March 06, 2019
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Black men with advanced prostate cancer achieve longer OS with docetaxel than white counterparts

Black men treated for metastatic castration-resistant prostate cancer with docetaxel had longer OS than their white counterparts after adjustment for prognostic factors, according to a meta-analysis of clinical trial data published in Journal of Clinical Oncology.

“Several studies have reported that among patients with localized prostate cancer, black men have a shorter OS time than white men, but few data exist for men with advanced prostate cancer,” Susan Halabi, PhD, associate professor of biostatistics and bioinformatics at Duke University School of Medicine, and colleagues wrote. “The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer who were treated in phase 3 clinical trials with docetaxel plus prednisone or a docetaxel plus prednisone-containing regimen.”

Halabi and colleagues conducted a systematic literature review of phase 3 trials and pooled data on 8,820 men from nine trials that met inclusion criteria. The final analysis, which eliminated Asian men and men classified as unknown or other ethnicity, included 8,028 men. Of them, 7,528 were white (median age, 69 years, 95% performance status 0 to 1) and 500 black (median age, 68 years, 90% performance status 0 to 1).

Black men had a higher median testosterone level (28 ng/mL vs. 18 ng/dL), median PSA level (127 ng/mL vs. 85 ng/mL) and median hemoglobin level (12 g/dL vs. 13 g/dL) than white men (P < .001 for all).

OS served as the study’s primary endpoint. The researchers used a Cox proportional hazards regression model to evaluate the prognostic significance of race (black vs. white) adjusted for known risk factors common among the trials, including age, PSA, performance status, alkaline phosphatase, hemoglobin and metastatic site.
The median follow-up was 31 months, and 5,045 deaths occurred.

In general, researchers saw little variation across trials in median OS for black men.

Although median survival was similar among black and white men (21 months), the combined multivariable HR of 0.81 (95% CI, 0.72-0.91) indicates that, after adjusting for prognostic factors, black men had a statistically reduced risk for death compared with white men (P < .001).

Additionally, black men had longer median OS than white men (21 months vs. 20 months) in three trials sponsored by the National Clinical Trials Network (pooled multivariable HR = 0.76; 95% CI, 0.66-0.88). These trials enrolled a higher proportion of black men compared with industry trials (12% vs. 4%).

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Among the 4,172 men assigned docetaxel and prednisone alone, black men had a median OS of 22 months vs. 21 months for white men (pooled multivariable HR = 0.79; 95% CI, 0.67-0.93).

Study limitations include the fact that the population analyzed was highly selected, and not all prognostic factors among trials were available,

“This large meta-analysis provides evidence that black men with metastatic castration-resistant prostate cancer treated with docetaxel plus prednisone in clinical trials had improved survival outcomes compared with white men when adjusted for baseline prognostic factors,” the researchers wrote. “Our understanding of these differences is limited and underscores the need for additional research.” – by Jennifer Byrne

Disclosures: Halabi reports consultant/advisory roles with Eisai and Ferring Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.