newly developed measures for patients with high‐grade (HG)‐ and low‐grade (LG)‐NHL: the EORTC QLQ‐NHL‐HG29 and the EORTC QLQ‐NHL‐LG20 to supplement the core questionnaire (EORTC QLQ‐C30). Methods: Overall, 768 patients with HG‐NHL (N = 423) and LG‐NHL (N = 345) from 12 countries completed the QLQ‐C30, QLQ‐NHL‐HG29/QLQ‐NHL‐LG20 and a debriefing questionnaire at baseline, and a subset at follow‐up for either retest (N = 125/124) or responsiveness to change (RCA; N = 98/49). Results: Confirmatory factor analysis showed an acceptable to good fit of the 29 items of the QLQ‐NHL‐HG29 on its five scales (symptom burden [SB], neuropathy, physical condition/fatigue [PF], emotional impact [EI], and worries about health/functioning [WH]), and of the 20 items of the QLQ‐NHL‐LG20 on its four scales (SB, PF, EI, and WH). Completion took on average 10 minutes. Test–retest reliability, convergent validity, known‐group comparisons, and RCA find satisfactory results of both measures. A total of 31%–78% of patients with HG‐NHL and 22%–73% of patients with LG‐NHL reported symptoms and/or worries (e.g., tingling in hands/feet, lack of energy, and worries about recurrence). Patients reporting symptoms/worries had substantially lower HRQOL compared to those without. Discussion: The use of the EORTC QLQ‐NHL‐HG29 and QLQ‐NHL‐LG20 questionnaires in clinical research and practice will provide clinically relevant data to better inform treatment decision‐making. Plain language summary: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed two questionnaires.These questionnaires measure health‐related quality of life.The questionnaires are for patients with high‐grade or low‐grade non‐Hodgkin lymphoma.They are called the EORTC QLQ‐NHL‐HG29 and QLQ‐NHL‐LG20.The questionnaires are now internationally validated.This study demonstrates that the questionnaires are reliably and valid, which are important aspects of a questionnaire.The questionnaires can now be used in clinical trials and practice.With the information gathered from the questionnaires, patients and clinicians can better evaluate treatments and discuss the best choice for a patient. This study provides two internationally validated questionnaires for health‐related quality of life assessment in non‐Hodgkin lymphoma: the European Organisation for Research and Treatment of Cancer (EORTC) QLQ‐NHL‐HG29 and EORTC QLQ‐NHL‐LG20. The use of these EORTC questionnaires in research and practice will provide clinically relevant data to better inform treatment decision‐making. [ABSTRACT FROM AUTHOR]
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- 2023
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14. Experience with the US health care system for Black and White patients with advanced prostate cancer.
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Rencsok, Emily M., Stopsack, Konrad H., Slopen, Natalie, Odedina, Folakemi T., Ragin, Camille, Nowak, Joel, McSwain, Lawrence, Manarite, Jan, Heath, Elisabeth, George, Daniel J., Kantoff, Philip W., Vinson, Jacob, Villanti, Paul, Haneuse, Sebastien, and Mucci, Lorelei A.
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PROSTATE cancer patients ,CANCER patients ,MEDICAL care ,PATIENT preferences ,UROLOGISTS ,WATCHFUL waiting ,AGE factors in disease - Abstract
Objective: The purpose of this study was to assess differences in reported information about treatment, integration into care, and respect by self‐identified Black and White individuals with advanced prostate cancer in the United States. Patients and Methods: This is a prospective cohort study of 701 participants (20% identifying as Black) enrolled in the International Registry for Men with Advanced Prostate Cancer at 37 US sites from 2017 to 2022. Participants were asked six questions from the Cancer Australia National Cancer Control Indicators about their experience with care at study enrollment. Prevalence differences by self‐reported race were estimated using marginal standardization of logistic‐normal mixed effects models (adjusted for age at enrollment and disease state at enrollment), and 95% CIs were estimated using parametric bootstrapping. Results: Most participants reported a high quality of care for each question. Black participants generally reported higher care quality compared with White participants. Black participants reported more frequently that they were offered a written assessment and care plan (71%) compared with White participants (58%; adjusted difference, 13 percentage points; 95% CI, 4–23). Black participants also reported more frequently being given the name of nonphysician personnel who would support them (64%) than White participants (52%; adjusted difference, 10; 95% CI, 1–20). Prevalence differences did not differ by disease state at enrollment. Conclusions: Black participants generally reported a higher quality of care compared with White participants. This study calls attention to the need to study potential mediating factors and interpersonal aspects of care in this population to improve survivorship. Patients with advanced prostate cancer in the United States reported a high quality of care. Black participants tended to report higher quality of care compared with White participants regarding information about treatment, integration into care, and respect for patient preference. [ABSTRACT FROM AUTHOR]
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- 2023
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15. Oncofertility‐related psycho‐educational therapy for young adult patients with breast cancer and their partners: Randomized controlled trial.
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Koizumi, Tomoe, Sugishita, Yodo, Suzuki‐Takahashi, Yuki, Nara, Kazuko, Miyagawa, Tomoko, Nakajima, Misako, Sugimoto, Kouhei, Futamura, Manabu, Furui, Tatsuro, Takai, Yasushi, Matsumoto, Hiroshi, Yamauchi, Hideko, Ohno, Shinji, Kataoka, Akemi, Kawai, Kiyotaka, Fukuma, Eisuke, Nogi, Hiroko, Tsugawa, Koichiro, and Suzuki, Nao
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YOUNG adults ,RANDOMIZED controlled trials ,POST-traumatic stress ,OLDER women ,SECONDARY traumatic stress ,MARITAL communication ,BREAST cancer ,CANCER patients - Abstract
Background: A couples' psycho‐educational program called Oncofertility! Psycho‐Education and Couple Enrichment (O!PEACE) therapy was created and its effect when provided before cancer treatment was examined. Methods: This multicenter randomized controlled trial with nonmasking, parallel two‐group comparison enrolled women aged 20 to 39 years with early‐stage breast cancer and their partners. They were randomly assigned to receive O!PEACE (37 couples) or usual care (37 couples). Primary end points were cancer‐related posttraumatic stress symptoms, symptoms of depression, and anxiety. Secondary end points were stress‐coping strategies, resilience, and marital relationship. Results: Women receiving psycho‐educational therapy had significantly reduced Impact of Event Scale‐revised version for Japanese scores (p =.011, ηp2 = =.089). For patients with Impact of Event Scale‐revised version for Japanese scores at baseline ≥18.27, O!PEACE therapy improved these scores when compared with usual care (U = 172.80, p =.027, r = 0.258). A >5‐point reduction was present in 59.3% and 30% of women in the O!PEACE therapy and usual‐care groups, respectively. For partners, O!PEACE therapy significantly improved stress‐coping strategies (95% CI, −0.60 to –0.05; p =.018, ηp2 = =.074) and escape‐avoidance marital communication (95% CI, –0.33 to –0.08; p =.001, ηp2 =.136). O!PEACE therapy significantly improved the partners' support (95% CI, 0.10–0.50; p =.001, ηp2 =.127), the rate of receiving fertility preservation consultations, and knowledge levels. Conclusions: O!PEACE therapy before cancer treatment can improve posttraumatic stress symptoms, stress‐coping behavior, and marital relationships. Larger sample sizes and longer term follow‐up are required. Plain Language Summary: A psycho‐educational program, the Oncofertility! Psycho‐Education and Couple Enrichment (O!PEACE) therapy program was developed and evaluated for women diagnosed with breast cancer and their partners.A multicenter randomized controlled trial showed that the O!PEACE psycho‐educational therapy, with only two precancer treatment sessions, can reduce cancer‐related posttraumatic stress symptoms and improve oncofertility knowledge and marital relationships in young adult patients with breast cancer.The therapy could also improve stress‐coping strategies in marital communications with their partners. Couples may use O!PEACE psycho‐educational therapy to consider fertility preservation and improve their psychosocial aspects. A psycho‐educational program, the Oncofertility! Psycho‐Education and Couple Enrichment (O!PEACE) therapy program, was developed and evaluated for women diagnosed with breast cancer and their partners. O!PEACE therapy before cancer treatment can improve posttraumatic stress symptoms, stress‐coping behavior, and marital relationships. [ABSTRACT FROM AUTHOR]
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- 2023
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16. Plasma levels of interleukin‐6 mediate neurocognitive performance in older breast cancer survivors: The Thinking and Living With Cancer study.
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Mandelblatt, Jeanne S., Small, Brent J., Zhou, Xingtao, Nakamura, Zev M., Cohen, Harvey J., Ahles, Tim A., Ahn, Jaeil, Bethea, Traci N., Extermann, Martine, Graham, Deena, Isaacs, Claudine, Jacobsen, Paul B., Jim, Heather S. L., McDonald, Brenna C., Patel, Sunita K., Rentscher, Kelly E., Root, James C., Saykin, Andrew J., Tometich, Danielle B., and Van Dyk, Kathleen
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CANCER survivors ,TUMOR necrosis factors ,BREAST cancer ,INTERLEUKIN-6 ,COGNITIVE processing speed ,CANCER fatigue - Abstract
Background: Immune activation/inflammation markers (immune markers) were tested to explain differences in neurocognition among older breast cancer survivors versus noncancer controls. Methods: Women >60 years old with primary breast cancer (stages 0–III) (n = 400) were assessed before systemic therapy with frequency‐matched controls (n = 329) and followed annually to 60 months; blood was collected during annual assessments from 2016 to 2020. Neurocognition was measured by tests of attention, processing speed, and executive function (APE). Plasma levels of interleukin‐6 (IL‐6), IL‐8, IL‐10, tumor necrosis factor α (TNF‐α), and interferon γ were determined using multiplex testing. Mixed linear models were used to compare results of immune marker levels by survivor/control group by time and by controlling for age, racial/ethnic group, cognitive reserve, and study site. Covariate‐adjusted multilevel mediation analyses tested whether survivor/control group effects on cognition were explained by immune markers; secondary analyses examined the impact of additional covariates (e.g., comorbidity and obesity) on mediation effects. Results: Participants were aged 60–90 years (mean, 67.7 years). Most survivors had stage I (60.9%) estrogen receptor–positive tumors (87.6%). Survivors had significantly higher IL‐6 levels than controls before systemic therapy and at 12, 24, and 60 months (p ≤.001–.014) but there were no differences for other markers. Survivors had lower adjusted APE scores than controls (p <.05). Levels of IL‐6, IL‐10, and TNF‐α were related to APE, with IL‐6 explaining part of the relationship between survivor/control group and APE (p =.01). The magnitude of this mediation effect decreased but remained significant (p =.047) after the consideration of additional covariates. Conclusions: Older breast cancer survivors had worse long‐term neurocognitive performance than controls, and this relationship was explained in part by elevated IL‐6. The mechanisms that contribute to cognitive problems among cancer survivors remain unclear. This study found that one inflammatory/immune activation marker, interleukin‐6, mediated some of the relationship between older breast cancer survivors/noncancer control group and cognitive performance. [ABSTRACT FROM AUTHOR]
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- 2023
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17. Intersectional disparities in climate vulnerability and cancer risk.
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Ashad‐Bishop, Kilan C., Cruz, Mayra, Bailey, Zinzi D., and Kobetz, Erin K.
