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A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

PURPOSE Timely lung cancer surgery is a metric of high-quality cancer care and improves survival for early-stage non–small-cell lung cancer. Historically, Black patients experience longer delays to surgery than White patients and have lower survival rates. Antiracism interventions have shown benefits in reducing racial disparities in lung cancer treatment. METHODS We conducted a secondary analysis of Accountability for Cancer Care through Undoing Racism and Equity, an antiracism prospective pragmatic trial, at five cancer centers to assess the impact on overall timeliness of lung cancer surgery and racial disparities in timely surgery. The intervention consisted of (1) a real-time warning system to identify unmet care milestones, (2) race-specific feedback on lung cancer treatment rates, and (3) patient navigation. The primary outcome was surgery within 8 weeks of diagnosis. Risk ratios (RRs) and 95% CIs were estimated using log-binomial regression and adjusted for clinical and demographic factors. RESULTS A total of 2,363 patients with stage I and II non–small-cell lung cancer were included in the analyses: intervention (n = 263), retrospective control (n = 1,798), and concurrent control (n = 302). 87.1% of Black patients and 85.4% of White patients in the intervention group ( P = .13) received surgery within 8 weeks of diagnosis compared with 58.7% of Black patients and 75.0% of White patients in the retrospective group ( P < .01) and 64.9% of Black patients and 73.2% of White patients ( P = .29) in the concurrent group. Black patients in the intervention group were more likely to receive timely surgery than Black patients in the retrospective group (RR 1.43; 95% CI, 1.26 to 1.64). White patients in the intervention group also had timelier surgery than White patients in the retrospective group (RR 1.10; 95% CI, 1.02 to 1.18). CONCLUSION Accountability for Cancer Care through Undoing Racism and Equity is associated with timelier lung cancer surgery and reduction of the racial gap in timely surgery.

PURPOSE There is increasing interest in implementing digital systems for remote monitoring of patients’ symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems. METHODS PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090 ). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians. RESULTS Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often. CONCLUSION These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

Equity in vaccine outreach and delivery has been prioritized given the disproportionate harms of the COVID-19 pandemic on communities of color and those with lower socioeconomic status. Health systems have largely communicated availability or signup for vaccines to patients through electronic patient portal messages, emails, or online materials; however, rates of portal use and internet access are limited among rural populations, individualswith lower socioeconomic status, and racial and ethnic minority patients. For purposes of this analysis, these groups are referred collectively as marginalized populations. Reliance on these media as the primary means for communication may inadvertently widen vaccination disparities.

Background Women with obesity are at higher risk for high-grade and/or advanced-stage breast cancer in comparison with women without obesity. Many women with a high body mass index (BMI) at breast cancer diagnosis experience further weight gain during and after treatment. This study investigated Black and White patient perspectives on conversations with their oncologists about weight and weight management. Methods Focus groups using a virtual platform (Zoom) were conducted with women after primary treatment for stage I to III breast cancer who were 21 years or older and had a BMI ≥ 30 kg/m2 : 2 with Black women (n = 12) and 2 with White women (n = 14). Results Participants asked that their oncologists be "transparent" about weight gain as a potential side effect of their cancer treatment and how excess weight might affect their prognosis and survival. They asked to be "seen as an individual" to facilitate both person-centered and culturally appropriate conversations about behavioral changes needed for weight management. Participants urged clinicians to take the lead in initiating conversations about weight to underscore its importance in cancer care and survivorship. They welcomed actionable recommendations about nutrition and exercise from either the oncology clinician or a specialist. Participants offered specific suggestions on how clinicians could initiate weight-related conversations, beginning with questions eliciting patients' perspectives on their weight and lifestyle. Conclusions Many women with early-stage breast cancer and obesity have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management. Lay summary Focus group discussions with Black and White women with early-stage breast cancer and obesity have elicited patient perspectives on conversations with their oncologists about weight and weight management. Many patients have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management.

