Phase II Study of Erdafitinib in Patients With Tumors With FGFR Amplifications: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K1.

PURPOSE: Despite fibroblast growth factor receptor (FGFR) inhibitors being approved in tumor types with select FGFR rearrangements or gene mutations, amplifications of FGFR represent the most common FGFR alteration across malignancies. Subprotocol K1 (EAY131-K1) of the National Cancer Institute-MATCH platform trial was designed to evaluate the antitumor efficacy of the oral FGFR1-4 inhibitor, erdafitinib, in patients with tumors harboring FGFR1-4 amplification. METHODS: EAY131-K1 was an open-label, single-arm, phase II study with central confirmation of presence of FGFR1-4 amplification in tumors. Patients with urothelial carcinoma were excluded. Enrolled patients received oral erdafitinib at a starting dose of 8 mg once daily continuously with escalation to 9 mg once daily continuously, on the basis of predefined time point assessments of phosphate levels, until disease progression or intolerable toxicity. The primary end point was centrally assessed objective response rate (ORR), with key secondary end points being 6-month progression-free survival (PFS6), PFS, overall survival (OS), and safety. RESULTS: Thirty-five patients were enrolled into this study with 18 included in the prespecified primary efficacy analysis. The median age of the 18 patients was 60 years, and 78% had received ≥3 previous lines of therapy. There were no confirmed responses to erdafitinib; however, five patients experienced stable disease (SD) as best response. One patient with an FGFR1-amplified breast cancer had a prolonged PFS >168 days (5.5 months). The median PFS was 1.7 months (90% CI, 1.1 to 1.8 months) and the median OS was 4.2 months (90% CI, 2.3 to 9.3 months). The estimated PFS6 rate was 13.8% (90% CI, 3.3 to 31.6). The majority of toxicities were grade 1 to 2 in nature, although there was one grade 5 treatment-related adverse event. CONCLUSION: Erdafitinib did not meet its primary end point of efficacy as determined by ORR in treatment-refractory solid tumors harboring FGFR1-4 amplifications. Our findings support that rearrangements and gene mutations, but not amplifications, of FGFR remain the established FGFR alterations with approved indications for FGFR inhibition.

Phase II Study of Erdafitinib in Patients With Tumors With Fibroblast Growth Factor Receptor Mutations or Fusions: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K2.

PURPOSE: Subprotocol K2 (EAY131-K2) of the NCI-MATCH platform trial was an open-label, single-arm, phase II study designed to evaluate the antitumor efficacy of the oral FGFR1-4 inhibitor, erdafitinib, in patients with tumors harboring FGFR1-4 mutations or fusions. METHODS: Central confirmation of tumor FGFR1-4 mutations or fusions was required for outcome analysis. Patients with urothelial carcinoma were excluded. Enrolled subjects received oral erdafitinib at a starting dose of 8 mg daily continuously until intolerable toxicity or disease progression. The primary end point was objective response rate (ORR) with key secondary end points of safety, progression-free survival (PFS), and overall survival (OS). RESULTS: Thirty-five patients were enrolled, and 25 patients were included in the primary efficacy analysis as prespecified in the protocol. The median age was 61 years, and 52% of subjects had received ≥3 previous lines of therapy. The confirmed ORR was 16% (4 of 25 [90% CI, 5.7 to 33.0], P = .034 against the null rate of 5%). An additional seven patients experienced stable disease as best-confirmed response. Four patients had a prolonged PFS including two with recurrent WHO grade IV, IDH1-/2-wildtype glioblastoma. The median PFS and OS were 3.6 months and 11.0 months, respectively. Erdafitinib was manageable with no new safety signals. CONCLUSION: This study met its primary end point in patients with several pretreated solid tumor types harboring FGFR1-3 mutations or fusions. These findings support advancement of erdafitinib for patients with fibroblast growth factor receptor-altered tumors outside of currently approved indications in a potentially tumor-agnostic manner.

A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS): Results from ECOG-ACRIN E1Z11.

