COVID-19-Related Treatment Cancellations and Oncology Patients' Psychological Health in Nigeria.

Objective: To explore the association between COVID-19-related cancer treatment cancellations and the psychological health of cancer patients in Nigeria.Methods: We analyzed data collected from 15 outpatient cancer clinics, comprising 1,097 patients between April to July 2020. Study outcome was ten psychological impacts, including feeling down, stressed, and unable to access treatment due to COVID-19 (used as continuous and categorical variable (0-3,4-7,8+ events). The independent variable was treatment cancellations due to COVID-19 categorized as 0, 1, and 2+ cancellations. Confounders included religion, ethnicity, income, cancer diagnosis/type, and treatment received. Stata/SE.v.17 was used to perform all analyses. P values of ≤0.05 were deemed statistically significant.Results: Of the 1,097 cancer patients, 65.7% were female, with a mean age (SD) of 49.4 (13.8) years. Most patients (50.3%) reported four to seven psychological health events. Cancer patients who reported two/more treatment cancellations made up only 12.8% of the study sample but accounted for a greater proportion of psychological impacts (23.5%; P<0.001). In the adjusted model, cancer patients with one treatment cancellation (Coef: 0.195, 95%CI: 0.089-0.302) and those with two/more cancellations (Coef: 0.379, 95%CI: 0.255-0.504) had a significantly higher risk of psychological health impacts than those with no treatment cancellations.Conclusion: More than half of our sample of primarily adult female cancer patients reported major psychological health effects due to COVID-19. Cancer patients who experienced at least one treatment cancellation had a higher risk of psychological health consequences than those who did not. The implications of our findings and how to mitigate the impact of COVID-19 on oncology service disruptions are discussed.

Racial disparities in survival outcomes among breast cancer patients by molecular subtypes.

PURPOSE: Differences in tumor biology, genomic architecture, and health care delivery patterns contribute to the breast cancer mortality gap between White and Black patients in the US. Although this gap has been well documented in previous literature, it remains uncertain how large the actual effect size of race is for different survival outcomes and the four breast cancer subtypes. METHODS: We established a breast cancer patient cohort at the University of Chicago Comprehensive Cancer Center. We chose five major survival outcomes to study: overall survival, recurrence-free survival, breast-cancer-specific survival, time-to-recurrence and post-recurrence survival. Cox proportional hazards models were used to estimate the hazard ratios between Black and White patients, adjusting for selected patient, tumor, and treatment characteristics, and also stratified by the four breast cancer subtypes. RESULTS: The study included 2795 stage I-III breast cancer patients (54% White and 38% Black). After adjusting for selected patient, tumor and treatment characteristics, Black patients still did worse than White patients in all five survival outcomes. The racial difference was highest within the HR-/HER2+ subgroup, in both overall survival (hazard ratio = 4.00, 95% CI 1.47-10.86) and recurrence-free survival (hazard ratio = 3.00, 95% CI 1.36-6.60), adjusting for age at diagnosis, cancer stage, and comorbidities. There was also a significant racial disparity within the HR+/HER2- group in both overall survival and recurrence-free survival. CONCLUSIONS: Our study confirmed that racial disparity existed between White and Black breast cancer patients in terms of both survival and recurrence, and found that this disparity was largest among HR-/HER2+ and HR+/HER2- patients.

Propensity score analysis of the prognostic value of genomic assays for breast cancer in diverse populations using the National Cancer Data Base.