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CLIMATE change ,EFFECT of human beings on climate change ,DISEASE risk factors ,INTERSECTIONALITY ,HEALTH equity - Abstract
Despite significant progress in the early detection, treatment, and survivorship of cancer in recent decades, cancer disparities continue to plague segments of the US population. Many of these cancer disparities, especially those among historically marginalized racial and ethnic groups and those with lower socioeconomic resources, are caused and perpetuated by social and structural barriers to health. These social and structural barriers, which operate beyond the framework of cancer control, also systematically increase vulnerability to and decrease adaptive capacity for the deleterious effects of anthropogenic climate change. The established and emerging overlap between climate vulnerability and cancer risk presents complex challenges to cancer control, specifically among populations who suffer compounding hazards and intersectional vulnerabilities. By embracing these intersections, we may be able to conceptualize promising new research frameworks and programmatic opportunities that decrease vulnerability to a wide range of climate and health threats to advance health equity. Many social determinants that underlie cancer disparities also increase vulnerability to and decrease adaptive capacity for the deleterious effects of anthropogenic climate change. The intersections of climate and disparities in cancer risk present promising new research frameworks to advance health equity. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Quality of life with cemiplimab plus chemotherapy for first‐line treatment of advanced non–small cell lung cancer: Patient‐reported outcomes from phase 3 EMPOWER‐Lung 3.
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Makharadze, Tamta, Quek, Ruben G. W., Melkadze, Tamar, Gogishvili, Miranda, Ivanescu, Cristina, Giorgadze, Davit, Dvorkin, Mikhail, Penkov, Konstantin, Laktionov, Konstantin, Nemsadze, Gia, Nechaeva, Marina, Rozhkova, Irina, Kalinka, Ewa, Gessner, Christian, Moreno‐Jaime, Brizio, Passalacqua, Rodolfo, Konidaris, Gerasimos, Rietschel, Petra, and Gullo, Giuseppe
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NON-small-cell lung carcinoma ,CEMIPLIMAB ,PATIENT reported outcome measures ,PROPORTIONAL hazards models ,CLINICAL trials - Abstract
Background: EMPOWER‐Lung 3, a randomized 2:1 phase 3 trial, showed clinically meaningful and statistically significant overall survival improvement with cemiplimab plus platinum‐doublet chemotherapy versus placebo plus chemotherapy for first‐line treatment of advanced non–small cell lung cancer. This study evaluated patient‐reported outcomes (PROs). Methods: PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks) for the first six doses, and then at start of every three cycles, using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life‐Core 30 (QLQ‐C30) and Quality of Life‐Lung Cancer Module (QLQ‐LC13) questionnaires. Prespecified analyses included a longitudinal mixed‐effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis performed for global health status/quality of life (GHS/QoL) and all scales from the questionnaires. Between‐arm TTD comparisons were made using a stratified log‐rank test and proportional hazards model. Results: A total of 312 patients were assigned to receive cemiplimab plus platinum‐doublet chemotherapy and 154 to receive placebo plus chemotherapy; 391 (83.9%) were male and the median age was 63.0 years (range, 25–84). For pain symptoms (EORTC QLQ‐C30), a statistically significant overall improvement from baseline (−4.98, 95% confidence interval [CI] −8.36 to −1.60, p =.004) and a statistically significant delay in TTD (hazard ratio, 0.39; 95% CI, 0.26–0.60, p <.0001) favoring cemiplimab plus chemotherapy were observed. Statistically significant delays in TTD, all favoring cemiplimab plus chemotherapy, were also observed in functioning and symptom scales. A significant overall improvement from baseline in GHS/QoL was seen for cemiplimab plus chemotherapy compared with nonsignificant overall change from baseline for placebo plus chemotherapy (1.69, 95% CI, 0.20–3.19 vs. 1.08, 95% CI, –1.34 to 3.51; between arms, p =.673). No analyses yielded statistically significant PRO results favoring placebo plus chemotherapy for any QLQ‐C30 or QLQ‐LC13 scale. Conclusion: Cemiplimab plus chemotherapy resulted in significant overall improvement in pain symptoms and delayed TTD in cancer‐related and lung cancer–specific symptoms and functions. Cemiplimab plus chemotherapy significantly improves pain in advanced lung cancer patients; significant delay in other symptom and function deterioration is also achieved. These results further support positive benefit‐risk profile of cemiplimab plus chemotherapy. [ABSTRACT FROM AUTHOR]
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- 2023
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19. Geographic diffusion of digital mammography in the United States.
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Wiese, Daniel, Stroup, Antoinette M., Islami, Farhad, Mattes, Molly, Baylor, Emma, Boscoe, Francis P., and Henry, Kevin A.
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DIGITAL mammography ,NATIVE American women ,TECHNOLOGICAL innovations ,TECHNOLOGY transfer ,HEALTH facilities - Abstract
Background: Examining temporal and spatial diffusion of a new technology, such as digital mammography, can provide important insights into potential disparities associated with access to new medical technologies and how quickly these technologies are adopted. Although digital mammography is currently a standard technology in the United States for breast cancer screening, its adoption and geographic diffusion, as medical facilities transitioned from film to digital units, has not been explored well. Methods: This study evaluated the geographic diffusion of digital mammography facilities from 2001 to 2014 in the contiguous United States (excluding Alaska and Hawaii) and estimated the geographic accessibility to this new technology for women aged ≥45 years at the census tract level within a 20‐minute drivetime by population density, rural/urban residence, and race/ethnicity. The number of mammography units by technology type (film or digital) and density per 10,000 women were also summarized. Results: The adoption of digital mammography advanced first in densely populated regions and last in remote rural areas. Overall, proportion of digital mammography units increased from 1.4% in 2001 to 94.6% in 2014, but since 2008, there was a decline in density of units from 2.31 per 10,000 women aged ≥45 years to 1.97 in 2014. In 2014, approximately 87% of women aged ≥45 years in the contiguous United States had accessibility to digital mammography, but this proportion was substantially lower for Native American women (67%) and rural residents (32%). Conclusion: Understanding the diffusion of and accessibility to digital mammography may help predict future medical technology diffusion and assess its role in geographic differences in cancer diagnosis and treatment. In this retrospective study, the changes from film to digital mammography in the United States from 2001‐2014 were examined and mapped; in addition, changes in geographic accessibility to digital mammography were evaluated for women aged ≥45 years at the census tract level, in respect to urban/rural residency, population density, and race/ethnicity. The geographic diffusion of digital mammography progressed unevenly throughout the United States, and by 2014, 87% of all women aged ≥45 years were living within a 20‐minute drive from a digital mammography facility, but this percentage was substantially lower for Native American women (67%) and rural residents (32%). [ABSTRACT FROM AUTHOR]
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- 2023
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20. A real‐world data analysis of predictors of early mortality after a diagnosis of multiple myeloma.
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Grant, Shakira J., Wildes, Tanya M., Rosko, Ashley E., Silberstein, Juliet, and Giri, Smith
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MULTIPLE myeloma ,OLDER patients ,OLDER people ,SURVIVAL rate ,DATA analysis ,RENOVASCULAR hypertension ,PLASMACYTOMA - Abstract
Background: Despite the increased availability and use of novel therapies for multiple myeloma, early mortality is a pervasive challenge with a significant impact on older adults. Reported rates and predictors of early mortality have varied in the literature, with most studies seldom focusing on community‐treated patients. Methods: In this retrospective cohort analysis of a real‐world electronic health record–derived deidentified database of 7512 patients newly diagnosed with multiple myeloma between January 1, 2011, and February 2, 2021, and treated primarily in US‐based community oncology practices, factors associated with early mortality (defined as death within 6 months after the multiple myeloma diagnosis) were examined with the use of binary logistic regression. Results: The median age was 70 years overall. We found an overall early mortality rate of 8.3%, with 73% of early deaths occurring in those aged ≥70 years. Among the early deaths, only 49 patients (8.7%) had documented disease progression before death (median time to progression, 30 days [interquartile range, 7–53 days]). Baseline factors associated with higher odds of early mortality included an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2, Revised International Staging System (R‐ISS) stage III, an age ≥ 70 years, receipt of proteasome inhibitor–doublet therapy, a light‐chain isotype, and the presence of renal dysfunction (estimated glomerular filtration rate < 30 mL/min). Among those aged ≥70 years, ECOG PS ≥ 2 and R‐ISS stage III remained the strongest predictors of early mortality. Conclusions: Early mortality disproportionately affects older adults (aged ≥70 years) with multiple myeloma. Interventions to support this population are needed to reduce disparate survival outcomes. Plain language summary: Factors associated with an increased risk of dying within 6 months (early mortality) of a new diagnosis of multiple myeloma (MM) among 7512 mostly community‐treated patients with MM were evaluated.The early mortality rate was 8.3%; among those deaths, 49 patients (8.7%) had documented evidence of MM progression before death.The risk of early mortality was greatest for older patients (aged ≥70 years) and those with a poor performance status, poor kidney function, a higher disease stage, and light‐chain MM and those receiving two‐drug MM therapies.These findings highlight the need for supportive interventions geared toward older adults with MM. Approximately 9% of adults newly diagnosed with multiple myeloma will die within 6 months. Most early deaths occur in those aged 70 years or older and among those with advanced disease, a poor performance status, and kidney dysfunction and those who have received a proteasome inhibitor‐based doublet regimen. [ABSTRACT FROM AUTHOR]
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- 2023
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21. Health behavior profiles in young survivors of childhood cancer: Findings from the St. Jude Lifetime Cohort Study.
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Webster, Rachel Tillery, Dhaduk, Rikeenkumar, Gordon, Mallorie L., Partin, Robyn E., Kunin‐Batson, Alicia S., Brinkman, Tara M., Willard, Victoria W., Allen, Jennifer M., Alberts, Nicole M., Lanctot, Jennifer Q., Ehrhardt, Matthew J., Li, Zhenghong, Hudson, Melissa M., Robison, Leslie L., and Ness, Kirsten K.
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HEALTH behavior ,CHILDHOOD cancer ,CANCER survivors ,PHYSICAL mobility ,MOTOR ability ,MENTAL health - Abstract
Background: There is limited understanding of associations between a combination of health behaviors (physical activity, sedentary/screen‐time, diet) and cardiometabolic health risk factors, physical performance, and emotional health among young (<18) childhood cancer survivors (CCS). The aims of this research were to address this gap by 1) deriving health behavior adherence profiles among CCS, and 2) examining associations among demographic, diagnosis and/or treatment exposures, cardiometabolic, physical performance, and emotional functioning with health behavior profile membership. Methods: Participants included 397 CCS (≥5 years post‐diagnosis; 10–17 years old) enrolled in the St. Jude Lifetime Cohort Study who completed physical health evaluations and questionnaires assessing health behaviors and psychological functioning. Latent profile analysis was used to derive profiles of health behavior adherence. Logistic regression and t‐tests were used to examine mean‐level differences and associations between profile membership with demographic, diagnosis, treatment exposures, cardiometabolic health, psychological functioning, and physical performance. Results: Two profiles emerged: inactive‐unhealthy‐diet ("IU") and active‐sedentary‐unhealthy‐diet ("ASU") to guidelines. More participants in IU demonstrated higher resting heart rate (mean [M], 76.54; SD = 12.00) and lower motor proficiency scores (M = 34.73; SD = 29.15) compared to ASU (resting heart rate, M = 71.95, SD = 10.74; motor proficiency, M = 50.40, SD = 31.02). Conclusions: CCS exhibited low adherence to multiple health behavior guidelines, with adherence patterns differentially associated with cardiometabolic health (i.e., resting heart rate) and physical performance. However, robust protection against all health variables was not observed. Findings suggest interventions designed to improve health outcomes should target multiple health behaviors simultaneously. Plain Language Summary: Pediatric cancer survivors are at‐risk for detrimental health outcomes associated with cancer and treatment.Engagement in healthy lifestyle behaviors serves to reduce health vulnerabilities among adult survivors but less is known about associations with lifestyle behaviors on young survivors.This study documents patterns of lifestyle behaviors among survivors of pediatric cancer, factors that increase susceptibility to nonadherence, and associations among lifestyle behaviors and health indicators. Young (<18 years of age) survivors of pediatric cancer exhibit poor adherence to diet and physical activity guidelines. Adherence is associated with clinical health outcomes. [ABSTRACT FROM AUTHOR]
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- 2023
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22. Chronic health conditions among long‐term survivors of adolescent and young adult cancer: A comparison of outcomes in Israel and the United States.
