Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy

Nazha, Bassel; Mishra, Manoj K.; Pentz, Rebecca D.; Owonikoko, Taofeek K.

doi:10.1200/edbk_100021

Cited by 193 publications

(180 citation statements)

References 47 publications

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“…Despite these efforts, very little is known about CD8 + tumor-infiltrating lymphocytes in Black women with breast cancer. Black patients are underrepresented in immunotherapy trials, and their unique tumor biology is mostly unaccounted for, adding to the challenge of investigating the efficacy of immunotherapeutic agents in this population [31]. In the few studies that have examined immune infiltrates in Black women with breast cancer, sample sizes were limited [11,[24][25][26][27]32].…”

Section: Discussionmentioning

confidence: 99%

Racial differences in CD8+ T cell infiltration in breast tumors from Black and White women

et al. 2020

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Background: African American/Black women with breast cancer have poorer survival than White women, and this disparity persists even after adjusting for non-biological factors. Differences in tumor immune biology have been reported between Black and White women, and the tumor immune milieu could potentially drive racial differences in breast cancer etiology and outcome. Methods: We examined the association of CD8 + cytotoxic T cells with clinical-pathological variables in the Women's Circle of Health Study (WCHS) population of predominantly Black breast cancer patients. We evaluated 688 invasive breast tumor samples (550 Black, 138 White) using immunohistochemical staining of tissue microarray slides. CD8 + T cells were scored for each patient tumor sample with digital image analysis. Results: Black women had a significantly higher percentage of high-grade, estrogen receptor (ER)-negative, and triple-negative tumors than White women and significantly higher CD8 + T cell density (median 87.6/mm 2 vs. 53.1/ mm 2 ; p < 0.001). Within the overall population and in the population of Black women only, CD8 + T cell density was significantly higher in younger patients and patients with high-grade and ER/PR-negative tumors. No significant associations were observed between CD8 + T cell density and overall survival or breast cancer-specific survival in the overall population, or when Black patients were analyzed as a separate group. However, when stratified by subtype, Black women with triple-negative breast cancer and high CD8 + T cell density showed a trend towards better overall survival in comparison with patients with low CD8 + T cell density (HR = 0.51; 95% CI 0.25-1.04). Conclusions: Our data raise the possibility that distinct mechanisms of immune cell action may occur in different racial groups.

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Section: Discussionmentioning

confidence: 99%

Racial differences in CD8+ T cell infiltration in breast tumors from Black and White women

et al. 2020

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“…Due to the unique biology of the host and the tumors from different subpopulations, it is critical to confirm a given therapy fits all relevant patient populations in the real world. 33 One study investigated population-based differences in the outcome of metastatic NSCLC, and found that Asian population had a better adjusted OS in the stage IV lung cancer patients. 34 Intriguingly, it is also reported that adverse events between ethnicities exist, such as the tyrosine kinase inhibitors.…”

Section: Discussionmentioning

confidence: 99%

A meta-analysis comparing responses of Asian versus non-Asian cancer patients to PD-1 and PD-L1 inhibitor-based therapy

et al. 2020

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Background: Subgroup analysis of clinical trials of PD-1/PD-L1 inhibitors have reported ethnic differences in outcomes. We systematically collected published data and performed a meta-analysis to compare therapeutic efficacy in Asian and non-Asian patients receiving PD-1/PD-L1 inhibitors. Methods: Eligible studies included phase II and III prospective clinical trials with available subgroup data on Asian versus non-Asian populations. Overall survival (OS) and progression-free survival (PFS) were used to evaluate differences in outcome between Asian versus non-Asian cancer patients. Results: A total of 11,020 cancer patients from 19 prospective randomized controlled clinical trials were included. The overall estimated HR for OS was 0.69 with 95% CI of 0.61-0.77 in Asian versus 0.82 with 95% CI of 0.77-0.88 in non-Asian patients. The estimated hazard ratio (HR) for PFS measured 0.54 (95% CI, 0.32-0.76) and 0.69 (95% CI, 0.54-0.85) in Asian and non-Asian patients, respectively. Pooled ratios of OS HRs and PFS HRs reported in Asian versus non-Asian cancer patients were 0.84 (95% CI, 0.75-0.94) and 0.78 (95% CI, 0.59-0.97), respectively. Conclusions: This meta-analysis shows for the first time that Asian cancer patients have a significantly improved survival benefit than non-Asian patients receiving PD-1/PD-L1 inhibitor-based therapy.

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“…Limited data on the epidemiology of MCL within Asian populations were found, emphasizing the importance of comprehensive and contemporary registry data. It is recognized that ethnic characteristics can affect treatment efficacy and side effect profiles [81]. With the availability of promising therapies for MCL based predominantly on Western datasets, this further emphasizes the importance of additional clinical trial data within Asian populations to better inform the appropriate use of MCL treatments in this population.…”

Section: Summary Of MCL Management In Asian Patientsmentioning

confidence: 99%

Treatment of mantle cell lymphoma in Asia: a consensus paper from the Asian Lymphoma Study Group

et al. 2020

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Background: Mantle cell lymphoma (MCL) is a B cell malignancy that can be aggressive and with a poor prognosis; the clinical course is heterogeneous. The epidemiology of MCL in Asia is not well documented but appears to comprise 2-6% of all lymphoma cases based on available data, with variation observed between countries. Although international guidelines are available for the treatment of MCL, there is a lack of published data or guidance on the clinical characteristics and management of MCL in patient populations from Asia. This paper aims to review the available treatment and, where clinical gaps exist, provide expert consensus from the Asian Lymphoma Study Group (ALSG) on appropriate MCL management in Asia. Body: Management strategies for MCL are patient-and disease stage-specific and aim to achieve balance between efficacy outcomes and toxicity. For asymptomatic patients with clearly indolent disease, observation may be an appropriate strategy. For stage I/II disease, following international guidelines is appropriate, which include either a short course of conventional chemotherapy followed by consolidated radiotherapy, less aggressive chemotherapy regimens, or a combination of these approaches. For advanced disease, the approach is based on the age and fitness of the patient. For young, fit patients, the current practice for induction therapy differs across Asia, with cytarabine having an important role in this setting. Hematopoietic stem cell transplantation (HSCT) may be justified in selected patients because of the high relapse risk. In elderly patients, specific chemoimmunotherapy regimens available in each country/region are a treatment option. For maintenance therapy after first-line treatment, the choice of approach should be individualized, with cost being an important consideration within Asia. For relapsed/ refractory disease, ibrutinib should be considered as well as other follow-on compounds, if available. Conclusion: Asian patient-specific data for the treatment of MCL are lacking, and the availability of treatment options differs between country/region within Asia. Therefore, there is no clear one-size-fits-all approach and further investigation on the most appropriate sequence of treatment that should be considered for this heterogeneous disease.

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Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy

Cited by 193 publications

References 47 publications

Racial differences in CD8+ T cell infiltration in breast tumors from Black and White women

Racial differences in CD8+ T cell infiltration in breast tumors from Black and White women

A meta-analysis comparing responses of Asian versus non-Asian cancer patients to PD-1 and PD-L1 inhibitor-based therapy

Treatment of mantle cell lymphoma in Asia: a consensus paper from the Asian Lymphoma Study Group

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