BACKGROUND: Genomic assays such as Oncotype Dx (ODX) and MammaPrint are used for risk-adapted treatment decisions among patients with early breast cancer. However, to the authors' knowledge, concordance between genomic assays is modest. Using real-world data, the authors performed a comparative analysis of ODX and MammaPrint. METHODS: A cohort of women diagnosed with early-stage, hormone receptor-positive breast cancer who received ODX or MammaPrint was established using the National Cancer Data Base (NCDB) for 2010 through 2016. Using the propensity score matching method, 2 groups of patients with similar clinical and demographic characteristics were defined: one group received ODX and the other received MammaPrint. The authors examined the association between use of the ODX or MammaPrint assays and overall survival using Cox models. RESULTS: Of the 451,693 eligible patients, approximately 45.3% received ODX and 1.8% received MammaPrint testing. The use of ODX increased from 36.1% in 2010 to 49.9% in 2016, whereas use of MammaPrint increased from 0.5% in 2010 to 3.3% in 2016. The authors matched 5042 patients who received ODX with 5042 patients who received MammaPrint. The 5-year risks of death for the MammaPrint low-risk group and the ODX low-risk group were 3.4% and 4.7%, respectively. The prognostic value of MammaPrint was similar to that of ODX; the C-index was 0.614 (95% confidence interval, 0.572-0.657) for MammaPrint and 0.581 (95% confidence interval, 0.530-0.631) for ODX. There was a difference in the performance of the ODX assay observed across racial and/or ethnic groups (P < .001), with a slightly better performance noted among white compared with African American and Hispanic individuals. CONCLUSIONS: Both the ODX and MammaPrint tests are good at identifying low-risk individuals who could be spared chemotherapy. The suboptimal performance of ODX in ethnic minority individuals deserves further investigation.

Implementing oncology clinical trials in Nigeria: a model for capacity building.

BACKGROUND: There is both higher mortality and morbidity from cancer in low and medium income countries (LMICs) compared with high income countries (HICs). Clinical trial activities and development of more effective and less toxic therapies have led to significant improvements in morbidity and mortality from cancer in HICs. Unfortunately, clinical trials remain low in LMICs due to poor infrastructure and paucity of experienced personnel to execute clinical trials. There is an urgent need to build local capacity for evidence-based treatment for cancer patients in LMICs. METHODS: We conducted a survey at facilities in four Teaching Hospitals in South West Nigeria using a checklist of information on various aspects of clinical trial activities. The gaps identified were addressed using resources sourced in partnership with investigators at HIC institutions. RESULTS: Deficits in infrastructure were in areas of patient care such as availability of oncology pharmacists, standard laboratories and diagnostic facilities, clinical equipment maintenance and regular calibrations, trained personnel for clinical trial activities, investigational products handling and disposals and lack of standard operating procedures for clinical activities. There were two GCP trained personnel, two study coordinators and one research pharmacist across the four sites. Interventions were instituted to address the observed deficits in all four sites which are now well positioned to undertake clinical trials in oncology. Training on all aspects of clinical trial was also provided. CONCLUSIONS: Partnerships with institutions in HICs can successfully identify, address, and improve deficits in infrastructure for clinical trial in LMICs. The HICs should lead in providing funds, mentorship, and training for LMIC institutions to improve and expand clinical trials in LMIC countries.

Community clinical practice patterns and mortality in patients with intermediate oncotype DX recurrence scores: Who benefits from chemotherapy?

BACKGROUND: The Oncotype DX recurrence score (RS) is used as a tool for making decisions about chemotherapy for patients who have hormone receptor (estrogen receptor or progesterone receptor)-positive, HER2-negative breast cancer. There is no benefit from chemotherapy among patients aged ≥50 years who have lymph node-negative disease and an RS from 11 to 25, but the benefit of chemotherapy in the lymph node-positive group remains unknown. METHODS: On the basis of data from the National Cancer Data Base between 2010 and 2014, a nationwide, retrospective cohort study included 73,185 women who had stage I through IIIA breast cancer and an RS between 11 and 30. RESULTS: Receipt of chemotherapy was associated with a reduced risk of death among patients who had lymph node-positive breast cancer (hazard ratio [HR] 0.58; 95% confidence interval [CI], 0.45-0.74; P < .001) after adjusting for other prognostic factors in a multivariable Cox model. The 5-year survival gain ranged from 1.3% (RS 11-17 subgroup), to 3.3% (RS 18-25 subgroup), and to 6.7% (RS 26-30 subgroup). Among patients who had lymph node-negative disease, chemotherapy was associated with a reduced risk of death for those with an RS from 25 to 30 (HR, 0.68; 95% CI, 0.48-0.96; P = .03; 5-year survival gain, 1.8%), but there was no benefit from chemotherapy for patients who had an RS from 11 to 17 (HR, 0.97; 95% CI, 0.61-1.55; P = .90), and there was a marginally significant benefit for women who had an RS from 18 to 25 (HR, 0.79; 95% CI, 0.62-1.00; P = .05). Similar results were observed using propensity score-matching method. CONCLUSIONS: The benefit of chemotherapy for patients with breast cancer who have an intermediate RS is driven in a nonlinear fashion by RS: the higher the RS, the larger the absolute benefit. Findings from this study underscore the utility of real-world data to inform joint decision making in practice.