Objective: Smoking cessation studies tailored for low-income and racial/ethnic minority cancer patients are limited. African American and low-socioeconomic status (SES) smokers have higher...

The COVID-19 pandemic and the simultaneous increased focus on structural racism and racial/ethnic disparities across the United States have shed light on glaring inequities in U.S. health care, both in oncology and more generally. In this article, we describe how, through the lens of fundamental ethical principles, an ethical imperative exists for the oncology community to overcome these inequities in cancer care, research, and the oncology workforce. We first explain why this is an ethical imperative, centering the discussion on lessons learned during 2020. We continue by describing ongoing equity-focused efforts by ASCO and other related professional medical organizations. We end with a call to action—all members of the oncology community have an ethical responsibility to take steps to address inequities in their clinical and academic work—and with guidance to practicing oncologists looking to optimize equity in their research and clinical practice.

Background Insufficient social support is associated with increased mortality among older adults. Lung cancer is primarily a disease of older adults and is the leading cause of all cancer deaths. We assessed the association of social support with outcomes among older adults with lung cancer. Materials and methods Adults age 65 and older with lung cancer with a completed geriatric assessment (GA) were assessed. Emotional social support (ES) and tangible (material, instrumental) support (TS) measures and patient characteristics were obtained from the GA. The electronic health record was used to extract clinical variables. Simple linear regression models evaluated the association between social support scales with patient and clinical factors. Results 79 adults were assessed. White race was positively associated with ES score (p=.04), while higher BMI (p=.03), depression (p=.03) and anxiety (p=.02) were associated with worse ES. Higher BMI was associated with higher/better TS score (p=.02) while living alone was associated with lower/worse TS score (p=.03). Completion of platinum-based doublet chemotherapy with immunotherapy as planned was associated with higher ES scores (p=.02) and higher TS scores (p=.02). Disease progression was associated with lower ES scores (p=.03). Conclusion Social support may influence clinical outcomes in older adults with lung cancer. As lung cancer often portends to poor prognosis, social support may be an important prognostic indicator.

Background Precision medicine in advanced non-small cell lung cancer (NSCLC) requires molecular biomarker testing in patients with nonsquamous and select patients with squamous histologies, and programmed death-ligand 1 (PD-L1) testing in both. Research Question What are rates of molecular and PD-L1 biomarker testing in patients with advanced NSCLC in community practices, and do rates vary by sociodemographic factors? What is the prevalence of molecular biomarker mutations and PD-L1 expression levels? Study Design and Methods From 389 stage IV NSCLC pathology reports obtained through the University of North Carolina Lineberger Comprehensive Cancer Center’s Rapid Case Ascertainment Program from 38 community hospitals across North Carolina, we abstracted demographics, histology, molecular biomarker testing and results, and PD-L1 testing and expression. We geocoded patient and hospital addresses to determine travel time, distance to care, and census block level contextual variables. We compared molecular biomarker and PD-L1 testing rates, the prevalence of molecular biomarkers, and PD-L1 expression levels by race and sex, using χ2 tests. We determined predictors of testing, using multivariable logistic regression and report adjusted ORs and 95%CI. Results Among patients with nonsquamous NSCLC, 64.4% were tested for molecular biomarkers, and among all NSCLC patients 53.2% were tested for PD-L1 expression. Differences in biomarker testing rates by sociodemographic factors were not statistically significant in univariate or adjusted analyses. Adjusted analyses showed that patients living in areas with higher household internet access were more likely to undergo PD-L1 testing (adjusted OR = 1.66, 95% CI, 1.02-2.71). Sociodemographic differences in molecular biomarker prevalence and PD-L1 expression levels were not statistically significant, except for human epidermal growth factor receptor 2 (HER2) mutations, which occurred in 16.7% of males vs 0% in females, P = .05. Interpretation Biomarker testing remains underused in NSCLC. Future work should include larger populations and evaluate hospital-specific testing protocols to identify and address barriers to guideline-recommended testing.