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Hayek, Samah, Libresco, Gilad, Barda, Noam, Chao, Chun, Xu, Lanfang, Cannavale, Kimberly L., Izraeli, Shai, and Armenian, Saro H.
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YOUNG adults ,CANCER patients ,CHRONIC diseases ,TEENAGERS ,CANCER survivors ,CANCER fatigue - Abstract
Background: There is a paucity of information on health outcomes of adolescent and young adult (AYA) cancer survivors living outside North America and Europe. This study compared outcomes in AYA cancer survivors in Israel with individuals without cancer and similar demographics and access to health care, and to AYA cancer survivors living in the United States. Methods: This study included 12,674 2‐year survivors of AYA (aged 15–39 years) cancer diagnosed between 2000 and 2018 at Clalit Health Services (CHS) in Israel. CHS participants without cancer (N = 50,696) were matched 4:1 to survivors on age, sex, ethnicity, and membership duration. Poisson regression was used to determine incidence rate ratios (IRRs) for chronic conditions. The US Kaiser Permanente Southern California AYA cohort (N = 6778) was used to estimate weighted (age, sex) standardized incidence ratios (SIRs) for CHS survivors. Results: CHS AYA cancer survivors were more likely to have any chronic condition (IRR, 1.6 95% CI, 1.5–1.7), compared with participants without cancer. Survivors had an increased risk across nearly all conditions examined, with especially elevated risks for osteoporosis (IRR, 4.7; 95% CI, 4.1–5.5) and cardiomyopathy (IRR, 4.2 95% CI, 3.4–5.3). Compared with the Kaiser Permanente Southern California cohort, CHS survivors had an overall lower (SIR, 0.68; 95% CI, 0.65–0.72) incidence of developing any health condition, with noticeably lower incidence of hyperlipidemia (SIR, 0.7; 95% CI, 0.64–0.75). Conclusion: AYA cancer survivors in Israel are at increased risk for developing chronic conditions compared with individuals without cancer, but the overall incidence was lower than in US survivors. These findings may allow for refinement of surveillance recommendations for AYA survivors, taking into consideration regional differences in sociodemographic characteristics and cancer care. Plain language summary: The burden of chronic conditions was consistently greater in Israeli adolescent and young adult cancer survivors compared with individuals without cancer, with clear differences in risk of specific conditions by cancer diagnosis.However, the overall incidence of chronic conditions in Israeli survivors was generally lower than in US survivors. The current study supports the development of age‐appropriate guidelines to facilitate risk‐based screening for late effects for adolescent and young adult (AYA) cancer survivors, taking into consideration regional differences in sociodemographic characteristics and cancer care. It may also allow for better characterization of the anticipated global burden of late effects in the growing population of AYA cancer survivors. [ABSTRACT FROM AUTHOR]
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- 2023
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23. Early intervention in myelofibrosis and impact on outcomes: A pooled analysis of the COMFORT‐I and COMFORT‐II studies.
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Verstovsek, Srdan, Kiladjian, Jean‐Jacques, Vannucchi, Alessandro M., Mesa, Ruben A., Squier, Peg, Hamer‐Maansson, J. E., and Harrison, Claire
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MYELOFIBROSIS ,BONE marrow cancer ,CLINICAL trials ,RUXOLITINIB ,SYMPTOMS ,FACTOR analysis - Abstract
Background: In a pooled analysis of the phase 3 Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment I (COMFORT‐I) and COMFORT‐II clinical trials, adult patients with intermediate‐2 or high‐risk myelofibrosis who received oral ruxolitinib at randomization or after crossover from placebo or best available therapy (BAT) had improved overall survival (OS). Methods: This post hoc analysis of pooled COMFORT data examined relevant disease outcomes based on the disease duration (≤12 or >12 months from diagnosis) before ruxolitinib initiation. Results: The analysis included 525 patients (ruxolitinib: ≤12 months, n = 84; >12 months, n = 216; placebo/BAT: ≤12 months, n = 66; >12 months, n = 159); the median age was 65.0–70.0 years. Fewer thrombocytopenia and anemia events were observed among patients who initiated ruxolitinib treatment earlier. At Weeks 24 and 48, the spleen volume response (SVR) was higher for patients who initiated ruxolitinib earlier (47.6% vs. 32.9% at Week 24, p =.0610; 44.0% vs. 26.9% at Week 48, p =.0149). In a multivariable analysis of factors associated with spleen volume reduction, a logistic regression model that controlled for confounding factors found that a significantly greater binary reduction was observed among patients with shorter versus longer disease duration (p =.022). At Week 240, OS was significantly improved among patients who initiated ruxolitinib earlier (63% [95% CI, 51%‒73%] vs. 57% [95% CI, 49%‒64%]; hazard ratio, 1.53; 95% CI, 1.01‒2.31; p =.0430). Regardless of disease duration, a longer OS was observed for patients who received ruxolitinib versus those who received placebo/BAT. Conclusions: These findings suggest that earlier ruxolitinib initiation for adult patients with intermediate‐2 and high‐risk myelofibrosis may improve clinical outcomes, including fewer cytopenia events, durable SVR, and prolonged OS. Plain Language Summary: Patients with myelofibrosis, a bone marrow cancer, often do not live as long as the general population. These patients may also have an enlarged spleen and difficult symptoms such as fatigue.Two large clinical trials showed that patients treated with the drug ruxolitinib lived longer and had improved symptoms compared to those treated with placebo or other standard treatments.Here it was examined whether starting treatment with ruxolitinib earlier (i.e., within a year of diagnosis) provided benefits versus delaying treatment.Patients who received ruxolitinib within a year of diagnosis lived longer and experienced fewer disease symptoms than those whose treatment was delayed. A pooled analysis of the Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment I (COMFORT‐I) and COMFORT‐II phase 3 trials suggests that earlier ruxolitinib initiation in adult patients with intermediate‐2 or high‐risk myelofibrosis is associated with improved clinical outcomes, including significantly prolonged overall survival and improved spleen and symptom responses. These data suggest that patients with myelofibrosis may benefit from earlier intervention. [ABSTRACT FROM AUTHOR]
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- 2023
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24. Switching the scope from "how to identify cancer survivors" to "who is participating in cancer survivorship research": A proposal for a new focus.
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van de Wal, Deborah, Janssen, Silvie H. M., van der Meer, Daniël J., Vlooswijk, Carla C. P., Roos, Daniëlle C., Bootsma, Tom I., Fles, Renske, Burgers, Vivian W. G., and Husson, Olga
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In our opinion, it is better to switch the scope in cancer survivorship research from "how to identify cancer survivors" to "who participates in surveys" and to find ways to be inclusive and reach as many cancer survivors as possible for research in the heterogeneous cancer survivor population. With great interest, we read the study by Doose and colleagues,1 who described survey questions used to identify and describe cancer survivors in national cross-sectional studies. [Extracted from the article]
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- 2022
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25. Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: A multisite longitudinal assessment.
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Wong, Chris I., Vannatta, Kathryn, Gilleland Marchak, Jordan, Quade, Emeric V., Rodgers, Isabelle M., Reid, Christine M., Dandoy, Christopher E., Billett, Amy L., Miller, Tamara P., Vaughn, Shelley, Daraiseh, Nancy M., Liu, Shanshan, Carle, Adam C., and Walsh, Kathleen E.
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MEDICATION errors ,LEUKEMIA ,CHILDHOOD cancer ,LYMPHOMAS ,RANDOM effects model - Abstract
Background: There is little longitudinal information about the type and frequency of harm resulting from medication errors among outpatient children with cancer. We aimed to characterize rates and types of medication errors and harm to outpatient children with leukemia and lymphoma over 7 months of treatment. Methods: We recruited children taking medications at home for leukemia or lymphoma from three pediatric cancer centers. Errors were identified by chart review, in‐home medication review, observation of administration, and interviews. Physician reviewers confirmed error (Fleiss' κ = 0.95), harm (Fleiss' κ = 0.82), and suggested interventions. Generalized linear mixed models with random effects were used to account for clustering by site. Results: Among 131 children taking 1669 medications with 367 home visits, 408 errors were identified, including 242 with potential for harm and 39 with harm (1.0 harm per 1000 patient‐days [95% CI, 0.1–9.8]). Ten percent of children were injured by errors and 42% had errors with potential for harm. Twenty‐six percent of caregivers reported that miscommunication led to missed doses or overdoses at home. Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p =.05). Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). Conclusions: In this longitudinal study, 10% children with leukemia or lymphoma experienced adverse drug events because of outpatient medication errors. Improvements addressing communication with and among caregivers should be codeveloped with families and based on human‐factors engineering. Plain Language Summary: In this longitudinal study, medication errors in the clinic, pharmacy, or at home among children with leukemia or lymphoma over a 7‐month period were common, and 10% suffered harm because of errors.Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p =.05).Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). Improvements addressing communication with and among caregivers should be codeveloped with families and based on human‐factors engineering. In this longitudinal study, medication errors in the clinic or at home among children with leukemia or lymphoma over a 7‐month period were common, and 10% suffered from harm from errors. Improvements addressing communication within and among caregivers may have prevented the most harm among the study population. [ABSTRACT FROM AUTHOR]
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- 2023
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26. Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial.
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El‐Jawahri, Areej, Luskin, Marlise R., Greer, Joseph A., Traeger, Lara, Lavoie, Mitchell, Vaughn, Dagny Marie, Andrews, Stephanie, Yang, Daniel, Boateng, Kofi Y., Newcomb, Richard A., Ufere, Nneka N., Fathi, Amir T., Hobbs, Gabriela, Brunner, Andrew, Abel, Gregory A., Stone, Richard M., DeAngelo, Daniel J., Wadleigh, Martha, and Temel, Jennifer S.
