Outcomes of Black (B) versus White (W) patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without orteronel (Ort): Analysis of pt-level data from SWOG-1216 phase 3 trial.

Authors

null

Nicolas Sayegh

Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT

Nicolas Sayegh , Umang Swami , Yeonjung Jo , Georges Gebrael , Benjamin Haaland , Shilpa Gupta , Melissa Plets , Maha H. A. Hussain , David I. Quinn , Primo N Lara Jr., Ian M Thompson Jr., Neeraj Agarwal

Organizations

Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, University of Utah/Huntsman Cancer Institute, Salt Lake City, UT, Cleveland Clinic, Cleveland, OH, SWOG Statistics and Data Management Center, Seattle, WA, Northwestern University, Feinberg School of Medicine, Chicago, IL, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, University of California Davis Comprehensive Cancer Center, Sacramento, CA, UT Health San Antonio, San Antonio, TX, Huntsman Cancer Institute (NCI-CCC), University of Utah, Salt Lake City, UT

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health, Millennium Pharmaceuticals (Takeda Oncology)

Background: Despite more aggressive prostate cancer (PCa) at presentation and higher mortality in real world, B pts with metastatic hormone resistant PCa did not have inferior outcomes than W pts when both were enrolled in clinical trials (PMID: 33951180). In the phase 3 S1216 trial, treatment with Ort, a novel CYP17 axis inhibitor, significantly improved progression-free survival (PFS) but not overall survival (OS) compared to bicalutamide (Bic) in pts with mHSPC receiving ADT. This trial enrolled the greatest number of B pts in a phase 3 trial in this setting to-date. We hypothesized that given comparable access to care as experienced in a clinical trial, outcomes in B pts would be similar to those of W pts in the mHSPC setting. Methods: Eligibility: Pts with mHSPC were enrolled. Only pts self-identifying as B or W were included in this analysis. PFS and OS for each group were estimated using Kaplan-Meier method. A multivariate analysis (MVA) adjusting for disease characteristics was conducted using a Cox proportional hazards model. Results: Among 1279 participants, 135 (10.6%) were B; 1077 (84.2%) were W. B and W were equally distributed between treatment arms, and had respectively similar proportion of pts with Gleason score ≥8 (61.3 vs 62.1%), Zubrod score ≥2 (5.1 vs 3.4%) and extensive disease (48.1 vs 48.7%). However, B pts, as compared to W, were younger (65.8 vs 68.4 yrs, p=0.001) and had a higher median baseline PSA (54.7 vs 26.7 ng/mL; p<0.001). PSA responses (≤ 0.2 ng/mL) at month 7 were similar in both groups (p=0.296). Overall, B vs W had similar median PFS (2.3 vs 2.9 yrs, p=0.71) and OS (5.5 vs 6.3 yrs, p=0.65). MVA confirmed similar PFS and OS after adjusting for known prognostic factors (Table). No interaction between race and treatment was observed (P-value interaction PFS= 0.77 and OS= 0.91). Conclusions: We demonstrate that even though B pts present with more aggressive disease in mHSPC setting, they did not have statistically significant worse OS and PFS than W pts and treatment effect was also similar for both racial groups. Equitable access to care may negate historical differences in outcomes among B vs W pts with advanced PCa. Funding: NIH/NCI/NCTN grant U10CA180888, U10CA180819; and Millennium Pharmaceuticals (Takeda Oncology). Univariate and MVA of PFS and OS.

CharacteristicPFSOS
HR195% CI1p-valueHR195% CI1p-value
Race
(Univariate; W vs B)
0.960.76-1.200.710.940.71-1.240.65
Race
(W vs B)
1.120.88-1.420.41.010.75, 1.350.90
Treatment
(Ort vs Bic)
0.580.50-0.68<0.0010.870.72, 1.040.14
Extensive disease
(Yes vs No)
1.911.64- 2.23<0.0012.061.69, 2.50<0.001
Gleason (≥8 vs <8)1.241.06- 1.450.0081.180.97, 1.430.10
Log PSA1.211.16- 1.26<0.0011.141.08, 1.20<0.001

1HR = Hazard Ratio, CI = Confidence Interval

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Health Services Research and Quality Improvement

Track

Quality Care/Health Services Research

Sub Track

Access to Care

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 6532)

DOI

10.1200/JCO.2023.41.16_suppl.6532

Abstract #

6532

Poster Bd #

24

Abstract Disclosures