The emergence of oral targeted therapy in the management of non-small cell lung cancer with targetable oncogenes has led to significant improvements in progression-free survival, toxicity profile, and quality of life compared to intravenous chemotherapy. However, patients unable to swallow or with exclusive enteral feeding are left without alternative formulations for these targeted therapies given their availability only in tablet or capsule formulations. We report a case of a woman with metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer who was unable to swallow and was successfully treated with an oil-based alectinib liquid suspension.

Background Safety net hospitals provide care mostly to low-income, uninsured, and vulnerable populations, in whom delays in cancer screening are established barriers. Socioeconomic barriers might pose important challenges to the success of a lung cancer screening program at a safety net hospital. We aimed to determine screening follow-up compliance, rates of diagnostic and treatment procedures, and the rate of cancer diagnosis in patients classified as category 4 by the Lung CT Screening Reporting and Data System (Lung-RADS 4). Methods We conducted a retrospective review of all patients enrolled in our multidisciplinary lung cancer screening program between March 2015 and July 2016. Demographics, smoking status, Lung-RADS score, and number of diagnostic and therapeutic interventions and cancer diagnoses were captured. Results A total of 554 patients were screened over a 16-month period. The mean patient age was 63 years (range, 47-85 years), and 60% were male. The majority (92%; 512 of 554) were classified as Lung-RADS 1 to 3, and 8% (42 of 554) were classified as Lung-RADS 4. Among the Lung-RADS 4 patients, 98% (41 of 42) completed their recommended follow-up; 29% (12 of 42) underwent a diagnostic procedure, for an overall diagnostic intervention rate of 2% (12 of 554). Eleven of these 12 patients had cancer, and 1 patient had sarcoidosis. The overall rate of surgical resection was 0.9% (5 of 554), and the rate of diagnostic intervention for noncancer diagnosis was 0.1% (1 of 554). Conclusions Implementation of a multidisciplinary lung cancer screening program at a safety net hospital is feasible. Compliance with follow-up and interventional recommendations in Lung-RADS 4 patients was high despite anticipated social challenges. Overall diagnostic and surgical resection rates and interventions for noncancer diagnosis were low in our initial experience.

Participatory research approaches can help ensure research is culturally relevant and aligned with stakeholder priorities, but barriers exist between researchers and community stakeholders, particularly in communities of color. We developed a measurement tool for assessing oncology researcher and provider readiness to undertake patient-engaged research, and piloted this measurement tool among oncology researchers and providers at the hospital's cancer care center. A survey was developed by drawing from existing PCORI assessments as well as creating original questions, in an effort to develop an evidence-based survey tailored to this project. A total of 23 researchers and providers responded to the survey. The majority of respondents indicated that they were moderately or very familiar with the concept of patient-centered outcomes research. Most respondents had little to no experience engaging in participatory research and endorsed several barriers to engaging patients in the research process, including lack of experience and time. A mechanism for preparing and supporting researchers and providers is needed if cancer centers are to implement patient-powered research agendas as recommended by PCORI.

Breast cancer mortality is higher in Black women than in White women. The prevalence of type 2 diabetes mellitus is also higher, yet data on whether diabetes affects breast cancer mortality in this population are lacking. We investigated the relation of diabetes at the time of breast cancer diagnosis to breast cancer mortality in the Black Women's Health Study, a prospective cohort study.1,621 Black women with invasive breast cancer diagnosed in 1995-2013 were followed by mailed questionnaires and searches of the National Death Index. Multivariable Cox regression analysis was used to compute hazard ratios (HRs) for diabetes in relation to breast cancer mortality and all-cause mortality, with adjustment for age, stage, treatment modality, estrogen receptor (ER) status, and body mass index.There were 368 deaths during follow-up, of which 273 were due to breast cancer. Breast cancer mortality was significantly increased in women who had been diagnosed with diabetes at least 5 years before breast cancer occurrence, HR 1.86 (95% CI 1.20-2.89), with elevations observed for both ER+ and ER- breast cancer. All-cause mortality was also higher in diabetics, with HRs of 1.54 (95% CI 1.12-2.07) overall and 2.26 (95% CI 1.62-3.15) for ≥5-year duration of diabetes relative to non-diabetics.Our results present the first solid evidence of a positive association of type 2 diabetes with breast cancer mortality in Black women. Given the higher prevalence and earlier onset of type 2 diabetes in Black women, it is likely that diabetes contributes to racial disparities in breast cancer mortality.