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ACUTE myeloid leukemia ,MOBILE apps ,PSYCHO-oncology ,PSYCHOTHERAPY patients ,CLINICAL trials ,PSYCHOLOGICAL distress - Abstract
Background: Patients with acute myeloid leukemia (AML) experience a substantial decline in quality of life (QoL) and mood during their hospitalization for intensive chemotherapy, yet few interventions have been developed to enhance patient‐reported outcomes during treatment. Methods: We conducted a pilot randomized trial (ClinicalTrials.gov identifier NCT03372291) of DREAMLAND, a psychological mobile application for patients with a new diagnosis of AML who are receiving intensive chemotherapy. Patients were randomly assigned to DREAMLAND or usual care. DREAMLAND included four required modules focused on: (1) supportive psychotherapy to help patients deal with the initial shock of diagnosis, (2) psychoeducation to manage illness expectations, (3) psychosocial skill‐building to promote effective coping, and (4) self‐care. The primary end point was feasibility, which was defined as ≥60% of eligible patients enrolling and 60% of those enrolled completing ≥60% of the required modules. We assessed patient QoL (the Functional Assessment of Cancer Therapy–Leukemia), psychological distress (the Hospital Anxiety and Depression Scale and the Patient Health Questionnaire‐9), symptom burden (the Edmonton Symptom Assessment Scale), and self‐efficacy (the Cancer Self‐Efficacy Scale) at baseline and at day 20 after postchemotherapy. Results: We enrolled 60 of 90 eligible patients (66.7%), and 62.1% completed ≥75% of the intervention modules. At day 20 after chemotherapy, patients who were randomized to DREAMLAND reported improved QoL scores (132.06 vs. 110.72; p =.001), lower anxiety symptoms (3.54 vs. 5.64; p =.010) and depression symptoms (Hospital Anxiety and Depression Scale: 4.76 vs. 6.29; p =.121; Patient Health Questionnaire‐9: 4.62 vs. 8.35; p <.001), and improved symptom burden (24.89 vs. 40.60; p =.007) and self‐efficacy (151.84 vs. 135.43; p =.004) compared with the usual care group. Conclusions: A psychological mobile application for patients with newly diagnosed AML is feasible to integrate during hospitalization for intensive chemotherapy and may improve QoL, mood, symptom burden, and self‐efficacy. A psychological mobile application for patients with newly diagnosed acute myeloid leukemia (AML) is feasible to integrate during hospitalization for intensive chemotherapy. The mobile application has promising preliminary efficacy for improving quality of life, mood, symptom burden, and self‐efficacy for patients with AML. [ABSTRACT FROM AUTHOR]
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- 2023
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27. Race‐free renal function estimation equations and potential impact on Black patients: Implications for cancer clinical trial enrollment.
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Schmeusser, Benjamin N., Palacios, Arnold R., Midenberg, Eric R., Nabavizadeh, Reza, Patil, Dattatraya H., Harvey, R. Donald, Bryksin, Janetta, Connor, Michael J., Ogan, Kenneth, Bilen, Mehmet A., and Master, Viraj A.
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BLACK people ,CLINICAL trials ,KIDNEY physiology ,RACE ,CANCER patients - Abstract
Background: Black patients face disparities in cancer outcomes. Additionally, Black patients are more likely to be undertreated and underrepresented in clinical trials. The recent recommendation to remove race from the estimated glomerular filtration rate (eGFR) results in lower eGFR values for Black patients. The ramifications of this decision, both intended and unintended, are still being elucidated in the medical community. Here, the authors analyze the removal of race from eGFR for Black patients with cancer, specifically with respect to clinical trial eligibility. Methods: In a cohort of self‐identified Black patients who underwent nephrectomy at a tertiary referral center from 2009 to 2021 (n = 459), eGFR was calculated with and without race in commonly used equations (Chronic Kidney Disease Epidemiology Collaboration [CKD‐EPI] and Modification of Diet in Renal Disease [MDRD]). The distribution of patients and changes within chronic kidney disease stages with different equations was considered. Theoretical exclusion at commonly observed clinical trial eGFR points was then simulated on the basis of the utilization of the race coefficient. Results: The median eGFR from CKD‐EPI was significantly higher with race (76 ml/min/1.73 m2) than without race (66 ml/min/1.73 m2; p <.0001). The median eGFR from MDRD was significantly higher with race (71.0 ml/min/1.73 m2) than without race (58 ml/min/1.73 m2; p <.0001). Observing results in the context of common clinical trial cutoff points, the authors found that 13%–22%, 6%–12%, and 2%–3% more Black patients would fall under common clinical trial cutoffs of 60, 45, and 30 ml/min, respectively, depending on the equation used. A subanalysis of stage III–IV patients only was similar. Conclusions: Race‐free renal function equations may inadvertently result in increased exclusion of Black patients from clinical trials. This is especially concerning because of the underrepresentation and undertreatment that Black patients already experience. Plain Language Summary: Black patients experience worse oncologic outcomes and are underrepresented in clinical trials.Kidney function, as estimated by glomerular filtration rate equations, is a factor in who can and cannot be in a clinical trial.Race is a variable in some of these equations.For Black patients, removing race from these equations leads to the calculation of lower kidney function.Lower estimated kidney function may result in more black patients being excluded from clinical trials.The inclusion of all races in clinical trials is important for offering best care to everyone and for making results from clinical trials applicable to everyone. Black patients face significant disparities in cancer outcomes and are underrepresented in cancer clinical trials. A current movement to remove race from renal function equations may result in additional exclusion of Black patients from clinical trials. [ABSTRACT FROM AUTHOR]
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- 2023
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28. Top advances of the year: Cervical cancer.
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Podwika, Sarah E. and Duska, Linda R.
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CERVICAL cancer ,GENITAL warts ,AMERICAN women ,HUMAN papillomavirus vaccines ,ANTIBODY-drug conjugates ,MEDICAL screening - Abstract
Cervical cancer continues to affect women in the United States and throughout the world despite an effective vaccine against human papillomavirus and cancer screening programs. For the women who develop cervical cancer, surgery, radiation, and chemotherapy have been the mainstays of treatment for years. Recently, novel therapeutics have been developed that offer new treatment opportunities for women living with advanced and/or recurrent disease. Immunotherapy has become an important tool against cervical cancer with the approval of pembrolizumab in the second line for advanced or recurrent disease. Checkpoint inhibitors have recently been approved in the front line for advanced and/or recurrent disease in combination with chemotherapy, and they are being studied in the front line in combination with chemoradiation. Antibody–drug conjugates—specifically tisotumab vedotin (TV)—also have recently received Food and Drug Administration (FDA) approval, and TV is currently being studied in combination with checkpoint inhibitors and with carboplatin. Tumor‐infiltrating lymphocytes have been studied in early‐phase trials and have shown promise in small patient series. Despite these new therapies, there continue to be racial, ethnic, and socioeconomic inequities with respect to access to care, access to and participation in clinical trials, and survival in the United States as well as globally. New FDA guidance requires researchers to work to reduce disparities by including women of more diverse backgrounds in clinical trials. Finally, as progress continues to be made in the treatment of established disease, prevention through vaccination and screening remains paramount. Plain language summary: The treatment of cervical cancer remains a significant problem in the United States and especially worldwide.Although early cases can be cured, cervical cancer that has spread remains difficult to treat.The past few years have seen significant advances in new therapies and combinations of therapies for women with advanced or recurrent disease.Although this is excellent news for these women, cervical cancer is a preventable disease through screening with Papanicolaou smears and vaccination with the human papillomavirus vaccine.By improving access to and acceptance of screening and vaccination, we can eradicate cervical cancer in the United States and the world. The past few years have seen US Food and Drug Administration approval of novel therapies and combinations for advanced and/or recurrent cervical cancer that are providing new hope for women with this disease. All cervical cancer can and must be eradicated by improving access to and acceptance of screening modalities and vaccination and by addressing disparities related to race, ethnicity, and socioeconomic status. [ABSTRACT FROM AUTHOR]
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- 2023
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29. Phase 2 prospective open label study of neoadjuvant nab‐paclitaxel, trastuzumab, and pertuzumab in patients with HER2‐positive primary breast cancer.
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Lavasani, Sayeh M., Somlo, George, Yost, Susan E., Frankel, Paul H., Ruel, Christopher, Cui, Yujie, Murga, Mireya, Tang, Aileen, Martinez, Norma, Kruper, Laura, Tumyan, Lusine, Schmolze, Daniel, Yeon, Christina, Yuan, Yuan, Waisman, James R., and Mortimer, Joanne
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HER2 positive breast cancer ,EPIDERMAL growth factor receptors ,TRASTUZUMAB - Abstract
Background: The objective of this study was to evaluate the safety and efficacy of nab‐paclitaxel, trastuzumab, and pertuzumab as neoadjuvant therapy (NAT) in patients with human epidermal growth factor receptor 2 HER2+ breast cancer (HER2+ BC) to determine pathologic complete response (pCR), invasive disease‐free survival (iDFS), and overall survival. Methods: Forty‐five patients with HER2+ BC Stages II–III were to be enrolled from 2013 to 2017. Patients were treated with weekly nab‐paclitaxel (100 mg/m2 intravenously), weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg), and six cycles of pertuzumab (840 mg loading dose, then 420 mg intravenously day 1 every 21 days). Results: Median follow‐up was 60 months (95% CI, 32.3–55.6) and pCR was 29/45 (64%). The 5‐year iDFS for patients who achieved pCR (N = 29) was 96.3% (95% CI, 76.5–99.5) and non‐pCR patients (N = 16) was 74.3% (95% CI, 39.1–91.0). The 5‐year overall survival (N = 45) was 94.1% (95% CI, 77.6–98.5). Based on hormonal status, the 5‐year iDFS for HR+ pCR patients (N = 14) was 92.3% (95% CI, 56.6–98.9) and for HR− (N = 15) was 100% (p =.3). Conclusions: This anthracycline/carboplatin‐free regimen with nab‐paclitaxel achieved a pCR rate of 64% in patients with HER2+ BC. The 5‐year iDFS in patients with and without pCR was 96.3% and 74.3%, respectively. The pCR rate is comparable with docetaxel, carboplatin, trastuzumab, and pertuzumab therapy in the NAT setting, but with fewer treatment‐associated toxicities. This finding suggests the possibility of safe avoidance of anthracyclines and carboplatin as components of NAT in patients with HER2+ BC. This anthracycline/carboplatin‐free regimen with nab‐paclitaxel achieved a pathologic complete response rate of 64% in patients with human epidermal growth factor receptor 2 breast cancer (HER2+ BC). This finding suggests the possibility of safe avoidance of anthracyclines and carboplatin as components of neoadjuvant therapy in HER2+ BC patients. [ABSTRACT FROM AUTHOR]
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- 2023
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30. Clinical effects and emerging issues of atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma from Japanese real‐world practice.
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Nakagawa, Miyuki, Inoue, Masanori, Ogasawara, Sadahisa, Maruta, Susumu, Okubo, Tomomi, Itokawa, Norio, Iino, Yotaro, Obu, Masamichi, Haga, Yuki, Seki, Atsuyoshi, Kikuchi, Yasuharu, Kogure, Tadayoshi, Yumita, Sae, Ishino, Takamasa, Ogawa, Keita, Fujiwara, Kisako, Iwanaga, Terunao, Fujita, Naoto, Sakuma, Takafumi, and Kojima, Ryuta
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BEVACIZUMAB ,HEPATOCELLULAR carcinoma ,ATEZOLIZUMAB ,VASCULAR endothelial growth factors ,FATTY liver ,CLINICAL trials - Abstract
Background: Although the efficacy of atezolizumab has been demonstrated in randomized controlled trials, its long‐term efficacy and association with adverse events in real‐world practice are unknown. This study was designed to shed light on these issues. Methods: In this multicenter retrospective study, data were collected from patients with advanced hepatocellular carcinoma treated with atezolizumab plus bevacizumab in seven institutions in Japan. The authors focused on the efficacy and adverse events related to vascular endothelial growth factor (VEGF) inhibition. Results: A total of 123 patients were enrolled in this study. The median progression‐free survival (PFS) for the first‐line treatment group was 8.0 months (95% confidence interval [CI], 6.1–9.9), whereas the median PFS for the second‐ or later‐line treatment group was 4.1 months (95% CI, 2.6–5.7), which was significantly worse than that of the first‐line treatment group (p =.005). Twenty‐seven patients had interrupted bevacizumab treatment. Proteinuria accounted for the largest proportion of bevacizumab treatment interruptions. The cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with hypertension and/or diabetes mellitus than in those without (p =.026). The landmark analysis showed that patients experienced bevacizumab interruption by 24 weeks from treatment initiation had poorer PFS than those who did not (p =.013). Conclusions: The PFS of atezolizumab plus bevacizumab as first‐line treatment mostly replicates that of a global phase 3 trial. Interrupted bevacizumab treatment was more common in patients with hypertension and/or diabetes mellitus, which may be associated with worsening long‐term PFS. Plain language summary: Atezolizumab plus bevacizumab has been the standard front line systemic therapy for advanced hepatocellular carcinoma.With the growing incidence of fatty liver due to metabolic syndrome as a background liver disease for hepatocellular carcinoma, the rate of comorbid hypertension and diabetes mellitus has been increasing accordingly.The present study demonstrated the cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with hypertension and/or diabetes mellitus.The landmark analysis clarified that interruption of bevacizumab might be a risk of impaired efficacy of atezolizumab plus bevacizumab over the long term in patients with advanced hepatocellular carcinoma. This report demonstrated that the cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with comorbid hypertension and/or diabetes mellitus during atezolizumab plus bevacizumab for advanced hepatocellular carcinoma. Interruption of bevacizumab might be a risk of impaired efficacy of atezolizumab plus bevacizumab over the long term in patients with advanced hepatocellular carcinoma. [ABSTRACT FROM AUTHOR]
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- 2023
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31. Patient perspectives of prostate cancer screening vary by race following 2018 guideline changes.
