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
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 Disclosures
2019 ASCO Annual Meeting
First Author: A. Oliver Sartor
2019 Genitourinary Cancers Symposium
First Author: Kelvin A. Moses
2020 Genitourinary Cancers Symposium
First Author: Rana R. McKay
2020 ASCO Virtual Scientific Program
First Author: Hala Borno