Racial disparities in omission of oncotype DX but no racial disparities in chemotherapy receipt following completed oncotype DX test results.

PURPOSE: To examine racial/ethnic disparities in Oncotype DX (ODX) testing among patients with node-negative, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers and possible racial/ethnic disparities in chemotherapy receipt following ODX testing within Recurrence Score (RS) category (Not Done, Low, Intermediate, High), as well as chemotherapy receipt time trends within RS categories. METHODS: A retrospective cohort list of 125,288 women who were potentially indicated for ODX testing from 2010 to 2014 was obtained using the National Cancer Database. We fit multivariate logistic regression predicting chemotherapy receipt, adjusting for clinical factors, patient demographic factors, and hospital-level factors, separately by RS category, and calculated odds ratios (OR) and 95% confidence intervals (CI), as well as time trends. RESULTS: Overall, ODX testing was completed for 46.1% of Non-Hispanic (NH) Whites, 43.9% of NH Blacks, and 41.7% of Hispanics. Among patients who did not receive ODX testing, NH Black and Hispanic women both experienced statistically significant increases in chemotherapy receipt relative to NH White women (NH Black OR 1.23; 95% CI 1.11-1.37; Hispanic OR 1.23; 95% CI 1.07-1.42). However, among patients with ODX results, no statistically significant racial/ethnic differences in chemotherapy receipt were observed within strata of RS category. Trend analyses demonstrated increasing adherence to national guidelines for ODX testing. CONCLUSIONS: We identified racial disparities in omission of ODX testing but no differences in chemotherapy receipt if ODX test results were obtained, suggesting increasing access to ODX testing may improve racial equality in efficacious use of adjuvant chemotherapy for ER-positive HER2-negative breast cancer.

Global Equity in Clinical Trials: An ASCO Policy Statement.

ASCO is a global professional society representing more than 50,000 physicians, other health care professionals, and advocates in over 100 countries specializing in cancer treatment, diagnosis, prevention, and advocacy. ASCO strives, through research, education, and promotion of the highest quality of patient care, to create a world where cancer is prevented or cured, and every survivor is healthy. In this pursuit, health equity remains the guiding institutional principle that applies to all its activities across the cancer care continuum. This ASCO policy statement emphasizes the urgent need for global equity in clinical trials, aiming to enhance access and representation in cancer research as it not only improves cancer outcomes but also upholds principles of fairness and justice in health care.

Association of Social Determinants and Tumor Biology With Racial Disparity in Survival From Early-Stage, Hormone-Dependent Breast Cancer.