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Riviere, Paul, Kalavacherla, Sandhya, Banegas, Matthew P., Javier‐Desloges, Juan, Martinez, Maria Elena, Garraway, Isla P., Murphy, James D., and Rose, Brent S.
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PROSTATE cancer patients ,EARLY detection of cancer ,HISPANIC Americans ,AFRICAN American men ,MEDICAL screening ,WATCHFUL waiting ,MEDICAL mistrust ,INSTITUTIONAL racism ,PROSTATE-specific antigen - Abstract
Background: The 2018 US Preventive Services Task Force guidelines recommend individualizing prostate cancer screening in 55‐ to 69‐year‐old men. Given the higher incidence of prostate cancer in African American (AA) compared to non‐Hispanic White (NHW) men, this study compared reported rates of prostate‐specific antigen (PSA) screening hypothesizing that it would not be commensurate with the relative risk between these two groups. Methods: Using the 2020 Behavioral Risk Factor Surveillance System, we identified 43,685 men (40,301 NHW and 3384 AA) interviewed about PSA screening. Results: AA men had an odds ratio (OR) of 0.80 (95% confidence interval [CI], 0.69–0.93; p =.004) of reporting PSA screening; sequentially correcting for access to care, smoking, and age had minimal effect on this finding, but when correcting for income significantly attenuated this difference (OR, 0.95; 95% CI, 0.81–1.12). Further adding education level eliminated the effect size of AA race entirely with OR, 0.99 (95% CI, 0.84–1.17; p =.91). Further analysis found significant interaction between education and race, with college‐educated AA men having 1.42 OR of receiving screening compared to college‐educated NHW men. Conclusions: Despite prostate cancer being more common and having higher population‐level mortality in AA than NHW men, PSA screening and education patterns do not reflect this increased risk even when adjusting for health access disparities. The authors' findings of significant effect from both income and education suggest that systemic racism is an important factor in the observed difference in PSA screening between AA men and NHW men. Lay summary: In the United States, prostate cancer is more common in African American menNew guidelines from 2018 encourage physicians to consider risk factors in deciding whether or not to recommend screening, but overall African American men continue to be screened at a lower rate than non‐Hispanic White menThis effect disappears when correcting for income and education level, suggesting that several factors including systemic racism, medical mistrust, and self‐advocacy may impact this observed difference African American men continue to report lower rates of PSA screening compared to non‐Hispanic White men in a nationwide survey. This effect appears to be mediated by income and education, suggesting that systemic racism as well as self‐advocacy and medical mistrust may be responsible for this observed difference. [ABSTRACT FROM AUTHOR]
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- 2023
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32. Impact of patient choice and hospital competition on patient outcomes after rectal cancer surgery: A national population‐based study.
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Han, Lu, Boyle, Jemma M., Walker, Kate, Kuryba, Angela, Braun, Michael S., Fearnhead, Nicola, Jayne, David, Sullivan, Richard, van der Meulen, Jan, and Aggarwal, Ajay
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RECTAL surgery ,RECTAL cancer ,ONCOLOGIC surgery ,ABDOMINOPERINEAL resection ,HOSPITAL patients ,SURGICAL margin - Abstract
Background: The objective of the current national cohort study was to analyze the correlation between choice and competition on outcomes after cancer surgery in rectal cancer. Methods: The analysis included all men who underwent rectal cancer surgery in the English National Health Service between March 2015 and April 2019 (n = 13,996). Multilevel logistic regression was used to assess the effect of a rectal cancer surgery center being located in a competitive environment (based on the number of centers within a threshold distance) and being a successful competitor (based on the ability to attract patients from other hospitals) on eight patient‐level outcomes: 30‐ and 90‐day emergency readmissions, 30‐day re‐operation rates, 90‐day postoperative mortality, length of stay >14 days, circumferential resection margin status, rates of primary procedure with a permanent stoma, and rates of persistent stoma 18 months after anterior resection. Results: With adjustment for patient characteristics, patients who underwent surgery in centers located in a stronger competitive environment were less likely to have an abdominoperineal excision or a Hartman's procedure (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.55–0.97, p =.04). Additionally, individuals who received treatment at hospitals that were successful competitors had a lower risk of a 90‐day readmission following rectal cancer surgery (OR, 0.86; 95% CI, 0.76–0.97, p =.03) and were less likely to have a persistent stoma at 18 months after anterior resection (OR, 0.75; 95% CI, 0.61–0.93, p =.02). Conclusions: Hospitals located in areas of high competition are associated with better patient outcomes and improved processes of care for rectal cancer surgery. The results of this study build on an emerging evidence base that demonstrates that hospitals located in areas of high competition are associated with better care quality. These results continue to challenge centralization or regionalization of some cancer surgical services as the dominant approach to deliver improvements in quality. [ABSTRACT FROM AUTHOR]
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- 2023
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33. Rationalizing rules for immunotherapy combination trials: About time for precision immunotherapy.
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Desai, Aakash and Subbiah, Vivek
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TIME trials ,IMMUNOTHERAPY ,CANCER prognosis ,PATIENT selection ,PATIENTS' rights - Abstract
Lay summary: Immunotherapy has changed the landscape of cancer treatment. However, the benefit of immunotherapy is seen only in some cases, with most patients experiencing cancer progression despite treatment with immunotherapy. To overcome this, combination immunotherapy treatments are being studied. Herein, we propose for a precision‐driven approach for patient selection to identify successful combinations of immunotherapy to improve outcomes for patients with cancer. Despite the success of immunotherapy, single‐agent immunotherapy fails to achieve durable disease control in most immune‐responsive tumors. Successful combinations and smartly designed studies would require improved patient selection for a much needed "precision immunotherapy" approach to identify the right dose of the right immunotherapy combination for the right patient at the right time. [ABSTRACT FROM AUTHOR]
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- 2023
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34. Complete tumor necrosis after neoadjuvant chemotherapy defines good responders in patients with Ewing sarcoma.
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Lozano‐Calderón, Santiago A., Albergo, Jose Ignacio, Groot, Olivier Q., Merchan, Nelson A., El Abiad, Jad M., Salinas, Vanessa, Gomez Mier, Luis Carlos, Montoya, Camilo Soto, Ferrone, Marco L., Ready, John E., Linares, Francisco J., Levin, Adam S., Peleteiro Pensado, Manuel, Pozo Kreilinger, José Juan, Ruiz, Irene Barrientos, Ortiz‐Cruz, Eduardo J., Gebhardt, Mark C., Cote, Gregory M., Choy, Edwin, and Spentzos, Dimitrios
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EWING'S sarcoma ,NEOADJUVANT chemotherapy ,SYMPTOMS ,SURGICAL margin ,BIVARIATE analysis ,NECROSIS - Abstract
Background: Survival in patients who have Ewing sarcoma is correlated with postchemotherapy response (tumor necrosis). This treatment response has been categorized as the response rate, similar to what has been used in osteosarcoma. There is controversy regarding whether this is appropriate or whether it should be a dichotomy of complete versus incomplete response, given how important a complete response is for in overall survival of patients with Ewing sarcoma. The purpose of this study was to evaluate the impact that the amount of chemotherapy‐induced necrosis has on (1) overall survival, (2) local recurrence‐free survival, (3) metastasis‐free survival, and (4) event‐free survival in patients with Ewing sarcoma. Methods: In total, 427 patients who had Ewing sarcoma or tumors in the Ewing sarcoma family and received treatment with preoperative chemotherapy and surgery at 10 international institutions were included. Multivariate Cox proportional‐hazards analyses were used to assess the associations between tumor necrosis and all four outcomes while controlling for clinical factors identified in bivariate analysis, including age, tumor volume, location, surgical margins, metastatic disease at presentation, and preoperative radiotherapy. Results: Patients who had a complete (100%) tumor response to chemotherapy had increased overall survival (hazard ratio [HR], 0.26; 95% CI, 0.14–0.48; p <.01), recurrence‐free survival (HR, 0.40; 95% CI, 0.20–0.82; p =.01), metastasis‐free survival (HR, 0.27; 95% CI, 0.15–0.46; p ≤.01), and event‐free survival (HR, 0.26; 95% CI, 0.16–0.41; p ≤.01) compared with patients who had a partial (0%–99%) response. Conclusions: Complete tumor necrosis should be the index parameter to grade response to treatment as satisfactory in patients with Ewing sarcoma. Any viable tumor in these patients after neoadjuvant treatment should be of oncologic concern. These findings can affect the design of new clinical trials and the risk‐stratified application of conventional or novel treatments. Complete tumor necrosis should be the index parameter to grade response to treatment as satisfactory in patients with Ewing sarcoma. Any viable tumor in these patients after neoadjuvant treatment should be of oncologic concern, and these findings can affect the design of new clinical trials and the risk‐stratified application of conventional or novel treatments. [ABSTRACT FROM AUTHOR]
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- 2023
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35. What happens in the long term: Uptake of cancer surveillance and prevention strategies among at‐risk relatives with pathogenic variants detected via cascade testing.