PURPOSE: Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS) are common and frequently lead to AI discontinuation. Single nucleotide polymorphisms (SNPs) in candidate genes have been associated with AIMSS and AI discontinuation. E1Z11 is a prospective cohort study designed to validate associations between 10 SNPs and AI discontinuation due to AIMSS. PATIENTS AND METHODS: Postmenopausal women with stage I-III hormone receptor-positive breast cancer received anastrozole 1 mg daily and completed patient-reported outcomes (PRO) to assess AIMSS (Stanford Health Assessment Questionnaire; HAQ) at baseline, 3, 6, 9, and 12 months. We estimated that 40% of participants would develop AIMSS, and 25% would discontinue AI treatment within 12 months. Enrollment of 1,000 women with a fixed number per racial strata provided 80% power to detect an effect size of 1.5-4. SNPs were in ESR1 (rs2234693, rs2347868, rs9340835), CYP19A1 (rs1062033, rs4646), TCL1A (rs11849538, rs2369049, rs7158782, rs7159713), and HTR2A (rs2296972). RESULTS: Of 970 evaluable women, 43% developed AIMSS and 12% discontinued AI therapy within 12 months. While more Black and Asian women developed AIMSS compared to White women (49% vs 39%, p=0.017; 50% vs 39%, p=0.004, respectively), AI discontinuation rates were similar across groups. None of the SNPs were significantly associated with AIMSS or AI discontinuation in the overall population, or in distinct cohorts. The odds ratio for rs2296972 (HTR2A) approached significance for developing AIMSS. CONCLUSION: We were unable to prospectively validate candidate SNPs previously associated with AI discontinuation due to AIMSS. Future analyses will explore additional genetic markers, PRO predictors of AIMSS, and differences by race.

Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E.

PURPOSE: The National Cancer Institute Molecular Analysis for Therapy Choice trial is a signal-finding genomically driven platform trial that assigns patients with any advanced refractory solid tumor, lymphoma, or myeloma to targeted therapies on the basis of next-generation sequencing results. Subprotocol E evaluated osimertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with EGFR mutations. METHODS: Eligible patients had EGFR mutations (T790M or rare activating) and received osimertinib 80 mg once daily. Patients with lung cancer with EGFR T790M were excluded. The primary end point was objective response rate (ORR), and the secondary end points were 6-month progression-free survival (PFS), overall survival, and toxicity. RESULTS: A total of 19 patients were enrolled: 17 were evaluable for toxicity and 13 for efficacy. The median age of the 13 included in the efficacy analysis was 63 years, 62% had Eastern Cooperative Oncology Group performance status 1, and 31% received >three previous systemic therapies. The most common tumor type was brain cancers (54%). The ORR was 15.4% (n = 2 of 13; 90% CI, 2.8 to 41.0) and 6-month PFS was 16.7% (90% CI, 0 to 34.4). The two confirmed RECIST responses were observed in a patient with neuroendocrine carcinoma not otherwise specified (EGFR exon 20 S768T and exon 18 G719C mutation) and a patient with low-grade epithelial carcinoma of the paranasal sinus (EGFR D770_N771insSVD). The most common (>20%) treatment-related adverse events were diarrhea, thrombocytopenia, and maculopapular rash. CONCLUSION: In this pretreated cohort, osimertinib did not meet the prespecified end point threshold for efficacy, but responses were seen in a neuroendocrine carcinoma with an EGFR exon 20 S768T and exon 18 G719C mutation and an epithelial carcinoma with an EGFR D770_N771insSVD mutation. Osimertinib was well tolerated and had a safety profile consistent with previous studies.

Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol J.

PURPOSE: NCI-MATCH assigned patients with advanced cancer and progression on prior treatment, based on genomic alterations in pretreatment tumor tissue. Arm J (EAY131-J) evaluated the combination of trastuzumab/pertuzumab (HP) across HER2-amplified tumors. PATIENTS AND METHODS: Eligible patients had high levels of HER2 amplification [copy number (CN) ≥7] detected by central next-generation sequencing (NGS) or through NCI-designated laboratories. Patients with breast/gastroesophageal adenocarcinoma and those who received prior HER2-directed therapy were excluded. Enrollment of patients with colorectal cancer was capped at 4 based on emerging data. Patients received HP IV Q3 weeks until progression or unacceptable toxicity. Primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS) and overall survival (OS). RESULTS: Thirty-five patients were enrolled, with 25 included in the primary efficacy analysis (CN ≥7 confirmed by a central lab, median CN = 28). Median age was 66 (range, 31-80), and half of all patients had ≥3 prior therapies (range, 1-11). The confirmed ORR was 12% [3/25 partial responses (colorectal, cholangiocarcinoma, urothelial cancers), 90% confidence interval (CI) 3.4%-28.2%]. There was one additional partial response (urothelial cancer) in a patient with an unconfirmed ERBB2 copy number. Median PFS was 3.3 months (90% CI 2.0-4.1), and median OS 9.4 months (90% CI 5.0-18.9). Treatment-emergent adverse events were consistent with prior studies. There was no association between HER2 CN and response. CONCLUSIONS: HP was active in a selection of HER2-amplified tumors (non-breast/gastroesophageal) but did not meet the predefined efficacy benchmark. Additional strategies targeting HER2 and potential resistance pathways are warranted, especially in rare tumors.

