Precision oncology is revolutionizing cancer care, allowing for personalized treatments to improve outcomes. Cancer research has benefitted from well-designed studies incorporating precision medicine ...objectives, but it is unclear if these studies are representative of the diverse cancer population.
To evaluate racial and ethnic representation in breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives in the Clinicaltrials.gov registry and compare with the incidence of these cancer types in racial and ethnic minority groups in the US population.
This cross-sectional study identified US-based breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives for reporting of race and ethnicity. The Surveillance, Epidemiology, and End Results and US Census databases were used to determine cancer incidence by race and ethnicity, linked with cancer type and median year of enrollment for each trial. Data were collected and analyzed between December 2020 and April 2021.
The expected number of participants per study by each racial and ethnic group was calculated based on the corresponding US-based proportion. Under- and overrepresentation was defined as the ratio of the actual number of enrolled cases to the expected number of cases for each trial by cancer type. Ratios above 1 indicated overrepresentation while a ratio below 1 indicated underrepresentation. Random-effects meta-analysis of representation ratios of individual trials was performed to weigh each individual study.
Of 93 studies encompassing 5867 enrollees with race and ethnicity data; 4826 participants (82.3%) were non-Hispanic White, 587 (10.0%) were Black, and 238 (4.1%) were Asian. Per observed-to-expected ratios, White participants were overrepresented in all studies, with a ratio of 1.35 (95% CI, 1.30-1.37), as well as Asian participants, with a ratio of 1.46 (95% CI, 1.28-1.66), while Black participants (ratio, 0.49; 95% CI, 0.45-0.54), Hispanic participants (ratio, 0.24; 95% CI, 0.20-0.28), and American Indian and Alaskan Native participants (ratio, 0.43; 95% CI, 0.24-0.78) were underrepresented. By individual cancer site, White participants were consistently overrepresented in all studies, while Black and Hispanic participants were underrepresented.
This analysis found that precision oncology studies for breast, lung, prostate, and colorectal cancers vastly underrepresent racial and ethnic minority populations relative to their cancer incidence in the US population. It is imperative to increase diversity among enrollees so that all individuals may benefit from cancer research breakthroughs and personalized treatments.
Biorepositories enable precision oncology research by sharing clinically annotated genomic data, but it remains unknown whether these data registries reflect the true distribution of cancers in ...racial and ethnic minorities. Our analysis of Project Genomics Evidence Neoplasia Information Exchange (GENIE), a real-world cancer data registry designed to accelerate precision oncology discovery, indicates that minorities do not have sufficient representation, which may impact the validity of studies directly comparing mutational profiles between racial/ethnic groups and limit generalizability of biomarker discoveries to all populations.
Abstract
Background
Gender disparities in academic medicine are a long-acknowledged concern, particularly at medical conferences. We investigated gender representation and prevalence of “manels” ...(all-men panels) among invited speakers at the 2018-2021 American Society of Clinical Oncology Annual Meetings.
Methods
Using American Society of Clinical Oncology online programs, 2018-2021 faculty information was obtained, including perceived or self-reported gender, medical specialty, session type, and topic. Primary outcomes were percentage of manels and proportion of women panelists over time; women representation among specialties and topics were evaluated. Cochran-Armitage and Fisher’s exact tests were used to analyze trends in proportion of manels and women representation over time and to compare each session type, topic, or specialty with other categories combined, respectively.
Results
During 2018-2021, there were 670 sessions, 81 of which (12.1%) were manels. Among 2475 panelists, 1181 (47.7%) were women. Over time, the percentage of manels significantly decreased from 17.4% in 2018 to 9.9% in 2021 (P = .030). The highest proportion of manels was observed for leadership or special sessions (17.1%, P = .419). Women panelists were underrepresented for the topics of genitourinary cancers (38.6%, P = .029) and translational or preclinical sciences (36.7%, P < .001). There was a positive trend toward improved women representation among translational or preclinical sciences (27.4% in 2018 vs 41.8% in 2021, P = .031) but not among genitourinary cancers (41.1% in 2018 vs 40.7% in 2021, P = .969).
Conclusions
The number of women panelists increased during the study period, with a corresponding decrease in the proportion of manels, specifically in education and leadership or special sessions. Ongoing underrepresentation of women in genitourinary cancers and translational or preclinical topics underscores the importance of annual meeting organizers continuing to strive for diverse gender representation.