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Frey, Melissa K., Ahsan, Muhammad Danyal, Badiner, Nora, Lin, Jenny, Narayan, Priyanka, Nitecki, Roni, Rauh‐Hain, Jose Alejandro, Moss, Haley, Fowlkes, Rana Khan, Thomas, Charlene, Bergeron, Hannah, Christos, Paul, Levi, Sarah R., Blank, Stephanie V., Holcomb, Kevin, Cantillo, Evelyn, Sharaf, Ravi N., Lipkin, Steven, Offit, Kenneth, and Chapman‐Davis, Eloise
- Abstract
Background: Cascade genetic testing for hereditary cancer syndromes offers affected relatives the opportunity to pursue cancer screening and risk‐reducing surgery and thus reduces morbidity and mortality. The purpose of this study was to measure the long‐term utilization of targeted cancer prevention and quality of life among at‐risk relatives offered clinician‐facilitated cascade genetic testing. Methods: In a pilot study, at‐risk relatives of patients with a hereditary cancer syndrome were contacted directly by the clinical team and offered telephone genetic counseling and genetic testing via an at‐home, mailed saliva kit. Two‐year follow‐up results evaluating the use of targeted cancer prevention strategies and the quality of life for enrolled relatives were reported. Quality‐of‐life was measured with validated surveys, and scores were compared to the time of initial contact by the Wilcoxon signed‐rank test. Results: Ninety‐five at‐risk relatives were enrolled in the initial pilot study, and 72 (76%) participated in the 2‐year follow‐up; 57 of these (79%) had completed genetic testing. Twenty‐five of those 57 relatives (44%) were found to harbor an inherited pathogenic variant. Guideline‐based cancer surveillance was recommended to 18 relatives; 13 (72%) completed at least one recommended screening, and six (33%) completed all recommended screenings. Risk‐reducing surgery was recommended to 10 relatives; four (40%) completed a total of eight procedures. Quality‐of‐life surveys demonstrated low levels of anxiety, depression, distress, and uncertainty. Conclusions: The 2‐year follow‐up of the original pilot study revealed that clinician‐facilitated cascade testing resulted in genetically targeted cancer screening and prevention with preserved quality of life. These results, to be confirmed by larger randomized controlled trials, suggest that medical systems should consider supporting clinician‐facilitated cascade testing programs. Cascade testing for cancer syndromes facilitated by the medical team resulted in identification of relatives with pathogenic variants and use of genetically targeted cancer prevention with preserved quality‐of‐life. [ABSTRACT FROM AUTHOR]
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- 2022
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36. Annual report to the nation on the status of cancer, part 1: National cancer statistics.
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Cronin, Kathleen A., Scott, Susan, Firth, Albert U., Sung, Hyuna, Henley, S. Jane, Sherman, Recinda L., Siegel, Rebecca L., Anderson, Robert N., Kohler, Betsy A., Benard, Vicki B., Negoita, Serban, Wiggins, Charles, Cance, William G., and Jemal, Ahmedin
- Abstract
Background: The American Cancer Society, the Centers for Disease Control and Prevention, the National Cancer Institute, and the North American Association of Central Cancer Registries collaborate to provide annual updates on cancer occurrence and trends in the United States. Methods: Data on new cancer diagnoses during 2001–2018 were obtained from the North American Association of Central Cancer Registries' Cancer in North America Incidence file, which is comprised of data from Centers for Disease Control and Prevention‐funded and National Cancer Institute‐funded, population‐based cancer registry programs. Data on cancer deaths during 2001–2019 were obtained from the National Center for Health Statistics' National Vital Statistics System. Five‐year average incidence and death rates along with trends for all cancers combined and for the leading cancer types are reported by sex, racial/ethnic group, and age. Results: Overall cancer incidence rates were 497 per 100,000 among males (ranging from 306 among Asian/Pacific Islander males to 544 among Black males) and 431 per 100,000 among females (ranging from 309 among Asian/Pacific Islander females to 473 among American Indian/Alaska Native females) during 2014–2018. The trend during the corresponding period was stable among males and increased 0.2% on average per year among females, with differing trends by sex, racial/ethnic group, and cancer type. Among males, incidence rates increased for three cancers (including pancreas and kidney), were stable for seven cancers (including prostate), and decreased for eight (including lung and larynx) of the 18 most common cancers considered in this analysis. Among females, incidence rates increased for seven cancers (including melanoma, liver, and breast), were stable for four cancers (including uterus), and decreased for seven (including thyroid and ovary) of the 18 most common cancers. Overall cancer death rates decreased by 2.3% per year among males and by 1.9% per year among females during 2015–2019, with the sex‐specific declining trend reflected in every major racial/ethnic group. During 2015–2019, death rates decreased for 11 of the 19 most common cancers among males and for 14 of the 20 most common cancers among females, with the steepest declines (>4% per year) reported for lung cancer and melanoma. Five‐year survival for adenocarcinoma and neuroendocrine pancreatic cancer improved between 2001 and 2018; however, overall incidence (2001–2018) and mortality (2001–2019) continued to increase for this site. Among children (younger than 15 years), recent trends were stable for incidence and decreased for mortality; and among, adolescents and young adults (aged 15–39 years), recent trends increased for incidence and declined for mortality. Conclusions: Cancer death rates continued to decline overall, for children, and for adolescents and young adults, and treatment advances have led to accelerated declines in death rates for several sites, such as lung and melanoma. The increases in incidence rates for several common cancers in part reflect changes in risk factors, screening test use, and diagnostic practice. Racial/ethnic differences exist in cancer incidence and mortality, highlighting the need to understand and address inequities. Population‐based incidence and mortality data inform prevention, early detection, and treatment efforts to help reduce the cancer burden in the United States. The American Cancer Society, the Centers for Disease Control and Prevention, the National Cancer Institute, and the North American Association of Central Cancer Registries collaborate annually to provide updated information about cancer occurrence and trends in the United States. Part 1 of this year's report provides information on cancer incidence and mortality rates and trends for males and females and by race/ethnicity for common cancer sites, with an in‐depth look at pancreatic cancer. [ABSTRACT FROM AUTHOR]
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- 2022
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37. Patient outcomes following implementation of an enhanced recovery after surgery pathway for patients with metastatic spine tumors.
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Chakravarthy, Vikram B., Laufer, Ilya, Amin, Anubhav G., Cohen, Marc A., Reiner, Anne S., Vuong, Cindy, Persaud, Petal‐Ann S., Ruppert, Lisa M., Puttanniah, Vinay G., Afonso, Anoushka M., Tsui, Van S., Brallier, Jess W., Malhotra, Vivek T., Bilsky, Mark H., and Barzilai, Ori
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ENHANCED recovery after surgery protocol ,SPINAL surgery ,TUMOR surgery ,LENGTH of stay in hospitals ,URINARY catheters ,METASTASIS - Abstract
Background: Metastatic spine tumor surgery consists of palliative operations performed on frail patients with multiple medical comorbidities. Enhanced recovery after surgery (ERAS) programs involve an evidence‐based, multidisciplinary approach to improve perioperative outcomes. This study presents clinical outcomes of a metastatic spine tumor ERAS pathway implemented at a tertiary cancer center. Methods: The metastatic spine tumor ERAS program launched in April 2019, and data from January 2018 to May 2020 were reviewed. Measured outcomes included the following: hospital length of stay (LOS), time to ambulation, urinary catheter duration, time to resumption of diet, intraoperative fluid intake, estimated blood loss (EBL), and intraoperative and postoperative day 0–5 cumulative opioid use (morphine milligram equivalent [MME]). Results: A total of 390 patients were included in the final analysis: 177 consecutive patients undergoing metastatic spine tumor surgery enrolled in the ERAS program and 213 consecutive pre‐ERAS patients. Although the mean case durations were similar in the ERAS and pre‐ERAS cohorts (265 vs. 274 min; p =.22), the ERAS cohort had decreased EBL (157 vs. 215 ml; p =.003), decreased postoperative day 0–5 cumulative mean opioid use (178 vs. 396 MME; p <.0001), earlier ambulation (mean, 34 vs. 57 h; p =.0001), earlier discontinuation of urinary catheters (mean, 36 vs. 56 h; p <.001), and shorter LOS (5.4 vs. 7.5 days; p <.0001). Conclusions: The implementation of a multidisciplinary ERAS program designed for metastatic spine tumor surgery led to improved clinical quality metrics, including shorter hospitalizations and significant reductions in opioid consumption. Metastatic spine tumor surgery consists of palliative operations performed on frail patients with multiple medical comorbidities. The implementation of a multidisciplinary enhanced recovery after surgery program designed for metastatic spine tumor surgery has led to improved clinical quality metrics, including shorter hospitalizations and significant reductions in opioid consumption. [ABSTRACT FROM AUTHOR]
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- 2022
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38. Disparities in cancer genetics care by race/ethnicity among pan‐cancer patients with pathogenic germline variants.
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Liu, Ying L., Maio, Anna, Kemel, Yelena, Salo‐Mullen, Erin E., Sheehan, Margaret, Tejada, Prince Ray, Trottier, Magan, Arnold, Angela G., Fleischut, Megan Harlan, Latham, Alicia, Carlo, Maria I., Murciano‐Goroff, Yonina R., Walsh, Michael F., Mandelker, Diana, Mehta, Nikita, Bandlamudi, Chaitanya, Arora, Kanika, Zehir, Ahmet, Berger, Michael F., and Solit, David B.
- Abstract
Background: Germline risk assessment is increasing as part of cancer care; however, disparities in subsequent genetic counseling are unknown. Methods: Pan‐cancer patients were prospectively consented to tumor‐normal sequencing via custom next generation sequencing panel (Memorial Sloan Kettering‐Integrated Mutation Profiling of Actionable Cancer Targets) inclusive of germline analysis of ≥76 genes from January 2015 through December 2019 (97.5% research nonbillable) with protocol for genetics referral. Rates of pathogenic/likely pathogenic germline variants (PVs) and downstream counseling were compared across ancestry groups (mutually exclusive groups based on self‐reported race/ethnicity and Ashkenazi Jewish [AJ] heritage) using nonparametric tests and multivariable logistic regression models. Results: Among 15,775 patients (59.6%, non‐Hispanic [NH]‐White; 15.7%, AJ; 20.5%, non‐White [6.9%, Asian; 6.8%, Black/African American (AA); 6.7%, Hispanic; 0.1%, Other], and 4.2%, unknown), 2663 (17%) had a PV. Non‐White patients had a lower PV rate (n = 433, 13.4%) compared to NH‐Whites (n = 1451, 15.4%) and AJ patients (n = 683, 27.6%), p <.01, with differences in mostly moderate and low/recessive/uncertain penetrance variants. Among 2239 patients with new PV, 1652 (73.8%) completed recommended genetic counseling. Non‐White patients had lower rates of genetic counseling (67.7%) than NH‐White (73.7%) and AJ patients (78.8%), p <.01, with lower rates occurring in Black/AA (63%) compared to NH‐White patients, even after adjustment for confounders (odds ratio, 0.60; 95% confidence interval, 0.37–0.97; p =.036). Non‐White, particularly Black/AA and Asian, probands had a trend toward lower rates and numbers of at‐risk family members being seen for counseling/genetic testing. Conclusions: Despite minimizing barriers to genetic testing, non‐White patients were less likely to receive recommended cancer genetics follow‐up, with potential implications for oncologic care, cancer risk reduction, and at‐risk family members. Lay summary: Genetic testing is becoming an important part of cancer care, and we wanted to see if genetics care was different between individuals of different backgrounds.We studied 15,775 diverse patients with cancer who had genetic testing using a test called MSK‐IMPACT that was covered by research funding.Clinically important genetic findings were high in all groups.However, Black patients were less likely to get recommended counseling compared to White patients.Even after removing many roadblocks, non‐White and especially Black patients were less likely to get recommended genetics care, which may affect their cancer treatments and families. Although rates of germline pathogenic variants in cancer predisposition genes varied by self‐reported ancestry, rates in high penetrance genes were similar across all groups, highlighting the importance of genetic testing in cancer patients. Despite minimizing barriers to genetic testing, non‐White, particularly Black, cancer patients were less likely to complete recommended counseling follow‐up compared to non‐Hispanic White patients with potential implications for oncologic care, cancer risk reduction, and at‐risk family members. [ABSTRACT FROM AUTHOR]
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- 2022
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39. Trying to outRun‐DIC in KMT2Ar AML: It's tricky.