Importance: Black women with hormone receptor-positive breast cancer experience the greatest racial disparity in survival of all breast cancer subtypes. The relative contributions of social determinants of health and tumor biology to this disparity are uncertain. Objective: To determine the proportion of the Black-White disparity in breast cancer survival from estrogen receptor (ER)-positive, axillary node-negative breast cancer that is associated with adverse social determinants and high-risk tumor biology. Design, Setting, and Participants: A retrospective mediation analysis of factors associated with the racial disparity in breast cancer death for cases diagnosed between 2004 and 2015 with follow-up through 2016 was carried out using the Surveillance, Epidemiology, and End Results (SEER) Oncotype registry. The study included women in the SEER-18 registry who were aged 18 years or older at diagnosis of a first primary invasive breast cancer tumor that was axillary node-negative and ER-positive, who were Black (Black), non-Hispanic White (White), and for whom the 21-gene breast recurrence score was available. Data analysis took place between March 4, 2021, and November 15, 2022. Exposures: Census tract socioeconomic disadvantage, insurance status, tumor characteristics including the recurrence score, and treatment variables. Main Outcomes and Measures: Death due to breast cancer. Results: The analysis with 60 137 women (mean [IQR] age 58.1 [50-66] years) included 5648 (9.4%) Black women and 54 489 (90.6%) White women. With a median (IQR) follow-up time of 56 (32-86) months, the age-adjusted hazard ratio (HR) for breast cancer death among Black compared with White women was 1.82 (95% CI, 1.51-2.20). Neighborhood disadvantage and insurance status together mediated 19% of the disparity (mediated HR, 1.62; 95% CI, 1.31-2.00; P < .001) and tumor biological characteristics mediated 20% (mediated HR, 1.56; 95% CI, 1.28-1.90; P < .001). A fully adjusted model that included all covariates accounted for 44% of the racial disparity (mediated HR, 1.38; 95% CI, 1.11-1.71; P < .001). Neighborhood disadvantage mediated 8% of the racial difference in the probability of a high-risk recurrence score (P = .02). Conclusions and Relevance: In this study, racial differences in social determinants of health and indicators of aggressive tumor biology including a genomic biomarker were equally associated with the survival disparity in early-stage, ER-positive breast cancer among US women. Future research should examine more comprehensive measures of socioecological disadvantage, molecular mechanisms underlying aggressive tumor biology among Black women, and the role of ancestry-related genetic variants.

Examining Cancer Patients' Perceptions of the Impact of COVID-19 on Teleoncology: Findings From 15 Nigerian Outpatient Cancer Clinics.

PURPOSE: To examine cancer patients' perspectives on the impact of COVID-19 on teleoncology in Nigeria. METHODS: Data from a multicenter survey conducted at 15 outpatient clinics to 1,097 patients with cancer from April and July 2020 were analyzed. The study outcome was telemedicine, defined as patients who reported their routine follow-up visits were converted to virtual visits because of COVID-19 (coded yes/no). Covariates included patient age, ethnicity, marital status, income, cancer treatment, service disruption, and cancer diagnosis/type. Stata/SE.v.17 (StataCorp, College Station, TX) was used to perform chi-square and logistic regression analyses. P values ≤ .05 were considered statistically significant. RESULTS: The majority of the 1,097 patients with cancer were female (65.7%) and age 55 years and older (35.0%). Because of COVID-19, 12.6% of patients' routine follow-ups were converted to virtual visits. More patients who canceled/postponed surgery (17.7% v 7.5%; P ≤ .001), radiotherapy (16.9% v 5.3%; P ≤ .001), and chemotherapy (22.8% v 8.5%; P ≤ .001), injection chemotherapy (20.6% v 8.7%; P ≤ .001) and those who reported being seen less by their doctor/nurse (60.3% v 11.4%; P ≤ .001) reported more follow-up conversions to virtual visits. In multivariate analyses, patients seen less by their doctors/nurses were 14.3 times more likely to have their routine follow-ups converted to virtual visits than those who did not (odds ratio, 14.33; 95% CI, 8.36 to 24.58). CONCLUSION: COVID-19 caused many patients with cancer in Nigeria to convert visits to a virtual format. These conversions were more common in patients whose surgery, radiotherapy, chemotherapy, and injection chemotherapy treatments were canceled or postponed. Our findings suggest how COVID-19 affects cancer treatment services and the importance of collecting teleoncological care data in Nigeria.

Breast Cancer Research to Support Evidence-Based Medicine in Nigeria: A Review of the Literature.