A review of dairy food intake for improving health among black geriatrics in the US.

The transition to older adulthood is generally marked by progressive declines in body composition, metabolism, cognitive function, and immunity. For socially disadvantaged geriatric populations such as Black Americans, this life stage may also include additional stressors, including dealing with discrimination, poor access to healthcare, and food insecurity. These types of chronic stressors are linked to a higher allostatic load, which is associated with accelerated biological aging, higher rates of adverse health outcomes, and an overall lower quality of life. Of the numerous factors involved in healthy aging, a growing body of research indicates that consuming a higher quality diet that is rich in fruits, vegetables, whole grains, protein foods, and dairy foods, is one of the most potent factors for helping to protect against age-related disease progression. Among the food groups listed above that are recommended by the 2020-2025 Dietary Guidelines for Americans dairy foods are unique in their ability to provide several of the essential nutrients (e.g., high-quality protein, calcium, potassium, vitamin B12, and vitamin D in fortified products) that are most often inadequately consumed by older Black Americans. However, dairy is the most inadequately consumed food group in the US, with older Black adults consuming fewer than half of the 3 daily recommended servings. Therefore, this review examines the current body of evidence exploring the links between dairy intake and age-related disease risk, with a special focus on health and disparities among older Black Americans. Overall, the evidence from most systematic reviews and/or meta-analyses focused on dairy intake and musculoskeletal health suggest that higher dairy intake across the life span, and especially from fermented and fortified products, is associated with better bone and muscle health outcomes in older adults. The evidence on dairy intake and neurocognitive and immune outcomes among older adults holds significant promise for potential benefits, but most of these results are sourced from individual studies or narrative reviews and are not currently corroborated in systematic reviews or meta-analyses. Additionally, most of the research on dairy intake and age-related disease risk has been performed in White populations and can only be extrapolated to Black populations. Nonetheless, older Black populations who do not meet the DGA recommended 3 servings of dairy per day due to lactose intolerance, restrictive dietary patterns, or for other reasons, are likely falling short of several of the nutritional requirements necessary to support healthy aging.

Executive summary: The role of dairy food intake for improving health among Black Americans across the life continuum.

Given the complex relationships that many Black individuals have with dairy foods, due to issues with lactose intolerance or other cultural factors, the National Medical Association has made considerable efforts to examine the role that dairy foods play in the health and well-being of Black Americans. Over the last two decades, the National Medical Association and its partners have produced multiple reports on the value of including adequate milk and dairy foods in the diets of Black Americans. These publications have highlighted the impact that inadequate consumption of dairy foods and nutrients have on chronic disease risks. Past publications have also provided evidence-based recommendations for the proper diagnosis and management of lactose intolerance. This new series of evidence reviews focuses on dairy's role in improving nutrition and health among Black Americans across the life course and covers an extensive amount of new research that highlights additional health disparities and provides further evidence-based strategies for the management of lactose intolerance. Much like the 2020-2025 Dietary Guidelines for Americans, this work utilizes a life course approach to better address dairy intake on health outcomes for different ages and life stages: 1) pregnancy, fetal development, and lactation, 2) infants, toddlers, and young children, 3) older children and adolescents, 4) adults, and 5) geriatric populations. Overall, the findings and conclusions from this series of evidence reviews continue to indicate that higher dairy intake is associated with reduced risk for many of the most commonly occurring deficiencies and diseases impacting each life stage, and that Black Americans would receive significantly greater health benefits by increasing their daily dairy intake levels to meet the national dietary recommendations than they would from continuing to fall short of these recommendations. However, these recommendations must be considered with appropriate context and nuance as the intake of different dairy products can have different impacts on health outcomes. For instance, vitamin D fortified dairy products and fermented dairy products like yogurt - which are low in lactose and rich in live and active cultures - tend to show the greatest impacts for reducing disease risk across the life continuum, while whole-fat dairy foods may be most beneficial in early life for optimal brain development, and more protein-rich options may be most beneficial in later life to help maintain muscle mass and function.

