ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer.

PURPOSE: Black women experience higher rates of taxane-induced peripheral neuropathy (TIPN) compared with White women when receiving adjuvant once weekly paclitaxel for early-stage breast cancer, leading to more dose reductions and higher recurrence rates. EAZ171 aimed to prospectively validate germline predictors of TIPN and compare rates of TIPN and dose reductions in Black women receiving (neo)adjuvant once weekly paclitaxel and once every 3 weeks docetaxel for early-stage breast cancer. METHODS: Women with early-stage breast cancer who self-identified as Black and had intended to receive (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel were eligible, with planned accrual to 120 patients in each arm. Genotyping was performed to determine germline neuropathy risk. Grade 2-4 TIPN by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was compared between high- versus low-risk genotypes and between once weekly paclitaxel versus once every 3 weeks docetaxel within 1 year. Patient-rated TIPN and patient-reported outcomes were compared using patient-reported outcome (PRO)-CTCAE and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity. RESULTS: Two hundred and forty of 249 enrolled patients had genotype data, and 91 of 117 (77.8%) receiving once weekly paclitaxel and 87 of 118 (73.7%) receiving once every 3 weeks docetaxel were classified as high-risk. Physician-reported grade 2-4 TIPN was not significantly different in high- versus low-risk genotype groups with once weekly paclitaxel (47% v 35%; P = .27) or with once every 3 weeks docetaxel (28% v 19%; P = .47). Grade 2-4 TIPN was significantly higher in the once weekly paclitaxel versus once every 3 weeks docetaxel arm by both physician-rated CTCAE (45% v 29%; P = .02) and PRO-CTCAE (40% v 24%; P = .03). Patients receiving once weekly paclitaxel required more dose reductions because of TIPN (28% v 9%; P < .001) or any cause (39% v 25%; P = .02). CONCLUSION: Germline variation did not predict risk of TIPN in Black women receiving (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel. Once weekly paclitaxel was associated with significantly more grade 2-4 TIPN and required more dose reductions than once every 3 weeks docetaxel.

Lower Urinary Tract Symptoms in US Women: Contemporary Prevalence Estimates from the RISE FOR HEALTH Study.

PURPOSE: We aimed to estimate the prevalence of a wide range of lower urinary tract symptoms (LUTS) in US women, and explore associations with bother and discussion with health care providers, friends, and family. MATERIALS AND METHODS: We analyzed baseline data collected from May 2022 to December 2023 in the RISE FOR HEALTH study-a large, regionally representative cohort study of adult female community members. LUTS and related bother were measured by the 10-item Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index, and discussion was assessed by a study-specific item. RESULTS: Of the 3000 eligible participants, 73% (95% CI 71%-74%) reported any storage symptoms, 52% (95% CI 50%-53%) any voiding or emptying symptoms, and 11% (95% CI 10%-13%) any pain with bladder filling, for an overall LUTS prevalence of 79% (95% CI 78%-81%). This prevalence estimate included 43% (95% CI 41%-45%) of participants with mild to moderate symptoms and 37% (95% CI 35%-38%) with moderate to severe symptoms. Over one-third of participants reported LUTS-related bother (38%, 95% CI 36%-39%) and discussion (38%, 95% CI 36%-40%), whereas only 7.1% (95% CI 6.2%-8.1%) reported treatment. Urgency and incontinence (including urgency and stress incontinence) were associated with the greatest likelihood of bother and/or discussion (adjusted prevalence ratios = 1.3-2.3), even at mild to moderate levels. They were also the most commonly treated LUTS. CONCLUSIONS: LUTS, particularly storage LUTS such as urgency and incontinence, were common and bothersome in the RISE study population, yet often untreated. Given this large burden, both prevention and treatment-related interventions are warranted to reduce the high prevalence and bother of LUTS.

Health-care workforce implications of the Dobbs v Jackson Women's Health Organization decision.

The Dobbs v Jackson Women's Health Organization Supreme Court decision, which revoked the constitutional right to abortion in the USA, has impacted the national medical workforce. Impacts vary across states, but providers in states with restrictive abortion laws now must contend with evolving legal and ethical challenges that have the potential to affect workforce safety, mental health, education, and training opportunities, in addition to having serious impacts on patient health and far-reaching societal consequences. Moreover, Dobbs has consequences on almost every facet of the medical workforce, including on physicians, nurses, pharmacists, and others who work within the health-care system. Comprehensive research is urgently needed to understand the wide-ranging implications of Dobbs on the medical workforce, including legal, ethical, clinical, and psychological dimensions, to inform evidence-based policies and standards of care in abortion-restrictive settings. Lessons from the USA might also have global relevance for countries facing similar restrictions on reproductive care.