The 2012 US Preventive Services Task Force (USPSTF) Grade D recommendation against prostate-specific antigen (PSA) screening for all men has been controversial, with data documenting a shift to a ...higher stage of disease at diagnosis. The association between the Grade D recommendation and prostate cancer-specific mortality (PCSM) among contemporary cohorts, however, is unclear.
To evaluate PCSM rates between 1999 and 2019, comparing trends in rates before and after the change in the 2012 USPSTF screening guideline to assess its association with PCSM.
The 2012 USPSTF Grade D recommendation against PSA screening for all men.
This cross-sectional study used Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research maintained by the National Center for Health Statistics to collect data on cause of death for all individuals who died of prostate cancer in the US from 1999 to 2019. Analysis was performed from January to August 2021.
Trends in PCSM rates were calculated from 1999 to 2012 and from 2014 to 2019, with a washout year of 2013, using linear regression, with year and binary indicator of pre-2013 and post-2013 status as interaction terms. Trends were further analyzed by age, race and ethnicity, urbanization category, and US Census region. Other measures included diagnosis of localized or metastatic prostate cancer and overall cancer mortality.
A total of 618 095 patients died of prostate cancer in the US from 1999 to 2019. Age-adjusted PCSM decreased linearly at a rate of -0.273 per 100 000 population per year from 1999 to 2012 and stalled at a rate of -0.009 per 100 000 per year from 2014 to 2019 (P < .001). This finding was significant among men aged 60 years or older, especially among men aged 60 to 69 years, men aged 80 years or older, and among Black men. Men aged 60 to 64 years had a decreasing, age-adjusted PCSM rate of -0.0088 per 100 000 population per year prior to 2013 followed by an increasing rate of 0.0014 per 100 000 per year. Men aged 65 to 69 years had a decreasing, age-adjusted PCSM rate of -0.024 per 100 000 population per year prior to 2013 followed by an increasing rate of 0.0011 per 100 000 population per year. Men aged 80 years or older had the largest absolute difference between rates before and after 2013 compared with all other age groups, with a difference of 0.06 for men aged 80 to 84 years and 0.07 for men 85 aged years or older. Black men had a decreasing, age-adjusted PCSM rate of -0.700 per 100 000 population per year prior to 2013 followed by a flattened rate of -0.091 per 100 000 population per year. Changes were observed across races and ethnicities, urbanization categories, and US Census regions and were accompanied by increased diagnoses of metastatic disease, which are inconsistent with mortality trends across all malignant neoplasms.
This cross-sectional study using comprehensive PCSM data through 2019 demonstrated decreasing PCSM rates that flattened or increased after the 2012 USPSTF Grade D recommendation, suggesting that decreased PSA screening may be a factor associated with this change. This change was seen across ages, races and ethnicities, urbanization categories, and US Census regions. The updated 2018 USPSTF guideline supporting shared decision-making may reverse these trends in the coming years.
Abstract only
3014
Background: Precision medicine has revolutionized oncologic care in the United States (US) in the past two decades. While the US cancer population is rapidly diversifying, ...enrollment of a diverse patient population into clinical trials lags behind. In particular, it is unclear whether minority patients are adequately represented in precision oncology trials. Herein, we report racial/ethnic representation in precision oncology studies spanning four common cancer types (breast, lung, prostate, colorectal cancers). Methods: Completed US clinical studies incorporating precision medicine objectives based on a set of 12 precision oncology search terms (including tumor biomarker, whole exome sequencing, tumor mutation testing, gene expression signatures, tumor microarray, tumor genomics, et cetera) were identified from Clinicaltrials.gov. Studies were reviewed for reporting race/ethnicity for inclusion in the analysis. The Surveillance, Epidemiology, and End Results (SEER) database was used to determine incidence of race/ethnicity in the US cancer population, correlated with disease site and median year of enrollment for each trial. The difference in incidence (D-I) was defined as the median absolute difference in study racial enrollment and SEER incidence, with a negative value corresponding to underrepresentation. Wilcoxon signed-rank test was used to compare median D-I to a value of 0 by racial/ethnic subgroups. Results: Overall, 156 studies were identified; 40.3 and 27.5% studies enrolling from 2000 through 2020 met the inclusion criteria for racial and ethnic subgroups reporting, respectively. Of 4,418 total enrollees, 82.5% were White, 10.5% Black, 3.8% Asian, and 0.4% American Indian/Alaskan Native (AIAN). Ethnically, 6.4% were Hispanic. The D-I was +2.2% for Whites (interquartile range (IQR) = -43.7% to 25.4%; P < 0.013), -0.74% AIAN (IQR = -0.8% to +5.9%; P < 0.001), -2.5% Asians (IQR = -4.1% to 30.4%; P < 0.152), -4.6% Blacks (IQR = -20.1% to +45.0%; P < 0.001), and -8.1% Hispanics (IQR = -14.8% to + 29.6%; P < 0.001). By disease site, Blacks were significantly underrepresented proportional to their cancer incidence among prostate (D-I of -11.8%, p = 0.009) and lung studies (D-I of -5.9%, p = 0.013), while prostate studies significantly overrepresented Whites (D-I +14.0%, p = 0.005). Lung studies overrepresented Asians (D-I +0.49%) consistent with the prominent role of targetable oncogene drivers in this population. Conclusions: Results demonstrate an underrepresentation of minority racial groups and an overrepresentation of Whites in precision oncology studies. Increased emphasis on equitable enrollment onto these studies is critical, as resulting precision Omic conclusions are used to stratify populations and personalize treatments. A continued lack of diversity among enrollees may further leave behind vulnerable minority populations in the era of precision oncology.
