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Purpose: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients., Materials and Methods: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them. Discussion focused on (1) specific elements of the training modules; (2) how to apply lessons learned; and (3) key considerations for developing a facilitation guide to support peer-to-peer discussions in cancer clinical research settings. We evaluated discussion via a qualitative assessment., Results: Participant completion rate was high: 49 of 50 participating cancer programs completed training; 126 of 129 participating individuals completed the training (98% response rate); and 119 completed the training and evaluations (92% response rate). Training increased the mean percentage change in knowledge scores by 19%-45% across key concepts (eg, causes of health disparities) and increased the mean percentage change in knowledge scores by 10%-31% about strategies/actions to address implicit bias and diversity concerns in cancer clinical trials. Knowledge increases were sustained at 6 weeks. Qualitative evaluation validated the utility and feasibility of facilitated peer-to-peer discussion., Conclusion: The pilot implementation of the training program demonstrated excellent utility and feasibility. Our evaluation affirms that an online training designed to raise awareness about implicit bias and develop strategies to mitigate biases among cancer research teams is feasible and can be readily implemented in cancer research settings.

Background: The prevention of youth marijuana use has become a national priority in the United States. This study examined the influence of parent and peer disapproval on youth marijuana use, mediated by youth risk perception. Because the legal status of marijuana use can influence individual perceptions of the drug, this study investigated differences in the mediating mechanism between youth living in states with medical marijuana legalization (MML) and those living in non-MML states., Methods: The 2019 National Survey of Drug Use and Health was used with a youth population aged 12-17 years (N = 2293). Structural equation modeling and bias-corrected bootstrapping were used to examine hypothesized path models and to evaluate the mediating effect of youth risk perception., Result: Findings demonstrated that parent and peer disapproval significantly increased youth risk perception of marijuana and reduced youth marijuana use. Second, youth risk perception significantly mediated the association between parent and peer disapproval and youth marijuana use. Third, parent disapproval had a more significant direct effect on youth marijuana use, while peer disapproval had a more significant indirect effect on youth marijuana use via youth risk perception. Finally, the results showed a similar pattern in the mechanism between youths living in MML states compared with those in non-MML states in terms of significance and direction., Conclusion: The findings suggested a need for improvements in marijuana related policies for both MML and non-MML states. Moreover, parent and peer focused strategies for education and prevention concerning marijuana use among youth are emphasized., Competing Interests: Declaration of Competing Interest The authors have no competing interest, financial or otherwise, in any of the programs or interventions included in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

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., Competing Interests: Leigh BoehmerConsulting or Advisory Role: Pfizer, AstraZeneca Al BensonConsulting or Advisory Role: Merck Sharp & Dohme, Array BioPharma, Bristol Myers Squibb, Samsung Bioepis, Pfizer, HalioDx, AbbVie, Janssen Oncology, Natera, Apexigen, Artemida Pharma, Xencor, Therabionic, Mirati Therapeutics, Boston Scientific, HutchmedResearch Funding: Infinity Pharmaceuticals (Inst), Merck Sharp & Dohme (Inst), Taiho Pharmaceutical (Inst), Bristol Myers Squibb (Inst), Celgene (Inst), Rafael Pharmaceuticals (Inst), MedImmune (Inst), Xencor (Inst), Astellas Pharma (Inst), Amgen (Inst), SynCoreBio (Inst), Elevar Therapeutics (Inst), Tyme Inc (Inst), st pharm (Inst), ITM Solucin (Inst) Julie R. GralowConsulting or Advisory Role: Genentech, AstraZeneca, Roche, Novartis, Seattle Genetics Carmen E. GuerraLeadership: Freenome, Guardant Health, Genentech, GRAIL, GlaxoSmithKlineStock and Other Ownership Interests: CRISPR Therapeutics, BEAM Therapeutics, Intellia Therapeutics, Editas MedicineHonoraria: LundbeckConsulting or Advisory Role: EB SquibbSpeakers' Bureau: Janssen, PfizerResearch Funding: Bristol Myers SquibbTravel, Accommodations, Expenses: Lundbeck, JanssenUncompensated Relationships: Tapestry NetworksOpen Payments Link: https://openpaymentsdata.cms.gov/physician/515813 Leila HamrounStock and Other Ownership Interests: Abbott Laboratories, CVS Health, Pfizer, AbbVie Grzegorz S. NowakowskiConsulting or Advisory Role: Celgene (Inst), MorphoSys (Inst), Genentech (Inst), Selvita, Debiopharm Group, Kite/Gilead, TG Therapeutics, Kymera, Karyopharm Therapeutics, Ryvu Therapeutics, BanthamResearch Funding: Celgene (Inst), NanoString Technologies (Inst), MorphoSys (Inst) Alice PressmanEmployment: PRECISIONHeorResearch Funding: Amgen (Inst)Uncompensated Relationships: AstraZeneca Amelie G. RamirezHonoraria: National Medical Fellowships, AstraZeneca, Genentech, Research Triangle Institute RTI Health SolutionsConsulting or Advisory Role: AstraZeneca, GenentechResearch Funding: Genentech/Roche Karen M. WinkfieldHonoraria: TakedaConsulting or Advisory Role: Merck, Pfizer, Bristol Myers Squibb, GRAIL, AstraZeneca Eddy S. YangConsulting or Advisory Role: Strata Oncology, AstraZeneca, Bayer, Clovis Oncology, LillyResearch Funding: Lilly (Inst), Novartis (Inst), Clovis Oncology (Inst), Puma Biotechnology (Inst) Lori J. PierceStock and Other Ownership Interests: PFS GenomicsPatents, Royalties, Other Intellectual Property: UpToDate, PFS GenomicsUncompensated Relationships: Bristol Myers Squibb, Exact SciencesOpen Payments Link: https://openpaymentsdata.cms.gov/physician/1250431No other potential conflicts of interest were reported.