A review of dairy food intake for improving health for black women in the US during pregnancy, fetal development, and lactation.

Pregnancy and lactation are special life stages that require regular nutritional and medical attention to help protect the health of the mother and promote the growth and development of the offspring. Despite an increased focus on maternal and fetal health over the last several decades, the rates of pregnancy-related morbidity and mortality are increasing in the United States (US). On average, Black women who are pregnant or lactating face greater health disparities and birth complications than other racial/ethnic groups in the US. The issues contributing to these disparities are multi-faceted and include sociocultural, economic, medical, and dietary factors. For example, Black women face greater rates of food insecurity, worse access to healthcare, and lower nutrient status when compared to White women. A growing body of research suggests that consuming a healthier dietary pattern is one of the most potent modifiable risk factors associated with improved fertility and reducing pregnancy-related complications. Recent publications have also shed light on the role of dairy foods in improving diet quality and nutrient status among Black women and for impacting maternal and fetal health outcomes, such as preeclampsia, spontaneous abortion, preterm birth, and fetal growth. To support healthy pregnancy and lactation, the current national dietary guidelines recommend the consumption of 3 servings of dairy foods per day. However, the vast majority of Black women in the US are falling short of these recommendations and are not meeting nutrient requirements for calcium and vitamin D. Therefore, strategies that target misconceptions surrounding lactose intolerance and focus on the health value of adequate dairy intake among Black women of child-bearing age may benefit both prenatal and postpartum health. This review presents the current evidence on health disparities faced by pregnant and lactating Black women in the US, and the role of dairy foods in supporting healthy pregnancy, fetal development, and lactation outcomes in this population.

A review of dairy food intake for improving health among black adults in the US.

The adult life stage encompasses a range of new experiences, opportunities, and responsibilities that impact health and well-being. During this life stage, health disparities continue to increase for Black Americans, with Black adults having a disproportionate burden of obesity, chronic diseases, comorbidities, and worse treatment outcomes compared to their White peers. While many of the underlying factors for these disparities can be linked to longstanding sociopolitical factors such as systemic racism, food insecurity, and poor access to healthcare, there are also several modifiable risk factors that are known to significantly impact health outcomes, such as improving diet quality, increasing physical activity, and not smoking. Of all the modifiable risk factors known to impact health, improving dietary habits is the factor most consistently associated with better outcomes for body weight and chronic disease. Of the major food groups recommended by the 2020-2025 Dietary Guidelines for Americans (DGA) for achieving healthier dietary patterns, dairy foods have a nutrient profile which matches most closely to what Black Americans are inadequately consuming (e.g., vitamin A, vitamin D, calcium, magnesium). However, Black adults tend to consume less than half the recommended daily servings of dairy foods, in part, due to issues with lactose intolerance, making higher intake of dairy foods an ideal target for improving diet quality and health in this population. This review examines the current body of evidence exploring the links between dairy intake, obesity, cardiometabolic disease risk, chronic kidney disease, and the most common types of cancer, with a special focus on health and disparities among Black adults. Overall, the evidence from most systematic reviews and/or meta-analyses published in the last decade on dairy intake and health outcomes has been conducted on White populations and largely excluded research on Black populations. The findings from this extensive body of research indicate that when teamed with an energy-restricted diet, meeting or exceeding the DGA recommended 3 daily servings of dairy foods is associated with better body weight and composition outcomes and lower rates of most common chronic diseases than lower intake (<2 servings per day). In addition to the number of daily servings consumed, the specific types (e.g., milk, yogurt, cheese) and subtypes (e.g., low-fat, fermented, fortified) consumed have also been shown to play major roles in how these foods impact health. For example, higher intake of fermented dairy foods (e.g., yogurt) and vitamin D fortified dairy products appear to have the most protective effects for reducing chronic disease risk. Along with lactose-free milk and cheese, yogurt is also generally low in lactose, making it an excellent option for individuals with lactose intolerance, who are trying to meet the DGA recommendations for dairy food intake.