Societal implications of the Dobbs v Jackson Women's Health Organization decision.

On June 24, 2022, the US Supreme Court's decision in Dobbs v Jackson Women's Health Organization marked the removal of the constitutional right to abortion in the USA, introducing a complex ethical and legal landscape for patients and providers. This shift has had immediate health and equity repercussions, but it is also crucial to examine the broader impacts on states, health-care systems, and society as a whole. Restrictions on abortion access extend beyond immediate reproductive care concerns, necessitating a comprehensive understanding of the ruling's consequences across micro and macro levels. To mitigate potential harm, it is imperative to establish a research agenda that informs policy making and ensures effective long-term monitoring and reporting, addressing both immediate and future impacts.

Intimate Partner Violence Detected during Abortion-Related Visits: A Systematic Review of Screenings and Interventions.

OBJECTIVE: To perform a systematic review of screening tools and interventions focused on reducing adverse health outcomes associated with intimate partner violence (IPV) at abortion-related visits. STUDY DESIGN: Studies were eligible if they included individuals seeking pregnancy options health care services in the United States, screening for or implementation of an intervention for IPV, and were published in English after the year 2000. The primary outcomes were to summarize screening tools, interventions studied, and if interventions led to individuals being connected to IPV-related resources. Secondary outcomes included patient responses to the IPV-related interventions and any other outcomes reported by the studies (PROSPERO #42021252199). RESULTS: Among 4,205 abstracts identified, nine studies met inclusion criteria. The majority (n = 6) employed the ARCHES (Addressing Reproductive Coercion in Health Settings) tool for identification of IPV. Interventions included provider-facilitated discussions of IPV, a safety card with information about IPV and community-based resources, and referral pathways to directly connect patients with support services. For the primary outcome, IPV-related interventions were shown to better inform patients of available IPV-related resources as compared to no intervention at all. For the secondary outcomes, screening and intervening on IPV were associated with improvements in patient perception of provider empathy (i.e., caring about safety) and safer responses by patients to unhealthy relationships. CONCLUSION: Screening for and intervening on IPV at abortion-related visits are associated with positive outcomes for patient safety and the patient-provider relationship. However, data on effective tools for identifying and supporting these patients are extremely limited. This review emphasizes the unmet need for implementation and evaluation of IPV-specific interventions during abortion-related clinical encounters. KEY POINTS: · The abortion visit offers a crucial setting to address IPV among a highly affected population.. · This study reviews others that analyzed interventions and associated outcomes for IPV at abortion-related visits.. · Appropriate interventions for IPV can improve patient-provider relationships and connect patients to essential resources..

Epidemiology and survival outcomes of HIV-associated cervical cancer in Nigeria.

INTRODUCTION: Invasive cervical cancer (ICC) is an HIV-associated cancer that is preventable and precancerous stages including early ICC stages could be detected through screening offering opportunities for treatment and cure. The high incidence in women living with HIV and late presentation often at advanced stages of ICC with limited treatment facilities often result in early mortality. We sought to compare the epidemiologic characteristics and survival differences in HIV status of ICC patients in Nigeria. METHODS: We conducted a cohort study at two federal academic hospital-based research sites in Jos University Teaching Hospital, and Lagos University Teaching Hospital Nigeria, between March 2018 and September 2022. We enrolled women with histologically confirmed ICC with known HIV status, and FIGO staging as part of the United States of America's National Institutes of Health/National Cancer Institute funded project titled 'Epigenomic Biomarkers of HIV-Associated Cancers in Nigeria'. The primary outcome was all-cause mortality with assessment of overall survival (OS) and time to death after ICC diagnosis. OS distribution was estimated using the method of Kaplan-Meier and compared between groups using the log-rank test. RESULTS: A total of 239 women with confirmed ICC were enrolled and included in this analysis, of whom 192 (80.3%) were HIV-negative (HIV-/ICC +), and 47 (19.7%) were HIV-positive (HIV +/ICC +). The HIV +/ICC + patients were younger with median age 46 (IQR: 40-51) years compared to 57 (IQR: 45-66) among HIV-/ICC + (P < 0.001). Squamous cell carcinoma was the commonest histopathologic variant in 80.4% of ICC diagnosis, moderately differentiated tumor grade in 68.1% in both groups. HIV +/ICC + diagnosis was at FIGO advanced stages in 64.9% compared to 47.9% in HIV-/ICC +. The HIV-/ICC + women had better OS compared to HIV +/ICC + participants (p = 0.018), with 12-month OS 84.1% (95%CI 75-90%) and 67.6% (95%CI 42-84%) respectively. CONCLUSION: ICC is diagnosed at a relatively young age in women living with HIV, with a significantly lower overall survival probability compared to women without HIV. The trend of presentation and diagnosis at advanced stages in women living with HIV could partly explain the differences in overall survival.