Abstract only
51
Background: The U. S. Preventative Services Task Force (USPSTF) recommendation regarding prostate-specific antigen (PSA) transitioned to a grade D recommendation against PSA ...screening for adult males in 2012. The impact of this recommendation against PSA screening on prostate cancer-specific mortality (PCSM) in contemporary cohorts is unknown. Our study evaluated PCSM between 1999-2019, comparing mortality rates before and after this change to screening guidelines. Methods: Age-adjusted PCSM rates per 100,000 men were obtained from the National Center for Health Statistics from 1999 – 2019. Trends in PCSM rates from 1999 – 2012 and 2014 – 2019 were estimated using linear regression with year and binary indicator of pre-2013/post-2013 status as interaction terms. Age-adjusted rates of PCSM were calculated for men ≥50 years and by race, ethnicity, urbanization and census region. Similarly, age-adjusted rates of overall cancer mortality (exclusive of PCSM) were calculated. Behavioral Risk Factor Surveillance System was used to establish trends in PSA screening from 2001 – 2018. North American Association of Central Cancer Registries was used to determine age-adjusted incidence of localized and metastatic PC at the time of diagnosis from 1999 – 2017. Results: The age-adjusted PCSM rate in the U.S. decreased linearly at a rate of (-)0.28 per 100,000/year from 1999 – 2012 and subsequently stalled at a rate of no change from 2014 – 2019 (p < 0.001). This effect was particularly striking for men aged 60 – 69, men > 80 years, and Black men. Men aged 60 – 64 had a decreasing rate of (-)0.009 per 100,000/year prior to 2013, followed by a rise of (+)0.001 per 100,000/year (p < 0.001). Among Black men, PCSM rate was decreasing linearly at (-)0.700/100,000/year from 1999-2012 and flattened at a rate of (-)0.091/100,000/year from 2014-2019 (p < 0.001). These changes were seen across races, urbanization and census regions (p < 0.001) and were accompanied by decreases in PSA screening (p = 0.02) together with increases in diagnosis of metastatic disease. These trends were inconsistent with mortality trends observed across all malignancies. Conclusions: Using comprehensive data on PCSM through 2019, this study illustrates decreasing PCSM over time which flattened or increased following the 2012 change in USPSTF guideline, along with a decrease in PSA screening. The change in PCSM was seen in all ages, races, ethnicities, urbanization and census regions, but particularly in men from 60 – 69 and > 80 years old, and Black men. These changes were accompanied by increased diagnosis of metastatic PC and are discordant from trends across other malignancies. These findings suggest that the change in PSA screening guideline may have contributed to the stagnancy of PCSM rates in recent years. The updated 2018 USPSTF guideline supporting shared-decision making may reverse these trends over time.
