Meeting
2018 ASCO Annual Meeting
Sipuleucel-T (sip-T) overall survival (OS) and clinical outcomes by baseline (BL) prostate-specific antigen (PSA) quartiles in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): PROCEED registry.
Authors
A. Oliver Sartor
Tulane Medical School, New Orleans, LA
A. Oliver Sartor , Celestia S. Higano , Matthew R. Cooperberg , Nicholas J. Vogelzang , Shaker R. Dakhil , Christopher Michael Pieczonka , Jeff Vacirca , Raoul S Concepcion , Ronald F Tutrone , Luke T. Nordquist , Carl A Olsson , David F. Penson , Ian Schnadig , James L. Bailen , Bryan Mehlhaff , Nancy N. Chang , Nadeem Anwar Sheikh , Bruce Brown , Andrew J. Armstrong
Organizations
Tulane Medical School, New Orleans, LA, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, University of California, San Francisco, San Francisco, CA, Comprehensive Cancer Centers of Nevada, Las Vegas, NV, Wichita NCORP, Wichita, KS, Associated Medical Professionals of New York, PLLC, Syracuse, NY, New York Cancer and Blood Specialists, New York, NY, Urology Associates P.C, Nashville, TN, Chesapeake Urology, Towson, MD, Urology Cancer Center and GU Research Network, Omaha, NE, Integrated Medical Professionals, PLLC, Columbia University Medical Center, North Hills, NY, Vanderbilt University Medical Center, Nashville, TN, Compass Oncology, US Oncology Research, Tualatin, OR, First Urology Research, Louisville, KY, Oregon Urology Institute, Springfield, OR, Dendreon Pharmaceuticals LLC, Seattle, WA, Dendreon Pharmaceuticals, LLC, Seattle, WA, Dendreon Pharmaceuticals LLC, Seattle, WA, US, Duke Cancer Institute, Duke University, Durham, NC
Research Funding
Pharmaceutical/Biotech Company
Background: Sip-T is an autologous cellular immunotherapy for asymptomatic/minimally symptomatic mCRPC. IMPACT analyses suggested that OS was longer in treated and control pts with low baseline PSA, and OS benefit was greatest for sip-T vs control in the pts with the lowest PSA (Schellhammer Urol 2013). We analyzed the prognostic value of BL PSA in PROCEED (NCT01306890), a phase 4 registry study in mCRPC pts. Methods: Eligible mCRPC pts were scheduled to receive 3 sip-T infusions at ~2-weekly intervals. Objectives included cerebrovascular event risk (primary) and OS (secondary). Follow-up was every 3 months after sip-T for 3 years minimum or until death or withdrawal. This is a post-hoc analysis (see Table for tests) of outcomes by PSA quartile. Results: 1976 pts were enrolled between 2011–2017: median age 72 yrs; 87% Caucasians, 12% African Americans; 51% had a Gleason score ≥8; prior therapies 78% (local) & 99% (hormonal). 1255 pts died. Median (range) BL PSA was 15 (0–7497) ng/mL. All outcomes in Table were significantly worse in the 2nd, 3rd& 4th PSA quartiles vs the 1st (lowest PSA) quartile. Clinical trial information: NCT01306890 Conclusions: OS & time to first ACI are longer in sip-T treated pts in the lowest BL PSA quartile vs sip-T treated pts with higher PSA. Survival of nearly 5 years was seen in the lowest PSA quartile. Although PROCEED did not have a comparator arm, the trend for longer OS is concordant with that seen in IMPACT.
| BL PSA ng/mL | ||||
|---|---|---|---|---|
| ≤5.27 N = 472 | > 5.27–≤15.08 N = 471 | > 15.08–≤46 N = 472 | >46 N = 471 | |
| Median time to event (months; 95% CI)a | ||||
| Hazard ratio (95% confidence interval) vs 1st quartile† | ||||
| OS | 48 (44–51) | 33 (31–36) 1.6 (1.3–1.9)† | 27 (24–30) 2.0 (1.7–2.4)† | 18 (16–21) 3.0 (2.6–3.6)† |
| Time to 1st ACI | 10 (9–12) | 8 (7–9) 1.4 (1.2–1.6)† | 7 (6–8) 1.5 (1.3–1.8)† | 6 (6–7) 1.7 (1.5–2.0)† |
| Time to death due to disease progressionb | 57 (49–not estimable) | 37 (34–42) 1.7 (1.4–2.1)† | 34 (29–39) 2.0 (1.7–2.5)† | 24 (21–27) 3.1 (2.5–3.7)† |
aKaplan Meier; bclinical or PSA progression
ACI, anticancer intervention (abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel)
†p < 0.001 (Cox regression model)
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
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 36, 2018 (suppl; abstr 5041)
DOI
10.1200/JCO.2018.36.15_suppl.5041
Abstract #
5041
Poster Bd #
268
Abstract Disclosures
Similar Abstracts
Abstract
2023 ASCO Genitourinary Cancers Symposium
Rucaparib for metastatic castration-resistant prostate cancer (mCRPC): TRITON3 interim overall survival and efficacy of rucaparib vs docetaxel or second-generation androgen pathway inhibitor therapy.
First Author: Alan Haruo Bryce
Abstract
2023 ASCO Annual Meeting
Concurrent chemo-hormonal therapy of enzalutamide (ENZ) and cabazitaxel (CAB) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC): Final analysis of objective response rate (ORR), radiographic progression-free survival (rPFS), and overall survival (OS).
First Author: Alexandra Sokolova
Abstract
2023 ASCO Genitourinary Cancers Symposium
TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
First Author: Neeraj Agarwal
Abstract
2024 ASCO Genitourinary Cancers Symposium
Real-world treatment (Tx) sequences and time to discontinuation (rwTTD) in the first-line (1L) metastatic castration-resistant prostate cancer (mCRPC) setting.
First Author: Emily Nash Smyth