Real-world outcomes in first-line treatment of metastatic castration-resistant prostate cancer (mCRPC): The prostate cancer registry.

Authors

null

Simon Chowdhury

Guy's, King's and St. Thomas' Hospitals, London, United Kingdom

Simon Chowdhury , Alison J. Birtle , Anders Bjartell , Luis Costa , Susan Feyerabend , Luca Galli , Ewa Kalinka-Warzocha , Gero Kramer , Nicolaas Lumen , Pablo Maroto , Vsevolod B. Matveev , Thomas Paiss , Salvatore Pisconti , Dominique Spaeth , Laurent Antoni , Edwin Klumper , Robert Wapenaar , Erik Van Den Berg , Emma Lee

Organizations

Guy's, King's and St. Thomas' Hospitals, London, United Kingdom, Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom, Skane University Hospital, Malmo, Sweden, Hospital de Santa Maria and Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal, Studienpraxis Urologie, Nurtingen, Germany, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy, Wojewodzki Szpital Specjalistyczny im Kopernika, Lodz, Poland, Department of Urology, Medical University Vienna, Vienna, Austria, Ghent University Hospital, Ghent, Belgium, Sant Pau Hospital, Barcelona, Spain, NN Blokhin Russian Cancer Research Center, Moscow, Russia, Urologieteam Ulm, Ulm, Germany, Medica Oncology Division S. Giuseppe Moscati Hospital, Taranto, Italy, ORACLE, Centre d'Oncologie de Gentilly, Gentilly, France, Janssen Pharmaceutica NV, Beerse, Belgium, SMS-Oncology BV, Amsterdam, Netherlands, Janssen-Cilag BV, Tilburg, Netherlands, Janssen Pharmaceutica, Beerse, Belgium, EMEA Medical Affairs, Janssen Pharmaceutica, Beerse, Belgium

Research Funding

Pharmaceutical/Biotech Company

Background: The Prostate Cancer Registry is the first prospective, international observational study in mCRPC documenting characteristics and management in routine clinical practice, independent of treatment used. The study began in June 2013 enrolling > 3000 mCRPC patients (pts) followed for ≤ 3 years. Methods: Source-verified data were collected from men with documented mCRPC initiating a new mCRPC treatment or in surveillance. A history of disease progression despite surgical or chemical ADT was confirmed in all pts. This interim analysis reports baseline characteristics, treatments and outcomes in pts with no prior mCRPC treatment. To evaluate comparative effectiveness between treatments, propensity scoring (PS) methods were used to reduce effects of confounding. Results: Of 1906 evaluable pts with ≥ 12-month follow-up, the most commonly initiated first-line mCPRC treatments (n ≥ 50) were abiraterone acetate + prednisone (AA, n = 472), enzalutamide (ENZ, n = 98) or docetaxel (DOC, n = 382). Baseline characteristics, time to progression (TTP) and prostate-specific antigen (PSA) response ( ≥ 50% decrease within 6 months) are shown in the table below. Conclusions: In this real-world study, pts receiving DOC as their first mCRPC treatment had more severe disease at entry and a trend for shorter TTP vs androgen inhibitors. TTP results are consistent with those in randomised clinical trials for AA and ENZ. Clinical trial information: NCT02236637

First-line mCRPC treatmentAA
(n = 472)
ENZ
(n = 98)
DOC
(n = 382)
Baseline characteristic
    Age at enrolment, mean yrs (SD)75.0 (8.3)73.6 (7.7)69.7 (7.7)
    Gleason score at initial diagnosis ≥ 8, n (%)a221 (52.4)46 (49.5)202 (55.0)
    M1 stage at initial diagnosis, n (%)a169 (37.2)33 (34.4)178 (47.3)
    Time from initial diagnosis to CRPC, median yrs (range)3.6 (0-28)3.9 (0-18)2.1 (0-18)
    Bone metastases at enrolment ≥ 5, n (%)a143 (39.5)23 (29.1)124 (43.5)
    Strong opioid use at enrolment, n (%)44 (9.3)7 (7.1)55 (14.4)
TTP, mo (95% CI)11.4 (9.8-12.7)13.8 (9.5-NE)8.3 (7.7-8.8)
PSA response, n (%)n = 425n = 88n = 353
181 (42.6)52 (59.1)174 (49.3)

aData are % pts with measurement/record TTP was longer for AA vs DOC and ENZ vs DOC (PS adjusted p = 0.008 and p = 0.011); no significant difference was seen for AA vs ENZ (p= 0.491)

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Abstract Details

Meeting

2017 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

NCT02236637

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 212)

DOI

10.1200/JCO.2017.35.6_suppl.212

Abstract #

212

Poster Bd #

H14

Abstract Disclosures