Real-world experience of therapeutic sequencing and time to first anticancer intervention (ACI) following sipuleucel-T (sip-T): Initial data from the PROCEED registry.

Authors

A. Sartor

A. Oliver Sartor

Tulane University School of Medicine, New Orleans, LA

A. Oliver Sartor , Matthew R. Cooperberg , Andrew J. Armstrong , Nicholas J. Vogelzang , Jeffrey L. Vacirca , Mark C. Scholz , Shaker R. Dakhil , Luke T. Nordquist , Elisabeth I. Heath , Nancy N. Chang , Jennifer Susan LIll , Celestia S. Higano

Organizations

Tulane University School of Medicine, New Orleans, LA, University of California, San Francisco, San Francisco, CA, Duke University Medical Center, Duke Cancer Institute Divisions of Medical Oncology and Urology, Duke University, Durham, NC, US Oncology Comprehensive Cancer Centers of Nevada, Las Vegas, NV, North Shore Hematology Oncology Associates, East Setauket, NY, Prostate Oncology Specialists, Marina del Rey, CA, Cancer Center of Kansas, Wichita, KS, Urology Cancer Center and GU Research Network, Omaha, NE, Karmanos Cancer Institute, Wayne State University, Detroit, MI, Dendreon Pharmaceuticals, Inc., Seattle, WA, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA

Research Funding

Pharmaceutical/Biotech Company

Background: Sip-T is an autologous immunotherapy approved for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).Many therapeutic agents have been approved in a short time frame, and their optimal sequencing in mCRPC is under investigation. The sequencing of agents post–sip-T treatment on PROCEED (NCT01306890) and factors associated with a shorter time to first ACI (tACI) are described. Methods: The number of unique and most common sequences and sequence trends were analyzed. Post–sip-T ACIs evaluated were abiraterone (abi), enzalutamide (enz), docetaxel (D), and cabazitaxel (cbz), excluding radium-223 due to its late approval relative to PROCEED initiation. The tACI and factors associated with shorter tACI were assessed. Results: 1902 pts received ≥1 sip-T infusion, and an estimated 37.0% and 21.2%had not received an ACI at 1 and 2 y, respectively, post–sip-T. 1331 (70%) pts received abi, enz, D, or cbz after sip-T. 47 therapy sequences were recorded post–sip-T, with the most used therapies in order of prevalence: abi alone, enz alone, D alone, abi enz, abi D, D enz, and D abi. The most common post–sip-T sequences beginning with abi, enz, or D are below (Table). Only 25 pts received cbz as the first ACI post–sip-T. Pts who received abi prior to sip-T had a shorter median tACI (4.6 mos) compared with all pts (8.3 mos) or pts with D prior to sip-T (7.3 mos). Higher baseline alkaline phosphatase, lower hemoglobin, and prior radical prostatectomy were associated with shorter tACI. Conclusions: In the evolving mCRPC space, 47 unique ACI sequences were recorded post-sip-T. The most common sequences post–sip-T were abi, enz, and D as single agents. Prior abi was associated with a shorter tACI post–sip-T, which warrants longer follow-up. While many pts received subsequent therapy, ~20% had not received an ACI at 2 y post–sip-T. Clinical trial information: NCT01306890

Abi (N = 730)abi aloneabi → enzabi → Dabi → enz → Dabi → D → enz
Pts413120764025
D (N = 340)D aloneD → enzD → abiD → cbzD → abi → enz
Pts12752503214
Enz* (N = 236)enz aloneenz → abienz → Denz → cbzenz → D → cbz
Pts1572525117

*Many pts in PROCEED received their first ACI prior to FDA approval of enz pre-D.

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Abstract Details

Meeting

2016 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer,Prostate Cancer

Sub Track

Prostate Cancer - Advanced Disease

Clinical Trial Registration Number

NCT01306890

Citation

J Clin Oncol 34, 2016 (suppl 2S; abstr 194)

DOI

10.1200/jco.2016.34.2_suppl.194

Abstract #

194

Poster Bd #

H9

Abstract Disclosures