Results of a phase II trial of docetaxel (DOC), bevacizumab (BEV), and androgen deprivation therapy (ADT) for biochemical relapse (BCR) after definitive local therapy for prostate cancer (PC).

Authors

null

Rana R. McKay

Dana-Farber Cancer Institute, Boston, MA

Rana R. McKay , Kathryn P. Gray , Julia H. Hayes , Glenn J. Bubley , Jonathan E. Rosenberg , Philip W. Kantoff , Mary-Ellen Taplin

Organizations

Dana-Farber Cancer Institute, Boston, MA, Beth Israel Deaconess Medical Center, Boston, MA, Memorial Sloan-Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: Despite primary treatment for localized PC, 20-30% of men experience a BCR, detected by a rise in prostate-specific antigen (PSA). Though 30% of these patients develop metastatic disease, the optimal treatment of men with BCR has yet to be determined. In this trial, we evaluate the efficacy of DOC, BEV, and ADT for men with BCR after local therapy for PC. Methods: 41 men with a BCR and PSA doubling time of ≤10 months (mos) were enrolled. Patients received 4 cycles of DOC (75 mg/m2) every 3 weeks, 8 cycles of BEV (15 mg/kg) every 3 weeks, 18 mos of a luteinizing-hormone releasing hormone (LHRH) agonist, and 15 mos of bicalutamide (50 mg daily) beginning after completion of DOC. The primary endpoint was the proportion of patients free from PSA-progression 1 year after completion of ADT. Secondary endpoints included PSA response, testosterone recovery, and toxicity. Results: Median follow-up was 27.6 mos. Median age at diagnosis was 58 years. Median PSA at diagnosis was 6.7 ng/mL, with the majority of patients (59%) having Gleason 7 disease. Most patients underwent radical prostatectomy +/- radiation therapy (n=36). At baseline, 33 men (81%) had a normal testosterone (> 240 ng/dL). The table describes the PSA responses for the entire cohort. 10 men (28%) had a normal testosterone 6 mos after completing ADT. 17 men (47%) had a normal testosterone 12 mos after completing ADT, of whom 5 (29%) had a PSA <0.2 ng/mL at that time. There were 15% grade 1, 34% grade 2, 39% grade 3, and 12% grade 4 adverse events (AEs). The most frequent grade 3-4 AEs included neutropenia (24%), febrile neutropenia (11%), and hypertension (9%). Conclusions: DOC, BEV, and ADT for BCR resulted in complete responses in 16 men (44%) 1 year after completion of therapy. Longer follow-up is needed to determine the efficacy of this regimen. Clinical trial information: NCT00658697.

PSA responses.
Median
PSA
ng/mL
PSA <0.2
ng/mL N
(%)
≥50% PSA
decrease
from baseline
N (%)
≥90% PSA
decrease
from baseline
N (%)
At completion of DOC (n=38) 0.08 28 (73.7) 38 (100) 34 (89.5)
At completion of ADT (n=37) 0.01 37 (100) 37 (100) 36 (97.3)
1 year after completion of ADT (n=36) 0.22 16 (44.4) 34 (94.4) 20 (55.6)

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Abstract Details

Meeting

2014 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Prostate Cancer

Track

Prostate Cancer

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT00658697

Citation

J Clin Oncol 32, 2014 (suppl 4; abstr 54)

DOI

10.1200/jco.2014.32.4_suppl.54

Abstract #

54

Poster Bd #

D10

Abstract Disclosures