Over-the-Counter Progestin-Only Oral Contraceptives.

This JAMA Patient Page describes progestin-only oral contraceptive pills, which recently have been approved to be sold over the counter.

Epidemiology and Survival outcomes of HIV-associated cervical cancer in Nigeria.

Introduction: Invasive cervical cancer (ICC) is an HIV-associated cancer that is preventable and precancerous stages including early ICC stages could be detected through screening offering opportunities for treatment and cure. The high incidence in women living with HIV and late presentation often at advanced stages of ICC with limited treatment facilities often result in early mortality. We sought to compare the epidemiologic characteristics and survival differences in HIV status of ICC patients in Nigeria. Methods: We conducted a cohort study at two federal academic hospital-based research sites in Jos University Teaching Hospital, and Lagos University Teaching Hospital Nigeria, between March 2018 and September 2022. We enrolled women with histologically confirmed ICC with known HIV status, and FIGO staging as part of the United States of America's National Institutes of Health/National Cancer Institute funded project titled 'Epigenomic Biomarkers of HIV-Associated Cancers in Nigeria'. The primary outcome was all-cause mortality with assessment of overall survival (OS) and time to death after ICC diagnosis. OS distribution was estimated using the method of Kaplan-Meier and compared between groups using the log-rank test. Results: A total of 239 women with confirmed ICC were enrolled and included in this analysis, of whom 192 (80.3%) were HIV-negative (HIV-/ICC+), and 47 (19.7%) were HIV-positive (HIV+/ICC+). The HIV+/ICC) patients were younger with median age 46 (IQR: 40-51) years compared to 57 (IQR: 45-66) among HIV-/ICC+) (P<0.001. Squamous cell carcinoma was the commonest histopathologic variant in 80.4% of ICC diagnosis, moderately differentiated tumor grade in 68.1% in both groups. HIV+/ICC+ diagnosis was at FIGO advanced stages in 64.9% compared to 47.9% in HIV-/ICC+. The HIV-/ICC+ women had better OS compared to HIV+/ICC+ participants (p=0.018), with 12-month OS 84.1% (95%CI: 75% - 90%) and 67.6% (95%CI: 42%-84%) respectively. Conclusion: ICC is diagnosed at a relatively young age in women living with HIV, with a significantly lower overall survival probability compared to women without HIV. The trend of presentation and diagnosis at advanced stages in women living with HIV could partly explain the differences in overall survival.

Community-Driven Conversations: Partnership Building through CHEC-Ins.

BACKGROUND: Chicago's systemically underserved communities have disproportionately high cancer rates. The Chicago Cancer Health Equity Collaborative (ChicagoCHEC) brings together academic and community partners to address these health inequities. The community conversations known as "CHEC-Ins" provide a space for community members to voice their experiences and needs and for ChicagoCHEC to fulfill its commitment to advancing health equity through collaboration and action. OBJECTIVE: This paper presents a community-generated approach to social networking about cancer health issues known as CHEC-Ins. Through this innovative approach, community members and organizations share cancer related information and experiences, as well as needs and concerns, which are then channeled to ChicagoCHEC academic and administrative members who incorporate them into outreach and research activities. In this way, community members set the agenda and the process and collect the information they deem relevant and important. This paper describes the process of organizing and conducting two pilot CHEC-Ins and the model of this approach, which we intend to employ moving forward to advance partnership building and collaborative research practice between academic institutions and community partners and organizations. This paper contributes a unique model of community-generated and led outreach as a cornerstone of the ChicagoCHEC approach to community engagement. METHODS: The leaders of the ChicagoCHEC Community Steering Committee spearheaded the design and implementation of CHEC-Ins, including developing the question guide and hosting events within their organizations. LESSONS LEARNED: CHEC-Ins proved to be a valuable strategy for defining the role of community partners and establishing the basis for a bi-directional flow of information, resources, and productive action. The two pilot CHEC-Ins revealed important insights related to sources of cancer information, meanings and associated attitudes, barriers to access and use of health services, and social support systems in the communities where ChicagoCHEC works. We will implement this approach and continue to refine it as we conduct CHECIns moving forward.