The role of dairy food intake for improving health among black Americans across the life continuum: A summary of the evidence.

Decades of health data show major health disparities occurring at every life stage between Black and White Americans. These disparities include greater mortality rates among Black mothers and their offspring, higher levels of malnutrition and obesity among Black children and adolescents, and a higher burden of chronic disease and lower life expectancy for Black adults. Although nutrition is only one of many factors that influence human health and well-being across the life continuum, a growing body of research continues to demonstrate that consuming a healthy dietary pattern is one of the most dominant factors associated with increased longevity, improved mental health, improved immunity, and decreased risk for obesity and chronic disease. Unfortunately, large percentages of Black Americans tend to consume inadequate amounts of several essential nutrients such as vitamin A, vitamin D, calcium, and magnesium; and simultaneously consume excessive amounts of fast foods and sugar-sweetened beverages to a greater degree than other racial/ethnic groups. Therefore, strategies that can help improve dietary patterns for Black Americans could make up a major public health opportunity for reducing nutrition-related diseases and health disparities across the life course. A key intervention strategy to improve diet quality among Black Americans is to focus on increasing the intake of nutrient-rich dairy foods, which are significantly underconsumed by most Black Americans. Compared to other food group, dairy foods are some of the most accessible and affordable sources of essential nutrients like vitamin A, D, and B12, calcium, magnesium, potassium, selenium, and zinc in the food supply, as well as being some of the primary sources of several health-promoting bioactive compounds, including polar lipids, bioactive proteins and peptides, oligosaccharides, and live and active cultures in fermented products. Given the complex relationships that many Black Americans have with dairy foods, due to issues with lactose intolerance, and/or negative perceptions about the health effects of dairy foods, there is still a need to examine the role that dairy foods play in the health and well-being of Black Americans of all ages and life stages. Therefore, the National Medical Association and its partners have produced multiple reports on the value of including adequate dairy in the diet of Black Americans. This present summary paper and its associated series of evidence reviews provide an examination of an immense amount of research focused on dairy intake and health outcomes, with an emphasis on evidence-based strategies for improving the health of Black Americans. Overall, the findings and conclusions from this body of research continue to indicate that higher dairy intake is associated with reduced risk for many of the most commonly occurring deficiencies and diseases impacting each life stage, and that Black Americans would receive significantly greater health benefits by increasing their daily dairy intake levels to meet the national recommendations than they would from continuing to fall short of these recommendations. However, these recommendations must be considered with appropriate context and nuance as the intake of different dairy products can have different impacts on health outcomes. For instance, vitamin D fortified dairy products and fermented dairy products like yogurt - which are low in lactose and rich in live and active cultures - tend to show the greatest benefits for improved health. Importantly, there are significant limitations to these research findings for Black Americans, especially as they relate to reproductive and child health, since most of the research on dairy intake and health has failed to include adequate representation of Black populations or to sufficiently address the role of dairy intake during the most vulnerable life stages, such as pregancy, lactation, fetal development, early childhood, and older age. This population and these life stages require considerably more research and policy attention if health equity is ever to be achieved for Black Americans. Sharing and applying the learnings from this summary paper and its associated series of evidence reviews will help inform and empower nutrition and health practitioners to provide more evidence-based dietary recommendations for improving the health and well-being of Black Americans across the life course.

A review of dairy food intake for improving health among black children and adolescents in the US.

Adequate nutrition during childhood and adolescence is crucial for proper neurological, musculoskeletal, immunological, and cardiometabolic health and development. Yet, disparities among socially underserved racial/ethnic groups in the United States (US) provide significant challenges to achieving adequate nutrition during these years of rapid growth and maturation. For example, Black children and adolescents are at greater risk for having food insecurity, lower-quality diets, obesity, and numerous associated health challenges that result from these disparities compared to their White peers. A growing body of evidence indicates that improving diet quality is critical for improving childhood and adolescent health and well-being, and that the diverse nutritional profile and bioactive compounds found within dairy foods may play multiple roles in promoting proper growth and development during these life stages. Therefore, to support overall health and development among Black youth, greater education and implementation efforts are needed to help this population meet the national dietary recommendations of 2.5 to 3 servings of dairy foods per day. Continuing to fall short of these recommendations puts Black children and adolescents at risk of multiple nutrient inadequacies and health disparities that can have lifelong impacts on disease development, mental health, and quality of life. This review presents the state of knowledge on health disparities and modifiable nutritional strategies involving milk and dairy foods to support the growth and maturation of children and adolescents, with a special focus on Black youth in the US.