Background While racial disparity in colorectal cancer survival have previously been studied, whether this disparity exists in patients with metastatic colorectal cancer receiving care at safety net hospitals (and therefore of similar socioeconomic status) is poorly understood. Methods We examined racial differences in survival in a cohort of patients with stage IV colorectal cancer treated at the largest safety net hospital in the New England region, which serves a population with a majority (65%) of non-Caucasian patients. Data was extracted from the hospital’s electronic medical record. Survival differences among different racial and ethnic groups were examined graphically using Kaplan-Meier analysis. A univariate cox proportional hazards model and a multivariable adjusted model were generated. Results Black patients had significantly lower overall survival compared to White patients, with median overall survival of 1.9 years and 2.5 years respectively. In a multivariate analysis, Black race posed a significant hazard (HR 1.70, CI 1.01–2.90, p = 0.0467) for death. Though response to therapy emerged as a strong predictor of survival (HR = 0.4, CI = 0.2-0.7, p = 0.0021), it was comparable between Blacks and Whites. Conclusions Despite presumed equal access to healthcare and socioeconomic status within a safety-net hospital system, our results reinforce findings from previous studies showing lower colorectal cancer survival in Black patients, and also point to the importance of investigating other factors such as genetic and pathologic differences.

MicroRNAs (miRNAs) have been shown to be reliable early biomarkers in a variety of cancers including that of lung. We ascertained whether the biomarker potential of miRNAs could be validated in microscopically normal and easily accessible buccal epithelial brushings from cigarette smokers as a consequence of lung cancer linked ‘field carcinogenesis’. We found that compared to neoplasia-free subjects, a panel of 68 miRNAs were upregulated and 3 downregulated in the normal appearing buccal mucosal cells collected from patients harboring lung cancer (n=76). The performance characteristics of selected miRNAs (with ≥1-fold change) were excellent with an average under the receiver operator characteristic curve (AUROC) of >0.80. Several miRNAs also displayed gender specificity between the groups. These results provide the first proof-of-concept scenario in which minimally intrusive cheek brushings could provide an initial screening tool in a large at-risk population.

Although a number of studies have found an inverse association between body mass index (BMI) and risk of lung cancer, there is little information on this relation in African Americans, who experience a higher incidence of lung cancer.We assessed the relation of BMI to incidence of lung cancer in the Black Women's Health Study, an ongoing prospective follow-up of 59,000 women in the USA. Cox proportional hazard models were used to estimate hazard ratios for various levels of BMI relative to BMI 18.5-24.9 kg/m2 ("normal weight") with adjustment for age, education, pack-years of smoking, and other covariates. Two other anthropometric measures, waist circumference (WC) and waist/hip ratio (WHR), were also assessed. A total of 323 primary lung cancer cases were identified from 1995 to 2011.The hazard ratio (HR) for BMI ≥ 30 relative to BMI 18.5-24.9 was 0.69 (95% CI 0.51-0.92). As expected, cigarette smoking was strongly associated with increased risk of lung cancer. In analyses stratified by smoking status, the HR for BMI ≥ 30 relative to BMI 18.5-24.9 was 0.62 (0.38-1.00) among current smokers, 0.90 (0.56-1.42) among former smokers, and 0.83 (0.41-1.70) among never smokers (p for interaction = 0.28). Control for pack-years of smoking or age started smoking had little effect on the hazard ratios. WC and WHR were not materially associated with lung cancer risk.Our results indicate that high BMI is associated with a lower risk of lung cancer in African American women, particularly among current smokers.