Background Reliable criteria to predict mortality after hepatectomy remain poorly defined. We sought to identify factors associated with 90-day mortality, as well as validate the “50-50” and peak ...bilirubin of >7 mg/dL prediction rules for mortality after liver resection. In addition, we propose a novel integer-based score for 90-day mortality using a large cohort of patients. Study Design Data from 2,056 patients who underwent liver resection at 2 major hepatobiliary centers between 1990 and 2011 were identified. Perioperative laboratory data, as well as surgical and postoperative details, were analyzed to identify factors associated with liver-related 90-day death. Results Indications for liver resection included colorectal metastasis (39%), hepatocellular carcinoma (19%), benign mass (17%), or noncolorectal metastasis (14%). Most patients had normal underlying liver parenchyma (71%) and resection involved ≥3 segments (36%). Overall morbidity and mortality were 19% and 2%, respectively. Only 1 patient fulfilled the 50-50 criteria; this patient survived and was discharged on day 8. Twenty patients had a peak bilirubin concentration >7 mg/dL and 5 died within 90 days; the sensitivity and specificity of the >7-mg/dL rule were 25% and 99.3%, respectively, but overall accuracy was poor (area under the curve 0.574). Factors associated with 90-day mortality included international normalized ratio (odds ratio = 11.87), bilirubin (odds ratio = 1.16), and serum creatinine (odds ratio = 1.87) on postoperative day 3, as well as grade of postoperative complications (odds ratio = 5.08; all p < 0.05). Integer values were assigned to each factor to develop a model that predicted 90-day mortality (area under the curve 0.89). A score of ≥11 points had a sensitivity and specificity of 83.3% and 98.8%, respectively. Conclusions The 50-50 and bilirubin >7-mg/dL rules were not accurate in predicting 90-day mortality. Rather, a composite integer-based risk score based on postoperative day 3 international normalized ratio, bilirubin, creatinine, and complication grade more accurately predicted 90-day mortality after hepatectomy.
Background The goal of this study was to investigate the surgical management and outcomes of patients with primary colorectal cancer (CRC) and synchronous liver metastasis (sCRLM). Study Design Using ...a multi-institutional database, we identified 1,004 patients treated for sCRLM between 1982 and 2011. Clinicopathologic and outcomes data were evaluated with uni- and multivariable analyses. Results A simultaneous CRC and liver operation was performed in 329 (33%) patients; 675 (67%) underwent a staged approach (“classic” staged approach, n = 647; liver-first strategy, n = 28). Patients managed with the liver-first approach had more hepatic lesions and were more likely to have bilateral disease than those in the other 2 groups (p < 0.05). The use of staged operative strategies increased over the time of the study from 58% to 75% (p < 0.001). Liver-directed therapy included hepatectomy (90%) or combined resection + ablation (10%). A major resection (>3 segments) was more common with a staged approach (39% vs 24%; p < 0.001). Overall, 509 patients (50%) received chemotherapy in either the preoperative (22%) or adjuvant (28%) settings, with 11% of patients having both. There were 197 patients (20%) who had a complication in the postoperative period, with no difference in morbidity between staged and simultaneous groups or major vs minor hepatectomies (p > 0.05). Ninety-day postoperative mortality was 3.0%, with no difference between simultaneous and staged approaches (p = 0.94). The overall median and 5-year survivals were 50.9 months and 44%, respectively; long-term survival was the same regardless of the operative approach (p > 0.05). Conclusions Simultaneous and staged resections for sCRLM can be performed with comparable morbidity, mortality, and long-term oncologic outcomes.
Abstract Objectives Management of liver metastasis (LM) from a non-colorectal, non-neuroendocrine primary carcinoma remains controversial. Few data exist on the management of hepatic metastasis from ...primary renal cell carcinoma (RCC). This study sought to determine the safety and efficacy of surgery for RCC LM. Methods A total of 43 patients who underwent surgery for RCC hepatic metastasis between 1994 and 2011 were identified in a multi-institution hepatobiliary database. Clinicopathologic, operative and outcome data were collected and analysed. Results Mean patient age was 62.4 years and most patients (67.4%) were male. The mean tumour size of the primary RCC was 6.9 cm and most tumours (72.1%) were designated as clear cell carcinoma. Nine patients (20.9%) presented with synchronous LM. Among the patients with metachronous disease, the median time from diagnosis of the primary RCC to treatment of LM was 17.2 months (range: 2.1–189.3 months). The mean size of the RCC LM was 4.0 cm and most patients (55.8%) had a solitary metastasis. Most patients (86.0%) underwent a minor resection (up to three segments). Final pathology showed margin status to be negative (R0) in 95.3% of patients. Postoperative morbidity was 23.3% and there was one perioperative death. A total of 69.8% of patients received perioperative chemotherapy. Overall 3-year survival was 62.1%. Three-year recurrence-free survival was 27.3% and the median length of recurrence-free survival was 15.5 months. Conclusions Resection of RCC hepatic metastasis is safe and is associated with low morbidity and near-zero mortality. Although recurrence occurs in up to 50% of patients, resection can be associated with long-term survival in a well-selected subset of patients.
PDF