SweetMama: Usability Assessment of a Novel Mobile Application Among Low-Income Pregnant People to Assist With Diabetes Management and Support.

Background: Mobile health tools may be effective strategies to improve engagement, education, and diabetes-related health during pregnancy. We developed SweetMama, a patient-centered, interactive mobile application (app) designed to support and educate low-income pregnant people with diabetes. Our objective was to evaluate the SweetMama user experience and acceptability. Methods: SweetMama is a mobile app with static and dynamic features. Static features include a customized homepage and resource library. Dynamic features include delivery of a theory-driven diabetes-specific curriculum via 1) motivational, tip, and goal-setting messages aligning with treatment and gestational age; 2) appointment reminders; and 3) ability to mark content as "favorite." In this usability assessment, low-income pregnant people with gestational or type 2 diabetes used SweetMama for 2 weeks. Participants provided qualitative feedback (via interviews) and quantitative feedback (via validated usability/satisfaction measures) on their experience. User analytic data detailed the duration and type of interactions users had with SweetMama. Results: Of 24 individuals enrolled, 23 used SweetMama and 22 completed exit interviews. Participants were mostly non-Hispanic Black (46%) or Hispanic (38%) individuals. Over the 14-day period, users accessed SweetMama frequently (median number of log-ins 8 [interquartile range 6-10]), for a median of 20.5 total minutes, and engaged all features. A majority (66.7%) rated SweetMama as having moderate or high usability. Participants emphasized design and technical strengths and beneficial effects on diabetes self-management and also identified limitations of the user experience. Conclusion: Pregnant people with diabetes found SweetMama to be user-friendly, informative, and engaging. Future work must study its feasibility for use throughout pregnancy and its efficacy to improve perinatal outcomes.

Addressing pediatric surgical health inequities through quality improvement efforts.

Concepts of healthcare quality and health equity should be inextricably linked but are often pursued separately. Quality improvement (QI) can serve as a powerful means to eliminate health inequities by adopting an equity-focused lens to diagnose and address baseline disparities among pediatric populations using targeted interventions. QI and pediatric surgery practitioners should integrate concepts of equity at every stage of formulating a QI project including conceptualization, planning, and execution. Early adaptation of an equity conscious perspective using QI methodology can prevent exacerbation of preexisting disparities while improving overall outcomes.

Reaching Populations to Address Disparities in Cancer Care Delivery: Results From a Six-Site Initiative.

BACKGROUND: Large segments of the US population do not receive quality cancer care due to pervasive and systemic inequities, which can increase morbidity and mortality. Multicomponent, multilevel interventions can address inequities and improve care, but only if they reach communities with suboptimal access. Intervention studies often underenroll individuals from historically excluded groups. METHODS: The Alliance to Advance Patient-Centered Cancer Care includes 6 grantees across the United States who implemented unique multicomponent, multilevel intervention programs with common goals of reducing disparities, increasing engagement, and improving the quality of care for targeted populations. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the evaluation efforts across sites. Each Alliance site identified their intended populations, which included underrepresented minorities (eg, Black and Latinx persons), individuals who prefer a language other than English, and rural residents. We evaluated the demographic characteristics of participants to determine program reach. RESULTS: Between 2018 and 2020, a total of 2,390 of 5,309 potentially eligible participants were enrolled across the 6 sites. The proportion of enrolled individuals with selected characteristics included 38% (n=908) Black adults, 24% (n=574) Latinx adults, 19% (n=454) preferring a language other than English, and 30% (n=717) rural residents. The proportion of those enrolled who were the intended population was commensurate to the proportion with desired characteristics in those identified as potentially eligible. CONCLUSIONS: The grantees met or exceeded enrollments from their intended populations who have been underserved by quality cancer care into patient-centered intervention programs. Intentional application of recruitment/engagement strategies is needed to reach individuals from historically underserved communities.

