Best of ASCO - 2014 Annual Meeting



Attend this session at the
2017 ASCO Annual Meeting!

Session: Plenary Session Including the Science of Oncology Award and Lecture

Type: Plenary Session

Time: Sunday June 4, 1:00 PM to 4:00 PM

Location: Hall B1

LATITUDE: A phase III, double-blind, randomized trial of androgen deprivation therapy with abiraterone acetate plus prednisone or placebos in newly diagnosed high-risk metastatic hormone-naive prostate cancer.

Advanced Disease

Genitourinary (Prostate) Cancer

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr LBA3)

Author(s): Karim Fizazi, Namphuong Tran, Luis Enrique Fein, Nobuaki Matsubara, Alfredo Rodríguez Antolín, Boris Y. Alekseev, Mustafa Ozguroglu, Dingwei Ye, Susan Feyerabend, Andrew Protheroe, Peter De Porre, Thian Kheoh, Youn C. Park, Mary Beth Todd, Kim N. Chi, On Behalf of the LATITUDE Investigators; Gustave Roussy Cancer Campus and University Paris-Sud, Villejuif, France; Janssen Research and Development, LLC, Los Angeles, CA; Instituto de Oncologia de Rosario, Rosario, Argentina; National Cancer Center Hospital East, Chiba, Japan; Hospital Universitario 12 de Octubre, Madrid, Spain; P.A. Herzen Moscow Cancer Research Institute, Moscow, Russia; Istanbul University, Istanbul, Turkey; Fudan University Shanghai Cancer Center, Shanghai, China; Studienpraxis Urologie, Nurtingen, Germany; Churchill Hospital, Oxford, United Kingdom; Janssen Research and Development, LLC, Beerse, Belgium; Janssen Research and Development, LLC, San Diego, CA; Janssen Research and Development, LLC, Raritan, NJ; Janssen Global Services, Raritan, NJ; BC Cancer Agency, Vancouver, BC, Canada

Abstract Disclosures


Background: Pts with newly diagnosed mHNPC, particularly with high-risk characteristics, have a poor prognosis. ADT+docetaxel showed improved outcomes in mHNPC, but many pts are not candidates for docetaxel and may benefit from alternative therapy. AA+P is indicated for metastatic castration-resistant prostate cancer pts. LATITUDE evaluates clinical benefit of early intervention with AA+P added to ADT in newly diagnosed, high-risk mHNPC pts. Methods: 1199 pts with newly diagnosed (≤ 3 mos prior to randomization) mHNPC (ECOG PS 0-2) with ≥ 2 of 3 risk factors (Gleason ≥ 8, ≥ 3 bone lesions, measurable visceral metastases) were randomized 1:1 to ADT+AA (1 g QD) + P (5 mg QD) or ADT+PBOs of AA and P. Co-primary end points were overall survival (OS) and radiographic progression-free survival (rPFS). One rPFS (~565 events), 2 interim, and 1 final OS analyses (~426, ~554, and ~852 events) were planned. Results: At this first interim analysis (median follow-up of 30.4 mos; 406 deaths [48%]; 593 rPFS events), OS, rPFS, and all secondary end points significantly favored ADT+AA+P (Table). The IDMC unanimously recommended unblinding the study and crossing pts to ADT+AA+P. Grade 3/4 adverse events (ADT+AA+P vs ADT+PBOs) (%): hypertension (20.3 vs 10.0); hypokalemia (10.4 vs 1.3); increased ALT (5.5 vs 1.3) or AST (4.4 vs 1.5). Conclusions: Early use of AA+P added to ADT in pts with high-risk mHNPC yielded significantly improved OS, rPFS, and all secondary end points vs ADT+PBOs alone. ADT+AA+P had a favorable risk/benefit ratio and supports early intervention with AA+P in newly diagnosed, high-risk mHNPC. Clinical trial information: NCT01715285

ADT+ AA+P (n=597)ADT+ PBOs (n=602)HR (95% CI)p value
(median, mos)
Co-primary end points
OSNR34.70.62 (0.51-0.76)< 0.0001
rPFS33.014.80.47 (0.39-0.55)
Secondary end points
Time to:
Pain progressionNR16.60.70 (0.58-0.83)< 0.0001
PSA progression33.27.40.30 (0.26-0.35)
Symptomatic skeletal-related eventNRNR0.70 (0.54-0.92)0.0086
ChemotherapyNR38.90.44 (0.35-0.56)< 0.0001
Subsequent PC therapyNR21.60.42 (0.35-0.50)

NR, not reached.

Other Abstracts in this Sub-Category:


1. Abiraterone + prednisone (Abi) +/- veliparib (Vel) for patients (pts) with metastatic castration-resistant prostate cancer (CRPC): NCI 9012 updated clinical and genomics data.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5001 First Author: Maha Hussain
Category: Genitourinary (Prostate) Cancer - Advanced Disease


2. A randomized phase II cross-over study of abiraterone + prednisone (ABI) vs enzalutamide (ENZ) for patients (pts) with metastatic, castration-resistant prostate cancer (mCRPC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 5002 First Author: Kim N. Chi
Category: Genitourinary (Prostate) Cancer - Advanced Disease


3. Adding abiraterone for men with high-risk prostate cancer (PCa) starting long-term androgen deprivation therapy (ADT): Survival results from STAMPEDE (NCT00268476).

Meeting: 2017 ASCO Annual Meeting Abstract No: LBA5003 First Author: Nicholas D. James
Category: Genitourinary (Prostate) Cancer - Advanced Disease