Purpose: National Cancer Institute-Molecular Analysis for Therapy Choice is a multicohort trial that assigns patients with advanced cancers to targeted therapies on the basis of central tumor genomic testing. Arm B evaluated afatinib, an ErbB family tyrosine kinase inhibitor, in patients with ERBB2 -activating mutations., Methods: Eligible patients had selected ERBB2 single-nucleotide variants or insertions/deletions detected by the National Cancer Institute-Molecular Analysis for Therapy Choice next-generation sequencing assay. Patients had performance status ≤ 1, left ventricular ejection fraction > 50%, grade ≤ 1 diarrhea, and no prior human epidermal growth factor receptor 2 (HER2) therapy. Patients received afatinib 40 mg once daily in 28-day cycles. The primary end point was objective response rate (ORR). Secondary end points were 6-month progression-free survival, overall survival, toxicity, and molecular correlates., Results: A total of 59 patients were assigned and 40 were enrolled. The median age was 62 years, 78% were female, 68% had performance status = 1, and 58% had received > 3 prior therapies. The confirmed ORR was 2.7% (n = 1 of 37; 90% CI, 0.14 to 12.2), and 6-month progression-free survival was 12.0% (90% CI, 5.6 to 25.8). A confirmed partial response occurred in a patient with adenocarcinoma of extra-mammary Paget disease of skin who progressed after cycle 6. Two unconfirmed partial responses were observed (low-grade serous gynecological tract and estrogen receptor-positive/HER2-negative immunohistochemistry breast ductal carcinoma). Of 12 patients with breast cancer, 1 additional patient with lobular carcinoma (estrogen receptor-positive/HER2 fluorescent in situ hybridization) had a 51% reduction in target lesions but progressed because of a new lesion at cycle 6. The most common (> 20%) treatment-related adverse events were diarrhea (68%), mucositis (43%), fatigue (40%), acneiform rash (30%), dehydration (27%), vomiting (27%), nausea (27%), anemia (27%), and anorexia (22%). Four patients (11%) discontinued because of adverse events., Conclusion: Although afatinib did not meet the prespecified threshold for antitumor activity in this heavily pretreated cohort, the response in a rare tumor type is notable. The safety profile of afatinib was consistent with prior studies.

Background: African-American race appears to be associated with higher stages of urothelial carcinoma of the bladder (UCB) at presentation and poorer survival. However, the independent effect of African-American race on objective tumor recurrence after radical cystectomy (RC) after controlling for clinical and pathologic variables is unknown., Patients and Methods: The data from consecutive patients with UCB who underwent RC with curative intent at a single institution (University of Alabama, Birmingham) from 2001 to 2012 with or without perioperative chemotherapy or chemoradiation were reviewed. The patient demographics, risk factors, clinical course, pathologic characteristics, and long-term outcomes were collected. Descriptive statistics were performed. Cox regression analysis was performed for key clinical, demographic, and pathologic variables, including race, stratified as African American versus white., Results: A total of 215 patients, 163 men (76%) and 52 women (24%), with a mean age at RC of 65.6 years, were identified and reviewed. A total of 186 patients (87%) were white and 28 (13%) were African American. The median follow-up period after RC was 17.6 months. On conventional multivariate analysis, African-American race nearly attained statistical significance (hazard ratio [HR], 2.48; 95% confidence interval [CI], 0.98-6.29; P = .055). In a stepwise regression model, race was significantly associated with tumor recurrence (HR, 3.11; 95% CI, 1.2-7.4; P < .011)., Conclusion: African-American race appears to be independently associated with a greater risk of tumor recurrence after RC for UCB. The effect of host genetics on tumor biology needs to be characterized at the genomic level to develop precision medicine., (Copyright © 2015 Elsevier Inc. All rights reserved.)