Current Approaches to Serving Catchment Areas in Cancer Centers: Insights from the Big Ten Cancer Research Consortium Population Science Working Group.

In 2021, the NCI issued updated guidance clarifying the mission and organizational structure for Community Outreach and Engagement (COE) for Cancer Center Support Grants. These guidelines outlined how cancer centers should address the cancer burden of the catchment area (CA) and define how COE would partner with the community to inform cancer research and implement programs to reduce the cancer burden. In this paper, the Common Elements Committee of the Population Science Working Group in the Big Ten Cancer Research Consortium describes their respective approaches to implementing these guidelines. We discuss our definitions and rationales for each CA, data sources used, and our approach to assessing the impact of COE efforts on the burden of cancer in our respective CA. Importantly, we describe methods of translating unmet CA needs into our cancer-relevant outreach activities, and cancer research addressing the needs of respective CAs. Implementing these new guidelines is a challenge, and we hope that sharing approaches and experiences will foster cross-center collaborations that may more effectively reduce the burden of cancer in the US and meet the mission of the NCI's Cancer Center Program.

Lessons learned in the practice of community-based participatory research with community partner collaboration in study design and implementation: the community scientist model.

Engagement of community participation is an innovative driver of modern research. However, to benefit the communities being studied, it is imperative to continuously evaluate ethical considerations, the relationship dynamic between researchers and community members, and the responsiveness of research teams to the needs and preferences of communities. Northwestern University's Center for Health Equity Transformation founded a community scientist program in 2018 that implemented a study using the Community-Based Participatory Research (CBPR) model. This project is an ongoing study of heavy metal exposure by geographic location in Chicago. Community scientists from various backgrounds, communities, and organizations formed an advisory panel, partnering with the cancer research team. This commentary describes lessons learned in structuring meaningful community involvement and benefit in CBPR, with a focus on three lessons learned that relate to ethics, relationships, and responsiveness. Our findings lay new groundwork for iteratively shaping best practices in CBPR.

The GIANT trial (ECOG-ACRIN EA2186) methods paper: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer - defining a new treatment option for older vulnerable patients.

INTRODUCTION: Pancreatic cancer is the fourth leading cause of cancer-related death in the US with an increasing incidence in older adults (OA) over age 70. There are currently no treatment guidelines for OA with metastatic pancreatic cancer (mPCA) and selecting a chemotherapy regimen for these patients is subjective, based largely on chronologic age and performance status (PS). Geriatric screening tools provide a more objective and accurate evaluation of a patient's overall health but have not yet been validated in patient selection for mPCA treatment. This study aims to elucidate the optimal chemotherapy treatment of vulnerable OA with mPCA and understand the geriatric factors that affect outcomes in this population. METHODS/DESIGN: The GIANT (ECOG-ACRIN EA2186) study is multicenter, randomized phase II trial enrolling patients over age 70 with newly diagnosed mPCA. This study utilizes a screening geriatric assessment (GA) which characterizes patients as fit, vulnerable, or frail. Patients with mild abnormalities in functional status and/or cognition, moderate comorbidities, or over age 80 are considered vulnerable. Enrolled patients are randomized to one of two dose-reduced treatment regimens (gemcitabine/nab-paclitaxel every other week, or dose-reduced 5-fluoruracil (5FU)/ liposomal irinotecan (nal-IRI) every other week). GA and quality of life (QoL) evaluations are completed prior to treatment initiation and at each disease evaluation. Overall survival (OS) is the primary endpoint, with secondary endpoints including progression free survival (PFS) and objective response rate (ORR). Enrolled patients will be stratified by age (70-74 vs ≥75) and ECOG PS (0-1 vs 2). Additional endpoints of interest for OA include evaluation of risk factors identified through GA, QoL evaluation, and toxicities of interest for older adults. Correlative studies include assessment of pro-inflammatory biomarkers of aging in the blood (IL-6, CRP) and imaging evaluation of sarcopenia as predictors of treatment tolerance. DISCUSSION: The GIANT study is the first randomized, prospective national trial evaluating vulnerable OA with mPCA aimed at developing a tailored treatment approach for this patient population. This trial has the potential to establish a new way of objectively selecting vulnerable OA with mPCA for modified treatment and to establish a new standard of care in this growing patient population. TRIAL REGISTRATION: This trial is registered with ClinicalTrial.gov Identifier NCT04233866.