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Venugopal, Sangeetha and Taylor, Justin
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DISSEMINATED intravascular coagulation ,ACUTE myeloid leukemia - Abstract
In this issue of Cancer, Nguyen and colleagues describe high risk of disseminated intravascular coagulation (DIC) in patients with KMT2Ar acute myeloid leukemia (AML) compared with matched controls in a retrospective single‐institution analysis. The authors of this editorial put this study into perspective of other AML subtypes at high risk of DIC and bleeding. [ABSTRACT FROM AUTHOR]
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- 2023
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40. A network analysis of self-reported psychoneurological symptoms in patients with head and neck cancer undergoing intensity-modulated radiotherapy.
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Lin, Yufen, Bruner, Deborah W., Paul, Sudeshna, Miller, Andrew H., Saba, Nabil F., Higgins, Kristin A., Shin, Dong M., Zhang, Wenhui, Miaskowski, Christine, and Xiao, Canhua
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HEAD & neck cancer ,INTENSITY modulated radiotherapy ,FATIGUE (Physiology) ,SLEEP interruptions ,PSYCHO-oncology ,SYMPTOMS ,ALCOHOL drinking ,COGNITION disorders - Abstract
Background: Patients with head and neck cancer experience psychoneurological symptoms (PNS) (i.e., depression, fatigue, sleep disturbance, pain, and cognitive dysfunction) during intensity-modulated radiotherapy (IMRT) that decrease their functional status, quality of life, and survival rates. The purpose of this study was to examine and visualize the relationships among PNS within networks over time and evaluate for demographic and clinical characteristics associated with symptom networks.Methods: A total of 172 patients (mean age, 59.8 ± 9.9 years; 73.8%, male; 79.4%, White) completed symptom questionnaires four times, namely, before IMRT (T1), 1 month (T2), 3 months (T3), and 12 months (T4) post IMRT. Network analysis was used to examine the symptom-symptom relationships among PNS. Centrality indices, including strength, closeness, and betweenness, were used to describe the degrees of symptom network interconnections. Network comparison test was used to assess the differences between two symptom networks.Results: Depression was associated with the other four symptoms, and fatigue was associated with the other three symptoms across the four assessments. Based on the centrality indices, depression (rstrength = 1.3-1.4, rcloseness = 0.06-0.08, rbetweeness = 4-10) was the core symptom in all symptom networks, followed by fatigue. Female gender, higher levels of stress, and no alcohol use were associated with stronger symptom networks in network global strength before IMRT.Conclusion: Network analysis provides a novel approach to gain insights into the relationships among self-reported PNS and identify the core symptoms and associated characteristics. Clinicians may use this information to develop symptom management interventions that target core symptoms and interconnections within a network.Lay Summary: This study describes the symptom-symptom relationships for five common symptoms in patients with head and neck cancer receiving radiotherapy. Depression and fatigue appeared to be two core symptoms that were connected with sleep disturbance, pain, and cognitive dysfunction within a network. Several characteristics (i.e., female, higher stress, no alcohol use) were associated with stronger symptom networks. [ABSTRACT FROM AUTHOR]- Published
- 2022
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41. Patient-reported outcomes among patients with systemic mastocytosis in routine clinical practice: Results of the TouchStone SM Patient Survey.
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Mesa, Ruben A., Sullivan, Erin M., Dubinski, David, Carroll, Brittany, Slee, Valerie M., Jennings, Susan V., Finnerty, Celeste C., Bohannon, Linda S., Mathias, Susan D., Lahue, Betsy J., and Castells, Mariana C.
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MAST cell disease ,PATIENT reported outcome measures ,PATIENT surveys ,MEDICAL care use ,LABOR productivity ,PATIENTS' attitudes - Abstract
Background: Systemic mastocytosis (SM) is a rare clonal neoplasm driven by KIT D816V and other mutations. Data were collected from the patient perspective on disease burden and included an SM-specific symptom assessment tool.Methods: US adults aged 18 years and older with a self-reported SM diagnosis completed an online TouchStone SM Patient Survey of 100 items, including the 12-item Short-Form Health Survey, the Indolent Systemic Mastocytosis Symptom Assessment Form, and the Work Productivity and Activity Impairment Questionnaire, as well as questions about SM diagnosis, the impact of SM on daily activities, work impairment, and health care use. The results were analyzed using descriptive statistics.Results: Fifty-six individuals completed the survey (89% women; median age, 48 years; mean time since diagnosis, 6.7 years), reporting indolent SM (66%), aggressive SM (9%), smoldering SM (5%), and unknown SM subtype (18%). Over a 1-year recall, respondents reported seeking emergency care for anaphylaxis (30%) and taking three or more prescription medications (52%) for SM. Over one half of patients (54%) reduced their work hours because of SM, and 64% avoided leaving home because of symptoms. A majority of respondents (93%) had experienced ≥10 SM-related symptoms, noting that the most bothersome were anaphylactic episodes (18%), abdominal/stomach pain (16%), diarrhea/loose stools (13%), and fatigue (11%). Whereas an Indolent Systemic Mastocytosis Symptom Assessment Form-derived total symptom score of 28 is used to indicate moderate-to-severe symptoms, the mean total symptom score was 52.7. Mental and physical component summary scores from the 12-item Short-Form Health Survey were below population norms.Conclusions: Patients who were surveyed reported substantial symptom burden and unmet needs because of SM, as evidenced by seeking emergency care and reporting bothersome symptoms, poor quality of life, and reduced work hours and productivity.Lay Summary: The objective of this research was to understand the burden and unmet needs in the rare disease of systemic mastocytosis (SM) to guide future care. Fifty-six patients completed an online survey containing questions about their diagnosis, medications, health care use, quality of life, and SM symptoms. The results demonstrated that SM is associated with severe and burdensome symptoms, anaphylactic events, emergency department visits, use of multiple medications, reduced ability to work, and poor physical and psychological quality of life. These findings suggest the need for future advances to address unmet needs in patients affected by SM. [ABSTRACT FROM AUTHOR]- Published
- 2022
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42. Responsiveness and interpretation of the PROMIS Cancer Function Brief 3D Profile.
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Smith, Sean R., Vargo, Mary, Zucker, David S., Shahpar, Samman, Gerber, Lynn H., Henderson, Maryanne, Jay, Gina, and Cheville, Andrea L.
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PAIN clinics ,PAIN measurement ,CLINICAL trials monitoring ,CANCER patients ,FATIGUE (Physiology) - Abstract
Background: Measuring function with valid and responsive tools in patients with cancer is essential for driving clinical decision‐making and for the end points of clinical trials. Current patient‐reported outcome measurements of function fall short for many reasons. This study evaluates the responsiveness of the Patient‐Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile, a novel measure of function across multiple domains. Methods: Two hundred nine participants across five geographically distinct tertiary care centers completed the assessment and pain rating at two outpatient cancer rehabilitation clinic visits. Patients and providers completed a global rating of change measure at the second visit to indicate whether the patient was improving or worsening in function. Multiple response indices and linear models measured whether the measure was responsive to self‐reported and clinician‐rated changes over time. Correlations between changes in function and changes in anchors (pain rating and performance status) were also calculated. Results: Function as measured by the PROMIS Cancer Function Brief 3D Profile changed appropriately as both patients and clinicians rated change. Small to moderate effect sizes supported the tool's responsiveness. Function was moderately correlated with pain and more strongly correlated with performance status, and changes in function corresponded with changes in anchor variables. No floor/ceiling effect was found. Conclusions: The PROMIS Cancer Function Brief 3D Profile is sensitive to changes over time in patients with cancer. The measure may be useful in clinical practice and as an end point in clinical trials. Lay summary: We gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were.This study tested that questionnaire to see whether the scores would change if patients got better or worse. Lay summary: We gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were.This study tested that questionnaire to see whether the scores would change if patients got better or worse. Short Abstract The PROMIS Cancer Function Brief 3D Profile was found to be responsive to measuring change in function in patients with cancer. The changes were correlated with changes in performance status, pain, and both patient‐ and physician‐reported global ratings of change. [ABSTRACT FROM AUTHOR]
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- 2022
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43. Prognostic communication about lung cancer in the precision oncology era: A multiple‐perspective qualitative study.
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Petrillo, Laura A., Shimer, Sophia E., Zhou, Ashley Z., Sommer, Robert K., Feldman, Jill E., Hsu, Kelly E., Greer, Joseph A., Traeger, Lara N., and Temel, Jennifer S.
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Background: Although most patients with cancer prefer to know their prognosis, prognostic communication between oncologists and patients is often insufficient. Targeted therapies for lung cancer improve survival yet are not curative and produce variable responses. This study sought to describe how oncologists communicate about prognosis with patients receiving targeted therapies for lung cancer. Methods: This qualitative study included 39 patients with advanced lung cancer with targetable mutations, 14 caregivers, and 10 oncologists. Semistructured interviews with patients and caregivers and focus groups or interviews with oncologists were conducted to explore their experiences with prognostic communication. One oncology follow‐up visit was audio‐recorded per patient. A framework approach was used to analyze interview transcripts, and a content analysis of patient–oncologist dialogue was conducted. Themes were identified within each source and then integrated across sources to create a multidimensional description of prognostic communication. Results: Six themes in prognostic communication were identified: Patients with targetable mutations develop a distinct identity in the lung cancer community that affects their information‐seeking and self‐advocacy; oncologists set high expectations for targeted therapy; the uncertain availability of new therapies complicates prognostic discussions; patients and caregivers have variable information preferences; patients raise questions about progression by asking about physical symptoms or scan results; and patients' expectations of targeted therapy influence their medical decision‐making. Conclusions: Optimistic patient–oncologist communication shapes the expectations of patients receiving targeted therapy for lung cancer and affects their decision‐making. Further research and clinical guidance are needed to help oncologists to communicate uncertain outcomes effectively. This qualitative study integrates patient, caregiver, and oncology perspectives as well as observations from recorded oncology follow‐up visits to describe how oncologists communicate with patients with lung cancer about what to expect from targeted therapy. [ABSTRACT FROM AUTHOR]
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- 2022
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44. First‐line chemotherapy in advanced intra‐abdominal well‐differentiated/dedifferentiated liposarcoma: An EORTC Soft Tissue and Bone Sarcoma Group retrospective analysis.
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Stacchiotti, Silvia, Van der Graaf, Winette T. A., Sanfilippo, Roberta G., Marreaud, Sandrine I., Van Houdt, Winan J., Judson, Ian R., Gronchi, Alessandro, Gelderblom, Hans, Litiere, Saskia, and Kasper, Bernd
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BACKGROUND: No prospective trial with anthracycline‐based chemotherapy has individually assessed response in a well‐differentiated (WD)/dedifferentiated (DD) liposarcoma patient cohort. We conducted a retrospective analysis of first‐line chemotherapy in liposarcoma of intra‐abdominal origin (IA‐LPS) in patients who had entered the European Organisation for Research and Treatment of Cancer (EORTC)/Soft Tissue and Bone Sarcoma Group (STBSG) trials. METHODS: We searched for all adult patients treated with first‐line chemotherapy for advanced IA‐LPS in the EORTC STBSG phase 2 and 3 trials from 1978. Treatment was aggregated into 5 groups: anthracycline alone, ifosfamide alone, doxorubicin plus ifosfamide (D+IFO), doxorubicin/cyclophosphamide/vincristine/dacarbazine, and "other" (brostallicin, trabectedin). Response was assessed prospectively by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. Progression‐free survival (PFS) and overall survival (OS) were computed by Kaplan‐Meier method. RESULTS: A total of 109 patients with IA‐LPS from 13 trials were identified (104 evaluable for response). Overall, there were 10/109 (9.2%) responders: 3/48 (6.3%) in the anthracycline alone group, 2/15 (13%) in the ifosfamide alone group, and 4/18 (22%) in the D+IFO group. At the 10‐month median follow‐up (interquartile range, 6‐24), the median OS was 19 months (95% CI, 15‐21) and median PFS 4 months (95% CI, 3‐6). D+IFO achieved a not statistically significant longer median PFS (12 months) and median OS (31 months) than observed with other regimens. Univariate/multivariate analysis did not identify prognostic factors. CONCLUSIONS: Cytotoxic chemotherapy, in particular anthracycline alone, had marginal activity in advanced IA‐LPS. Ifosfamide‐containing regimens showed higher activity, although it was not statistically significant and in a small number of cases, with the combination of doxorubicin and ifosfamide appearing to be the more active regimen available in fit patients. This series provides a benchmark for future trials on new drugs in WD/DD liposarcoma.; [ABSTRACT FROM AUTHOR]
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- 2022
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45. Frailty and checkpoint inhibitor toxicity in older patients with melanoma.