PURPOSE: Breast cancer is the most common malignancy in women worldwide. In Nigeria, it accounts for 22.7% of all new cancer cases among women. Evidence-based medicine (EBM) entails using the results from healthcare research to enhance the clinical decision-making process and develop evidence-based treatment guidelines. Level 1 and 2 studies, such as randomized controlled trials, meta-analyses, and systematic reviews of randomized controlled trials, yield more robust types of evidence. This study reviewed the levels of evidence of breast cancer publications in Nigeria. METHODS: We conducted an electronic literature search of all studies published on breast cancer in Nigeria from January 1961 to August 2019. We reviewed all the articles found under the search term "Breast Cancer in Nigeria" on medical databases. RESULTS: Our search identified 2,242 publications. One thousand two hundred fifty duplicates were removed, and 520 were excluded. A total of 472 articles were considered eligible for this review. Most of these articles were case series or reports (30.7%), qualitative studies (15.7%), followed by cross-sectional studies (13.3%), laboratory studies (12.9%), case-control studies (6.1%), case reports (7%), and cohort (5.7%). CONCLUSION: Breast cancer research in Nigeria is yet to produce much evidence of the types considered to best support EBM. The scarcity of data hampers the implementation of EBM in Nigeria. Currently, most treatment guidelines are adapted from those developed in other countries, despite genetic differences among populations and different environmental influencing factors.

Cancer Clinical Trials in Africa-An Untapped Opportunity: Recommendations From AORTIC 2019 Conference Special Interest Group in Clinical Trials.

Cancer is now a formidable health care burden in sub-Saharan Africa (SSA) due to lifestyle westernization and longer life expectancy. The exponential increase in cancer incidence coupled with high mortality rate is not comparable with that seen in westernized countries. To address global cancer disparity, globalization of cancer clinical trials to involve sub-Saharan Africa can serve as a platform where innovative targeted therapies can be made available to patients in the environ. In the 2019 African Organization for Research and Training in Cancer (AORTIC) conference held at Maputo, Mozambique, a group of clinical trialists spanning across multiple continents highlighted the opportunities in Africa for the conduct of cancer clinical trials. The secondary purpose of the meeting was to address the belief that Africa was incapable of conducting interventional cancer trials but showed the in-continent strengths, such as available capacities, trained local clinical trialists with clinical trial experiences, clinical trial consortia, local capabilities, mapping out logistics, ethical consideration, political will, real-time benefits of clinical trials to clinical practice, and future directions for trials.

Emerging Use of Public-Private Partnerships in Public Radiotherapy Facilities in Nigeria.

PURPOSE: Radiotherapy (RT) treatment at public hospitals in Nigeria is often interrupted by prolonged periods of machine breakdown because of insufficient funds for maintenance and repair. These delays have prompted the uptake of public-private partnerships (PPPs) to acquire and maintain RT equipment. This study aimed to understand Nigeria's current RT capacity and the impact of PPPs on RT availability and cost. METHODS: Eleven radiation oncologists, each representing one of the 11 RT centers in Nigeria (eight public and three private), were invited to complete a survey on the type, status, acquisition, and maintenance plan of existing RT equipment, cost incurred by patients for external-beam radiation (EBRT) and brachytherapy treatment, and number of patients treated per year on each machine. Type and status of equipment at nonresponding facilities were obtained through literature review and confirmed with the facility. RESULTS: A total of eight (81%) respondents completed the survey, all representing public centers, three of which reported PPP use. They reported 11 megavoltage units in total (seven linear accelerators [LINACs] and four Cobalt-60s) and 10 brachytherapy afterloaders. Of those, 57% (4/7) of the LINACs, 100% (4/4) of the Cobalt-60s, and 63% (7/11) of the afterloaders were in clinical use. All commissioned equipment supported by PPPs (three LINACs and one afterloader) were in operation. The public EBRT equipment were nonfunctional 35% of the year (resulting in 60% fewer patients treated per year). The PPP EBRT and afterloaders did not experience any periods of breakdown, but PPP costs were 338% higher than public equipment. CONCLUSION: This study characterizes the use of PPP as a more reliable method of RT delivery in Nigeria, albeit at higher costs.

ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol.

