Meeting
2016 ASCO Annual Meeting
Characteristics and anticancer interventions (ACIs) in African American (AA) and Caucasian (CAU) patients (pts) treated with sipuleucel-T (sip-T): Real-world experience from the PROCEED registry.
Authors
Andrew J. Armstrong
Duke University Medical Center, Duke Cancer Institute Divisions of Medical Oncology and Urology, Duke University, Durham, NC
Andrew J. Armstrong , Celestia S. Higano , Matthew R. Cooperberg , Chiledum Ahaghotu , Ronald F. Tutrone , Laurence H. Belkoff , Carl A. Olsson , Sanjay Goel , Robert Claude Tyler , Nancy N. Chang , Jennifer Susan LIll , A. Oliver Sartor
Organizations
Duke University Medical Center, Duke Cancer Institute Divisions of Medical Oncology and Urology, Duke University, Durham, NC, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA, University of California, San Francisco, San Francisco, CA, Howard University Hospital, Washington, DC, Chesapeake Urology Research Associates, Baltimore, MD, Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, Integrated Medical Professionals, Icahn School of Medicine at Mount Sinai, New York, NY, Montefiore Einstein Center for Cancer Care, Bronx, NY, Dendreon Pharmaceuticals, Inc., Seattle, WA, Tulane University School of Medicine, New Orleans, LA
Research Funding
Pharmaceutical/Biotech Company
Background: AA men have higher prostate cancer (PC) incidence and mortality than CAU men, potentially related to biologic or socioeconomic factors. A retrospective subgroup analysis suggested greater overall survival (OS) benefit in AA metastatic castration-resistant PC (mCRPC) pts treated with sip-T compared with the overall population (McLeod et al, AUA 2012, abstract 953). Data on AA and CAU pts from PROCEED (NCT01306890), a phase 4 registry of mCRPC pts receiving sip-T, may further delineate treatment benefit for AA men. Methods: Men age ≥18 y with mCRPC treated with sip-T were enrolled in PROCEED. Baseline pt characteristics, treatment history, safety, OS, ACIs, and time to ACIs (tACI) were recorded. Results: 902 pts received ≥1 sip-T infusion, including 231 (11.7%) AA men. Primary Gleason score 5 was more common in CAU pts (p<0.05). In AAs, median baseline prostate-specific antigen (PSA) was higher (p<0.001), and PSA doubling time (PSADT; p<0.01) was shorter (Table). Other baseline pt characteristics were similar between groups. A trend toward lower percentage of AAs receiving radical prostatectomy before sip-T (p=0.06) was observed. Post–sip-T, both groups had similar time to first (CAU 7.3 vs AA 6.9 mo) and second (CAU 28.7 vs AA 27.1 mo) ACI. Over 30% of pts had not received an ACI 12 mo after sip-T (CAU 32.3% vs AA 31.9%). Conclusions: Despite higher baseline PSA in AA pts, which may predict less clinical benefit post–sip-T, CAU and AA pts had similar tACI after sip-T. Additional follow-up will assess potential OS differences in AA and CAU pts. Clinical trial information: NCT01306890
| Characteristic, n (%) | CAU (n=1,711 or as noted) | AA (n=231 or as noted) |
|---|---|---|
| Gleason sum | - | - |
| 7 | 516 (30.2) | 67 (29.0) |
| ≥8 | 875 (51.1) | 106 (45.9) |
| Primary Gleason score 5 | n=1478 | n=184 |
| 208 (14.1)* | 17 (9.2)* | |
| Positive lymph nodes | 538 (31.4) | 78 (33.8) |
| Bone metastasis | n=1430 | n=191 |
| 1-10 | 997 (69.7) | 136 (71.2) |
| >10 | 248 (17.3) | 29(15.2) |
| ECOG PS | - | - |
| 0 | 1130 (66.0) | 141 (61.0) |
| 1 | 501 (29.3) | 80 (34.6) |
| Alkaline phosphatasea, U/L | 81 | 87 |
| Lactate dehydrogenasea, U/L | 185 | 192 |
| Time from diagnosisa, mo | 59.4 | 72.0 |
| PSAa, ng/mL | 13.9† | 33.2† |
| PSADTa, mo | 8.36** | 8.01** |
aMedian. *p=0.03; †p<0.001; **p=0.007 for CAU vs AA.
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Abstract Details
Session Type
Poster Session
Session Title
Genitourinary (Prostate) Cancer
Track
Genitourinary Cancer—Prostate, Testicular, and Penile
Sub Track
Prostate Cancer - Advanced Disease
Clinical Trial Registration Number
NCT01306890
Citation
J Clin Oncol 34, 2016 (suppl; abstr 5025)
DOI
10.1200/JCO.2016.34.15_suppl.5025
Abstract #
5025
Poster Bd #
282
Abstract Disclosures
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