A review of dairy food intake for improving health among black infants, toddlers, and young children in the US.

Adequate nutrition is paramount for proper growth and musculoskeletal, neurocognitive, and immunological development in infants, toddlers, and young children. Among breastfeeding mother-child dyads, this critical window of development, is impacted by both maternal and offspring dietary patterns. For mothers, their dietary patterns impact not only their own health and well-being, but also the nutrition of their breast milk - which is recommended as the sole source of food for the first 6 months of their infant's life, and as a complementary source of nutrition until at least 2 years of age. For infants and toddlers, the breast milk, formulas, and first foods they consume can have both short-term and long-term effects on their health and well-being - with important impacts on their taste perception, microbiome composition, and immune function. According to dietary intake data in the US, infants and young children meet a greater number of nutrient requirements than older children and adults, yet numerous disparities among socially disadvantaged racial/ethnic groups still provide significant challenges to achieving adequate nutrition during these early life stages. For example, Black children are at greater risk for disparities in breastfeeding, age-inappropriate complementary feeding patterns, nutrient inadequacies, food insecurity, and obesity relative to most other racial/ethnic groups in the US. For infants who do not receive adequate breast milk, which includes a disproportionate number of Black infants, dairy-based infant formulas are considered the next best option for meeting nutritional needs. Fermented dairy foods (e.g., yogurt, cheese) can serve as ideal first foods for complementary feeding, and cow's milk is recommended for introduction during the transitional feeding period to help meet the nutrient demands during this phase of rapid growth and development. Low dairy intake may put children at risk for multiple nutrient inadequacies and health disparities - some of which may have lifelong consequences on physical and mental health. A burgeoning body of research shows that in addition to breast milk, cow's milk and other dairy foods may play critical roles in supporting physical growth, neurodevelopment, immune function, and a healthy gut microbiome in early life. However, most of this research so far has been conducted in White populations and can only be extrapolated to Black infants, toddlers, and young children. Therefore, to better understand and support the health and development of this population, greater research and education efforts on the role of milk and dairy products are urgently needed. This review presents the current evidence on health disparities faced by Black children in the US from birth to four years of age, and the role that dairy foods can play in supporting the normal growth and development of this vulnerable population.

Disparities in care of older adults of color with cancer: A narrative review.

This review describes the barriers and challenges faced by older adults of color with cancer and highlights methods to improve their overall care. In the next decade, cancer incidence rates are expected to increase in the United States for people aged ≥65 years. A large proportion will be older adults of color who often have worse outcomes than older White patients. Many issues contribute to racial disparities in older adults, including biological factors and social determinants of health (SDOH) related to healthcare access, socioeconomic concerns, systemic racism, mistrust, and the neighborhood where a person lives. These disparities are exacerbated by age-related challenges often experienced by older adults, such as decreased functional status, impaired cognition, high rates of comorbidities and polypharmacy, poor nutrition, and limited social support. Additionally, underrepresentation of both patients of color and older adults in cancer clinical research results in a lack of adequate data to guide the management of these patients. Use of geriatric assessments (GA) can aid providers in uncovering age-related concerns and personalizing interventions for older patients. Research demonstrates the ability of GA-directed care to result in fewer treatment-related toxicities and improved quality of life, thus supporting the routine incorporation of validated GA into these patients' care. GA can be enhanced by including evaluation of SDOH, which can help healthcare providers understand and address the needs of older adults of color with cancer who face disparities related to their age and race.

INDIVIDUAL ARTICLE: USCOM Algorithm for the Prevention and Management of Cutaneous Immunotherapy-Related Adverse Events.