Human epidermal growth factor receptor 2 (HER2) subtype of breast cancer is aggressive, leading to a poor outcome. Targeted therapy with trastuzumab has been shown to be effective in the treatment of HER2-positive breast cancer. Cardiotoxicity is a specific adverse effect associated with trastuzumab. The initial formulation of trastuzumab was intravenous, but presently, a subcutaneous formulation (Herceptin SC) is available. Insufficient data on the response rate and cardiotoxic effects of trastuzumab among indigenous Black populations exist. In all studies evaluating the efficacy and toxicity of trastuzumab alone or in combination with chemotherapy, indigenous Black populations in Africa were not included, yet they are the ones most likely to benefit from highly effective cancer medicines. This is partly due to poor oncology clinical trial infrastructure in sub-Saharan Africa. The ARETTA study protocol (ClinicalTrials.gov identifier: NCT03879577) is a phase II multicenter feasibility study to evaluate the efficacy and toxicity of docetaxel given every 3 weeks for 4 cycles plus trastuzumab in 60 previously untreated women with nonmetastatic breast cancer. The primary endpoint is to assess the proportion of patients with complete pathologic response. Secondary endpoints include the number of patients who require dose delays in docetaxel and trastuzumab attributed to hematologic, GI, and cardiac toxicity. Pharmacokinetic profiles of subcutaneous trastuzumab will also be determined. The ARETTA study will provide important information on the clinical response and cardiac safety of subcutaneous trastuzumab in combination with docetaxel among indigenous African women with nonmetastatic breast cancer. It can also be used as a blueprint for conducting biomarker-driven oncology clinical trials in low-resource settings such as sub-Saharan Africa.

Infrastructural Challenges Lead to Delay of Curative Radiotherapy in Nigeria.

PURPOSE: In low- and middle-income countries, there has been an exponential increase in cancer incidence. According to the International Atomic Energy Agency, the biggest gap in radiotherapy availability and need is in Nigeria, where each machine serves an estimated 25.7 million people. This study aimed to characterize the barriers to radiotherapy and to identify areas for intervention. METHODS: This was a cross-sectional study conducted at the University College Hospital in Ibadan, Nigeria, from June 2017 to August 2017. Demographic, sociocultural, and infrastructural factors relating to radiotherapy were collected through a questionnaire (N = 186). Ordinal logistic regression was used to identify the factors leading to delays in referral and delays in treatment initiation. RESULTS: Patients traveled from 20 of Nigeria's 36 states. The median age was 50 years (range, 19-79 years). The most common cancers treated were breast (37.5%), cervical (16.3%), head and neck (11.9%), and prostate (10.9%). In ordinal logistic regression, sociocultural factors, including the inability to pay (odds ratio [OR], 1.99; P = .034), a bad hospital experience (OR, 7.05; P = .001), and travel time (OR, 1.36; P = .001), increased the odds of referral delay to radiotherapy. In contrast, there was no significant relationship between time to treatment initiation and sociocultural factors including age, education, and inability to pay. Infrastructural barriers, including machine breakdown (OR, 2.92; P = .001), worker strikes (OR, 2.64; P = .001), and power outages (OR, 2.81; P = .022), increased the odds of treatment delay. CONCLUSION: Although delays caused by patient factors are reported extensively, patients overcame these barriers in the hopes of curative treatment. However, staff and equipment malfunctions prevented patients from receiving timely radiotherapy. Policies aimed at addressing machine maintenance, health care worker satisfaction, and the aging power grid in Nigeria must be implemented in the future to strengthen the health care system to care for patients with cancer.

Formal Assessment of Teamwork Among Cancer Health Care Professionals in Three Large Tertiary Centers in Nigeria.