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Bruijnen, Cheryl P., Koldenhof, José J., Verheijden, Rik J., van den Bos, Frederiek, Emmelot‐Vonk, Mariëlle H., Witteveen, Petronella O., and Suijkerbuijk, Karijn P. M.
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Background: Immune checkpoint inhibitors (ICIs) can cause immune‐related adverse events (irAEs) that range from mild to life‐threatening. Age itself does not seem to be a predictor for the occurrence of irAEs. It is unknown whether frailty plays a role in the occurrence of irAEs. Therefore, the authors assessed whether irAEs and their sequelae occur more often in frail patients than in fit patients according to the Geriatric 8 (G8) assessment. Methods: Patients with melanoma aged 70 years and older who were about to start ICI therapy and were screened with the G8 assessment were enrolled in this prospective, observational study. Patients were classified by the G8 as either fit or frail. The primary outcome was the occurrence of grade ≥3 irAEs. Results: In total, 92 patients were included for statistical analyses, 26 (29%) of whom were classified as frail. Grade ≥3 irAEs occurred in 20% of patients. There was no significant difference in the occurrence of grade ≥3 irAEs between fit and frail patients (17% vs 27%; P =.26). Frail patients were admitted to the hospital because of irAEs significantly more often than fit patients (29% vs 54%; P =.02) and showed a trend toward increased length of hospitalization (5 vs 8 days; P =.06) and more frequent use of immunosuppressants or ICI discontinuation for irAEs (36% vs 58%; P =.06). Conclusions: Although frailty appears to be unrelated to the occurrence of severe irAEs, it is an indicator of irAE‐related adverse sequelae, such as hospital admission. Screening for frailty can be of added value in the shared decision‐making process for older patients who qualify for ICI treatment. Frailty screening with the Geriatric 8 (G8) was used as a guide for making individualized treatment decisions. Frailty according to the G8 was associated with sequelae of immune‐related adverse events, such as hospitalizations and visits to the emergency department. [ABSTRACT FROM AUTHOR]
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- 2022
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46. The clinical dilemma of JAK inhibitor failure in myelofibrosis: Predictive characteristics and outcomes.
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Mascarenhas, John O. and Verstovsek, Srdan
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Two Janus‐associated kinase inhibitors (JAKi) (initially ruxolitinib and, more recently, fedratinib) have been approved as treatment options for patients who have intermediate‐risk and high‐risk myelofibrosis (MF), with pivotal trials demonstrating improvements in spleen volume, disease symptoms, and quality of life. At the same time, however, clinical trial experiences with JAKi agents in MF have demonstrated a high frequency of discontinuations because of adverse events or progressive disease. In addition, overall survival benefits and clinical and molecular predictors of response have not been established in this population, for which the disease burden is high and treatment options are limited. Consistently poor outcomes have been documented after JAKi discontinuation, with survival durations after ruxolitinib ranging from 11 to 16 months across several studies. To address such a high unmet therapeutic need, various non‐JAKi agents are being actively explored (in combination with ruxolitinib in first‐line or salvage settings and/or as monotherapy in JAKi‐pretreated patients) in phase 3 clinical trials, including pelabresib (a bromodomain and extraterminal domain inhibitor), navitoclax (a B‐cell lymphoma 2/B‐cell lymphoma 2‐xL inhibitor), parsaclisib (a phosphoinositide 3‐kinase inhibitor), navtemadlin (formerly KRT‐232; a murine double‐minute chromosome 2 inhibitor), and imetelstat (a telomerase inhibitor). The breadth of data expected from these trials will provide insight into the ability of non‐JAKi treatments to modify the natural history of MF. Janus‐associated kinase inhibitor (JAKi) agents improved spleen volume and symptoms in patients who had myelofibrosis but were associated with high discontinuation rates, a lack of predictors of response, and poor outcomes after discontinuation. Non‐JAKi agents, in combination with or subsequent to JAK agents, were being actively explored in phase 3 clinical trials. [ABSTRACT FROM AUTHOR]
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- 2022
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47. Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study.
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Battaglia, Tracy A., Gunn, Christine M., Bak, Sharon M., Flacks, JoHanna, Nelson, Kerrie P., Wang, Na, Ko, Naomi Y., and Morton, Samantha J.
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Background: Sociolegal barriers to cancer care are defined as health-related social needs like affordable healthy housing, stable utility service, and food security that may be remedied by public policy, law, regulation, or programming. Legal support has not been studied in cancer care.Methods: The authors conducted a randomized controlled trial of patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers. English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer were eligible within 30 days of diagnosis. The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation) at baseline and at 6 months.Results: In total, 201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78%). The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment. Ninety-six percent of participants with breast cancer and 73% of those with lung cancer initiated treatment within 90 days. No significant effect of enhanced navigation was observed on the receipt of timely treatment among participants with breast cancer (odds ratio, 0.88; 95% CI, 0.17-4.52) or among those with lung cancer (odds ratio, 4.00; 95% CI, 0.35-45.4). No differences in patient-reported outcomes were observed between treatment groups.Conclusions: Navigation enhanced by access to legal consultation and support had no impact on timely treatment, patient distress, or patient needs. Although most patients reported sociolegal barriers, few required intensive legal services that could not be addressed by navigators.Lay Summary: In patients with cancer, the experience of sociolegal barriers to care, such as unstable housing, utility services, or food insecurity, is discussed. Addressing these barriers through legal information and assistance may improve care. This study compares standard patient navigation versus enhanced navigation partnered with legal advocates for patients with breast and lung cancers. Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation. Although 75% of patients in the study had at least 1 sociolegal barrier identified, few required legal advocacy beyond what a navigator who received legal information and coaching could provide. [ABSTRACT FROM AUTHOR]- Published
- 2022
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48. Development of a workflow process mapping protocol to inform the implementation of regional patient navigation programs in breast oncology.
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Casanova, Nicole L., LeClair, Amy M., Xiao, Victoria, Mullikin, Katelyn R., Lemon, Stephenie C., Freund, Karen M., Haas, Jennifer S., Freedman, Rachel A., Battaglia, Tracy A., James, Ted A., McCauley, Susan, Ohrenberger, Ellen, Ross, JoEllen, Magrini, Leo, Gershman, Susan T., Kennedy, Mark, Levine, Anne, Warner, Erica T., Clark, Cheryl R., and Adams, William G.
- Abstract
Background: Implementing city-wide patient navigation processes that support patients across the continuum of cancer care is impeded by a lack of standardized tools to integrate workflows and reduce gaps in care. The authors present an actionable workflow process mapping protocol for navigation process planning and improvement based on methods developed for the Translating Research Into Practice study.Methods: Key stakeholders at each study site were identified through existing community partnerships, and data on each site's navigation processes were collected using mixed methods through a series of team meetings. The authors used Health Quality Ontario's Quality Improvement Guide, service design principles, and key stakeholder input to map the collected data onto a template structured according to the case-management model.Results: Data collection and process mapping exercises resulted in a 10-step protocol that includes: 1) workflow mapping procedures to guide data collection on the series of activities performed by health care personnel that comprise a patient's navigation experience, 2) a site survey to assess program characteristics, 3) a semistructured interview guide to assess care coordination workflows, 4) a site-level swim lane workflow process mapping template, and 5) a regional high-level process mapping template to aggregate data from multiple site-level process maps.Conclusions: This iterative, participatory approach to data collection and process mapping can be used by improvement teams to streamline care coordination, ultimately improving the design and delivery of an evidence-based navigation model that spans multiple treatment modalities and multiple health systems in a metropolitan area. This protocol is presented as an actionable toolkit so the work may be replicated to support other quality-improvement initiatives and efforts to design truly patient-centered breast cancer treatment experiences.Lay Summary: Evidence-based patient navigation in breast cancer care requires the integration of services through each phase of cancer treatment. The Translating Research Into Practice study aims to implement patient navigation for patients with breast cancer who are at risk for delays and are seeking care across 6 health systems in Boston, Massachusetts. The authors designed a 10-step protocol outlining procedures and tools that support a systematic assessment for health systems that want to implement breast cancer patient navigation services for patients who are at risk for treatment delays. [ABSTRACT FROM AUTHOR]- Published
- 2022
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49. Barriers and opportunities to measuring oncology patient navigation impact: Results from the National Navigation Roundtable survey.
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Battaglia, Tracy A., Fleisher, Linda, Dwyer, Andrea J., Wiatrek, Dawn E., Wells, Kristen J., Wightman, Patrick, Strusowski, Tricia, Calhoun, Elizabeth, and National Navigation Roundtable Evidence-Based Task Group
- Abstract
Background: Patient navigation improves cancer care delivery for those most at risk for poor outcomes. Lack of sustainable funding threatens the full integration of navigation services into health care delivery systems. Standardized navigation metrics that document impact and identify best practices are necessary to support sustainability.Methods: The National Navigation Roundtable administered a web-based, cross-sectional survey to oncology patient navigation programs to identify barriers and facilitators to the use of navigation metrics. The 38-item survey asked about data-collection practices and specific navigation metrics used by the program. Exploratory and descriptive statistics were used to identify factors associated with data collection and reporting.Results: Seven hundred fifty respondents from across the country represented navigation programs across the continuum of care. Although 538 respondents (72%) reported participating in routine data collection, only one-half of them used data for reporting purposes. For the 374 programs that used electronic health records, only 40% had discrete, reportable navigation fields, and 25% had an identifier for navigated patients. Program funding was identified as the only characteristic associated with data collection, whereas the type of data collected was associated with work setting, participation in alternative payment models, and where on the continuum navigation services are provided. Respondents participating in an oncology accreditation program were more likely to collect specific outcome metrics across the continuum and to use those data for reporting purposes. The most common barriers to data collection were time (55%) and lack of support for complex data systems and/or platforms (50%).Conclusions: Inconsistent data collection and reporting of oncology navigation programs remain a threat to sustainability. Aligning data collection with oncology accreditation, funding, and reimbursement is a viable path forward. [ABSTRACT FROM AUTHOR]- Published
- 2022
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50. Generalizing approaches to surveillance for complex social outcomes in broad‐range patient populations—The cost in terms of lost information and subgroup utility.
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Boman, Krister K., Lannering, Birgitta, von Essen, Louise, and Jarfelt, Marianne
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Complex social outcomes, including those related to education and employment, depend on compound combinations of background factors that are significantly different for childhood and adult cancers. Medical and psychosocial prerequisites related to the age at cancer diagnosis and treatment require surveillance for complex social outcomes that meets the particularized needs of corresponding patient subgroups. [ABSTRACT FROM AUTHOR]
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- 2022
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