We report on the clinical presentation and histopathology of a series of seven patients with localized amyloidosis of the breast. These patients were diagnosed by biopsy performed to rule out malignancy because of calcifications seen by mammography, and represented 0.5% of patients referred to the Amyloid Treatment and Research Program at Boston University Medical Campus in an 18-year period. The patients ranged in age from 35 to 75, median 63 years. None of these seven patients had evidence of a systemic plasma cell dyscrasia or amyloidosis in other organs, nor did systemic disease develop with a median follow-up of 6 years. Thus, other than excisional biopsy to exclude malignancy, no systemic therapy is indicated for this disorder.

Background: The evidence on the relation of family history of cancers other than breast cancer to breast cancer risk is conflicting, and most studies have not assessed specific breast cancer subtypes. Methods: We assessed the relation of first-degree family history of breast, prostate, lung, colorectal, ovarian, and cervical cancer and lymphoma or leukemia, to the risk of estrogen receptor–positive (ER+), ER−, and triple-negative breast cancer in data from the African American Breast Cancer Epidemiology and Risk Consortium. Multivariable logistic regression models were used to calculate ORs and 95% confidence intervals (CI). Results: There were 3,023 ER+ and 1,497 ER− breast cancer cases (including 696 triple-negative cases) and 17,420 controls. First-degree family history of breast cancer was associated with increased risk of each subtype: OR = 1.76 (95% CI, 1.57–1.97) for ER+, 1.67 (1.42–1.95) for ER−, and 1.72 (1.38–2.13) for triple-negative breast cancer. Family history of cervical cancer was associated with increased risk of ER− (OR = 2.39; 95% CI, 1.36–4.20), but not ER+ cancer. Family history of both breast and prostate cancer was associated with increased risk of ER+ (3.40; 2.42–4.79) and ER− (2.09; 1.21–3.63) cancer, but family history of both breast and lung cancer was associated only with ER− cancer (2.11; 1.29–3.46). Conclusions: A family history of cancers other than breast may influence the risk of breast cancer, and associations may differ by subtype. Impact: Greater surveillance and counseling for additional screening may be warranted for women with a family history of cancer. Cancer Epidemiol Biomarkers Prev; 25(2); 366–73. ©2015 AACR.

Introduction We investigated clinical and pathologic features of breast cancers (BC) in an unselected series of patients diagnosed in a tertiary care hospital serving a diverse population. We focused on triple-negative (Tneg) tumours (oestrogen receptor (ER), progesterone receptor (PR) and HER2 negative), which are associated with poor prognosis. Methods We identified female patients with invasive BC diagnosed between 1998 and 2006, with data available on tumor grade, stage, ER, PR and HER2 status, and patient age, body mass index (BMI) and self-identified racial/ethnic group. We determined associations between patient and tumour characteristics using contingency tables and multivariate logistic regression. Results 415 cases were identified. Patients were racially and ethnically diverse (born in 44 countries, 36% white, 43% black, 10% Hispanic and 11% other). 47% were obese (BMI > 30 kg/m2). 72% of tumours were ER+ and/or PR+, 20% were Tneg and 13% were HER2+. The odds of having a Tneg tumour were 3-fold higher (95% CI 1.6, 5.5; p = 0.0001) in black compared with white women. Tneg tumours were equally common in black women diagnosed before and after age 50 (31% vs 29%; p = NS), and who were obese and non-obese (29% vs 31%; p = NS). Considering all patients, as BMI increased, the proportion of Tneg tumours decreased (p = 0.08). Conclusions Black women of diverse background have 3-fold more Tneg tumours than non-black women, regardless of age and BMI. Other factors must determine tumour subtype. The higher prevalence of Tneg tumours in black women in all age and weight categories likely contributes to black women's unfavorable breast cancer prognosis.