PURPOSE: There are strategies to bring quality cancer care to underserved patients, but poor use of the principles of teamwork is a major barrier to achieving quality services. The intent of this study was to assess teamwork as perceived by health care workers caring for patients with cancer. METHODS: We conducted a survey among health care professionals in cancer care at 3 tertiary centers in southwestern Nigeria from July to November 2016. Respondents rated teamwork using the Safety Attitudes Questionnaire; we focused on the teamwork climate subscale comparing health care providers and institutions using analysis of variance and on collaboration using logistic regression. RESULTS: Three hundred seventy-three professionals completed the survey: 177 physicians (47%), 51 nurses (14%), 21 pharmacists (6%), 31 laboratory technicians (8%), and 88 others (24%); 5 (1%) participants had missing professional information. The average teamwork climate score across all professionals in the study was 70.5 (SD = 24.2). Pharmacists rated the teamwork climate the lowest, with a mean score of 63.9 (SD = 29.5); nurses and laboratory technicians rated teamwork higher, with means of 74.5 (SD = 21.7) and 74.2 (SD = 27.1), respectively; and physicians rated teamwork 66.0 (SD = 23.6). Collaboration with other health care providers was reported as poorer by physicians compared with nurses and pharmacists. CONCLUSION: Although overall teamwork scores were consistent with ambulatory studies in the United States, important subgroup variations provide targets for intervention. Physicians rated collaboration as poor both intra- and interprofessionally. Pharmacists rated interprofessional teamwork with nurses as poor. Efforts to transform cancer care must focus on building trust among the key stakeholders. This is critical in low-resource settings, which must maximize the use of limited resources to improve patient outcomes.

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer.

Purpose Abiraterone acetate (AA) is a standard of care for metastatic castration-resistant prostate cancer (CRPC). Despite a large food effect, AA was administered under fasting conditions in its pivotal trials. We sought to test the hypothesis that low-dose AA (LOW; 250 mg with a low-fat meal) would have comparable activity to standard AA (STD; 1,000 mg fasting) in patients with CRPC. Patients and Methods Patients (n = 72) with progressive CRPC from seven institutions in the United States and Singapore were randomly assigned to STD or LOW. Both arms received prednisone 5 mg twice daily. Prostate-specific antigen (PSA) was assessed monthly, and testosterone/dehydroepiandrosterone sulfate were assessed every 12 weeks with disease burden radiographic assessments. Plasma was collected for drug concentrations. Log change in PSA, as a pharmacodynamic biomarker for efficacy, was the primary end point, using a noninferiority design. Progression-free survival (PFS), PSA response (≥ 50% reduction), change in androgen levels, and pharmacokinetics were secondary end points. Results Thirty-six patients were accrued to both arms. At 12 weeks, there was a greater effect on PSA in the LOW arm (mean log change, -1.59) compared with STD (-1.19), and noninferiority of LOW was established according to predefined criteria. The PSA response rate was 58% in LOW and 50% in STD, and the median PFS was approximately 9 months in both groups. Androgen levels decreased similarly in both arms. Although there was no difference in PSA response or PFS, abiraterone concentrations were higher in STD. Conclusion Low-dose AA (with low-fat breakfast) is noninferior to standard dosing with respect to PSA metrics. Given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers, and patients. Additional studies are indicated to assess the long-term efficacy of this approach.

Referral Patterns and Clinical Outcomes for Transplant-Eligible Lymphoma and Myeloma Patients Evaluated at an Urban County Hospital.

Disparities in clinical care have been described for patients with limited insurance coverage or social support. We hypothesized that patients with relapsed Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), or multiple myeloma (MM) treated at an urban county hospital serving indigent and under-insured patients would face barriers for referral to a private academic transplant center for autologous stem cell transplantation (ASCT). Charts of patients with HL, NHL, or MM treated at Grady Memorial Hospital between 2007 and 2013 were reviewed, and 215 patients with diagnosis of HD (n=40), NHL (n=96), and MM (n=79). 55 patients were referred for ASCT consults and 160 patients were not referred. Reasons for transplant non-referral included established clinical criteria (64% of cases), poor performance status (13%), refusal (4%), moved/lost-to-follow-up (4%), medical non-compliance (3%), death (3%), or referral to another hospital (1%). Non-referral based upon socio-economic criteria included: lack of legal immigration status/insurance (2%), and lack of social support/substance abuse (2%). Among the 55 referred patients, 27 patients (49%) underwent ASCT. Median follow-up for all referred patients from the time of diagnosis was 3.9 [0.7-22.7] years. 5-year survival from the date of diagnosis for patients who received ASCT was 80.2% versus 65.7% for non-transplanted patients (log-rank test, p-value=0.11). While the referral process did not demonstrate significant barriers based upon insurance or social status, further evaluation is needed to identify modifiable factors that can improve referral and assess the impact of the Affordable Care Act on access to ASCT.