Disparities in Castration-Resistant Prostate Cancer Trials

Spratt, Daniel E.; Osborne, Joseph R.

doi:10.1200/jco.2014.58.1751

Cited by 46 publications

(44 citation statements)

References 16 publications

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“…Reasons behind the larger representation of African Americans in the current study are unknown, given historically African Americans have been under-represented in clinical trials [8,27]. One contributing factor may be the time frame of the PROCEED registry (first subject first visit 27 January 2011 and last subject last visit 17 January 2017), a period of significant change in advanced prostate cancer treatment.…”

Section: Discussionmentioning

confidence: 98%

Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

Sartor

Armstrong

Ahaghotu³

et al. 2020

Prostate Cancer Prostatic Dis

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Purpose African Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T. Patients and methods OS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies. Results Median follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37-0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48-0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races. Conclusion In this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.

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Section: Discussionmentioning

confidence: 98%

Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

Sartor

Armstrong

Ahaghotu³

et al. 2020

Prostate Cancer Prostatic Dis

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“…Still, TCGA can be commended for their enrollment of racial minorities that has been far more successful than many clinical trial efforts. 5 …”

Section: Discussionmentioning

confidence: 99%

Racial/Ethnic Disparities in Genomic Sequencing

et al. 2016

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Importance Although poorly understood, there is heterogeneity in the molecular biology of cancer across race and ethnicities. The representation of racial minorities in large genomic sequencing efforts is unclear, and could have an impact on health care disparities. Objective To determine the racial distribution among samples sequenced within The Cancer Genome Atlas (TCGA) and the deficit of samples needed to detect moderately common mutational frequencies in racial minorities. Design, Setting, and Participants This was a retrospective review of individual patient data from TCGA data portal accessed in July 2015. TCGA comprises samples from a wide array of institutions primarily across the United States. Samples from 10 of the 31 currently available tumor types were analyzed, comprising 5729 samples from the approximately 11 000 available. Main Outcomes and Measures Using the estimated median somatic mutational frequency, the samples needed beyond TCGA to detect a 10% and 5% mutational frequency over the background somatic mutation frequency were calculated for each tumor type by racial ethnicity. Results Of the 5729 samples, 77% (n = 4389) were white, 12% (n = 660) were black, 3% (n = 173) were Asian, 3% (n = 149) were Hispanic, and less than 0.5% combined were from patients of Native Hawaiian, Pacific Islander, Alaskan Native, or American Indian decent. This overrepresents white patients compared with the US population and underrepresents primarily Asian and Hispanic patients. With a somatic mutational frequency of 0.7 (prostate cancer) to 9.9 (lung squamous cell cancer), all tumor types from white patients contained enough samples to detect a 10% mutational frequency. This is in contrast to all other racial ethnicities, for which group-specific mutations with 10% frequency would be detectable only for black patients with breast cancer. Group-specific mutations with 5% frequency would be undetectable in any racial minority, but detectable in white patients for all cancer types except lung (adenocarcinoma and squamous cell carcinoma) and colon cancer. Conclusions and Relevance It is probable, but poorly understood, that ethnic diversity is related to the pathogenesis of cancer, and may have an impact on the generalizability of findings from TCGA to racial minorities. Despite the important benefits that continue to be gained from genomic sequencing, dedicated efforts are needed to avoid widening the already pervasive gap in health care disparities.

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“…However, our study population was 25% non-white compared to 10% in similar matching studies and was able to reach a higher proportion of minority populations [ 22 ]. Spratt and colleagues reported that African American men comprise about 3.3% of phase III randomized clinical trials in prostate cancer [ 23 ]. Our study found that 5.1% of participants who used the matching tool when the Google AdWords campaign was live identified as African American.…”

Section: Discussionmentioning

confidence: 99%

“…When implemented at scale and over a longer duration, such interventions may help to better balance demographic representation among trial participants. While prostate cancer clinical trials continue to underrepresent racial/ethnic minorities [ 23 ], these findings suggest that underrepresented minorities are actively seeking online health information. Therefore, this study serves as an important rationale for future investigators to develop novel Internet-based interventions to deliver health information to a diverse population of men with prostate cancer.…”

Section: Discussionmentioning

confidence: 99%

A bilingual, Internet-based, targeted advertising campaign for prostate cancer clinical trials: Assessing the feasibility, acceptability, and efficacy of a novel recruitment strategy

Kaplan

Siegel

Leykin

et al. 2018

Contemporary Clinical Trials Communications

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BackgroundTo address limitations in recruitment and enrollment of diverse, low-literacy patients into prostate cancer clinical trials, we evaluated the feasibility, acceptability, and efficacy of an English and Spanish, Internet-based, multilevel recruitment intervention.MethodsIntervention components included (1) a low-literacy, bilingual, automated, Internet-based clinical trial matching tool; (2) a bilingual nurse who assisted individuals with questions and enrollment; and (3) a targeted, Internet-based advertising campaign. We evaluated (a) completion of matching tool, (b) expression of interest in a clinical trial, (c) number of patients who matched to clinical trials at a single institution, (d) discussion of risks and benefits of clinical trials (via follow-up interviews), and (e) effect of the advertising on completing the matching tool. Feasibility, acceptability, and preliminary estimates of efficacy were measured through user engagement with the matching tool and subsequent qualitative interviews with these same users.ResultsDuring the 28-week study period, 523 users provided demographic information, 263 were identified with prostate cancer, 192 (73%) matched to at least one clinical trial, and 29 (15.1%) of those who matched provided contact information. During the study period, 17 prostate cancer clinical trials were available for matching. We completed follow-up interviews with 14 of the 29 men who provided contact information. Of the 14, 85.7% discussed the risks and benefits of clinical trials with their physician, and 35.7% enrolled in a clinical trial. The Internet-based advertising campaign resulted in an increased number of matching tool completions.ConclusionsOur study demonstrates that an Internet-based clinical trial matching tool that is advertised using a targeted Internet-based campaign can provide an effective means to reach diverse, low-literacy patients. When implemented at scale and over a longer duration, such interventions may help increase trial participation among underrepresented populations.

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Disparities in Castration-Resistant Prostate Cancer Trials

Cited by 46 publications

References 16 publications

Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

Racial/Ethnic Disparities in Genomic Sequencing

A bilingual, Internet-based, targeted advertising campaign for prostate cancer clinical trials: Assessing the feasibility, acceptability, and efficacy of a novel recruitment strategy

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