BACKGROUND: In 2023, nearly 2 million patients will be diagnosed with cancer in the United States and at least 40% will be eligible for treatment with an immune checkpoint inhibitor (ICI). Cutaneous immune related adverse events (cirAEs) from ICIs are common and include pruritus as well as maculopapular, eczematous, bullous, lichenoid, and psoriasiform reactions. All clinicians interfacing with cancer patients must expedite proper evaluation and diagnosis, treatment, and/or consultation that supports the need for evidence-directed guidelines. MATERIALS AND METHODS: A panel of advisors was selected, and a systematic literature review generated foundational evidence to develop a treatment algorithm for cirAEs via a modified Delphi process. Iterations of the algorithm were performed until the group met consensus. RESULTS: An algorithm that tailors the management of cirAEs was developed based on the CTCAE v.5 grading of skin disorders. Representative clinical images and suggested diagnostic measures, supplement the algorithm. CONCLUSION: Recognition and treatment of cirAEs guided through a multidisciplinary, physician-developed algorithm will limit disruption of immunotherapy, optimize quality of life, and enhance overall outcomes in patients treated with ICIs. J Drugs Dermatol. 2023;22:11(Suppl 1):s3-10.

Racial disparities in new-onset diabetes mellitus in prostate cancer patients on androgen deprivation therapy: a retrospective analysis of TriNetX data.

BACKGROUND: Prostate cancer (PCa) is the most common cancer in men in the US and androgen deprivation therapy (ADT) is the most frequently used systemic therapy for PCa. Data suggest that ADT is associated with an increased risk of new-onset diabetes mellitus (NODM) and cardiovascular complications. As the incidence and mortality of PCa are highest among the African American (AA) population, it is important to evaluate the difference in the incidence of NODM and ischemic heart disease (IHD) between AA men compared to Caucasian men. METHODS: This is a retrospective cohort study utilizing the TriNetX database to assess NODM and IHD risk, risk difference, and risk ratio (RR) after recent ADT initiation in an AA cohort and a Caucasian cohort of patients with PCa. Propensity score matching (PSM) was performed by age, BMI, and confounding comorbidities. RESULTS: After matching, the cohort included 1159 AA patients and 843 Caucasian patients with NODM after ADT initiation. The IHD cohort included 1269 AA patients and 1248 Caucasian patients. The risk of incidence of NODM is higher among AA men at 11.6% risk compared to Caucasian men at 7.4%. The risk difference is 4.1% (95% CI = 3.4, 4.9) p = 0.000. The RR is 1.56 (95% CI = 1.43, 1.70). In contrast, risk difference and risk ratio of IHD was not significant between AA and Caucasian groups. CONCLUSION: ADT exposure increases the risk of NODM in men with PCa, especially among AA men compared with Caucasian men. Men receiving ADT should be monitored routinely for signs and symptoms of metabolic syndrome and diabetes. Targeted close monitoring of AA men on ADT would be critical to prevent and treat metabolic complications with potential of reducing disparities in PCa morbidity.

Bevacizumab in Combination With Oxaliplatin, Fluorouracil, and Leucovorin (FOLFOX4) for Previously Treated Metastatic Colorectal Cancer: Results From the Eastern Cooperative Oncology Group Study E3200.

PURPOSE: Colorectal cancer is the second leading cause of cancer mortality in the United States. Antiangiogenic therapy with bevacizumab combined with chemotherapy improves survival in previously untreated metastatic colorectal cancer. This study was conducted to determine the effect of bevacizumab (at 10 mg/kg) on survival duration for oxaliplatin-based chemotherapy in patients with previously treated metastatic colorectal cancer. PATIENTS AND METHODS: Eight hundred twenty-nine metastatic colorectal cancer patients previously treated with a fluoropyrimidine and irinotecan were randomly assigned to one of three treatment groups: oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) with bevacizumab; FOLFOX4 without bevacizumab; or bevacizumab alone. The primary end point was overall survival, with additional determinations of progression-free survival, response, and toxicity. RESULTS: The median duration of survival for the group treated with FOLFOX4 and bevacizumab was 12.9 months compared with 10.8 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for death = 0.75; P = .0011), and 10.2 months for those treated with bevacizumab alone. The median progression-free survival for the group treated with FOLFOX4 in combination with bevacizumab was 7.3 months, compared with 4.7 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for progression = 0.61; P < .0001), and 2.7 months for those treated with bevacizumab alone. The corresponding overall response rates were 22.7%, 8.6%, and 3.3%, respectively (P < .0001 for FOLFOX4 with bevacizumab v FOLFOX4 comparison). Bevacizumab was associated with hypertension, bleeding, and vomiting. CONCLUSION: The addition of bevacizumab to oxaliplatin, fluorouracil, and leucovorin improves survival duration for patients with previously treated metastatic colorectal cancer.