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Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial.

Publication ,  Conference
Graff, JN; Baciarello, G; Armstrong, AJ; Higano, CS; Iversen, P; Forer, D; Mansbach, HH; Phung, D; Tombal, BF; Beer, TM; Sternberg, CN
Published in: Journal of Clinical Oncology
March 1, 2015

200 Background: In the phase 3 PREVAIL trial, enzalutamide (ENZA), an androgen receptor inhibitor, improved overall survival (OS) and radiographic progression-free survival (rPFS) relative to placebo (PBO) in chemotherapy-naïve men with mCRPC. Methods: PREVAIL randomized 1,717 patients (pts) with asymptomatic or minimally symptomatic chemotherapy-naïve mCRPC 1:1 to ENZA 160 mg daily or PBO. Coprimary endpoints were OS and rPFS. This prespecified analysis evaluated the impact of age (≥ 75 vs < 75 years) on efficacy and safety. Results: In PREVAIL, 609 (35%) pts were aged ≥ 75 years. This older subset had several poorer baseline prognostics relative to those aged < 75 years: worse ECOG performance status (ECOG 1: 45.0% vs 24.7%), higher prostate-specific antigen (PSA; 73.3 vs 37.3 ng/mL) and more cardiovascular disease (26.9% vs 16.5%). In both older and younger pts, ENZA improved OS, rPFS and time to PSA progression (Table). Pts aged ≥ 75 years in both the ENZA and PBO groups combined had a higher rate of grade ≥ 3 adverse events (46% vs 37% in younger pts) and among enzalutamide-treated men more older pts reported falls (any grade; ENZA 19% and PBO 8%) than younger pts (ENZA 7% and PBO 4%). Fewer pts ≥ 75 years received subsequent antineoplastic therapies. Conclusions: In PREVAIL, efficacy outcomes in elderly (≥ 75 years) and younger (< 75 years) pts with chemotherapy-naïve mCRPC were comparable and pts consistently benefited from ENZA treatment. Safety with ENZA was similar in both age groups, although older pts reported a higher incidence of falls and received fewer subsequent antineoplastic therapies. Clinical trial information: NCT01212991. [Table: see text]

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2015

Volume

33

Issue

7_suppl

Start / End Page

200 / 200

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Graff, J. N., Baciarello, G., Armstrong, A. J., Higano, C. S., Iversen, P., Forer, D., … Sternberg, C. N. (2015). Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial. In Journal of Clinical Oncology (Vol. 33, pp. 200–200). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2015.33.7_suppl.200
Graff, Julie Nicole, Giulia Baciarello, Andrew J. Armstrong, Celestia S. Higano, Peter Iversen, David Forer, Harry H. Mansbach, et al. “Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial.” In Journal of Clinical Oncology, 33:200–200. American Society of Clinical Oncology (ASCO), 2015. https://doi.org/10.1200/jco.2015.33.7_suppl.200.
Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Forer D, et al. Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. 200–200.
Graff, Julie Nicole, et al. “Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial.Journal of Clinical Oncology, vol. 33, no. 7_suppl, American Society of Clinical Oncology (ASCO), 2015, pp. 200–200. Crossref, doi:10.1200/jco.2015.33.7_suppl.200.
Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Forer D, Mansbach HH, Phung D, Tombal BF, Beer TM, Sternberg CN. Clinical outcomes and safety in men ≥ 75 and < 75 years with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in the phase 3 PREVAIL trial. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. 200–200.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2015

Volume

33

Issue

7_suppl

Start / End Page

200 / 200

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences